Comments

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.