Comments

Region 5 | 09/25/2024

• Online feedback showed the majority did not agree that cold ischemic time (CIT) threshold alone should be used to define a kidney as “hard to place” or at increased risk of non-use. Attendees commented that CIT should be a factor, but not the only factor, and that it is just one attribute that makes kidney hard to place. Other factors include age of donor, biopsy findings if TMA, chronicity, AKI IN donor, etc. Another attendee suggested that factors identifying potentially hard to place organs could be captured earlier in the process. Regarding specific anatomy characteristics or considerations that should be included in a definition of a “hard to place” kidney, or a kidney at increased risk of non-use, attendees suggested multiple vessels, capsular tear, en – bloc, dual kidney, pediatric en-bloc, and 95-100% KDPI. Regarding whether there is a specific number of candidate or program declines at which an organ could be considered harder to place or at risk of non-use, attendees suggested candidate declines over 250, or 100 candidates and 2 program declines. Another attendee commented that she didn’t have a specific number but she supports the idea and leans toward the number of programs declining. Another member said that if 5 centers turn down the organ then that is a good indication that the organ is “hard to place”. A member said that it is difficult to define “hard to place” and commented that it is all so multifactorial.

• An attendee commented that it's crucial to ensure that pediatric priority is retained for pediatric donors in the ongoing organ distribution system.

• A member said that it is important to consider transportation logistics in the continuous distribution model in order to mitigate loss of organ due to transplantation.

• A member provided a general comment that is applicable to all organs in continuous distribution. They asked that the committee keep in mind directly and indirectly related increased costs associated with continuous distribution implementations.

Gift of Life Michigan | 09/24/2024

We support ongoing pursuit and refinement of continuous distribution of kidneys. Several questions were posed in this comment period; however, we will comment more comprehensively to the concept.

We strongly support definition of “hard-to-place” kidneys, with full accounting of all or most of the variable that pose challenges in matching donated kidneys with waiting patients. Several comments have addressed Cold Ischemic Time (CIT), which is certainly a major variable, but should not be the sole determinant of classification of hard-to-place. A major challenge in placing medically complex kidneys or those with other anomalies is that key pieces of data are not known or available until the donor kidney is surgically recovered from the donor. Kidney anatomy, biopsy results, flush characteristics, and other indicators cannot be known prior to recovery, thus placing more pressure on placement because CIT is accumulating.

We support prioritization of pediatric and high CPRA patients in the continuous distribution model.

We do not believe all the unintended consequences of broader distribution, such as huge increases in the numbers of kidneys offers and the expansion of travel, have been fully resolved and continue to contribute to the complexity of kidney placement. As continuous distribution evolves, we encourage the intentional inclusion of those factors in the considerations.

We remain acutely aware that regardless of dramatic increases in organ donation, transplant surgeons and centers must continue to evaluate the offered organ against the potential benefit for the patients for whom that organ is offered. In other words, despite more organs being available, not all organs are the right fit for patients who match them. We recommend vigilance against a sense of organ availability that does not reflect reality and that all stakeholders continue to find equitable, accessible solutions to getting patients transplanted.

In addition to a definition of “hard-to-place”, we recommend robust modeling to understand the implications of various proposals to solve the problems. We further recommend thorough analysis of progress of measures already incorporated, such as minimum biopsy criteria, to understand whether those measures are helpful, harmful, or non-contributory.

Loren Gragert | 09/24/2024

Equalizing access across CPRA groups does deserve more effort. The goal of "equalize access across CPRA" seems to not have been met as there are still substantial differences in transplant rates across CPRA categories. Is there an intuition as to why the transplant rates across CPRA groups in Figure 9 are so stubbornly disparate? What is driving the substantially higher transplant rates for the 80-98% and the 99.5-99.9% categories? The weighting for CPRA has increased substantially to 40% of the composite allocation score, which it appears will improve the capability of transplanting the most highly sensitized patients (99.9%+). Could SRTR model how often compatible donors for these 99.9%+ candidates would be offered first to other candidates with lower CPRA? That would give us the upper bound on how much allocation policy could influence transplant rates for the highest CPRA candidates.

The proposed updated rating scale for CPRA in Figure 7 is not continuous, as there is a massive discontinuity at 99.5% that effectively keeps intact the previous discrete point group 100 in the current system. This updated rating scale seems to go against the fundamental design principles of continuous distribution. Could it be that this policy was selected by a machine learning method mainly as a side effect of equity metrics still being evaluated for discrete CPRA categories (e.g. 99.5-99.9% and 99.9-100%)? Is this model overfitting? The 99.5-99.9% group has double the transplant rates compared to 98-99.5%, so it's not clear how the huge increase in points at 99.5% could possibly be optimal, so it's surprising the machine learning methods couldn't improve this further.

The proposal noted that "Simulators are limited in accuracy with respect to CPRA, as the population of the most highly sensitized is very small. As a result simulators will inherently overestimate the transplant rate for certain CPRA groups?" What are the current ideas on how to improve accuracy of these models? Is there a way that OASIM could sample from a larger distribution of highly sensitized HLA antibody profiles and HLA genotypes than is included in the current dataset?

DR mismatch will have far less influence on allocation under CD than it does until current policy (at most 3% of the composite allocation score for D2 and only 1% for A2). It seems these changes should decrease post-transplant survival, but nowhere in this update is the expected post-transplant survival results for the new models shown, even though it is one of the 5 goals for kidney allocation objectives. The update remains silent as to if the committee believes that a weighting of 1% for DR matching is consistent with the results of the community-driven values prioritization exercise.

The dramatic improvement in ABO equity appears to be entirely driven by a decrease in transplant rates for AB candidates, which are a small fraction of candidates. It appears each ABO category contributes equal weighting to the equity metric. Has SRTR considered using an equity metric for ABO that is weighted for relative population size?

American Society of Nephrology | 09/24/2024

Kindly see attachment.

View attachment from American Society of Nephrology

OPTN Pancreas Transplantation Committee | 09/24/2024

The OPTN Pancreas Transplantation Committee thanks the OPTN Kidney Transplantation Committee for their ongoing work on continuous distribution and for the opportunity to comment on this update. The Committee offers the following items for further consideration:

1.     The Committee recommends further consideration be given on how to prevent penalization of programs that are adjusting their risk profile in accepting hard-to-place kidneys. There is concern that it could disincentivize utilization of those organs.

2.     Regarding the allocation threshold for hard-to-place kidneys, the Committee recommends using sequence numbers rather than total center declines, as this approach would be more sensitive to regional differences across the country.

3.     With regard to expedited placement, the Committee suggests that logistical constraints be given appropriate consideration. Some centers face logistical challenges, particularly in terms of transportation options, which limit their ability to be aggressive in the placement and transplantation of a kidney.

4.     It is recommended that though ischemic cold time can be used in conjunction with clinical or allocation considerations, there need to be standards of practice across the system to ensure equity and transparency in allocation.

5.     Greater sharing of outcomes data is recommended, particularly from programs that are more aggressive in accepting hard-to-place kidneys. This information could help other centers better understand the risks and potential outcomes associated with accepting these organs.

6.     The Committee supports including anatomical considerations in the definition of hard-to-place kidneys, especially in cases where surgical damage has been indicated. This information could be crucial for centers making informed decisions about organ acceptance.

Region 3 | 09/24/2024

During the meeting, in-person attendees participated in group discussions. The Kidney group commented that CIT (cold ischemic time) should not be the only threshold used to define hard-to-place kidneys until the CIT exceeded 8 hours. The group also commented that kidneys with increased glomerular sclerosis, anatomical injuries making the kidneys unsuitable for pumping, older donors and high KDPI should be included in the definition of “hard to place” or a kidney at increased risk of non-use. The group also commented that using the number of candidates with declines rather than the number of programs who have declined the kidney should be used to determine if a kidney is harder to place or at risk of non-use. Virtual attendees also provided feedback on key questions. One attendee commented that there are multiple factors that should be considered for a kidney to be at increased risk of non-use and a cold ischemic time threshold alone should not be used. They went on to comment that KDPI, biopsy findings and location of the donor/transplant centers all play a role. There was also feedback on specific anatomy characteristics that should be included in a definition of a “hard to place” kidney. Suggestions included: ureter length and size mismatch, ureter injury and whether the kidneys are placed as dual organs or en bloc. Another question focused on the number of candidate or program declines at which an organ could be considered harder to place or at risk of non-use. One attendee commented that they supported candidate declines over program declines. They added that consideration for each candidate takes some time and delays transplantation, increasing risk of overall non-use. Another attendee commented that sequence number is more important than program threshold, particularly in areas where there are fewer programs. 

Vikram Pattanayak | 09/24/2024

Re: Modeling and Optimization/Do you support the updated optimized CPRA rating scale that ensures access for the most highly sensitized candidates?

1)

I am encouraged by the weights for CPRA in policies A1, B2, C2, and D2 and the modeling outcomes, and I’m encouraged by the data shown in Figure 9 with the optimized models. Overall, the goal of the CPRA scale should be to achieve roughly equal rates of transplant across CPRA groups, with the caveat that by definition the >99.9% population will only be compatible with 10 or fewer of every 10,000 donors. The proposal includes the comment on p.9 that simulators are limited in accuracy with respect to CPRA, which makes sense, due to the small numbers. Therefore, I would be curious to see an analysis that is a bit more tangible than the model. Does a weight of 0.4 for the CPRA scale essentially ensure that those very highly sensitized candidates do not get passed over by an unsensitized candidate for that limited, small number of available donors? Would it be possible to look at actual match runs from the past several years to see what would happen to the highly sensitized population in the new model? In other words, do the 99.9%+ CPRA candidates who have been transplanted recently still end up getting those same offers in the new system?

From a modeling perspective, it seems that there are differences in the transplant rates for current policy in Figure 6 compared to the data in the “Eliminate Use of DSA and Region from Kidney Allocation One Year Post-Implementation Monitoring Report” (https://optn.transplant.hrsa.gov/media/p2oc3ada/data_report_kidney_full_20220624_1.pdf). Table 4 of that report suggests that the transplant rate is approximately 30 transplants per 100 active patient years. However, Figure 6 of this report puts the rate at 15 per year. Similarly, in the One Year Post-Implementation Monitoring Report, the transplant rate for the 98-100% CPRA group is roughly similar to the 0-80% group (36 per 100 patient years vs. 30). However, in the model in this proposal it looks to be much higher. The 98-99.5% group is at 47 per 100, and the 99.5-99.9% group is at 59 per 100, while the 0-60% group is at 14.4 and the 60-80% group is at 22. Given the proposal’s comments on the challenges in accuracy with respect to CPRA, it would be encouraging to see further analysis to confirm that the modeling will correlate to real-world post-implementation match runs.

2)

I have a comment about how the CPRA weights may impact allocation efficiency and the Committee’s desire to expand the use of virtual crossmatch. The best way to promote allocation efficiency and use of virtual crossmatch would be to encourage centers to list all bona fide anti-HLA specificities as unacceptable donor antigens, regardless of MFI. That way, there would usually be no need for a physical crossmatch and essentially all virtual crossmatches would be negative. However, the updated CPRA curve in Figure 7 seems to be flat between a cPRA of 90 and even a CPRA of 99.5%. If for any individual patient there is only a minimal benefit in allocation to listing unacceptable antigens that move their CPRA from 90 to 99%, it may turn that the best way to get to transplant would be to rely on a physical crossmatch to rule out compatibility issues with low-level DSA. That would make sense in practice if the extra allocation points between 90% and 99% do not overcome the narrowing of the donor pool by 10x between from 10% (100%-90%) to 1% (100%-99%). Therefore, it is possible that the CPRA curve as designed could come with a cost to placement efficiency. In other words, the models are being run on current data based on current practices. However, it is possible that weights being defined for the models will end up shifting current practice.

OPTN Operations and Safety Committee | 09/24/2024

The Operations and Safety Committee thanks the OPTN Kidney Transplantation Committee for their efforts and update on the Continuous Distribution of Kidney project and the opportunity to comment. The Committee provided the following feedback for consideration:

• “Hard-to place” Kidneys
  • The Committee suggested collecting information to evaluate surgical damage. There are programs willing to accept these kidneys and this information would be useful. Additionally, the Committee discussed anatomical characteristics that should be considered in defining “hard to place” kidneys that include kidneys with three or more arteries, and kidneys with large hematomas or perinephric hematomas.
  • The Committee also suggested consideration of donor characteristics such as diabetes, hypertension, age, and creatinine, which can also result in kidneys being hard to place. All of this information is readily available at the beginning of the offer being sent out; it was suggested the Kidney Transplantation Committee consider developing a pathway that incorporates this information at the start of the organ offer process in an efficient and fair manner.
  • There was a suggestion to incorporate pump numbers (specifically the initial set of pump numbers); a member stated that there are times when a program is waiting for pump numbers and then later decline the offer due to this. 
  • The Committee also discussed and voiced concern that the root cause is not clearly identified. It is being observed that programs are putting in provisional yeses in and then declining post-recovery due to information that is already known (creatinine, medical history, etc.). These processes can be done but OPOs will still be under scrutiny. There needs to be a solution in how to have programs truly review the offers if they are primary.
• Expedited Placement:
  • The Committee suggested that expedited placement not start at 5 hours cross clamp due to lack of information available during that time. It was recommended that expedited placement not exceed 9 hours due to there being observance of the increased risk for non-use of that kidney; additionally, this provides a buffer when considering logistics such as transportation to get the kidney to the accepting hospital within 12 hours. The Committee added that there is a need to clearly define expedited placement before determining how this process would be operationalized.

OPTN Pediatric Transplantation Committee | 09/24/2024

The Pediatric Transplantation Committee appreciates the opportunity to provide feedback on the Continuous Distribution of Kidneys Update.  

Defining “hard to place”: Allocation thresholds based on number of programs having responded with a total center decline, or sequence number, seem arbitrary. We would suggest instead using factors such as KDPI, anatomy, surgical damage, cold ischemic time to define “hard to place” kidneys. 

Mathematical optimization for pediatric travel distance: We remain supportive of allowing programs the flexibility to apply offer filters as needed to manage offer volume under a continuous distribution framework. We do not support decreasing pediatric prioritization to address travel distance issues.  

Kidney Expedited Placement: Generally, we would recommend excluding pediatric donor organs from expedited placement protocols. Instances of bypassing pediatric candidates should be minimized to the greatest extent possible.

American Nephrology Nurses Association | 09/24/2024

ANNA agrees. We have reviewed the updates and support continuous work on this project.

Nancy Marlin | 09/23/2024

Thank you for your comprehensive mointoring and update. Although it was indicated that prior living donors were to continue to receive high priority, I did not see any data. Please provide data to assure prior living donors receive priority under continuous distribution.

NATCO | 09/23/2024

Updating Continuous Distribution for Kidneys
NATCO supports the efforts of a continuous allocation system for kidneys. We do believe that both pediatric patients and prior living donors should have priority. We support access for the 99.9% cPRA group. We support defining “hard to place” kidneys, and believe that criteria are multifactorial and cannot be defined by one single criteria, such as CIT. We do believe that CIT, ice or pump preservation, biopsy results, KDPI score, DCD status and age would all be important factors in definition of “hard to place”.

Michael Daily | 09/23/2024

While there have certainly been some merits to the broader distribution of kidneys, it has not been without its problems. The best kidneys continue to be scooped up quickly. They are often not transplanted quickly, as they are commonly (at least on the Eastern Seaboard) claimed by a center up to 250 nm away from the donor hospital, adding ischemic time, complexity, and cost to an organ that could have been used closer to recovery for less money with shorter ischemic times and, therefore, better outcomes.
The less desirable kidneys are still often used. What those of us who watch closely have noticed is dozens of transplant centers are contacted for each each organ. These dozens of centers often put a provisional yes in for the offer. When the time comes to accept the offer, centers are taking at least their allotted 30 minutes, and often more to decline (even if there is no new information). Each successive decline adds ischemic time. Eventually so the kidney will not be lost due to this added complexity, some mechanism of expedited placement is offered. Whether this is an "auction" for out-of-sequence allocation, "calling local centers," or "calling aggressive centers." In any case, this giant, cumbersome, complex, costly system of allocating within 250 nm is scrapped in the middle of the night with no UNOS oversight!
I understand why it is done. It is done so the kidneys do not get wasted since the system we have decided on is too complex to allow rapid allocation. I do not believe the solution to this is to increase the complexity of the system.
In its current form, 250nm circles has the result that:
- The best kidneys often get shipped great distances
- The marginal kidneys have allocation delayed
- The complex system designed to make everything fair is scrapped after some delay in allocation, and kidney allocation becomes the Wild West. It is scrapped without any oversight or protocol.
Please do not proceed with further complications of organ allocation with continuous distribution without addressing the fact that the current allocation system only delays the placement of the organs that can handle that delay the least.

Region 11 | 09/23/2024

Participants suggested that allocation thresholds could be based on the number of declines or the number of programs declining for all their candidates, with some proposing specific numbers like 200 candidate declines or 5 centers declining as potential indicators. Specific anatomical characteristics were identified as factors that could make a kidney hard to place, including DCD with WIT greater than 30 minutes, multiple ureters, en bloc kidneys, anatomical damage, sclerosis, high percentage of glomerulosclerosis on biopsy, and inadequate vessel or ureter length. While cold ischemic time alone was not considered sufficient to define a kidney as hard to place, it was suggested that it could be used as a trigger for expedited placement. Participants emphasized the need for a more comprehensive approach that considers multiple factors beyond just cold time. There was general agreement on the need for allocation thresholds and a recognition that the new allocation system has significantly increased the number of organ offers, necessitating a way to reach acceptance more quickly.

OPTN Transplant Coordinators Committee | 09/23/2024

The OPTN Transplant Coordinators Committee thanks the OPTN Kidney Transplantation Committee for updating them on their continuous distribution work.

The Committee supports the idea of setting thresholds for "hard-to-place" kidneys, believing this could improve kidney utilization. They suggest using the top 10 in the allocation sequence as a threshold, which could ensure these hard-to-place organs are allocated and used appropriately.

The Committee also agrees that a clear definition of "hard-to-place" is needed. They suggest that even a scale-based definition could provide valuable insights into why some kidneys are not used or utilized.

Additionally, the Committee encourages and is in support of making offer filters mandatory. This could help identify which types of kidneys programs consider "hard-to-place."

Lenore Hicks | 09/23/2024

I surely appreciate all the work that has been and is being done on the Continuous Distribution Committee. The committee is headed in the right direction regarding shared decision-making. This will allow the patient to be informed and be a part of the decision-making hopefully decreasing the number of non-usage organs. This also will lead to the transparency of the program. If we could find a way to identify "hard to place" kidneys early on, we could decrease non-usage and cold ischemic time. The model that we use for kidneys could also be used for other organs by adding more or less attributes.

Lenore Hicks | 09/22/2024

I surely appreciate all the work that has been and will be done on Continuous Distribution. Continuous distribution will go a long way to reach people who might not have had an opportunity before. The Committee is headed in the right direction regarding the importance of shared decision-making. This will allow the patient to be informed at every step and have them involved in the decision-making. Hopefully, this will help to decrease the number of nonusuage organs. This will also lead to transparency in the program. It would help if we Identified "hard to place" organs early in the process, as it could decrease the time it takes to place these organs. The model effective for kidney distribution may be adaptable for other organs by adjusting the number of attributes. "attachment"

American Society for Histocompatibility and Immunogenetics (ASHI) | 09/20/2024

The American Society for Histocompatibility and Immunogenetics (ASHI) and its National Clinical Affairs Committee (NCAC) appreciate the opportunity to provide feedback on this update. ASHI continues to be supportive of prioritizing the attributes of candidate biology for transplant access, especially of the highly sensitized patient population.

In addition to the prioritization of candidate biology, additional strategies should be taken into consideration to support graft survival. There has been significant advancement in making high resolution HLA typing faster, more accurate and cost-effective for deceased donors. We advocate for updates to allow for high-resolution HLA typing in the UNET database as a first step in improving matching and avoiding allocation in the presence of HLA allele-specific antibodies, which currently delays allocation.

Regarding the optimized CPRA calculation, ASHI supports the appropriate weighting of candidate biology, to include the CPRA attribute, to facilitate the transplantation of highly sensitized candidates. This remains an important topic in support of equity given multiparous women make up a large portion of that population. We would however need more modeling to evaluate the impact on the other groups that may or may not be disadvantaged with the implementation of this new rating scale.

Region 10 | 09/20/2024

The discussion focused on defining "hard to place" kidneys and the factors influencing their placement and utilization in transplant programs. Attendees agreed that cold ischemic time (CIT) should be considered as a significant factor in evaluating kidneys for transplant, especially once the organ is outside the body. However, it was emphasized that CIT should not be the sole determinant for defining a kidney as "hard to place" or at risk of non-use. Other factors, such as anatomy characteristics (e.g., horseshoe kidneys, plaques, short or multiple arteries and veins), donor age, function, biopsy results, pump numbers, and surgical damage, should also be considered. There was consensus that CIT, when combined with other characteristics, could be more useful in determining risk and guiding decisions. The conversation touched on the skewing of data from programs with high offer acceptance rates and discussed potential thresholds for defining a "hard to place" kidney. Suggestions included defining a "hard to place" kidney based on non-acceptance by all centers within 250 nautical miles or using criteria like 3 or more program declines, 200 candidate declines, or 350 candidate declines. Other considerations include surgical or procurement damage, more than two arteries or veins, hard plaque, multiple cysts, hematoma, discoloration, or a shortened or less-than-optimal ureter. There was also a suggestion that the OPTN should consider reducing outcome requirements for "hard to place" kidneys meeting specific criteria to encourage more risk-neutral behavior among transplant centers. This would help increase the acceptance of these kidneys. It was noted that increased costs and adverse outcomes (e.g., delayed graft function, longer hospital stays) are associated with harder-to-place kidneys, which necessitates careful consideration of these financial and clinical impacts. Attendees agreed that more modeling and data analysis are needed to better define "hard to place" kidneys and to optimize the continuous distribution model for kidneys. The use of offer filters by individual transplant centers was recommended to minimize late declines and reduce CIT, thereby potentially improving the placement process.

OPTN Ethics Committee | 09/20/2024

The OPTN Ethics Committee thanks the OPTN Kidney Transplantation Committee for their ongoing work on continuous distribution and for the opportunity to provide feedback. In general, the Committee is supportive of the concepts outlined in the update paper. In particular, ethics members offer the following points for consideration.

It is clear from the update that the Kidney Committee is highly focused on utility and avoiding non-use, as directed by the OPTN Board. Will this clear focus on avoiding non-use, improving post-transplant outcomes, and overcoming transportation burdens potentially diminish the attention to equity and transparency? The Committee emphasizes that these efficiency-related goals are important, but must be achieved in balance with equity and transparency.

The Committee also appreciates the Kidney Committee’s work to better understand and define a hard-to-place kidney, and to propose systems for expedited placement. The Ethics Committee is currently undertaking an ethical analysis of organs allocated out of sequence, and notes that understanding some of the drivers and consequences of this will help create an efficient and balanced system for allocating hard-to-place organs.

Finally, the Committee recommends that the Kidney Committee consider monitoring and takeaways from the implementation of lung continuous distribution to inform policy development. 

Region 7 | 09/17/2024

Attendees discussed the complexities in defining and managing hard-to-place kidneys, focusing on factors such as multiple declines during allocation, specific anatomical challenges like infarcts and renal artery plaque, and donor characteristics like age and health. There was general agreement that cold ischemic time alone should not be the sole criterion for determining a hard-to-place kidney; attendees suggested a combination of factors including donor risk profiles, kidney anomalies, and biopsy results should be considered along with cold ischemic time. Additionally, attendees raised concerns about transplant centers prioritizing "perfect" kidneys while there are patients who would accept organs that are more high risk.

During the meeting, attendees participated in group discussions and provided the following feedback:

• Participants agreed that cold ischemic time alone shouldn’t qualify a kidney as “hard to place.”

• In defining hard to place kidneys, multiple factors should be considered, including inability to pump, sever plaques, surgical damage, and DCD status (in addition to CIT).

• Difficult to determine a sequence number that should qualify a kidney as hard to place.

American Society of Transplant Surgeons | 09/16/2024

Attachment

View attachment from American Society of Transplant Surgeons

OPTN Living Donor Committee | 09/13/2024

The Living Donor Committee commends the OPTN Kidney Transplantation Committee for their continued efforts in developing this project. The Committee strongly supports providing prior living donor priority to all living donors, which is stated as “high priority” in this update. The Committee strongly supports maintaining high priority for prior living donors by acknowledging the altruism of living donors, demonstrating the value of reciprocity, and recognizing the need to support living donors. The Living Donor Committee believes this attribute should be given the appropriate weight to maintain their current level of priority in the new continuous distribution system. The Committee appreciates the OPTN Kidney Transplantation Committee’s support of living donors as valued members of the transplant community. The Living Donor Committee offers the following as key points to consider for inclusion of prior living donor priority into continuous distribution:

·      Prior living donors should receive priority if they are listed for transplant

·      All prior living donors should receive priority for any organ needed

·      Prior living donor priority should not have a time restriction

·      Prior living donors should not be valued differently based on organ donated

·      Prior living donor priority should not be optional to individual candidates

American Society of Transplantation | 09/12/2024

The American Society of Transplantation (AST) is generally supportive of what is outlined in committee update, “Continuous Distribution of Kidneys Update, Summer 2024” and offers the following comments for consideration:

•The AST strongly opposes any policy changes that could disadvantage pediatric candidates. The AST supports stratification by distance, followed by a slight reduction in the weight of pediatric priority; however, there are concerns that offer filters and screening may impose significant burdens on kidney transplant programs, potentially disadvantaging patients at programs with less accessible airports. Regardless of adjustments made to the modeling, the AST advocates for a defined, early assessment period of six months to evaluate if pediatric weights are achieving their intended effect and evaluate for the existence of any unintended consequences such as delayed graft function, increased cold ischemia time, and transportation challenges. Additionally, the AST believes encouraging pediatric centers to use offer filters and candidate acceptance criteria to maximize efficiency in managing offers for each pediatric patient is reasonable.

•The AST supports the optimized CPRA rating scale to ensure access for the most highly sensitized candidates. The goal "equalize access across CPRA" does not seem to have been realized as there are still substantial differences in transplant rates across CPRA categories. The modeling data presented in the proposal in Figure 9 suggest that, overall, the four proposed policies do not significantly impact transplant rates across cPRA categories when compared to the current policy. If the goal is to increase transplant access for highly sensitized candidates, particularly those with a cPRA between 99.9% and 100%, no amount of points equivalent to waiting years will benefit these patients. These highly sensitized candidates are incompatible with almost all available donors and only HLA-identical donors will be compatible. Therefore, offering increased cPRA attributable weight for patients with a cPRA between 99.9% and 100% provides no significant benefit unless HLA-identical donors are prioritized for these patients.

•The AST generally supports a multi-faceted approach to defining hard-to-place kidneys and advocates for a comprehensive focus on data obtained after kidney recovery, such as vascular anatomy, anatomic abnormalities, biopsy results, pump metrics, and transportation challenges. The AST believes well defined definitions that recognize “hard-to-place” kidneys much earlier in the allocation process is critical to successful allocations and transplants. Additionally, standardized availability of digital pathology could positively impact acceptance of kidneys that may otherwise be declined when relying on the pathology report. The AST is less supportive of stratifying clinical criteria by KDPI, as the formula will soon be updated and currently does not capture many variables that may lead a transplant hospital to decline a kidney post-recovery.

•The AST favors using both allocation and cold ischemia time thresholds, as these are post-recovery data points, but recognize the need for ongoing evaluation of these parameters as they evolve.

•Standardized approaches to expedited placement with a focus on transparency are critical. The AST supports the proposed expedited placement research and the research already conducted. Specifically, the AST believes that the “time used” during kidney placement is poorly understood and that there are efficiency opportunities to accelerate the allocation process. Allocation efficiency would be improved with a better understanding of transplant center and OPO behavior and the use of mandatory and optional filters. Currently, the available data do not seem granular enough to make specific recommendations or changes in expedited placement.

Region 9 | 09/10/2024

Two comments were submitted online supporting the use of a cold ischemic time (CIT) threshold to define a kidney as “hard to place”.  Three online comments were made opposing the use of a (CIT) threshold to define “hard to place”.  An attendee noted that CIT is often not the driving factor for whether a program chooses to accept a kidney.  A member stated that anatomy and biopsy results should be included in the “hard to place” kidney definition.  Another attendee suggested including surgical damage during the donor operation in the “hard to place” definition.  A member supported including type and severity of aortic and arterial plaques, as well as other factors identified by the OPTN Contractor in an abstract submitted to the American Transplant Congress. There were suggestions of allocation thresholds of sequence 200 or 500 being options for triggers for rescue allocation.  Another attendee stated ideally it would be data-driven, but that Europe has experience with rescue allocation being triggered by declines from 5 centers, so it would be worth considering a threshold.  

During the meeting, attendees participated in group discussions and provided the following feedback:  

• A cold ischemic time threshold alone to define “hard to place” would not work. 
• Specific anatomic considerations are hard to objectively define. 
• It might make sense to combine the sequence number with other factors to create a definition of “hard to place”.

Anonymous | 09/07/2024

Transplant centers should be accountable when they sit on an offer for hours to days prior to OR only to decline after OR and do so consistently.
Offer filters should not require being set up by the center. They should automatically be applied to a center based on their past acceptancences.

VICTOR LEWIS | 09/05/2024

As much as can be said about distribution, More needs to be done about TESTING potential LIVE donors and candidates coming in the door also. In my personal experience, my LIVE donor was NOT tested at a previous hospital before being tested at my Transplant hospital.

What bothers me is that I was on 2 Transplant List at 2 hospitals, my first hospital and list never followed up on the opportunity presented to them.

Only after the offer was presented to the second hospital and list did I receive my transplant.

Anonymous | 09/05/2024

My concern for a “more flexible” placement of kidneys is the further inequality it will create. I have been part of the transplant community for 30 years and I have witnessed inequality in kidney placement and it appears to be increasing. Certain transplant centers “play games” and OPO’s are placing kidneys out of sequence on a daily basis. I believe there should be stricter oversight not less.

Rebecca Baranoff | 09/05/2024

I would like to see the Continuous Distribution of Kidneys project move forward. The idea of having kidneys get to more recipients is a goal for the transplant community. It is also important to have less wasted organs. I also think that providing a "data-driven definition of “hard to place” kidneys" is important for the longevity of the process and for better transparency.

OPTN Transplant Administrators Committee | 09/04/2024

The OPTN Transplant Administrators Committee appreciates the opportunity to comment on the OPTN Kidney Committee’s update on Continuous Distribution of Kidneys. The Committee offers the following feedback for consideration:

• The Transplant Administrators Committee suggests increasing transparency in the kidney offer process. 

• The Committee suggests standardization of policy quality definitions as well as increased stringency around provisional acceptances, allowing provisional acceptances to become more meaningful.

• The Committee suggests more data fields highlighting possible organ declination reasons as to increase communication.

Overall, the Committee is supportive of the developments on Heart Continuous Distribution and wants transparency to be considered in the development process.

The Oxalosis and Hyperoxaluria Foundation | 09/03/2024

In the update, the committee may want to consider highlighting genetic conditions, including Primary Hyperoxaluria, that can result in kidney failure and the need for kidney/liver transplant. The committee can highlight the need for a thorough workup, including genetic testing to ensure the underlying diagnosis does not result in allograft failure.

Region 6 | 09/03/2024

During the meeting, in-person attendees participated in group discussions. The kidney group suggested that a six-hour threshold for cold ischemic time (CIT) would be reasonable for defining "hard-to-place" kidneys. They noted that CIT can vary depending on procurement timing and flight availability. The group also discussed anatomical factors that could contribute to a kidney being harder to place or at risk of non-use, agreeing that multiple arteries, surgical damage, cysts, infarctions, and aortic plaque should be considered. Additionally, when using allocation thresholds to assess kidneys, the group supported using sequence data, specifically citing sequence 200 as a potential threshold. They emphasized that patient declines, rather than transplant center declines, should be used.

Virtual attendees also provided feedback on key questions. Some attendees supported cold ischemic time as the only threshold to use when defining a “hard to place” kidney, while others commented that location should also be considered. One attendee commented that cold ischemic time, as a result of late turndowns of higher quality kidneys, should not result in expedited placement. There was also feedback on specific anatomy characteristics that should be included in a definition of a “hard to place” kidney. Suggestions included: multiple vessels, enbloc, hard plaque, petechiae, poor flush and significant sclerosis. Another question focused on the number of candidate or program declines at which an organ could be considered harder to place or at risk of non-use. Attendees supported using a sequence number for the threshold, rather than number of center declines.

Region 1 | 08/29/2024

A comment was submitted stating that kidney allocation should be based on best use and efficiency, since kidney transplants are not as life-saving as heart or liver transplants. The commenter supports exhausting the list of patients who are “local” before considering any patients at further distances. They added that the single largest barrier to kidney allocation is programs who express interest in a kidney, only to turn it down after cross-clamp and that this must be addressed. Another comment suggested looking at kidney offer filters to help define “hard to place”. A virtual attendee stated that programs differ in their tolerance to cold ischemic time limits, so using that alone to define a “hard to place” kidney would not be useful. The attendee also does not believe there are specific anatomy characteristics that should be included in a “hard to place” definition.

During the meeting, attendees participated in group discussions and provided the following feedback:

· Cold ischemic time (CIT) should be major factor in defining hard to place kidneys. Attendees commented that their OPO allocates kidneys 12-24 hours pre-recovery, so if these were “easy to place” they should be accepted right after recovery.

· A member suggested that if programs thoroughly review the offers, there might not be a need for expedited or rescue pathways. Creatinine, age of donor are examples of things to be evaluated related to offers.

· An attendee remarked that many times their program doesn’t hear about kidney until 12-15 hours post-procurement. CIT is a major consideration but not the only one – they would also consider factors like KDPI and location of donor. For example, if there is a high KDPI kidney in New York and the program is notified it at 12 hours, they may not take it. Other important factors to consider would be biopsy, pump pressure, and anatomy.

· The group felt that determining allocation thresholds for defining “hard to place” is difficult. They remarked that it would be helpful to see the data within each KDPI group to see how far it goes. They said that once a kidney starts getting turned down, it develops a reputation based more on assumptions than actual organ quality, so attendees felt initially that “hard to place” should be stringently defined. 

UAMS Medical Center | 08/28/2024

After reviewing the Summer 2024 update to the continuous distribution of kidneys proposal, we appreciate the additional information provided and offer the following feedback. When an organ is classified as “hard to place”, we feel that the transplant center should receive an additional SRTR risk adjustment or waiver. This would allow centers to use “hard to place” organs and receive accurate risk adjustment for SRTR releases. Transplant centers are expected to carry the burden of the additional cost these organs incur such as increased length of stay, readmissions, long term care needs and frequent clinic/lab visits. The financial burden this places on transplant centers needs to be considered and solutions need to be identified before additional regulations are added. To classify an organ as “hard to place”, we feel a variety of factors should be considered including donor comorbidities, prior HD/CRRT, Cold Ischemic Time, Biopsy results, etc. We agree that the creation of clear and consistent definitions for “hard to place” organs will be beneficial to transplant centers and OPOs. While we support the creation of an expedited kidney placement policy, we firmly believe that this should not take away a surgeon/OPOs ability to quickly place organs. It is important that OPOs are allowed to “skip the list” and place organs with known aggressive centers quickly and efficiently versus requiring time consuming and tedious documentation.

Region 8 | 08/27/2024

Online members pointed out that as more centers decline a kidney, others become skeptical. A member suggested the number of 50 declines is the number at which an organ should be considered “hard to place” or at risk of non-use. The number of transplant center programs that have declined for all recipients is a very good indicator of kidney non-use. More specifically kidney centers who have been deemed "aggressive", if they decline it is more likely for non-use.

· An attendee explained there are many factors that make a kidney difficult to place. Kidney biopsy being one large factor in non-utilization.

· For specific anatomy characteristics or considerations that should be included in the “hard to place” kidney or kidney at increased risk of non-use, attendees suggested the following: plaque, stripped or multiple ureters, and biopsy results.

· An attendee commented that they did not recommend reducing the pediatric weight (even slightly) to reduce median travel distance.

· Another attendee commented how continuous distribution has greatly increased transportation logistics. For organs such as lungs, hearts, and even livers, charter jets are more mainstream. For kidneys, there is a real risk of increased non-use due to extended CITs by using commercial aircraft unless CMS makes an announcement that charter jets can be used as standard of care in transportation logistics over longer distances.

During the meeting, in-person attendees participated in group discussions and provided feedback on the following questions:

· Should a cold ischemic time (CIT) threshold alone be used to define a kidney as “hard to place” or at increased risk of non-use? 

o  The group reported that no, we should not use CIT threshold alone. Twenty hours of CIT may mean something very different in one donor than another. They suggested to consider factors in conjunction with CIT.

· Are there specific anatomy characteristics or considerations that should be included in a definition of a “hard to place” kidney, or a kidney at increased risk of non-use?

o Regarding specific anatomy characteristics - not biopsy but gross anatomy inspection, i.e. multiple arteries, presence of plaque in arterial veins, and overall kidney size.

· Allocation thresholds are based on the progress of allocation, specifically in terms of increasing numbers of declines. For example, allocation efforts reaching sequence number 200 means that the organ offer has been declined for 199 candidates. Alternatively, another allocation indicator under consideration could be the number of programs who have declined for all of their candidates. Is there a number of candidate or program declines at which an organ could be considered harder to place or at risk of non-use? 

o  Programs may be more reflective of when a kidney is getting harder to place. For example, if five programs pass, then OPOs may start getting nervous. It also depends on where you are/transplant program density.

OPTN Organ Procurement Organization Committee | 08/22/2024

The six-hour mark is indeed critical, as it significantly increases the risk of non-use for kidneys. The group seems to agree that decisions should be made more quickly, ideally before this point.

• Regarding moving through allocation better and identifying high-risk kidneys:
• There's a suggestion to create specific pathways for hard-to-place kidneys, especially those with high KDP scores.
• Consider cold ischemic time as a key factor in decision-making, starting from the cross-clamp time.

Develop clearer definitions and consistent language across OPOs and transplant centers to improve communication and decision-making.

On the issue of clear definitions:

• The group agrees this is necessary, both for OPOs and transplant centers.
• It's suggested that everyone should use the same language to ensure consistency.
• This standardization could help in making quicker, more informed decisions about organ allocation.

Region 4 | 08/19/2024

The kidney and pancreas group commented that continuous distribution should not take away the discretion of OPOs and surgeons to place kidneys quickly and efficiently. One attendee strongly advocated for giving priority to prior living donors noting that over the past 25 years, the number of prior living donors who are listed for transplant is very low but has a high impact on promoting trust in the system and is important for how the transplant community connects with the community at large. There was also a recommendation that the committee collaborate with the Expeditious Task Force as there is much work being done to assess kidney allocation and continuous distribution will directly affect the allocation policies as they are updated.  

Virtual attendees also provided feedback on key questions. Several attendees commented that cold ischemic time should not be used as the sole definition of hard-to-place kidneys.  They added that there are multiple reasons behind increased cold ischemic time including anatomical issues, hypertension, age, serologies, glomerular function, en bloc, etc., that need to be considered.  Specific to anatomy characteristics, attendees commented that the following kidney characteristics should be included in hard-to-place kidney definition: trauma to kidney/parenchyma or vasculature, greater than 3 arteries, dual or enbloc kidneys, cysts, surgical injury, discoloration/mottling, mass, excessive dense fat or plaque.  There were also on-line comments that hard-to-place kidneys should include decline thresholds of 25 centers and 250NM.

Region 2 | 08/16/2024

Feedback submitted online highlighted the need to limit penalties for transplant centers that accept organs with unadjusted risks, emphasizing that many donor organs now carry significant risks not accounted for in standard SRTR risk adjustments or KDPI. Examples include donors on dialysis before donation or with a history of acute kidney injury/renal failure. Once an organ is deemed "hard to place" after multiple centers decline it, it should not be scrutinized under standard SRTR criteria, and recipients of such organs should receive priority if the organ fails early. Additionally, there was support for giving patients a greater role in decision-making and transparency regarding organ preferences, as well as agreement on the importance of optimizing outcome modeling for hard-to-place organs. 

During the meeting, attendees participated in group discussions and provided feedback on the following questions: 

• Should a cold ischemic time threshold alone be used to define a kidney as “hard to place” or at increased risk of non-use?   
• Cold ischemia time (CIT) should not be the sole factor in decision-making for kidney transplants, as there are many other important considerations, such as medical comorbidities, the reliability of virtual crossmatch, and biopsy results, especially for hard-to-place organs. While some agreed that CIT is important, they noted that its definition varies, and for some, CIT should ideally be less than 24 hours from cross-clamp to departure from the OPO. 
• Are there specific anatomy characteristics or considerations that should be included in a definition of a “hard to place” kidney, or a kidney at increased risk of non-use? 
• The discussion highlighted key anatomical and medical factors that can make a kidney difficult to place, including multiple vessels, suspicious cysts or nodules, and specific vascular anomalies or damage, such as renal artery surgical injuries and poor flush quality. Additionally, medical comorbidities like a history of diabetes (DM), hypertension (HTN), and the use of continuous renal replacement therapy (CRRT) or hemodialysis (HD) during admission were noted as new challenges in kidney placement. 
• Allocation thresholds are based on the progress of allocation, specifically in terms of increasing numbers of declines. For example, allocation efforts reaching sequence number 200 means that the organ offer has been declined for 199 candidates. Alternatively, another allocation indicator under consideration could be the number of programs who have declined for all of their candidates. Is there a number of candidate or program declines at which an organ could be considered harder to place or at risk of non-use?   
• The discussion emphasized that the allocation of kidneys should consider not only the number of declines but also the specific centers that decline them, as surgeon behavior can significantly impact placement. Geographic factors and reasons for declines were acknowledged as driving influences in the process. A kidney should not be deemed hard to place based solely on decline numbers; rather, if five different programs decline offers to standard adult single organ candidates—excluding high CPRA, pediatric cases, or other organ transplant priorities—the organ should be flagged as at risk. The proposed distance for evaluating placements was noted as 150 to 200 nautical miles. Overall, both the quantity and reasons behind declines are critical in assessing a kidney's placement challenges. 

George Bayliss | 08/12/2024

The Kidney Committee has produced a thorough examination of the continuous distribution of kidneys and efforts to include increased use of kidneys and decreased waste of organs in this new point-based system of matching donated organs and recipients.

Continuous distribution always has always intended to decrease waste by using each patient's composite allocation score to match kidneys and potential recipients more closely. Adding a specific mandate to decrease non-use of organs while developing a transparent system for expedited placement of organs at risk of discard acknowledges that this may be difficult to do in the new allocation system.

The Kidney Committee has made useful suggestions on ways to reduce delays while individual programs exam offers, such as the shift to virtual cross matches; standardization of biopsy and pump data and closer examination of whether they are necessary; simultaneous allocation; expanded use of organ allocation filters to help reduce risk of programs becoming overwhelmed with the need to examine many orders simultaneously.

The Kidney Committee writes about the need for flexibility in determining what donor and organ characteristics, and logistical aspects will define hard to place and need to offer a kidney for expedited placement or a rescue pathway. They note the difficulty OPOs might have in deciding which centers are able to take such a challenged kidney. Universal use of offer filters would help create an initial screen, in addition to past OPO experience with centers.

Another idea would be to include as part of the composite score an indicator of whether a candidate is willing to take a rescue kidney. This would only come into play when a kidney has hit the threshold of “hard to place.” It would allow ranking according to the standard composite allocation score but identify candidates for one of these kidneys early.

The Kidney Committee’s future updates on continuous distribution should consider what effect new efforts to assess programs on organ acceptance as a function of expected acceptance and the Department of Health and Human Services “Increasing Organ Transplant Access” model will have on allocating “hard-to-place” organs.

Lydia Clipper | 07/31/2024

The anti a1 question of yes or no for eligibility in the UNOS system is flawed. When an answer is updated, the system automatically uses the date of entry. Because being eligible for anti a1 is date specific the system should ask to document the date the specimen was obtained so the timeframes may be figured appropriately according to the date of the blood draw that makes them eligible.

She Gay | 07/31/2024

I am excited we have more living donors stepping up than in the past. I believe this will help reduce the numbers of kidney candidates. Sadly, the kidney wait time is too long. I am a strong proponent of our state candidates first considered if all the criteria is equal.

Keith Plummer | 07/31/2024

I would like to see a system that centers can use to convey current placement on “the list”. My surgeon has mentioned to me that some kidneys are shipped with the recipients then needing a blood transfusion to accept the kidney. He claims most of these type fail and the organs are wasted.