Comments

OPTN Living Donor Committee | 09/13/2024

The OPTN Living Donor Committee thanks the OPTN Heart Transplantation Committee for their efforts on the Update on Continuous Distribution of Hearts paper.

The Committee strongly supports incorporation of prior living donor priority into the composite allocation score for heart continuous distribution as prior living donors should be acknowledged and receive priority if they were to require a transplant after living organ donation. The Committee supports prioritization of all prior living donors. Although this prioritization status would apply to only a very small number of individuals, it would have a high impact within the living donor and transplant communities by acknowledging the altruism of living donors, demonstrating the value of reciprocity, and recognizing the need to support living donors. The Committee appreciates the OPTN Heart Transplantation Committee’s support of living donors as valued members of the transplant community. The Living Donor Committee offers the following 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) offers the following comments in response to the committee update, “Continuous Distribution of Hearts Update, Summer 2024":

•The AST remains in support of

-all sub-categories of priority except for post-transplant survival, with the proviso that a second iteration of this policy incorporates post-transplant survival into prioritization. A suggestion for eventually incorporating post-transplant survival is to include this attribute for weighting but assigning all candidates the same score until an accurate predictive model is developed.

-standardized allocation points for highly sensitized candidates, if unacceptable antigens are recorded in Donornet.

-continued pediatric priority, including continuous monitoring pre- and post-implementation to ensure vulnerable populations such as pediatric recipients are not impacted by unintended consequences not evident in the ongoing analyses to develop a heart continuous distribution allocation algorithm. The current proposal removes the additional priority that children receive in existing policy for pediatric donors. The AST recommends that the Committee consider modeling the addition of points for pediatric candidates when the donor is pediatric (or to add points for donor/recipient pairs that fall within the age brackets mentioned in the comment below).

•The AST’s overarching concern is how the new policy will manage medical urgency. Medical urgency continues to be prioritized in every iteration of heart allocation, without specific regard for age or co-morbidities – attributes which drive post-transplant survival. There is a broad range of risks within each status and thus all the patients within a status should not receive the same points or weight. Data should drive this separation of risk because post-transplant survival remains somewhat problematic, given associations with center expertise (access) and socioeconomic circumstances (insurance coverage of important therapies). One way to incorporate age and co-morbidities into pre-transplant priority is to give points for an age differential less than or equal to 15 years between the candidate and donor. If a candidate is 70 years old, they are prioritized to receive donor offers between 55-70. If a candidate is 25 years old, they are prioritized to receive donor offers between 25-40. This age bracketing component is part of the French Allocation System. All candidates are open to all age donors but gain priority points for age bracketed donor pools.

•The heart allocation system implemented by the OPTN in 2018 included more than 40 mandatory variables collected to move to a cardiac allocation score (CAS). How will these data be used in the development of the heart continuous distribution system? While the hope and goal of continuous distribution is that the different components of the CAS can be changed more expediently without requiring a total policy overhaul, and there are new components that are of great interest to the transplant community (biologic disadvantage), medical urgency of both adult and pediatric heart candidates remain at the forefront of concerns in the heart transplant community.

•The AST believes that patients in need of re-transplantation for severe cardiac allograft vasculopathy including restrictive cardiac physiology (as defined using the International Society for Heart and Lung Transplantation standardized nomenclature for CAV3), should have a higher status than current policy provides due to their high mortality risk.

•The AST agrees with and would like to reiterate prior public comments that prior durable left ventricular assist devices (LVAD) should provide priority status similar to having been a prior organ donor. Every patient who accepts an LVAD instead of a heart transplant allows for a heart that can be transplanted in another patient who anatomically cannot accept LVAD therapy. Given that some patients on LVAD do recover heart function enough to be weaned off, this further increases the donor pool for patients who do not recover.

Region 9 | 09/10/2024

A comment was submitted online that the low prioritization of proximity efficiency in the VPE results did not seem appropriate, given the narrow travel and cold ischemic time windows for donor hearts.  Another commenter stated support for the general priority of attributes, as well as the relatively low priority of the proximity efficiency attribute. 

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

• The group mostly agreed with the prioritization of attributes as identified by the VPE results. 
• They felt it was appropriate to prioritize medical urgency over post-transplant outcomes, as they are not well known.   
• The group supported the lower relative priority for proximity efficiency. 
• Those in the group with a personal connection to donation and transplant requested more information about continuous distribution that can be easily understood by the average person. A patient may not be receptive to details at the time they are listed and waiting for a transplant, but details should be available to them. 

Mythreyi Govindarajan | 09/06/2024

Thank you for the detailed analysis and sharing the outcome of Values Prioritization Exercise. Ranking biology and composition compared to prior donor living can be re-evaluated especially in case of pediatrics where the kid will not have the ability to sign up for prior donor living.

OPTN Transplant Administrators Committee | 09/04/2024

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

• The Transplant Administrators Committee wants the Heart Committee to keep in mind that the rise of normothermic technologies has significantly increased the costs associated with heart transplants. This trend may reduce the accessibility of transplants for patients at centers that cannot implement such technology due to financial constraints and long-term financial impacts. 

Overall, the Committee is supportive of the developments on Heart Continuous Distribution and advises that equity be considered in the development process.

Region 6 | 09/03/2024

During the meeting, in-person attendees participated in group discussions and commented that they generally agreed with the VPE (Value Prioritization Exercise) priorities, noting that the identification of prior living donor was interesting, as it offers a way to give back to the community that donates. They also commented that candidates with prolonged waiting times, especially those with durable LVADs, could be at a disadvantage if waiting time is given low priority. They added that the committee will need to determine how to prioritize those on long-term LVAD support. There was also feedback on the relatively low prioritization of the proximity efficiency attribute suggested by the VPE results and noted that proximity efficiency involves the cost and equipment needed to procure distant hearts and brings in quality considerations for transplant centers. Another attendee pointed out that lessons learned from lung continuous distribution indicate that logistical and financial constraints will affect transplant centers. They added that small programs, in particular, are vulnerable, which could lead to closures or behavioral changes. Since over 50% of heart transplant centers fall into the low and mid categories, many could be impacted. One attendee questioned why outcomes after transplant was weighted so low. They went on to comment that there should be a standard weighting for futility across all organs.

Virtual attendees also provided feedback on key questions. One attendee commented that the priority of the attributes in the VPE results seem reasonable, but since a majority of the respondents were transplant clinicians, the results may not reflect the values of the patients, families and members of the public. They went on to comment that they supported the low priority that proximity efficiency received in the VPE results if travel costs are not a consideration, and the only goal is maximizing the number of transplants.

Anonymous | 08/31/2024

I agree with the general priority of attributes, but have concerns: It makes sense to encourage living donation as it increases the available pool of organs. However, could a living donor attribute result in a disparate impact for a candidate who is unable to afford time lost on the job, childcare expenses, or other indirect costs associated with being a living organ donor? If so, how can this be mitigated or resolved?

While I am not opposed to the low prioritization of the proximity efficiency attribute, OPTN should be cautious and realistic when it comes to determining acceptable geographic distances so as not to jeopardize the organ's viability.

Regarding consideration of the use of new perfusion technologies and their impact on travel distance, I am concerned smaller programs might not be able to afford these technologies. This could put their patients at a disadvantage.

I support an attribute of post-transplant survival and look forward to updates on the development of appropriate patient metrics.

Once implemented, the policy must be closely monitored so OPTN can consult with the community to make adjustments when concerns are identified that might undermine equity and/or efficiency.

I am a heart recipient who recently learned of the public comment process. I needed to get up to speed quickly on the continuous distribution concept. The OPTN website has a closer look section on continuous distribution. The section has relevant and easy to understand discussion and videos. I suggest adding a link to the continuous distribution closer look section going forward when seeking public comment on any proposal relating to continuous distribution.

Region 1 | 08/29/2024

A comment was submitted supporting the results of the Values Prioritization Exercise (VPE) and the work of the committee. Another online comment requested the committee consider a higher level of priority on proximity efficiency than what came out of the VPE. They also believe that post-transplant survival should factor into heart continuous distribution, as it is an important part of utility. The commented also noted that thoracic NRP may have an impact on survival and allow hearts to be allocated to more distant candidates. 

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

•Regarding proximity efficiency, traveling further distances and new preservation technology result in higher and higher costs for programs, which can impact access and equity. Some programs are not able to keep up with these costs, which could jeopardize the survival of small programs.  

•The group had several heart patients participating in the discussion, and they appreciated having the patient perspective. 

Gloria Gubbels | 08/27/2024

Would it be possible to identify heart donors by blood type through a computer program? 1. Collection of data to show where high volume of certain blood types is in the territory assigned to harvest hearts. 2. Collect the data from driver license facilities, physician offices etc. 3. When someone is listed1-6 put the person in the category but with people of the same blood type in that category. "Life is precious, continue your good work that you do for people." Gloria Gubbels

Region 8 | 08/27/2024

Online feedback showed agreement with general priority of attributes as identified by the VPE results. However, an attendee said except the case in which a recipient has been waiting a long time since those recipients are more likely to die waiting on a heart organ. There was some agreement with the relatively low prioritization of the proximity efficiency attribute suggested by the VPE results. But one attendee disagreed with the low prioritization of the proximity efficiency attribute suggested by the VPE results. The attendee explained they believed the thoracic organ offers distance is important, with the understanding that as new preservation technologies are available and become standardized, distance should be less of a deciding factor.

· An attendee requested clarification on multivisceral requirements in allocation. Another attendee pointed out that continuous distribution framework requires more transparency in candidate rating, and explained how factors like religious beliefs affecting medical choices are weighted for unbiased evaluation. They said clarification is needed on how to handle special populations, such as Jehovah's Witnesses refusing blood transfusions, and addressing growing concerns about their acceptance rates. They said it would help to share simulation data on the impact on different patient groups, including those requiring bloodless transplantation. The framework should explain the balance of ethical considerations of equity and utility, reflecting OPTN Ethics Committee recommendations. Additionally, information on the system's adaptability to incorporate advancements in bloodless transplantation and address disparities over time is crucial. And developing patient education materials on fair access regardless of religious beliefs would enhance understanding and potentially contribute to increasing overall transplant numbers.

· For pediatric recipients, attendees recommend constructing a mechanism to retain pediatric priority for pediatric donors, at least to some degree. If the outcomes of continuous distributions of hearts mirrors the outcomes for lung (i.e. traveling further distances for organs), they had concerns about limited access to donor organs in pediatric programs. Further, pediatric programs do not have as much access to organ preservation devices which limits their ability to travel further for organs.

· An attendee implored the committees to consider allocation efficiency in developing equitable organ allocation in relation to the impact of donor families. With the implementation of the lung continuous distribution allocation, the allocation process is extended, adding time required to facilitate gifts given by donor family. On average, donor cases are taking 50-60 hours prior to going to the operating room, which is hard on donor families. The clarification of the multi-organ priorities should help. The attendee explained that as we improve the system, we need to consider the needs of the donor families.

 

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

·  Do you agree with the general priority of attributes as identified by the VPE (Value Prioritization Exercise) results?

o  The group agreed with medical urgency and pediatric priority but felt that candidate biology should have more priority than prior living donor. They also felt that being located close to the donor should have more priority than in the exercise.

·  Do you agree with the relatively low prioritization of the proximity efficiency attribute suggested by the VPE results?

o  A lung colleague described their lung continuous distribution experience and recommended prioritizing pediatric donors for pediatric candidates due to better outcomes.

· The Committee is very interested in hearing from those with a personal connection to organ donation and transplantation and would like to know if there is any additional information the OPTN could provide to help you better understand the concepts associated with the continuous distribution of hearts allocation framework?

o  Recipients agreed with VPE but felt that knowing they are active on the list and offers are coming in is more important and want to consider how to keep families aware of what is happening with organ offers. 

Region 4 | 08/19/2024

The heart group discussed the results of the VPE and agreed that medical urgency should be the primary factor in score. 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. It was noted that for patients with high medical urgency, their points would be so substantial that even if a lower-status patient accumulated additional points from other categories, it would be nearly impossible to surpass the medically urgent patient. Another key discussion focused on the impact of continuous distribution on multi-organ candidates, with concerns raised from an OPO perspective about the challenges of matching organs and the potential for non-compliance with policy.  

Virtual attendees also provided feedback on key questions. Several attendees suggested that proximity should have a higher priority due to increased cold ischemic time with travel and rising travel costs, which threaten program survival. One attendee recommended that post-transplant survival be prioritized similarly to the lung model. Another suggested prioritizing medical urgency, including patients with LVADs. There was also a recommendation for the committee to maintain ongoing communication with the community by providing regular updates. 

Region 2 | 08/16/2024

Feedback submitted online highlighted concerns and support for the new organ allocation system, particularly regarding its impact on smaller transplant centers and rural communities. While there is general support for the inclusion of additional factors in the continuous allocation model, one attendee expressed concern that too much emphasis is being placed on prior living donors, suggesting that more weight should be given to biologically difficult-to-match candidates. There was also apprehension about the financial burden the new system might impose, especially on smaller centers. As seen with the lung allocation transition to a Continuous Allocation Score (CAS), there has been an increase in travel distances and upfront costs, which could force smaller centers—particularly those serving rural communities with limited financial means—out of the system. This raises concerns about how the transplant community will support these centers and ensure equal organ distribution for all patients. Overall, there is acknowledgment that helping those on the waitlist should be a priority, as it would ultimately benefit both costs and health outcomes. However, there is a need for careful consideration of the potential inequities the new system could create. 

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

• Do you agree with the general priority of attributes as identified by the VPE (Value Prioritization Exercise) results? 
• The feedback on the VPE results was generally supportive and in line with expectations. However, concerns were raised about the negative impact of the current attribute list on stable LVAD (Left Ventricular Assist Device) patients, as it fails to consider the duration of mechanical circulatory support. While the new system is seen as more equitable and patient-centric—similar to the lung allocation model—there is worry that not everyone fully understands the implications of their prioritization choices. One significant concern is the low emphasis placed on post-transplant outcomes. The fear is that this could lead to a system where patients with a longer potential survival suffer poorer outcomes due to extended wait times, while others receive transplants but with significantly worse long-term results. Such extreme outcomes could ultimately be unacceptable to all involved. 
• Do you agree with the relatively low prioritization of the proximity efficiency attribute suggested by the VPE results?  
• The discussion on Placement Efficiency raised concerns about equitable access to organs, particularly when some programs have the resources to facilitate long-distance travel, potentially disadvantaging others. The inefficiency of organs crisscrossing the country was highlighted as a poor use of resources. There was acknowledgment of the increasing use of organ perfusion systems like TransMedics, which could improve the ability to transport organs over longer distances. However, the true impact on organ procurement and outcomes is still uncertain and may need to be reassessed in the future. 
• The Committee is very interested in hearing from those with a personal connection to organ donation and transplantation and would like to know if there is any additional information the OPTN could provide to help you better understand the concepts associated with the continuous distribution of hearts allocation framework?  
• An attendee noted that the videos and graphics on the OPTN website are simple and easy to understand, which is a good thing.  

Luke Preczewski | 08/02/2024

The proposed weighting does far too little to take into account the logistic and financial aspects of allocation. Past changes have led to a system in which far too many unnecessary flights occur. This has dramatically increased logistic challenges and costs for transplant centers. Additionally, organs that could be successfully transplanted with lower transportation and perfusion costs are going on machines to go greater distances at astronomical costs. This trend is not financially or logistically sustainable, and any future changes need to take this seriously. Unfortunately, this proposal does not.

Jake Kleinmahon | 08/01/2024

Thank you for the careful consideration of characteristics that will go into the future continuous distribution system. I do have a concern about the inclusion of being a previous living donor as a factor. Living donors in pediatrics is ethically challenging. As discussed in the paper "Minors as Living Solid-Organ Donors Pediatrics (2008) 122 (2): 454–461." there is a risk that further incentivizing living donation may lead to coercion of a minor to donate or feelings of guilt or decreased self-worth for minors who have chosen not to donate or whose parents have not let them donate in the past. While adults have the ability to make decisions and consent on their own, lumping children into this is a slippery slope. While pediatric patients will be allocated additional points in the proposed new system, many of them will not have the ability to access additional points if consideration of a living donation is in the algorithm. While a fair percentage of respondents to the survey listed prior living donation as a fairly important consideration, many of the respondents do not take care of children so do not have the perspective of how this may be problematic when applied to the pediatric population. Thank you for the hard work put into coming up with this system and the consideration of my concerns.

She Gay | 07/31/2024

I am a heart recipient 2002 and a heart/kidney recipient 2012. Currently my brother has been on the waiting list for a heart for 4 1/2 years for Status 4. He has an LVad and recently was upgraded to Status 2 Inpatient. My concern is for those waiting in our state and the number of hearts going out of state - out of region. When a local candidate is the same status and other qualifications, I would hope hearts would stay in state. Due to quality of organs being better in the 4-6 hour range (unless "heart in box"), I feel this is an important part of the allocation process.

Aurangzeb Baber | 07/31/2024

There should be more discussion in regards to medical urgency. The current system takes into account medical urgency but still has drawbacks especially when it comes to multi organ failure and need for multi organ transplant. One specific example is patients in need for heart liver or heart lung transplant. In reality they are much sicker but objective data like hemodynamics might not give the full picture.