Comments

Waitlist Zero | 03/22/2024

Waitlist Zero supports this change.

UC San Diego Health Center for Transplantation | 03/20/2024

UCSD Center for Transplantation (CASD) appreciates the effort the Ad Hoc Multi-Organ Transplantation Committee put forward Concepts for Modifying Multi-Organ Policies as well as the opportunity to provide feedback.

While we generally support the Committee's aims to improve equity and efficiency for multiorgan candidates, it is critical to note the in-flux of multi-organ transplants in recent years, creating a supply issue in an already limited area. We believe that finding a balance between severity of illness and accrued waiting time will be crucial to this as we cannot disadvantaged those in need of a single organ (generally kidney) simply because they have additionally functioning organs and the option of dialysis. Perhaps creating a threshold for multi-organ offers (above a certain heart or lung status or MELD score) would increase fairness?

Further, we generally support the concept of requiring one kidney go to a kidney-alone candidate if the other kidney is placed with a multi-organ candidate; the team was however unable to reach consensus on whether kidney-pancreas candidates should or should NOT be prioritized with kidney-alone candidates. We appreciate the Committee's continued work in this area.

Infinite Legacy | 03/19/2024

Infinite Legacy is pleased provide the following comments, which emphasize time constraint situations, late declines, and high volume of pancreata from Kidney-pancreas (KPs) that are declined in the OR. There should be criteria for required shares for MOT; however, time constraints and late declines will impact either primary kidney offer patients or MOT patients. KP should not be considered for MOT priority; there is not a consistent monitoring plan for transplant centers that accept a KP and decline the pancreas when the organs arrive at the center. This happens more frequently in KP rather than heart/kidney and liver/kidney. The Ad Hoc Multi Organ Committee should consider standardization in virtual crossmatch practices. A policy that prioritizes which patients are eligible for required shares could add efficiency to allocation. Defining late declines and monitoring late declines would benefit the community; clinical urgency in the allocation and donor characteristics impact the incidence of out of sequence allocation as it relates to MOT on the match run.

Anonymous | 03/19/2024

Currently, heart/livers and lung/livers take priority over status 1 liver patients. OPTN leaves the decision ultimately to the OPO as to whether to allocate the liver to the status 1 candidate vs the dual organ patient. Given that the short-term waitlist mortality for a status 1 liver patient is most certainly higher, may the committee please review this policy?

International Society for Heart and Lung Transplantation | 03/19/2024

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Mid-America Transplant | 03/19/2024

Mid-America Transplant (MT) appreciates the opportunity to provide feedback to the OPTN regarding Multi-Organ (MOT) Allocation. As a high-performing organ procurement organization (OPO), MT is committed to its mission of saving lives through excellence in organ and tissue donation, and we are grateful for OPTN’s efforts to improve efficiency in the organ transplant system.

MT believes that, when both kidneys are available from a donor with a KDPI between 0-34 percent, one kidney should be allocated to MOT (including kidney-pancreas/KP), as pancreas transplants almost always occur with a kidney transplant as well. Therefore, to promote pancreas transplants, it is important to prioritize KPs.

The current policy prioritizes all kidneys to multi-organ recipients, but this is disadvantageous to single-organ recipients.

When there is only one kidney available, MT advocates for an allocation system that prioritizes kidney-pancreas transplants first, as it increases overall organs transplanted.

MT does not believe that certain policies should be left to OPO discretion. The allocation system should be written in such a way that it maximizes organ utilization; one example being the prioritization of KPs.

Organ allocation is not complete until the organ is actually transplanted into its intended recipient; therefore, the system up to that point is a moving target. The more complex a policy is around allocation, the more opportunity there is for inefficiency and lives lost.

OPTN Transplant Administrators Committee | 03/19/2024

The OPTN Transplant Administrators Committee appreciates the opportunity to comment on the OPTN Multi-Organ Transplantation Committee’s concept paper Concepts for Modifying Multi-Organ Policies. The Committee acknowledges the importance of developing comprehensive and equitable multi-organ allocation policy, however, feels that at this time, the populations referenced in the paper are not as negatively impacted as perceived. Members of the Committee agree that providing adequate organ access for pediatrics is important to be maintained, specifically for the low Kidney Donor Profile Index (KDPI) kidneys.

Region 10 | 03/19/2024

Overall, members of the region were appreciative of the chance to provide early feedback as the committee works towards a potential policy proposal. The discussions reflected a comprehensive exploration of the complexities and considerations in multi-organ transplantation policies, touching on equity, patient prioritization, and the need for standardized procedures. One attendee expressed contentment with the existing data which does not seem to be significant issues. The Simultaneous Liver Kidney (SLK) policy was noted, and there was a call for MOT-specific policies across all organs. Attendees touched on the exclusion of privileged groups, such as pediatric patients and those with high CPRA. Suggestions were made to consider including certain groups, like high CPRA kidney-pancreas (KP) candidates and heart-kidney candidates. Many attendees agreed with prioritizing candidates with 100% CPRA, contingent on the availability of crossmatching. Concerns were raised about the lack of a standardized acuity score across organs. A suggestion emerged to categorize KP candidates as kidney candidates who also need a pancreas, emphasizing the need for clarity in distinguishing between different patient groups. Next, concerns were raised about the current system disadvantaging pediatric kidney candidates, leading to prolonged wait times for kidney offers. Suggestions included having at least one kidney allocated to a kidney-alone recipient and adjusting the allocation policies for pediatric donors and recipients. Participants called for clarification and standardization of multi-organ allocation policies. The idea of giving greater priority to specific groups, such as pediatric, high CPRA, medically urgent, and former living donors, was discussed. Some participants advocated for a system allowing simultaneous allocation of heart, lung, and liver from one match run to streamline the process and reduce delays in organ placement. The importance of addressing issues related to required shares and the timing of allocations was highlighted. Concerns were raised about the unequal distribution of kidneys based on KDPI, particularly affecting pediatric patients. Suggestions included offering kidneys to kidney-only patients when both kidneys are available and implementing criteria based on KDPI for MOT allocation. For example, donors with a KDPI less than 35% should be offered first to kidney alone candidates, specifically pediatric candidates, and donors with a KDPI greater than 35% could be offered to MOT candidates first.

American Nephrology Nurses Association | 03/19/2024

ANNA recommends consideration of placing multi-organ transplants in the A/B/C/D Sequence Grid currently used in kidney allocation, and potentially considering kidney-pancreas as one organ. We strongly support a kidney-only candidate to be considered for one kidney when both kidneys are being offered. We agree that clear and concise policies are needed, though we respectfully request you consider not “disadvantaging” kidney-only patients any more than they already are.  

Region 9 | 03/19/2024

An attendee commented that status five heart/kidney candidates are really not getting transplanted, so they would support allocating one kidney to a multi-organ candidate and one to a kidney alone candidate. A member requested that the committee also review heart/liver and lung/liver allocation, as these are currently taking priority over status 1 liver patients, and that the decision is ultimately left to the OPO to decide whether to allocate the liver to the status 1 patient or the multi-organ patient. One attendee requested more transparency in the workflow for multi-organ allocation. Another member asked that OPOs be given more direction in multi-organ allocation. An attendee supported including outcomes in determining multi-organ allocation in the future. 

OPTN Transplant Coordinators Committee | 03/19/2024

The Transplant Coordinators Committee appreciates the opportunity to provide input on the OPTN Ad Hoc Multi-Organ Transplantation Committee public comment proposal and provides the following comments for consideration:

The Committee suggests developing a single integrated list displaying all MOT candidates across regions, including their status and rankings, to simplify real-time decision-making.

The Committee recognizes that technology and system enhancements would be necessary following any policy decisions and frameworks developed for the MOT allocation process. The Committee emphasizes the importance of ensuring that the necessary technological infrastructure is in place to support the implementation of any proposed changes.

Region 6 | 03/19/2024

Several attendees commented that kidney-pancreas (KP) candidates should be considered as kidney candidates. One added that most pancreas are allocated with kidneys, and they shouldn't compete with multi-organ transplant (MOT) combinations that aren't always transplanted together. They went on to comment that this would help to avoid scenarios where the pancreas remains unused, potentially increasing non-utilization rates. Another attendee recommended adding non-use to the metrics. One attendee supported limiting multi-organ placement to one kidney per donor and establishing a specific time point prior to going to the operating room, to finalize isolated kidney offers. They added that pediatric candidates are often affected by delayed offers of ideal, low KDPI (Kidney Donor Profile Index) kidneys due to OPOs delaying placement to accommodate backup multi-organ candidates on match runs. This delay increases the risk of ischemia time for kidney recipients unnecessarily. They also recommended implementing a metric to monitor the non-utilization of KDPI 1-34% kidneys. One attendee supported pediatric priority above MOT.  

Patrick Almond | 03/19/2024

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UW Health Organ and Tissue Donation | 03/18/2024

As an OPO, we support any process that maximizes the gifts made available by donors. This being said we are aware that it is very challenging to place a pancreas unless a kidney is also available since the vast majority of pancreas transplants occur as a simultaneous kidney pancreas transplant. We would support separating the pancreas waitlist from the MOT waitlisted patients to maximize the donor’s gift in every instance. Guidance on how to allocate kidneys when there are only two (or one) kidneys available and the “top 3 patients” all require a kidney would be welcomed from an OPO perspective.

OPTN Kidney Transplantation Committee | 03/18/2024

The Kidney Committee (the Committee) thanks the OPTN Multi-Organ Transplantation Committee for their efforts on this request for feedback. The Committee provides the following feedback for consideration.  

One member acknowledged that while it makes sense that multi-organ recipients have greater access to low KDPI kidneys due to the clinical requirements of thoracic and liver donors, this still raises questions regarding equity in access.  

A member noted that the data provided may assuage some concerns in the kidney community that kidney patients may be disadvantaged by the increase in multi-organ allocation, particularly regarding the relative rarity of donors where both kidneys are allocated as part of multi-organ combinations.  

The Committee agreed that kidney-pancreas candidates should not be considered multi-organ candidates, and instead could be considered kidney candidates, given they are required to meet the same qualification requirements in order to accrue waiting time points in allocation. One member noted that it is rare for a pancreas to be transplanted alone. The member added that the best way to increase utilization of pancreata is to allocate the kidney with the pancreas as well.  

One member shared that it is not uncommon for multi-organ programs in their area to accept and later turn down kidneys without a clear reason, and that this results in late offers to kidney-alone candidates, and delays programs from preparing patients and transplanting these organs. The member expressed support for pediatric kidney-alone candidates receiving some priority over multi-organ adult candidates, noting that there is no metric to compare the benefit a pediatric recipient receives from transplant compared to an adult recipient, particularly in considering life experiences, development, and opportunity to thrive and grow. The member explained that pediatric candidates have high morbidity and mortality on dialysis compared to their peers, but that this difference is significantly reduced when these patients receive transplants.  

OPTN Pancreas Transplantation Committee | 03/18/2024

The OPTN Pancreas Transplantation Committee thanks the OPTN Ad Hoc Multi-Organ Transplantation Committee for their efforts on the Concepts for Modifying Multi-Organ Policies request for feedback. The Committee provides the following feedback for consideration:

• The Committee recommends that the unique needs for pancreas transplantation, such as donor organ quality, factor into utilization discussions.
• The Committee agrees with maintaining Kidney-Pancreas (KP) candidates within the Kidney candidate pool rather than categorizing them separately with other multi-organ transplants. It was noted that there is still a need to prioritize simultaneous pancreas-kidney due to the potential increase in pancreas non-use if they are not appropriately prioritized, as most pancreata are transplanted with kidney.
• The Committee discussed the need to prioritize medically urgency pancreas/KP patients; the Committee’s current work of identifying/defining medical urgency criteria could be of benefit to these efforts.
• The Committee suggests careful consideration to ensure pediatric kidney candidates maintain appropriate access to high-quality kidney offers, such as those with a low Kidney Donor Profile Index (KDPI).
• It was highlighted that logistical challenges exist at the organ procurement organization (OPO) level, where prolonged holds on kidneys pending placement of other organ types can compromise kidney and pancreas quality.

The Committee appreciates the opportunity to provide their feedback on this project and looks forward to the further development and enhancement of equitable allocation practices for multi-organ transplantation to increase utilization.

Region 7 | 03/18/2024

The discussion revolved around the classification of kidney-pancreas (KP) transplants as multi-organ transplants (MOT) and its potential impact on organ allocation and utilization. Several participants expressed concerns that categorizing KP transplants as MOT could diminish access to pancreas transplantation and lead to decreased utilization of pancreata from donors. Arguments were made for treating KP transplants as single organs with kidney-only status to ensure that pancreas utilization is maximized. Participants highlighted the complexities involved in organ allocation, especially when considering the needs of different patient groups and the limitations of current allocation systems. There was consensus that while some priority may be warranted for MOTs, there should be careful consideration to avoid disadvantaging certain patient populations or hindering organ allocation efficiency. If the OPTN develops strict allocation policy for MOT candidates, given the relatively small number of MOT transplants, could negatively impact overall allocation efficiency. Suggestions were made for a universal match system across all organs that prioritizes the most medically urgent patients for organ allocation, regardless of transplant type. Overall, there's a shared sentiment against including KP transplants in MOT groups, with concerns centered around potential negative implications for pancreas utilization and transplantation rates in the United States.

Region 1 | 03/18/2024

A member noted that pancreas alone candidates were missing from the presentation. An attendee commented that we should consider post-transplant survival when considering how to allocated kidneys and that because kidney post-transplant survival is so high, high KDPI kidneys should be going to single-organ transplants. Another member commented that the safety net policy has provided options for patients and that sometimes when a candidate receives a good heart transplant, they do not need the kidney or can wait a bit longer. The member added they support additional review of the data to help drive this policy. Another attendee agreed that whatever decision is made should be data-driven. A member stated their support for one kidney being allocated to hard to match candidates, like those with blood type B or a high PRA. An attendee expressed concern that multi-organ candidates have too much priority and there is not enough oversight over these transplants. Several members shared they do not believe that kidney-pancreas candidates should be grouped with multi-organ candidates because they are driven by the need for the kidney.

UPenn | 03/18/2024

The Hospital of the University of Pennsylvania thanks the OPTN Ad Hoc Multi-Organ Transplantation Committee for their efforts on this initiative and offers the following comments for consideration in response to the request for feedback:

Should kidney-pancreas (KP) candidates be considered multi-organ candidates?
No. A KP candidate is a kidney candidate who needs a pancreas.

When both kidneys are available from a donor with a Kidney Donor Profile Index (KDPI) between 0-34 percent:
Should one kidney be allocated to an MOT candidate (including KP), and the second kidney allocated to a kidney alone candidate?
Not if the MOT candidate is a SHK or SLK and a kidney alone. KP candidates are kidney candidates.

Should one kidney be allocated to an MOT candidate, and the second kidney to either a KP candidate or kidney alone candidate?
Yes, but only if there is not a compelling reason not to have the MOT simply receive a kidney through the safety net process. Many MOT candidates have sufficient renal function and don't require a kidney after extra-renal transplant.

What are the potential impacts to KP and pediatric candidates?
Pediatric programs are very conservative and have a smaller list. We favor offering these kidneys after the KP list has been exhausted.

How should MOT candidates be prioritized when there is only one kidney available?
Kidney Pancreas candidates need priority ahead of kidney alone candidates otherwise pancreas transplants will become obsolete as the available donor quality for pancreas transplantation would become drastically limited. KP is therefore not appropriate to consider a part of MOT. KP patients are kidney patients who happen to need a pancreas as opposed to other "traditional" MOT patients where survival is driven by the non-kidney organ. In terms of MOT (heart, lung, liver), deceased donor kidneys should be allocated in a data driven manner. The current data shows a significantly higher risk of death and kidney graft failure in MOT recipients vs. kidney only transplants. (PMID:37379084)

MOT should be prioritized below kidney alone and only after more stringent kidney listing criteria for MOT are created and after transplant center performance metrics include MOT outcomes. It seems reasonable to rely on safety-net kidney allocation for MOT, especially given the frequency of primary non-function in thoracic MOT recipients.

OPTN Liver & Intestinal Organ Transplantation Committee | 03/18/2024

The OPTN Liver & Intestinal Organ Transplantation Committee thanks the OPTN Ad Hoc Multi Organ Transplantation Committee for their efforts on the Concepts for Modifying Multi-Organ Policies paper.

The Committee is encouraged by the data presented with this proposal. They believe that the data showing the number of kidney-alone compared to multi-organ transplants seem fair and as such is in favor of the current allocation remaining the same. The Committee proposes that a potential compromise may entail 0-34% KDPI kidneys being reserved for kidney-alone candidates and higher KDPI (e.g. 40-70%) kidneys being utilized for liver-kidney and other multi-organ combinations.

The Committee recommends that kidney-pancreas transplants should not be categorized as multi-organ combinations. Some members note that if kidney-pancreas were to be classified as multi-organ combinations that it would have unintended consequences on organ procurement organizations’ metrics. Additional members caution the OPTN Ad Hoc Multi Organ Transplantation Committee from making decisions that could potentially disadvantage the pancreas transplant programs as it is challenging to receive quality offers.

The Committee recommends that the OPTN Ad Hoc Multi Organ Transplantation Committee could revisit the criteria for simultaneous liver-kidney transplants.

Region 5 | 03/15/2024

Region 5 supported this concept paper and offered the following feedback. There was a lot of support for allocating one kidney to a multi-organ (MOT) candidate and the other kidney to a kidney-alone candidate. There was differing opinion on whether a kidney-pancreas candidate should be categorized as an MOT candidate. A member commented that it will be disadvantageous for kidney-pancreas candidates to be included amongst the MOT candidate pool, since pancreas donors are rare and for someone to be a pancreas donor there will have to have a low KDPI, and heart, liver, etc. candidates may not need a low KDPI kidney. For each donor, at least one kidney should be allocated to kidney-alone candidates and potentially both kidneys for the difficult to transplant candidates: pediatric, high PRA, previous living donor.  

Another attendee commented that pediatric patients only receive offers from 0-34% donors, it’s a limited donor pool, and in their experience the low KDPI kidneys go to MOTs instead of pediatric candidates. Several members and a small pediatric center commented that they are heavily impacted by MOT's and support policy change in this area. They support one kidney being allocated to a MOT candidates (including kidney-pancreas candidates) and one kidney being allocated to kidney-alone list. They explained that they need the kidney's with KDPI 0-34%, which limits their pool, and if those kidneys are always allocated to MOT candidates, then it would be a significant disservice to their small patient population and extends dialysis time which in turn increases morbidity and mortality. A member supported the pediatric, prior living donor, and high PRA to be before the MOT in the allocation sequence.  

An attendee suggested that the Committee consider if the kidney alone patients should take priority on the list. They support a proposal that states which high priority kidney alone candidates should receive priority over MOT candidates, includes policy allocation order, and that kidney-pancreas should be considered a MOT transplant.  

An attendee commented that kidney-pancreas patients more aligned with kidney alone patients (no one would accept kidney alone for heart/kidney but would consider kidney alone for a kidney-pancreas candidate), while another attendee disagreed with this comment.  

A member explained that kidney-pancreas allocation needs to be further discussed since technically it is a MOT allocation but more like kidney allocation. They noted that the wait time benefit of kidney-pancreas allocation would be diminished if not considered MOT. And requested survival date related to wait time for each of the MOT recipients to make final allocation and policy decisions. 

A member supported one kidney going to the MOT candidates and one kidney to the kidney-alone candidate, and when there is an individual heart candidate at the top of the list (i.e. status 1), then the two kidneys should go to single organ candidates.  

Another attendee commented how challenging this area of policy is, and that in their individual practice area, there isn’t enough broad experience since they are only familiar with their own patient populations, which makes it difficult to make policy decisions. They suggested the committee investigate mortality data on MOT patients and provide this data in future policy proposals.  

A member suggested creating a waitlist for the following MOT combinations: lung/kidney, heart/kidney and liver/kidney candidates. An attendee suggested that the committee create an allocation order for MOT candidates based on medical urgency, mortality on wait list, and post-transplant survival benefit. And should also include the same factors for kidney alone. So, for example, a highly sensitized who is also medically urgent kidney alone candidate should be placed higher than kidney-pancreas candidate. A member commented that allocation of a kidney going to the kidney MOT candidate will be driven by heart, liver, or the lung list. With regards to which kidney MOT candidates (heart versus liver versus lung) should be prioritized in the allocation of the kidney, the order should be based on pre-transplant mortality risk. From an OPO perspective, an attendee commented that these concepts could increase the number of times OPOs need to make allocation decisions for MOT candidates. 

American Society of Transplantation | 03/15/2024

The American Society of Transplantation (AST) offers the following comments in response to the request for feedback, “Concepts for Modifying Multi-Organ Policies:”

•The AST supports the concept that policy should direct the order in which OPOs allocate organs. There should not be a geographic discrepancy arbitrarily introduced by OPOs for organ allocation, especially as broader sharing is implemented. OPOs will continue to struggle with simultaneous lists to guide allocation until all organs are allocated using continuous distribution systems and there are single, integrated match runs for each donor.

•To help address the waitlist mortality of multi-organ transplant (MOT) candidates, when two donor kidneys are available for transplant, the AST supports allocating one kidney to an MOT potential transplant recipient and the other kidney to a kidney transplant alone (KTA) or simultaneous pancreas kidney (SPK) potential transplant recipient. When only one donor kidney is available, the AST recommends prioritizing MOT candidates but consider establishing standard criteria for prioritization of certain KTA candidates before MOT candidates. Considerations for KTA prioritization should include pediatric patients, highly sensitized patients, medically urgent patients with exhausted access options, and previous living donors.

•The AST supports a policy that allocates at least one kidney from 0-34 KDPI donors to a pediatric recipient unless a competing adult MOT candidate meets predefined urgency criteria.

•The AST recommends more expansive safety net policies in future iterations in concert with development of other strategies to help with allocation of low-KDPI kidneys to KTA candidates. Data analysis of outcomes should drive further decisions on kidney allocation to MOT and KTA candidates.

Association of Organ Procurement Organizations | 03/14/2024

AOPO appreciates the goal to revise the multi-organ allocation policies to improve equity in access to transplants for kidney-alone candidates and kidney multi-organ candidates. Policy needs to provide clarity and direction to OPOs on the allocation of organs. This lack of clarity can cause confusion and delays for OPOs, transplant centers, and waiting recipients. To this end, direction on when to make primary offers on the kidney match run is warranted.

AOPO supports the prioritization list offered in the proposal, which is as follows:

• Pediatric candidates

• High CPRA candidates

• Medically urgent kidney-alone candidates

• Prior living donors

• Kidney-Pancreas candidates

We support the prioritization of kidney-pancreas candidates along with kidney-alone candidates. The rarity with which a patient receives a pancreas transplant alone puts these pancreas-only patients at a disadvantage. 

OPTN Heart Transplantation Committee | 03/14/2024

The OPTN Heart Transplantation Committee (Committee) thanks the Ad Hoc Multi-Organ Transplantation (MOT) Committee for presenting their request for feedback document, Concepts for Modifying Multi-Organ Policies during the Committee’s February 20, 2024 meeting. The Committee members appreciated the MOT Committee’s efforts to collect public feedback regarding whether policy should direct the order in which OPOs allocate organs, especially transplants involving kidney-alone and kidney-pancreas candidates. Two members discussed the proposal’s request for feedback questions in terms of lifesaving transplants versus non-lifesaving transplants, and that kidney-pancreas transplants are not lifesaving in the way a high-status heart-kidney transplant is. As such, kidney-pancreas transplants should not be prioritized ahead of other multi-organ transplants, and should instead be considered along with kidney-alone transplants. It was pointed out that safety net policy exists by which a heart recipient who also needs a kidney gets priority for a kidney under certain conditions. The group was asked if the pathway to obtaining a heart and a kidney transplant provided by the safety net policy is adequate enough to meet the needs of heart-kidney candidates. The Committee members responded it does not. Two Heart Committee members pointed out that published data exists showing that heart transplant recipients who require dialysis postoperatively are at the greater risk of mortality in the first three months after transplant. Because heart transplant recipients are likely to still be recovering three months post-transplant, they are not great candidates for use of the heart-kidney safety net established in OPTN policy. A member asked that the MOT Committee consider a pathway by which the adult heart candidates at highest daily risk of mortality (currently status 1 candidates), can be prioritized to receive the second kidney from a heart and kidney donor even after one kidney has already been allocated to an MOT candidate.

Luke Preczewski | 03/12/2024

Some of this appears to be a solution in search of a problem. For instance, the proposal to require one of the two kidneys to go to a kidney-alone recipient is already happening virtually all of the time. The data provide absolutely no reason to change policy there. I have no problem with a formal way to prioritize order of allocation if OPOs believe the current silence in policy puts them in a difficult position. Otherwise, the policies that set appropriate criteria with safety net for when a kidney is needed appear to be working. Let's stick with and refine those as needed. Otherwise, let's not make changes that don't solve any actual problem.

I have heard the argument about pediatric recipients. Since recent allocation changes, pediatric recipients are finally being transplanted with the appropriate urgency. Five years ago, I would have supported a fix. At this point, that part of the system appears to be working.

I am an employee of an OPTN member, but my comments are submitted on behalf of myself as a transplant professional, not on behalf of my employer nor any other organization.

Region 3 | 03/11/2024

Members in the region offered several suggestions for the committee to consider as they address this very important issue. One attendee speaking from an OPO perspective recommended flexibility in a policy that prioritizes multi-organ allocation so that OPOs are able to maximize organ utilization. Several attendees supported kidney/pancreas as a multi-organ transplant. They added that the utilization and outcomes for pancreas is highest when transplanted with a kidney. One added that multi-organ for liver/kidney and heart/kidney should be ranked based on the highest risk of death on the waiting list.  Other attendees supported treating the kidney/pancreas candidates similarly to kidney candidates. One added that kidney/pancreas should not be prioritized ahead of pediatric candidates. Another attendee commented that organ availability for actively wait-listed kidney candidates has improved markedly. They added that trying to divide organs between multi-organ candidates and kidney alone candidates when allocating kidneys from KDPI<35 donors could be problematic for many of the high-mortality, high urgency heart/kidney, liver/kidney, kidney/pancreas recipients. Another attendee commented that kidneys should be prioritized to multi-organ candidates who have high risk of pre-transplant mortality. 

American Society for Histocompatibility and Immunogenetics (ASHI) | 03/09/2024

This proposal is not pertinent to ASHI or its members.

OPTN Operations and Safety Committee | 03/07/2024

The Operations and Safety Committee thanks the OPTN Ad Hoc Multi-Organ Transplantation (MOT) Committee for their efforts on the Concepts for Modifying Multi-Organ Policies request for feedback. The Committee acknowledges the complexity of this topic and appreciate the concepts presented and the opportunity to provide the following questions and feedback for consideration.

The Committee noted that with the challenges OPOs have with multi-organ transplantation (MOT) currently, there is hesitation in making any changes. The Committee noted that the struggle for OPOs is having time constraints and needing to get through the heart-liver or lung-liver before the liver can be primary. The challenge is that policy requires the MOT offers be made before the single organ offers; the time constraints related to this make this process complicated and challenging and can ultimately result in non-use of organs.

In response to the concept of offering one kidney to the kidney list and the other kidney as an MOT offer, the Committee suggested consideration in prioritizing status 1A liver recipients. If, for example, you have a heart-kidney, and the OPO is supposed to allocate out a single kidney offer, but there is a status 1A liver that also needs a kidney, there needs to be some clinical urgency for the thoracic and liver organs.

The Committee noted considerations on testing that may be needed and the availability of testing during a particular time of day can vary. If there is an allocation issue that needs a certain test result that may not be available for 12 hours, there is a potential for non-use of an organ. The Committee advised that there would need to be policy in place that would prioritize which MOT would receive a kidney designated for the MOT. The decision making would ultimately come back to the OPO and noted that there would need to be considerations related to kidney-pancreas and pediatric patients as well. It was suggested that there may be a need that one organ is prioritized and that there are statuses assigned within that organ that would need to be considered for allocation.

The Committee reiterated that it should be stressed moving forward that if there are firm time constraints and set operating room (OR) times, then OPOs need to bypass the policy and offer organs to the programs. The member provided an example: this may be complex such as if there is a heart-kidney at sequence 2 and lung-kidney at sequence 4 and a liver-kidney at sequence 10. If an OPO thinks there is a heart-kidney at sequence 2 and it is then declined, the reallocation efforts this may initiate could add complexity from an OPO perspective. It could be difficult to manage if there is only one kidney available for the multi-organ.

The Committee discussed physical cross-matches and noted that typically blood is needed, and asked if the OPO should be expected to wait for that to come back to release the other kidney. It was suggested that as a community, virtual crossmatch be considered as standard practice.

The Committee agrees that the allocation system currently is complicated and with last minute declines and reallocations, the process needs to be made easier by developing a solution that could help streamline rather than add more steps to the process.

Region 8 | 03/05/2024

Region 8 provided constructive feedback for this concept paper. An attendee supported offering the second KDPI < 34 kidney to the isolated kidney list if the first is allocated to a multi-organ or kidney-pancreas candidate. Another attendee commented that the Final Rule may favor the multi-organ candidate to maximize the number of organs transplanted, especially for kidney-pancreas since there are few pancreas-alone transplants. However, there would be kidney-alone recipients that are disadvantaged. The attendee suggested limiting allocating one kidney to the multi-organ candidate, and the other to the kidney-alone candidate in order to balance both interests. They suggested the committee do their best to make a transparent and clear policy, enforce it, study it for unintended consequences, then modify it, if needed. An attendee recommended that one kidney be allocated to a multi-organ candidate, then to a kidney-pancreas candidate, since multi-organ transplant is better for recipients at the time of the OPO allocation process. The attendee then explained that often a pancreas is declined in the operating room after the surgeon physically sees the pancreas. And if that occurs then the kidney should be allocated on the kidney-alone list. Another attendee said that the transplant hospital should not be allowed to rescind the acceptance because this could create more late turn downs. A member asked if it would be more appropriate for multiple organ offers to be run through the kidney-only list. A member pointed out that kidney-pancreas transplants should be considered a multi-organ transplant since there are two organs. An attendee inquired if there should be acknowledgment of the OPO making a second attempt. The member also suggested notifying both contacts at the same time. 

Amy Becker | 03/02/2024

Only one kidney should be offered to MOT candidates with the second kidney offered to a kidney-only candidate. KP should not count as a MOT.

Anonymous | 03/01/2024

It is VERY important to recognize that EVERY SPK/KP candidate could be downgraded to a kidney alone candidate. This is NOT true for heart-kidney, lung-kidney, or even liver-kidney where patients with short-term renal dysfunction are listed. EVERY KP/SPK candidate has underlying TRUE renal failure the same as every other kidney-alone candidate. Thus KP/SPK allocation should take priority over multi-organ allocation where there is a chance that organs may recover or in patients where GFR is still >20 when listed. SPK kidneys do not take kidneys from the kidney alone list.
Furthermore, pancreata of good quality are RARE and kidneys have THE LONGEST waiting list and waiting time compared to all other organs. Fueling increased multi-organ transplants by giving perfectly healthy kidneys to recipients who have low anticipated patient survival contributes to lower long-term kidney outcomes for patients who could easily live 30-40 years - if only they could ever find a high quality donor kidney (this is increasingly rare due to multiorgan transplants). Thus, excellent donor kidneys should also be preserved for the kidney-only list - especially pediatric patients.
For an ideal all-organ donor, likely a solution would be to offer 1 kidney to a peds candidate, and if there is no peds kidney-only candidate, then to offer it as a multi-organ kidney. The other kidney should go with the SPK. If there is no SPK candidate locally (250NM), then it should go to the kidney list, then multiorgan. Multiorgan candidates can show up on the kidney list in the place they would rank and through this qualify for a heart-kidney or lung-kidney or liver-kidney and then this would somewhat even the playing field.
Lastly, there are likely patients in need of multi-organ (HK, LK, SLK) transplants who may have living donors. If they had a donor donate to the list for them prior to their own transplant/this particular offer, then those recipients who brought their own donor should have priority for HK, LK, SLK transplants from ideal donors.

Region 2 | 02/29/2024

For the question, “How should MOT candidates be prioritized when there is only one kidney available?”, an attendee advocated for a more comprehensive approach in determining organ transplant priorities. Instead of arbitrary factors, focus on anticipated waitlist survival. The suggestion was to link decision-making to a standardized measure, allowing for a consistent and defensible approach across different scenarios. Another attendee noted the effectiveness of the safety net policies, particularly in liver-kidney combinations. However, concerns were raised about the potential alteration of decision-making when it comes to heart-kidney and lung-kidney combinations. Another attendee highlighted the significant variability in the decision to list MOT candidate across different transplant centers and providers. The absence of uniform criteria for MOT across various domains and organs highlights the need for a standardized bar to determine the necessity of kidney inclusion in combination with other organs. Another attendee noted perceived flaws in using the Kidney Donor Profile Index (KDPI) as a sole criterion for organ acceptance. There are times when a high KDPI kidney would be suitable for kidney-liver recipients. Kidney-liver allocation should assess KDPI similarly to kidney-alone cases. Another attendee added that the primary need in MOT allocation is more organs. One solution would be to increase organ availability through living donation and encouraging voluntary donations to address the critical shortage. It was also noted that the higher mortality rates associated with multi-organ candidates, such as heart-kidney transplants should not be considered as a factor to deprioritize heart-kidney allocation. In regard to the question “Should kidney-pancreas (KP) candidates be considered multi-organ candidates and be prioritized among other multi-organ combinations?”, attendees largely felt that KP candidates should be considered MOT candidates and should be prioritized among other multi-organ combinations and should have priority over kidney alone candidates. When both kidneys are available from a donor with a kidney donor profile index (KDPI) between 0-34 percent, there was support for allocating one kidney to kidney alone candidates and the other kidney should be offered to multi-organ candidates. An attendee emphasized that too many kidney candidates are waiting for a very long time to get a transplant. In regard to policy guidance for OPOs, attendees emphasized the significance of additional policy and system considerations for OPOs. There was a call for a policy to define which patients are at highest risk of graft failure, as well as a policy to provide clarity and standardization for out-of-sequence allocation. OPOs currently decide on the aggressive allocation of organs, and different OPOs may have varying criteria for out-of-sequence allocation. Another attendee noted that in the near future similar considerations will be needed for liver transplants involving liver-heart and liver-lung scenarios. The need for objective criteria was emphasized, with a suggestion to consider waitlist mortality as a relevant factor. However, concerns were raised about potential disadvantages for kidneys if waitlist mortality is the sole criterion. It was suggested to have one kidney allocated to kidney alone and the other kidney to multi-organ candidates with waitlist mortality as the deciding factor. Another attendee added that there is an arbitrary priority granted to pediatric and prior living donor candidates, while the greater concern should be for high CPRA candidates. They emphasized the importance of prioritizing those least likely to receive an organ over those with a higher likelihood. The principles of benefit and justice in ethical considerations underline the need to prioritize those with a lower likelihood of receiving an organ in the near future.

Region 11 | 02/29/2024

An attendee stated it is crucial to determine how multi-organ candidates appear on a match. The attendee agreed with priority for highly sensitized candidates, pediatric candidates, and candidates with a high risk of mortality without a multi-organ transplant. A member was reassured to see that a high percentage of low KDPI kidneys go to kidney-alone recipients, but was concerned that since pediatric candidates, those with a high CPRA, and 0-ABDR mismatch candidates get priority for those kidney alone offers, young adult kidney alone candidates face severely prolonged wait times if they don’t find a living donor. The member would like to see some priority for young adult kidney alone candidates for low KDPI kidneys. One attendee commented that they would support one kidney going to a kidney alone candidate and one kidney going to a multi-organ recipient. They added that the greatest utility is for kidneys to go to candidates on dialysis rather than those with decreased function. One person suggested having a cutoff time before reallocating the organ. Another member remarked that allocation is often driven by the timing of the collection of required and requested data for each individual organ, and dictating by policy how organs are allocated could have the unintended consequence of delaying allocation of organs when you have information for some, but not all of them. An attendee suggested that consistent application of allocation policies for OPOs is important because they do not feel that occurs right now. They recommended including a time frame in the allocation so that when changes happen during allocation, multi-organ candidates are not needlessly excluded and late primary allocation can occur to the candidate that was intended to be the recipient, but not so late that logistical issues result in the organ going to a backup candidate. A member stated that organ offers need to be clear prior to procurement. Another attendee supports multi-organ recipients receiving priority over kidney-alone candidates, as heart, lung, and liver candidates typically do not have the ability to receive life extending treatments that kidney-alone candidates do, such as dialysis and diabetic management protocols.  

OPTN Pediatric Transplantation Committee | 02/27/2024

The OPTN Pediatrics Committee would like to thank the MOT Committee for the opportunity to provide feedback on this concept paper. The Committee agrees with the idea that when both kidneys from a donor are available for transplant, one kidney should go to a multi-organ candidate and the other should go to a kidney-alone candidate. If the kidney that is being allocated to kidney-alone candidates has a KDPI less than 35%, pediatric candidates should be given priority over kidney-pancreas candidates. Reviewing the available data, the Committee believes a policy like this could greatly reduce, if not eliminate, the pediatric kidney waiting list. The Committee discussed at length the placement of kidney-pancreas candidates with kidney-alone candidates for allocation. As long as kidney-pancreas candidates are offered the kidney after the pediatric list has been exhausted for kidneys less than 35% KDPI, the Committee is comfortable with the inclusion of kidney-pancreas candidates with kidney-alone candidates. The Committee also feels that living donors, 100% CPRA, and medically urgent candidates should also be given priority over kidney-pancreas candidates and other kidney-alone candidates for kidneys with a KDPI less than 35%. As for the specific order of allocation for MOT combinations, the Committee does believe this process should be dictated by policy and should be consistent. The order should be dictated by data including waitlist survival and mortality rates but should still prioritize pediatric candidates. 

OPTN Ethics Committee | 02/27/2024

The OPTN Ethics Committee thanks the OPTN Ad-Hoc Multi-Organ Transplantation Committee for the opportunity to provide feedback on these topics. The Committee appreciates that these are challenging questions that involve clinical decision-making as well as values prioritization. In general, the Committee is supportive of a common algorithm for OPOs to use to determine the order in which organs are allocated. The Committee encourages the MOT Committee to consider the outcomes for each organ combination, the possibility of extended wait time for kidney-pancreas candidates if pancreas offers are not prioritized, non-use of pancreas, and prioritization for pediatric and urgent-need candidates when further refining these concepts. Also, it is important to consider appropriate timing of release for organs being held for multi-organ transplant and associated negative impacts on utilization for single-organ offers, especially pancreas. The Committee is supportive of the MOT Committee further exploring these topics and developing policy proposals to promote consistency and fairness in MOT allocation.

UAMS | 02/27/2024

After an evaluation of OPTNs proposal to modify Multi-Organ Policies, we believe there would need to be more clarification and feedback from transplant centers before we determine a level of support. We believe that Kidney-Pancreas (KP) patients should be evaluated in the same way that other MOT patients are. While there can be insulin therapies that provide successful treatment for patients waiting for a pancreas transplant, not giving these patients the same prioritization for transplant can lead to deterioration in condition and complications with current treatment regimens. We do not believe that there can be a set policy for who receives the organ when both kidneys are available from a donor with a KDPI between 0-34. Creating a set policy for this situation has the potential to place certain candidates on organ waiting lists at a disadvantage. We do believe that OPTN should provide guidance in these situations and ensure the OPOs are not being left to navigate allocating these organs without any support.

Region 4 | 02/26/2024

Members in the region offered several suggestions for the committee to consider as they address this very important issue. Several attendees supported prioritizing kidney alone candidates who were highly sensitized, medically urgent, pediatric and prior living donors. Another attendee commented that the policies need to consider the relative benefit to recipients of receiving a multi-organ transplant, versus the relative benefit to the two (or more) individuals who would otherwise receive the multi-organ transplant. They added that the allocation system has not historically considered the loss of benefit to the other potential recipients and as a system it seems that that focus on potential benefit to multiple individuals vs. a single multi-organ transplant candidate should be considered. Several attendees supported one kidney being allocated to a multi-organ transplant and one to a kidney/pancreas or kidney alone candidate. One attendee supported increasing utilization of low KDPI kidneys under a safety net policy adding that the allocation system should be modified in a way that high quality kidneys don’t just go to multi-organ transplant candidates. One attendee commented that the threshold for heart/kidney varies from center to center, adding that the committees need to continue to monitor the safety net criteria to determine if the policy needs to be updated. One attendee commented that if we remove race and HCV from the KDPI calculation there may be more kidneys available with lower KDPIs. One attendee recommended a Values Prioritization Exercise (VPE) for multi-organ allocation to get a better idea of how the community prioritizes allocation across the organs, as well as medically urgent kidney alone and pediatric versus adult. One attendee recommended that the committee consider the racial breakdown of multi-organ transplant candidates versus kidney alone candidates to make sure we are not creating a racial bias or access issue with allocation policy.

OPTN Organ Procurement Organization Committee | 02/20/2024

The OPTN Organ Procurement Organization (OPO) Committee thanks the Multi-Organ Transplantation Committee for their work on this proposal and the opportunity to provide feedback. The Committee agreed that the OPTN should provide guidance in determining which organs and organ combinations should receive priority. Several members shared their experiences and challenges in the allocation of multi-organs, particularly with extra-renal and abdominal multi-organ allocation. Members noted that OPTN guidance or policy would reduce the burden on OPOs to make clinical priority determinations.

In considering a requirement for KDPI 0-34 percent donors to have only one organ allocated to a multi-organ candidate, with the other allocated to a kidney-alone candidate, the Committee expressed concerns that this policy could potentially disadvantage certain multi-organ groups. The Committee also specifically noted that this policy could have a greater impact on OPOs in their ability to allocate pancreata, particularly as isolated pancreas transplantation is rare, and most pancreas candidates are also listed for a kidney.

Déboralis Ramos | 01/31/2024

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