Comments

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

UCSD Center for Transplantation (CASD) appreciates the effort the Heart Transplantation Committee has put into keeping the community updated on the progress of the development of the Continuous Distribution Framework as well as the opportunity to provide feedback.

While we generally support the concept, we have some concerns that the current attributes related to placement efficiency included in the first iteration of the framework are lacking. With novel ways for heart preservation and the ability to safely travel for adequate hearts eliminates this as a variable that should be applied to all hospitals. Resources for transplant are not equal and a program such as ours that does emphasize finding donors even if travel is required, should not be used against us when allocating organs. Furthermore, programs in less populous areas or those bordered by other countries or bodies of water are inherently disproportionally impacted and have less organ visibility due to a smaller area where they would get priority.

One team member also noted that with regards to the specific feedback requested, while LVAD should be accounted for, we do not believe candidates assigned to adult heart status 4 using the LVAD criterion should be allowed to receive a higher percentage of medical urgency priority points than candidates assigned to the highest medical urgency rating groups, such as candidates on VA ECMO.

Anonymous | 03/19/2024

Additional priority should be given to those with VAD for extended periods of time whether or not they have complications.

Ed McGee | 03/19/2024

Durable LVADs are a cornerstone of the treatment for heart failure. it has become impossible to transplant patients with durable LVADs in the current system. increasing the status of durable lvads would mitigate the reticency to deploy durable LVADs in a timely manner. The 30 day increased status makes no sense and is outdated and provides no advantage to most recipient.

ECMO in patients over 50 is highly morbid and often mortal. patients in this age group should not be granted status 1. most can receive a durable LVAD with acceptable mortality and improve post transplant outcomes.

type O donors should ideally be allocated to Type O recipients. doing so would mitigate the disadvantage of O's receiving transplant. a weighted system that takes this into account should be organized.

Thanks for your attention and efforts.

STAVROS DRAKOS | 03/19/2024

This comment is being submitted on behalf of the following individuals (in alphabetical order):

Christian Bermudez, Emma Birks, Stavros Drakos, James Fang, Maryjane Farr, Daniel J Goldstein, Ulrich Jorde, Manreet Kanwar, Snehal Patel, Omar Wever Pinzon, Joseph Rogers, Kelly Schlendorf, Craig Selzman, Palak Shah, Scott Silvestry, Randall Starling, Josef Stehlik.

First, we would like to thank the OPTN heart committee members for their thoughtful approach to continuous distribution.

In abdominal organ transplantation a prior living donor, who has contributed "net positive 1” organ to the donor pool, is rewarded with priority if they eventually require abdominal organ transplantation. Using this as a conceptual precedence we are proposing that transplant-eligible patients with advanced heart failure (HF) who pursue a durable LVAD bridge-to-recovery (BTR) strategy (i.e. essentially contributing “net positive 1” organ back to the donor pool) be provided higher wait-list priority if they eventually require heart transplantation.

Furthermore, another conceptual precedence that applies to the LVAD BTR strategy is the “safety net” rule which incentivizes programs to avoid using organs that they may not be absolutely necessary.

In practice, we suggest this could be implemented by adding two pathways:

1. Patient Access Component: advanced HF patients who undergo LVAD weaning (via durable pump explantation or decommissioning) after pursuing a BTR strategy, who subsequently experience recurrence of HF requiring transplantation, are given priority.

2. Patient Access Component: advanced HF patients with a high likelihood of recovery on durable LVAD support (young age, shorter duration of HF, non-ischemic cardiomyopathy, and other clinical characteristics consistent with high likelihood of cardiac recovery – REF #1) who enter a recovery program would receive additional medical urgency points if the LVAD weaning process is unsuccessful and they decide to pursue transplantation. Such a recovery program would need to provide evidence of optimization of guideline directed medical therapy (GDMT) and echocardiographic monitoring for at least one year (REF #1).

Can the proposed change benefit the donor allocation system in a significant and meaningful way?

a) The proportion of advanced HF patients/candidates for heart transplantation that can be affected by this change is not trivial and can meaningfully contribute to easing waiting list congestion. Specifically, two STS INTERMACS studies (REF #2-3) and other multicenter studies (REF #4-5) demonstrated that candidates for heart transplantation/advanced HF patients with reduced left ventricular ejection fraction (LVEF) can achieve the following phenotypes post LVAD support: (a) 10% Responders: LVEF improved an average of 27% absolute units (range 23-33%) and reached an absolute level > 40% with cardiac dimensions decreasing to within normal range; (b) 30% Partial Responders: LVEF improved an average of 9% absolute units (range 6-14%) but did not reach an absolute level of > 40% but was associated with cardiac dimensions decreasing to within normal range, and; (c) 60% Non-Responders: no significant improvement in systolic function with cardiac dimensions decreased significantly but not reaching normal range.

b) Following LVAD weaning, the sustainability of cardiac improvement and associated survival is similar to the ISHLT registry post-transplant survival and is accompanied by significant improvements in exercise capacity and quality of life. These findings have been reproduced in single- and multi-center studies (REF #2,3,6-10). Therefore, the duration of the achieved benefit to the waitlist decongestion will be lasting and not transient.

c) A recent publication using the UNOS dataset demonstrated that rates of cardiac recovery and waitlist removal in the setting of temporary mechanical circulatory support for acute HF were eight times higher before the 2018 UNOS allocation change (REF #11). This finding demonstrates that in the absence of reliable access to transplant when initial attempts of cardiac recovery fail, clinicians and patients will opt for “early” heart transplant as a safer strategy than BTR LVAD. However, this results in higher utilization of donor allografts for patients that could have achieved cardiac recovery, instead of these allografts being utilized for patients with no such option.

The upcoming donor allocation change offers an opportunity to incentivize bridge-to-recovery LVAD strategy for appropriate patients which could obviate the need for heart transplantation in a proportion of advanced HF patients and thereby add allografts back to the donor pool.

REFERENCES

1. Kanwar M, Selzman C, Ton VK, et al. Clinical myocardial recovery in advanced heart failure with long term left ventricular assist device support. J Heart Lung Transplant. 2022;41:1324−1334.

2. Topkara VK, Garan AR, Fine B, et al. Myocardial recovery in patients receiving contemporary left ventricular assist devices: Results from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). Circ Heart Fail. 2016;9. 10.1161/CIRCHEARTFAILURE.116.003157 e003157

3. Wever-Pinzon O, Drakos SG, McKellar SH, et al. Cardiac recovery during long-term left ventricular assist device support (INTERMACS study). J Am Coll Cardiol. 2016;68:1540-53.

4. Shah P, Psotka M, Taleb I, et al. Framework to classify reverse cardiac remodeling with mechanical circulatory support: The Utah-Inova Stages. Circ Heart Fail. 2021;14:e007991.

5. Drakos SG, Wever-Pinzon O, Selzman CH, et al. Magnitude and time course of changes induced by continuous-flow left ventricular assist device unloading in chronic heart failure: insights into cardiac recovery. J Am Coll Cardiol. 2013;61: 1985-94.

6. Birks EJ, Drakos SG, Patel SR, et al. Prospective Multicenter Study of Myocardial Recovery Using Left Ventricular Assist Devices (RESTAGE-HF [Remission from Stage D Heart Failure]). Circulation. 2020;142:2016-2028

7. Jakovljevic DG, Yacoub MH, Schueler S, et al. Left ventricular assist device as a bridge to recovery for patients with advanced heart failure. J Am Coll Cardiol. 2017;69:1924-1933.

8. Antonides CFJ, Schoenrath F, de By T, et al. Outcomes of patients after successful left ventricular assist device explantation: a EUROMACS study. ESC Heart Fail. 2020;7(3):1085-94.

9. Birks EJ, George RS, Firouzi A, et al. Long-term outcomes of patients bridged to recovery versus patients bridged to transplantation. J Thorac Cardiovasc Surg. 2012;144(1):190-6.

10. Patel SR, Knierim J, Goldstein D, et al. Long-Term Clinical Trajectory after Durable LVAD Weaning: An International Registry Report. JHLT 2023; 42 (4): S105-S106

11. Topkara VK, Sayer GT, Clerkin KJ et al. Recovery with temporary mechanical circulatory support while waitlisted for heart transplantation. J Am Coll Cardiol. 2022;79:900-913.

Abiomed | 03/19/2024

Abiomed applauds the OPTN heart committee’s efforts to develop a continuous distribution framework for the equitable allocation of hearts. The patient’s composite allocation score will incorporate medical urgency as one component of the overall score.

The current proposal includes Medical Urgency Groupings for consideration in Table 4. Abiomed requests the committee reconsider Medical Urgency Grouping 2. Table 2 of the OPTN proposal sites deaths per 100 active years waiting as a reference for consideration of patient criteria to define medical urgency. The deaths sited for patient criteria include:

1. biventricular assist device (BiVAD) 55.64,

2. ventricular fibrillation (VF) or ventricular tachycardia (VT) 25.81,

3. MCSD + RV failure 23.92,

4. percutaneous endovascular LVAD 18.73, and

5. TAH 17.55.

These criteria have similar death rates per 100 active years waiting, and warrant being grouped together as group 2.

IABP, with a death rate of 6.75, is significantly less of a risk and should be included in a lower priority group. The logical placement for IABP would be with Re-transplant in medical urgency group 6. The Re-transplant death rate per 100 active years waiting is higher than IABP at 7.45. The placement of IABP in group 2 is unlike any other grouping, and should be strongly reconsidered.

A recent review of the United Network of Organ Sharing registry revealed excellent outcomes of patients who were bridged to heart transplant with Impella 5.0 and 5.5, achieving 1 year post transplant survival of 91.3% and 94.6% respectively.(1) Furthermore, the University of Pennsylvania reported 1 year post transplant survival rate of 89.5% using Impella 5.5.(2)

Impella 5.5 temporary left ventricular assist device optimizes care of heart transplant recipients by providing superior hemodynamic support, mobility, improved renal function, and right ventricular function as reported by Mayo Clinic Jacksonville.(3) These published outcomes reveal the ability to support patients in cardiogenic shock, promote end-organ recovery, and achieve an excellent post-transplant survival rate.

Thank you for the opportunity to publicly comment on the proposed continuous distribution scoring and proposed medical urgency grouping. Abiomed appreciates your consideration of our requests.

1. Hill, M et al. Waitlist and transplant outcomes for patients bridged to heart transplantation with Impella 5.0 and 5.5. Journal of Cardiac Surgery, October 2022.

2. Cevasco, M, et al. Impella 5.5 as a bridge to heart transplantation: Waitlist outcomes in the United States. Clinical Transplantation, June 2023.

3. Haddad, O et al. Short-term outcomes of heart transplant patients bridged with Impella 5.5 ventricular assist device. ESC Heart Failure, March 2023.

Infinite Legacy | 03/19/2024

Infinite Legacy encourages the Heart Transplantation Committee to consider donor factors in prediction models and align with allocation policy.

BrioHealth Solutions | 03/19/2024

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Intermountain Medical Center | 03/19/2024

Our Program supports prioritizing for the time after LVAD, the recipient biology ( sensitization and blood type), however we suggests low prioritization for placement efficiency due to the risk of decreased the broad sharing of donors which might affect transplant centers in states with lower population and hospitals density compared to other states in the same region.
We agree that post transplant survival is not included in the new proposed allocation system.

We would suggest to provide more information regrading:

- Are these attributes assessed between different recipients in the same listing status based on the current allocation system ?

- Does time on the list in general still count?

- Include a main session at ISHLT meeting to discuss and explain the new allocation along with lessons that learnt from the lung experience.
Thank you

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

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Anonymous | 03/19/2024

There are a lot of barriers to the current upgraded system from 2018 that causes a disservice to several types of pt's, including LVAD pt's, especially those with complications, pt's with ABO O blood type, and those that have an increased PRA. The system makes it difficult to help to these patients get transplanted in a timely manner. These types of patients should get points for those particular areas if the system goes to continuous distribution design.

It is always the goal to get patients transplanted faster, have more offer opportunities, and give priority to the sickest patients. the thought of a continuous distribution system for hearts is great if it works correctly and the call system is changed as well. it needs to be more efficient and effective than just roll calling the system to alert the first whatever - 100 of the donor list or whatever the OPO decides - there is no set system, and it doesn't make call very bearable when you are given the same offer for each person we have on that donor list, instead of one call for all of the patients.

Lastly, a continuous distribution system would be good if it helps those that need it most of listed patients. one being LVAD pt's with complications. For a status 3 they can meet these qualifications for a Status 3 at home, but if 1 thing is missing and an exception letter is needed, that null and voids their status 3 listing at home, which I do not believe is fair, since otherwise they can be outpatient. there needs to be more flow, fairness, and consistency with a new system after we have definitely identified many complications and barriers with the current updated system.

Anonymous | 03/19/2024

There are inequities within statuses from the 2018 allocation changes. The system is tedious and we're all getting adjusted to transplanting sicker patients. I believe the new system should increase priority for LVAD device complications. Post transplant survival as a metric would be difficult to develop as an attribute as there is not a validated tool at this time. Programs avoid people who they believe won’t survive to do no harm, SRTR data, and to maintain a status of excellence.
The focus of continuous distribution is to increase the number of transplants that we do more equitably. The focus should be put into the infrastructure for the call process. This is leading to provisional yes without initially reviewing. We are told testing is unable to be completed or we must hurry up because the family put stipulations on the OR time. I believe brain dead donor should have a spot for different inclusion criteria.
Living donation is an altruistic and beautiful gift; however, it should have no bearing in the heart transplant allocation score. If someone donates a kidney and they begin to have kidney failure, then they should be prioritized for the organ they gave. Giving an organ should not allow you to jump the line for a different organ.
O blood types wait the longest and anything that can ease their burden should be considered. Consider allocating all the way through status 4 before allocating to other blood types.
Although PRA makes it difficult to transplant individuals at times; programs used to desensitize and now they are not. Should stipulations be placed that this should occur after some, or all efforts have been exhausted to desensitize.

OPTN Transplant Administrators Committee | 03/19/2024

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

· The Committee advises considering driving distance/time when developing the Placement Efficiency attribute. It was mentioned that prioritizing local organ placements over flying when possible could aim to avoid situations where organs crisscross metropolitan areas and could enhance organ utilization.

· It was cautioned that there could be unintended consequences for smaller heart transplant programs if there becomes a greater need to use expensive technologies for organ perfusion for longer-distance procurements.

Overall, the Committee is supportive of the developments on Heart Continuous Distribution and advises that priorities around travel logistics and equitable access for smaller programs be considered in the development process.

Albert Hicks MD, MPH | 03/19/2024

I applaud UNOS in tackling the current allocation system and attempting to address disparities in transplant access. In our current state patients with left ventricular assist devices essentially are not receiving hearts unless they have major complications which can affect their post-transplant morbidity and mortality. O blood type has consistently been associated with the longest transplant wait times of any blood type. Lastly patients that are highly sensitized inherently have a limited pool of hearts from which to match due to hemocompatibility. Many of the issues disproportionately effect Black patients who also suffer the highest morbidity and mortality at all stages of heart failure, with mechanical support, on the waitlist, and post-transplant.

LVAD wait time and sensitization need to be included into the current continuous distribution model for hearts and weighted heavily. For LVAD wait time a patient should receive points for every year they remain on the transplant list with no cap. We should still prioritize acuity, and MCS complications in the policy.

Region 10 | 03/19/2024

Overall, there was appreciation for the committee's efforts, and support for continuous distribution. Participants expressed interest in understanding specific variables under "medical urgency" and inquired about potential shifts away from the heavy reliance on mechanical devices in the current allocation system. There was acknowledgment of the pressure on OPOs to transplant more organs, with hopes that expedited placement will enhance efficiency without compromising equity. One attendee recommended incorporating commonly used "standard" exception requests as attributes to minimize the use of exceptions and potential inequities. Additionally, there was agreement on including Ventricular Assist Device (VAD) status as an attribute, with considerations for stability on VAD and measures to prevent manipulation of the system. Measurable indicators of end-organ perfusion may be useful, for example, to help define medical urgency. Lastly, there was consensus on monitoring the impact of the continuous distribution model on equity during implementation.

Region 9 | 03/19/2024

A member agreed that time on LVAD should give candidates some points, and that including post-transplant survival would help ensure longer term successful transplants. An attendee expressed support for not including post-transplant survival in the first iteration of continuous distribution because centers would be disincentivized to transplant high risk patients. Another member was not sure why continuous distribution of hearts would give living donors priority because while it makes sense for kidney or liver allocation, living donors are not contributing to the donor pool for hearts. A member was interested to know how people with complex congenital heart disease who do not do well on LVADs would be accounted for in continuous distribution. An attendee expressed strong support for including points for living donors. An attendee supports the overall concept and would like to see post-transplant outcomes included in the future. 

OPTN Transplant Coordinators Committee | 03/19/2024

The OPTN Transplant Coordinators Committee appreciates the opportunity to provide public comment on the efforts to further develop Heart Continuous Distribution.

The Committee commends the efforts to actively engage with relevant stakeholders, including pediatric heart transplant experts, in the development of the pediatric classifications. Continued collaboration and incorporation of diverse perspectives, particularly from representatives of vulnerable pediatric populations, will strengthen the proposed framework.

Anonymous | 03/19/2024

We applaud the work of the committee to champion improved distribution and utilization of donor hearts. With regard to Proximity efficiency, data is starting to demonstrate that new technologies will emerge in the next few years that allow donor hearts to be preserved for significantly longer periods of time and to travel over greater distances. We believe the allocation system should prepare to embrace the additional flexibility offered by new technologies, to the extent that the results are demonstrated in well-designed studies and the economics associated with the technology are sustainable. There should be thought given to how and when to adjust the Proximity efficiency attribute as preservation improves.

Khadijah Breathett, MD, MS, FACC, FAHA, FHFSA | 03/19/2024

I applaud the committee on creating changes to enhance needs based access to heart transplants. The 2018 change in policy has been associated with cultural changes in provision of durable ventricular assist device therapies presumably related to lower likelihood of receiving a heart transplant post VAD in the post versus pre 2018 period. Thus, durable VAD volumes have declined post 2018. I would encourage the committee to consider how planned changes may impact existing disparities in receipt of heart transplant for patients according to patient race, ethnicity, and sex.

-The inclusion of sensitization is applauded. This risk of sensitization is traditionally higher among women and Black patients given higher likelihood of pregnancy and higher likelihood of prior VAD respectively.
-Consider providing more information about how post-transplant survival may be used in the algorithm for matching in the future. National data suggests worsened post-transplant survival for minoritized racial and ethnic groups than white patients, but use of specialized, multi-disciplinary care has removed racial differences in survival. Using post-transplant survival risk to deprioritize patients may worsen existing disparities in wait-list mortality since wait time varies by patient race, ethnicity, and sex. It may worsen upstream racial, ethnic, and gender disparities in listing patients in the first place.

OPTN Living Donor Committee | 03/19/2024

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. A binary approach to awarding points is supported. The Committee cautions the OPTN Heart Transplantation Committee from weighing differences in living donation based on organ donated. The Committee supports prior living donor for all living donors as it is a high impact initiative that will impact a small amount of candidates. It is important to show that a prior living donor’s altruism is accounted for and that sufficient weight is given to the attribute to show that the community values the donation that the prior living donor provided.

The Committee also would not support a solution that would allow prior living donors to opt in or out of the priority. It is important that the system advocates and protects living donors as they tend to be selfless in nature and may choose to opt out given the choice, which is not the purpose of the prior living donor priority attribute.

The Mended Hearts, Inc. | 03/19/2024

Navigating the heart transplant journey is a complex and often agonizing experience for patients and their families. Mended Hearts, Inc. (MHI), a non-profit founded by and dedicated to serving heart patients since 1951, understands these challenges intimately.

We endorse the progress made on the proposed Continuous Distribution of Hearts policy by the OPTN Heart Transplantation Committee and believe it has the potential to greatly improve heart allocation. By implementing a more granular system based on medical urgency and compatibility, this policy could significantly reduce wait times for a substantial portion of patients on the waiting list. Additionally, streamlining the process would lead to greater transparency for the heart transplant community, fostering trust in the system.

However, much more progress is needed. To maximize the positive impact on patients' lives and reduce strain on the current system, we strongly urge the OPTN to increase the resources needed to expedite thorough development and implementation of this policy. With the many priorities placed on the OPTN we fear that the importance of this new allocation system may be deescalated at a time when there are inequities and inefficiencies in the current heart allocation system.

Region 6 | 03/19/2024

The feedback from attendees emphasizes the importance of considering unique geographic differences/constraints, particularly in regions like region 6, where prioritizing location can disadvantage large patient populations. Geographic differences, including distance, population density, and the number of transplant programs, should be heavily weighted in allocation decisions. The actual attribute for efficiency should not be based on physical distance in miles for the whole US because of the differences in population density, density of candidates and density of centers in the US. A different variable should be used. Suggestions include using population density to normalize criteria across different regions and considering placement efficiency and travel logistics, especially for areas without access to normothermic pumps. Concerns were raised about the economic barriers and decreased access to transplants for patients in regions with long travel times, such as Region 6. Specific issues highlighted include the economic barriers posed by using organ preservation technologies like OCS, as well as logistical challenges such as plane availability and ECMO capacity. The impact on sparsely populated regions must be carefully considered, and any changes should be followed by assessments of their impact on utilization rates.

HonorBridge | 03/19/2024

HonorBridge encourages the committee to continue to work to implement post-transplant survival attribute in early updates of Heart CD to limit futile transplants.

Allocation efficiency is of great importance to HonorBridge. Proximity of recipient to donor hospital remains important to minimize transportation challenges and stretching of the limited resources of aircraft availability, pilot time, and transplant center procurement staff. Additionally, it has been our experience that increasing distances between donor hospital and recipient center can lead to increased case times which can be difficult to manage with donor family expectations and desires to bring their loved one’s donation to a timely closure. We encourage the Committee to consider donor factors that could be used to impact the proximity calculation. A complex donor in combination with extended transportation time could impact acceptance rates, outcomes, and utilization.

Additionally, with the increasing number of DCD hearts being utilized for transplantation it will be important for allocation efficiency that those offers only go to centers willing to consider accepting a DCD heart.

Jason Goldberg | 03/18/2024

This is an opportunity to incorporate the standardized exception criteria that the review board members are asked to review, specifically for recipients with congenital heart disease and PLE or elevated pulmonary pressures. Incorporation of these factors (for both pediatric and adult recipients) will help continuous distribution to adequately risk stratify these patients and reduce workload of review board members.

NATCO | 03/18/2024

NATCO appreciates the efforts of the OPTN Heart Transplantation Committee for their work on continuous distribution of hearts. Our membership believes that candidates assigned to adult heart status 4 using LVAD criterion should received a higher percentage as a patient with an LVAD of >5 years has a higher mortality rate than those patients with status 4 criteria. In addition, membership supports the proposed inclusion of sensitization and feels we need to make sure that complex congenital heart disease patients are given thoughtful consideration and appropriate points within this scoring system regarding longer waiting times and inability to benefit from MCS due to size and anatomy. NATCO membership believes that the attributes chosen for the first iteration of the policy seem reasonable.

OPTN Ethics Committee | 03/18/2024

The OPTN Ethics Committee thanks the OPTN Heart Transplantation for the opportunity to provide continued feedback on the development of continuous distribution. The Committee recognizes the importance of the VPE as a way to gather community input and looks forward to the report-out of the results. Additionally, members appreciated the Heart Committee’s thinking regarding not including post-transplant survival as an attribute at this time- it is important to consider how any allocation change may disadvantage high risk candidates. In line with the Ethics Committee’s past public comment on the development of heart continuous distribution, members urge the Heart Committee to keep equity concerns with prior living donors in mind. Transparency and public perception will be important to consider as the Heart Committee further discusses the PLD attribute.

Region 7 | 03/18/2024

One attendee expressed their full support for Continuous Distribution of hearts and encouraged the OPTN to get to implementation as soon as possible. Another attendee representing the pediatric heart community echoed that sentiment and raised concerns about the OPTN Modernization Initiative causing delays to Continuous Distribution implementation. They also encouraged the OPTN to more broadly publicize the Values Prioritization Exercise as there are professional and patient groups that are unaware of the exercise. They also suggested that with the changes to ABO incompatible allocation for pediatric heart candidates, the committee should consider possible re-transplantation for those patients as they enter adulthood. Lastly, another attendee noted that with the adult heart allocation changes in 2018, heart programs have been entering a large amount of data for their candidate’s risk stratification data with each listing and status update. This has become a very heavy burden on transplant programs, and they would like to see this data used in some way, or help alleviate the burden by cutting back on the required data.

Anonymous | 03/18/2024

Continuous distribution of hearts and lungs makes sense to me. Some candidates are in need of emergent transplant with reasonable frequency in allocation. Broader sharing saves lives. Continuous distribution makes the system more responsive to evidence-based improvements.
This however is not the case in renal transplantation. Broader sharing should be restricted except in cases of expedited placement. The current system, KAS250, has increased workloads tremendously with minimal impact on transplantation.
It's hard to believe that there is often if ever a case of a kidney recipient in RI who does not have a well-matched equally deserving recipient in Philadelphia or New Jersey, who couldn't benefit for the same donor. This has been a costly, impractical and challenging "fix" to allocation as a means to promote "equilibrium" of wait times.

Region 1 | 03/18/2024

Attendees discussed a comparison of how continuous distribution of lungs has been working since implementation and how the OPTN Heart Transplantation Committee could learn from their work. A member noted that for lung allocation is has been very successful especially for Region 1, as they now have expanded access to donors and can get harder to match candidates transplanted faster. While has meant additional travel, perfusion technology makes it feasible. Also the new allocation system is more responsive, for example when an issue with the amount of points for blood type was discovered, it could be fixed quickly. An attendee asked that the committee keep an eye on out of sequence allocation and extended allocation times impacting overall utilization rates. A member said they do not support including time on LVAD in the calculation. An attendee endorsed the closer review of continuous distribution of hearts regarding allocation for transplant recipients with LVADs, with increased sensitization, and nautical mileage constrictions. A member requested the committee monitor the effect of continuous distribution on multi-organ allocation. Another attendee commented that continuous distribution makes sense for hearts, but not for kidneys because it is overly complex.

Anonymous | 03/18/2024

I want to thank the committee for holding this open comment period for the continuous allocation model for heart transplant.
I agree with many of the points made by an anonymous commenter, especially on the topic of mechanical support (durable LVAD) and the urgency status or priority for candidates on mechanical circulatory support (MCS).
1. Durable MCS has proven to be a good option (64% survival at 5 years) for bridge to transplant (BTT) and bridge to candidacy (BTC) for patients with advanced heart failure, who are, or may eventually become heart transplant candidates.
2. As a result of the 2018 changes in the heart allocation system, there was a decline in the use of durable MCS for both BTT and BTC because as a result of that system, there was no real established way to get a patient on MCS to transplant when the device begins to fail or when there are other adverse events (GI bleeding, infection and stroke), the likelihood of which increases over time, with each year the patient is supported by the device. There needs to be criteria that will be used for defining urgency when LVAD complications arise.
3. Because of the likelihood of adverse events and lack of criteria to get a patient with an LVAD complication to transplant, the use of durable MCS as BTT will continue to decrease in popularity. There is no real incentive for a patient to agree with device implantation when they are aware that it will, under the current system, delay the ultimate goal of heart transplantation.
4. Finally, there is the idea of the “double jeopardy” the patient who is implanted with a durable device can be exposed to. Initially, they often present to the hospital in extremis related to an exacerbation of their heart failure and among the treatment options is implantation of an LVAD. Even if they are a candidate for heart transplantation, they may be too ill to actively list for transplant and the LVAD is implanted as BTT. Once they have survived the acute event and are discharged from the hospital they remain on the heart transplant list as status 4 and not eligible for a higher priority unless there is an adverse event (infection, hemolysis, pump thrombosis, right heart failure, GI bleeding or severe aortic insufficiency) which elevates them to a status 3 or device malfunction/failure, qualifying them for status 2. So in essence, MCS patients are required to “die twice”, before being transplanted.
I am not sure about how to solve the issue of patients on MCS waiting so long, and sometimes too long, to be transplanted but I believe the answer starts with a change in the criteria for medical urgency status which will include a system that adds points for each year of LVAD support as the risk of adverse events increases over time on the device. This will make the system more equitable for MCS recipients and help to remove the growing stigma of the possibility of never being transplanted attached to agreeing to an LVAD.
I would also support mandatory education of and full disclosure to, the prospective LVAD recipient about the pros and cons of receiving an LVAD, with regard to their likelihood of eventually being transplanted.

American Society of Transplant Surgeons | 03/18/2024

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Ryan Tedford | 03/17/2024

I appreciate work by the committee and the opportunity to comment. I would urge the committee to strongly consider "time on LVAD support" in prioritization of transplant candidates. Additionally, complications related to LVAD support or those at high risk of developing complications with LVAD support (i.e. those with or at risk of late right heart failure) should be given additional priority. The latter can now be predicted with modeling.

https://pubmed.ncbi.nlm.nih.gov/36191552/

Anonymous | 03/17/2024

Dear UNOS,

Eight years ago, my son was put on ECMO with an ejection fraction of 5%. A week later, an LVAD was implanted and, consequently, he laid in a drug induced coma for a month. He then spent three more months in the hospital recovering and rehabilitating from the intense hospital course. Now, he gets up every morning and straps on two batteries just to make it through the day. His mother and I spend every second of everyday praying that he gets a heart since only God knows how long this LVAD will last. Can you imagine the fear of knowing that the mechanical device implanted in your chest, the one that keeps you alive, that feeds your brain, your lungs and all the other organs can fail in an instant? In that moment, the odds for my son look incredibly bleak. The LVAD can certainly be replaced, but at what cost? He worked this hard to make it this far all to return back to square one? That’s the nightmare that our family lives with every day.

My son is going to medical school with dreams of being a doctor. I believe that this experience will make him a great doctor with the ability to relate and be compassionate towards his patients in a way most others cannot. I am begging you to look at the how you decide who gets a heart, especially as it relates to those with an LVAD. The way it is currently done ignores the inherent risk and array of adverse events that patients like my son accept every day. He’s a 28-year-old young man who's trying to go to medical school and make a difference in this world. He already tried to die once, and our family doesn’t need to go through those days again. We all pray that he wakes up every morning, can we please make that a bit easier for him?


Thank you for your consideration.

Region 5 | 03/15/2024

Region 5 appreciated the update on Heart Continuous Distribution and offered the following feedback on the committee’s work thus far. A member encouraged all attendees to participate in the values prioritization exercise and suggested including post-transplant survival (even if rudimentary/low weight) as part of first iteration and a category for waiting time. He explained it was important for medically urgent patients. An attendee commented that she agreed with exclusion of post-transplant survival from this first iteration. While another attendee suggested the committee include some component of post-transplant survival, and several members suggested to include HLA sensitization for allocation (cPRA especially and similar to CAS lung allocation). A member suggested the committed consider continuous medical urgency score rather than status. Another member commented on proximity – the willingness to travel a longer distance reflects on program infrastructure particularly in the era of improved storage strategies of organs. Proximity criteria will limit visibility to programs that are able to travel negatively. An attendee commented that lung CAS lead to increased distances to procurement, high costs, less access, and more dry runs. As a result, they believe that CAS will be difficult to maintain. While several members were in support of continuous distribution, and an attendee commented that the committee’s progress is a big step forward to moving toward continuous distribution.

American Society of Transplantation | 03/15/2024

The American Society of Transplantation (AST) offers the following comments in response to the request for feedback, “Update on Continuous Distribution of Hearts:”

•The AST believes that attributes created (medical urgency, post-transplant survival, reducing biological disadvantages, patient access, and placement efficiency) are appropriate, albeit with anticipated challenges including the following:

o Medical urgency – programs may ask for more exceptions as this is a major driver of where the patient ends up on the allocation list. As a result, exception requests may be used to increase priority of candidates with lower degree of medical urgency.1 Furthermore with 95% approval rate of exception requests, without further monitoring and optimization of exception request process, the continuous distribution model may be further manipulated.2 To incentivize durable LVADs, waitlist time with durable LVAD should be included in the composite allocation score as outlined in the concept paper. We would also emphasize that choosing variables that are truly reflective of medical urgency (Cr, disease entity, bilirubin, etc.) rather than just method of support will help further risk stratify and reduce gaming. This validated method is currently included in the new French allocation system.3

o In addition to the status categories, the patient groups within the statuses should be further spread out in the risk stratification point assignment. For example, a status 2 for VT/VF has a much higher waitlist mortality than a patient on an IABP and thus should have more points.

o Post-transplant survival – The AST believes that post-transplant survival is an appropriate attribute to consider; however, it should not be included in the first version of heart continuous distribution allocation policies. Post-transplant survival is variable based on patient co-morbidities, in hospital status 1-3, single vs multi-organ transplants, and the transplant program’s level of expertise (e.g., certain centers may do more congenital cases than others or simply high-volume vs low volume transplant centers). As such, there should be a guidance document first advising which components would be included in the incorporation of a post-transplant survival score and then integrate the components in a follow up version. The new French allocation system accounts for donor and recipient variables, rendering a Transplant Risk Score (TRS) which factors into their allocation to assess for post-transplant survival (the score has been prospectively validated). The TRS includes seven recipient factors: age, indication for transplantation, previous cardiac surgery, diabetes mellitus, mechanical ventilation, GFR, and total bilirubin level and two donor factors: age and gender.3 Perhaps premature, but incorporation of more donor and recipient variables should be considered to help optimize patient outcomes.

o Reducing biological disadvantages- The AST supports the inclusion of HLA sensitization. While there is a need to help those at a disadvantage, heart transplant centers vary on their definition of sensitization and may not use the same lab for cPRA calculation. Highly sensitized also varies in definition with cPRA anywhere between 20-80%, depending on the transplant hospital or study. To add this, the AST agrees the proposed method of listing unacceptable antigens to obtain points for desensitization is likely the best approach for this particular component.

o Patient access – agree with this component

o Placement efficiency – agree with this component

•The AST recommends the following to evaluate success toward the outcome of that specific attribute:

o Medical Urgency: death on waitlist, increase in status requiring upgrades or additional tMCS or chemical support, removal of waitlist for further deterioration requiring durable MCS or palliation. Additionally, adverse events from tMCS such as limb ischemia, stroke, infection, and bleeding should be collected to assess rates of complication with success to transplant.

o Post-transplant survival: not in this version until more data is available.

o Reducing biological disadvantages: rate of highly sensitized patient time to transplant or time on waitlist, modification of listed unacceptable antigens based on waitlist time.

o Placement Efficiency: Assess why hearts are turned down – if heart programs frequently turn down offers primarily due to distance and worry for post-transplant outcomes – is more research and technology optimization that allows broader sharing necessary? Are heart programs with access to NRP and advanced cooling mechanisms such as Sherpak, able to do more transplants with similar effects on post-transplant survival and outcomes?

References:

1. Johnson DY, Ahn D, Lazenby K, et al. Association of high-priority exceptions with waitlist mortality among heart transplant candidates. J Heart Lung Transplant. 2023;42(9):1175-1182. doi:10.1016/j.healun.2023.05.009

2. Alam A, Hall S. Navigating the rough seas of heart allocation. J Heart Lung Transplant. 2023;42(9):1183-1184. doi:10.1016/j.healun.2023.05.021

3. Dorent R, Jasseron C, Audry B, et al. New French heart allocation system: Comparison with Eurotransplant and US allocation systems. Am J Transplant. 2020;20(5):1236-1243. doi:10.1111/ajt.15816

Anonymous | 03/15/2024

Heart transplant candidates, supported by LVADs, should receive additional priority (points) for organ distribution, the longer they are listed for transplant.

Association of Organ Procurement Organizations | 03/14/2024

AOPO applauds the progress of the Committee since the initial concept paper last year. The Association emphasizes the Committee’s importance in expeditiously developing a model that may serve as the basis for including a post-transplant attribute in an upcoming iteration of the continuous distribution of hearts. While the Committee’s rationale for not including a posttransplant survival attribute in the first version of Heart CD was sound, it must be prioritized in early updates of Heart CD to prevent futile transplants. 

AOPO agrees with the other attributes the Committee has identified for inclusion of the first version of Heart CD. Allocation efficiency is of critical importance to AOPO. Proximity of recipient to donor hospital remains important to minimize transportation challenges and stretch the limited resources of aircraft availability, pilot time, and transplant center procurement staff. Additionally, it has been our experience that increasing distances between donor hospital and recipient center can lead to increased case times, which can be difficult to manage with donor family expectations and desires to bring their loved one’s donation to a timely closure. 

AOPO encourages the Committee to consider donor factors that could be used to impact the proximity calculation. A complex donor, in combination with extended transportation time, could impact acceptance rates, outcomes, and utilization. Additionally, with the increasing number of DCD hearts being utilized for transplantation, it will be important for allocation efficiency that those offers only go to centers willing to consider accepting a DCD heart. 

William Fenske | 03/14/2024

In 2017 I was hospitalized with end stage idiopathic cardiomyopathy. I was told that I would need a new heart, however I was not a candidate for transplantation at that time because of my physical condition. My only option was to use the LVAD as a bridge to transplant. The LVAD has allowed me to lead a fairly normal life. My plan is to eventually get a new heart. This is not the case for many LVAD patients who have issues with stroke, right heart failure, GI bleeds, and driveline infections. I believe that another factor for allocation of hearts for transplant should be length of time on a device such as an LVAD.

Anonymous | 03/13/2024

Days on LVAD support is an important aspect in the allocation of organs.

Luke Preczewski | 03/12/2024

This, and any, revision should take into account cost to the system. As a specific recommendation, I suggest inclusion of drive time from donor hospital to receipient center with some cutoff likely to reflect drive vs. fly. I realize that some centers almost always fly, but others don't for short distances. That should be heavily prioritized where it can be done without significantly impacting access to organs for the sickest patients. Right now, the model inadequately addresses this, which has significantly increased flight costs and unnecessarily increased the dependence on extremely expensive cold storage and NMP technologies. Beyond cost, the availability of flights is increasingly an issue. These logistic issues should not be the primary consideration of these policies, but they do need to take on a much greater consideration.

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

Robert Kormos | 03/11/2024

Abbott appreciates the complex discussions surrounding the recommendation from the UNOS Heart Transplantation Committee (the Committee) and commends it for the thoughtful approach to heart distribution policy changes found in this Request for feedback on the Continuous Distribution Model (CDM) for Hearts. In developing this new distribution model, the Committee should examine several factors that will help ensure the right therapy is administered for the right patient and at the right time: a) capturing immediate surgical risk, b) promoting best post-transplant outcomes for the patient and the donor organ, and c) equitable transplant access to all members of the U.S. population, including those with modifiable risks. Furthermore, Abbott believes that a candidate with a durable LVAD must receive appropriate status to ensure physician equipoise will permit ongoing therapeutic application. We agree that assigning priority points for every year on LVAD support (within the Medical Urgency Attribute) is a step in the right direction. However, the points for time on LVAD should be adjusted in an incremental fashion per year and not limited to 6 years. We applaud the recent changes made to the Adult Heart Status 2 policy whereby a patient’s waitlist status is defined by hemodynamic criteria with defined levels of pharmacological therapy as opposed to a decision based on just the presence of temporary support devices. We also encourage the Committee to incorporate the December 2023 policy changes into Table 4, as well as the rest of the document, where appropriate.
Our principal recommendation is that priority points and weighting for medical urgency assigned for patients on LVADs be increased in an appropriate risk adjusted fashion, and adequate considerations be given to the acuity of illness and the patient’s risk of death at the time of LVAD implantation such that healthcare systems are not disincentivized for offering LVADs to patients. This disincentive is in the face of evidence that an LVAD provides a path to more stability as a transplant candidate with resolution of the comorbidities associated with extreme heart failure. Here are some of the key points to consider that underline this recommendation.

1.) Healthcare systems and patients shouldn’t be disincentivized to offer LVADs to patients: A review of the OPTN/UNOS database showed that the number of patients supported with a durable LVAD at the time of transplant dropped from 47% to 14% under the new allocation system. These changes occurred even though a durable LVAD can almost completely normalize the risk of post-transplant mortality, resulting in comparable post-transplant and post-LVAD survival for patients presenting with equivalent status (INTERMACS 1-2, UNOS 1-2), with a comparable 1-year mortality differing only by 2% between these groups(1). An allocation policy that reduces the priority of LVAD patients based on their positive prognosis, disincentivizes healthcare institutions from using LVADs for all patients that would benefit from time on LVAD.
2.) LVAD patients shouldn’t have to die “twice” before being transplanted: Within the current strategy of assigning priority points on LVAD support, a patient who receives an LVAD as an Intermacs 1 or 2 candidate must get significantly “sick” again on LVAD with the need to have a significantly morbid complication before being meaningfully considered for heart transplantation at the same priority as someone who is supported on temporary MCS. Time on LVAD is an appropriate adjustment for points starting at the time of LVAD implantation regardless of UNOS Status.

In light, of the above rationale, we strongly recommend that the committee consider the following changes to the continuous distribution model as it pertains to LVADs:

1.) Priority points for medical urgency for LVAD patients must be increased in an appropriate risk adjusted fashion. We propose that after a period of stable LVAD support, the priority points assigned to LVAD patients must be re-adjusted to consider their original acuity of illness at the time of LVAD implantation, i.e., if a patient received an LVAD off ECMO or temporary support, and becomes a stable candidate, then the priority score should be adjusted to reflect that initial critical state. Doing so will help mitigate the disproportionate bias against LVADs that exists under the proposed policy. Not doing so will perpetuate the existing inequity in access to transplant for LVAD patients. We support adding points for time on LVAD, however, the instantaneous risk with time is not a linear one, especially the further one lives on a durable LVAD.
2.) Priority score for medical urgency for an LVAD complication must also be increased appropriately to reflect the risk of the complication. If a patient experiences a serious adverse event, then the priority score should be appropriately adjusted for medical urgency and should be cumulative to other priority scores already assigned until the occurrence of the serious adverse event. The Committee should consider that there is often a multiplicity of possible adverse events. These include repeated infections and bleeding episodes that carry considerable risk and may result in other consequences such as thrombotic events, stroke, and sensitization from blood transfusion. While the continuous distribution does attempt to account for time at risk for an adverse event, the present allocation (based on the backbone of UNOS Classes 1-6) does not consider the presence of multiple simultaneous adverse events or even the scale of severity of events(2).
3.) Adverse event definitions of device complications must be updated to the most recently published and adopted definitions established by the Academic Research Consortium. This will more appropriately reflect the hierarchy of risk imparted by an adverse event. These definitions have created a hierarchy of risk that should be incorporated(3).
4.) Mortality and morbidity risk post-transplant outcomes must be factored in the CDM. If a patient has a high risk of morbidity (e.g. renal failure) as a result of prolonged temporary MCS support, then that should adversely impact the priority score. For example, the current policy favors a more aggressive use of temporary MCS, which puts patients at a high risk for end organ dysfunction while waiting for a heart transplantation if used for a prolonged duration of time. Although the committee has decided not to include factors that measure post-transplant survival, we believe that a review of key covariables needed for risk prediction should be developed and subsequent data be collected as soon as possible so this metric can be embedded within the allocation system over time.

With post-transplant survival not a factor in the current allocation system for heart, extensive modeling is important to assess if there is risk for unintended impact to candidate accessibility. We are increasingly moving to a model where urgency is dictated by complex comorbidities that accompany shock that are later transferred to the post-transplant recipient and although they do not cause 1-year mortality they confer on the recipient long term risk and comorbidity in particular a risk of opportunistic infections and renal dysfunction that effect quality of life. It is evident when reviewing SRTR data that although centers very commonly meet the desired 1 -Year Survival, 3-year survival is less optimal in those same centers.
In summary, Abbott strongly supports a change to the current allocation policy as a step in the right direction. Abbott shares the joint goal with OPTN to utilize the limited availability of donor hearts in a manner that reduces disparity and improves equity as it relates to the use of the available donor hearts. We also support the recommendations regarding reducing biological disadvantages, optimizing patient access, providing priority for living donors and maximizing placement efficiency. Left ventricular assist device outcomes have significantly improved over the year with survival outcomes approaching heart transplantation in similar patients(4) and especially for candidates under 50 years of age. If younger patients with their physicians decide to wait 5 years on an LVAD before listing, they provide access to donors for other patients and like a living donor should receive weighting acknowledgment for this selfless behavior added to time on LVAD. We strongly urge the committee to consider the suggestions provided in this document such that healthcare institutions and patients do not consider implantation of an LVAD as a detriment to their likelihood for getting a heart in the future.

1) M Barghash, MD, K Mahmood, MD, SP. Pinney. Durable LVADs as a Bridge to Transplantation: Still a Good Idea. J A C C : H e a rt Failure. VOL . 1 1 , NO. 8 , 2 0 2 3.
A u g u s t 2 0 2 3 : 1 1 6 0 – 1 1 6 3
2) A S. Rali MD, C Inampudi, Zalawadiya MBBS Shah MD , JJ. Teuteberg MD ,GC Stewart MD, MPh, RS Cantor PhD , Deng PhD , JP Jacobs MD 7, JK Kirklin MD , LW Stevenson MD . Changing Strategy Between Bridge to Transplant and Destination LVAD Therapy After the First 3 Months: Analysis of the STS-INTERMACS Database. Journal of Cardiac Failure, https://doi.org/10.1016/j.cardfail.2023.09.011
3) Kormos RL, Antonides CFJ, Goldstein DJ, Cowger JA, Starling RC, Kirklin JK, Rame JE, Rosenthal D, Mooney ML, Caliskan K, Messe SR, Teuteberg JJ, Mohacsi P, Slaughter MS, Potapov EV, Rao V, Schima H, Stehlik J, Joseph S, Koenig SC, Pagani FD. Updated Definitions of Adverse Events for Trials and Registries of Mechanical Circulatory Support: A Consensus Statement of the Mechanical Circulatory Support Academic Research Consortium. J Heart Lung Transplant. 2020 Apr 18: S1053-2498(20)31471-6. doi: 10.1016/j.healun.2020.03.010.
4) Jorde, UP.; Saeed, O; Koehl, D; Morris, A A.; Wood, K L.; Meyer, M.; Cantor, R; Jacobs, J P.; Kirklin, J K.; Pagani, D.; Vega, J. D. The Society of Thoracic Surgeons Intermacs 2023 Annual Report: Focus on Magnetically Levitated Devices. Annals of Thoracic Surgery, Jan2024, Vol. 117 Issue 1, p33-44,

Anonymous | 03/11/2024

Agree with a modification to provide additional percentages to LVAD patients for duration of support on device therapy.

Kiran Khush | 03/11/2024

US-CRS medical urgency comment:
Thank you to the OPTN heart committee for your thoughtful approach to continuous distribution. We are requesting that the OPTN heart committee consider a multivariable prediction model like the US-CRS for the medical urgency attribute in continuous distribution.

Since 2018, the OPTN has directed centers to collect important laboratory data on candidates- specifically sodium, BNP, creatinine, bilirubin, and albumin- data that is highly predictive of death without a transplant in multiple studies. A team of researchers recently used this data to develop the US-Candidate Risk Score (US-CRS), a multivariable prediction model for death without a transplant that utilized these important data (Zhang KC et al. Development and Validation of a Risk Score Predicting Death Without Transplant in Adult Heart Transplant Candidates. JAMA. 2024 Feb, doi: 10.1001/jama.2023.27029. PMID: 38349372; PMCID: PMC10865158). A score like the US-CRS can potentially reduce the reliance of the allocation system on the treatment practices of individual centers.

These results suggest that the OPTN committee should direct the SRTR to simulate both the 1) proposed mapping of the current criteria to waitlist mortality and 2) a multivariable prediction model like the US-CRS.


LVAD:
Regarding durable LVAD priority, we agree entirely that these patients need a reliable path to transplantation to incentivize bridge-to-transplant LVAD use. We suggest the committee design these LVAD waiting time points in the “patient access” component of the composite allocation score to fit within the normative framework of continuous distribution.

Anonymous | 03/11/2024

I believe time on LVAD should be strongly considered in consideration for cardiac transplantation status.

Anonymous | 03/11/2024

1) I worry about the process and integration of exceptions into continuous listing
2) I worry about the feasibility of transplant for anyone without a temporary mechanical support device, even among historically favorable blood types
3) I worry about the worrisome trends wherein volumes are increasingly concentrated at fewer and fewer transplant centers with geographical constraints, which risks limiting access to patients in need of advanced therapies

Region 3 | 03/11/2024

Meeting attendees offered several suggestions for the committee to consider as they move forward with continuous distribution. One attendee supported moving forward with continuous distribution for hearts, especially with meaningful consideration of sensitized candidates. Another attendee recommended further enhancements to enable organ placement efficiency. One attendee commented that the committee should learn lessons from lung continuous distribution and include offer filters. One attendee commented that there is an article in JAMA about developing validation risk of predicting death without transplant (by Stanford and Chicago) and encouraged the committee to review the paper.  

Andrew Boyle | 03/11/2024

The current allocation system has prioritized the Impella device as a BTT above all other patients. I do not believe it is fair to prioritize these patients above patients with a durable VAD particularly with a life threatening complication related to the VAD. In many communities it is impossible to get a donor offer on Status below 2, particularly in Blood Group O. As a result, the decision to put in a VAD has become a bad decision in Blood Group 0 patients as they will never get transplanted even if they have a severe complication. I think that is vastly unfair.

I believe VAD patients with complications should be equivalent to the Impella patients so that they too can get transplanted before further complications develop and the the uncomplicated VAD patient should be just behind the Impella patient (currently Status 3 not 4) in terms of their prioritization.

I also think the progress that has been made in the past for prioritization of patients with intractable angina and restrictive cardiomyopathies should not be lost as we move towards continuous distribution of hearts.

Prioritization of patients who have previously been kidney donors, while noble, should not be a significant determinant and should not replace the medical needs of other patients.

Anonymous | 03/10/2024

I would like to support the notion to allocate additional percentage points for the amount of time a candidate is on an LVAD. The evidence is quite clear. That length of LVAD is associated with higher morbidity and mortality, regardless of complication. Individual should not be punished for having a stable LVAD and definitely should not have to wait for an acute potentially life-threatening complication to occur before they were able to get their transplant. I think the new proposal is a perfect way to strike an appropriate balance.

Joseph Maniaci | 03/10/2024

Undergoing an open-heart surgery for LVAD implantation is already a daunting task. The risks/benefits are difficult to calculate, and currently weighing your chance to get a transplant should be placed under the “risks” category. In the current heart distribution rules, durable MCS (LVAD) patients seem to be penalized for their hard work and commitment to maintaining their health. Meanwhile, hospitalized patients on MCS are classified completely differently. While higher acuity and emergent situations certainly arise, the indication for placement of an MCS device is Heart Failure. The patient’s ability to take care of themselves, rehabilitate and become discharged from the hospital should have little bearing on their place on the transplant list. Penalizing patients for “improving’ their health seems backwards. Furthermore, there is no question that those who undergo transplant in a healthier state do better post-op with recovery and adverse events.

The proposed changes to the heart distribution rules are a good start to properly classifying durable MCS patients. While these patients are able to go home and live life, they still must carry the risk of stroke, device malfunction, bleeding and all other MCS device-related adverse events. With these risks, durable MCS patients are more similar to the temporary MCS patient awaiting transplants than they are to other ambulatory patients awaiting transplant. The proposed changes will go a long way in justly listing ambulatory LVAD patients and reducing the mortality these patients face awaiting heart transplantation.

Furthermore, giving more priority to LVAD patients will allow more providers to feel comfortable with suggesting LVAD for heart failure patients, and will allow more patients to feel satisfaction with accepting LVAD implantation. This should go a long way in making LVADs more commonly used across the country. Rewarding patients and providers, instead of punishing them in the current model, will lead to further patient satisfaction and increase outcomes.

At the end of the day, the LVAD was created to help heart failure patients live longer and have a higher quality of life. There are absolutely no reasons patients should be punished for undergoing implantation and working incredibly hard to recover and live their lives to the fullest. Please consider accepting and implementing the proposed changes to help the LVAD community who are waiting for that precious call.

Thank you!

Jeffrey Teuteberg | 03/10/2024

Thank you to the OPTN heart committee for your thoughtful approach to continuous distribution. We are requesting that the OPTN heart committee consider a multivariable prediction model like the US-CRS for the medical urgency attribute in continuous distribution.

Since 2018, the OPTN has directed centers to collect important laboratory data on candidates- specifically sodium, BNP, creatinine, bilirubin, and albumin- data that is highly predictive of death without a transplant in multiple studies. A team of researchers recently used this data to develop the US-Candidate Risk Score (US-CRS), a multivariable prediction model for death without a transplant that utilized these important data (Zhang KC et al. Development and Validation of a Risk Score Predicting Death Without Transplant in Adult Heart Transplant Candidates. JAMA. 2024 Feb, doi: 10.1001/jama.2023.27029. PMID: 38349372; PMCID: PMC10865158). A score like the US-CRS can potentially reduce the reliance of the allocation system on the treatment practices of individual centers.

These results suggest that the OPTN committee should direct the SRTR to simulate both the 1) proposed mapping of the current criteria to waitlist mortality and 2) a multivariable prediction model like the US-CRS.

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

The American Society for Histocompatibility (ASHI) and its National Clinical Affairs Committee (NCAC) appreciate the opportunity to provide feedback on the concept of continuous distribution of hearts. ASHI supports the consideration of additional priority points for sensitized recipient candidates based on CPRA.

Anonymous | 03/08/2024

The Field’s dedication to improving outcomes in patients with end-stage heart failure and acute shock is clear. The field has achieved an average patient survival of 13 years after heart transplant and survivals are now over 60% at 5 years following contemporary durable LVAD (Jorde ATS 2024;117:33-44). These outcomes are in patients with estimated mortalities >40% at 30 days for acute cardiogenic shock and >50% at 1 year for inotrope dependence. Similarly, the goals of UNOS policy are regularly changing to meet the ever-changing needs of the modern transplant community, inclusive of patients served.

Additionally, the 2018 UNOS allocation change did achieve several of its goals, successfully transplanting those with biventricular failure needing ECMO- those with highest mortality- in a faster time frame; broader organ sharing leading to improved transplant volumes at many programs previously with poor access; and lack of a detrimental impact on organ utilization. However, it has not fully succeeded in several other very important areas, and the presently proposed continuous allocation system, which has the urgency criteria at its foundation, may remain limited in efficacy and equality. Specifically, there are important concerns (all fixable) regarding the proposed continuous allocation as outlined below.

To date, I do not see data published by SRTR in granular form that are restricted to 2018-2023. Thus, the arguments below are largely from the UNOS website from the UNOS research committee re: 4 year outcomes after the 2018 allocation change (https://optn.transplant.hrsa.gov/media/asdpqli5/data_report_heart_committee_4yr_rpt1.pdf), as well as published, peer reviewed analyses referenced herein.

1) The current proposal on continuous allocation will not address the field’s lack of equipoise on the urgency criteria attribute. Since present urgency criteria will heavily guide the new continuous allocation system (“urgency points”), it is important that the field feels the present criteria (especially for UNOS 2-4) for urgency adequately capture all key facets guiding mortality risk for patients listed for heart transplant. In the Tokara analysis (Circ Heart Fail. 2021;14:e007916), 30% of active listings (2018-2020) were exceptions. Of 1245 UNOS 2 listings, 483 (39%) were by exception. Of 2419 UNOS 4 listings, 753 (31%) were by exception. In the UNOS 4 year data report, 47% of initial UNOS listings are now by exception (figure 5 and 52, 53, 57, 58)- this is even after amendments and guidance documents/videos. This is a sign that the field is not embracing the present urgency criteria and this has been the subject of prior publication (Defilippis JCF 2022;28:670) and innumerable editorials. In the general literature, there has yet to be a robust paper showing clinical benefit from tMCS vs. inotropes. Few would argue for removal of tMCS as a risk criterion but limitations of data in general (including CPO, SBP, lacatate, WP, RA:WP) to guide UNOS 2-3 criteria and continuous allocation “urgency” must be acknowledged. These limitations likely explain some of the exception burden.

This lack of equipoise and high exception requests should be a cause of pause in continous allcoation system creation using present urgency criteria as the platform. Why? Persistent exceptions of these magnitudes reduce efficiency of the process (board review time and energy) and the clear variability in time to transplant and wait list mortality of exception patients (Topkara Circ HF;2021:14, Golbus JHLT 2023;42:1298) makes the process unfair to low exception utilization centers and their PATIENTS. For example, Region 3 had 45% of their patients listed with exception (associated with faster transplant) vs

2) The proposed continuous allocation system does not do enough to tip equipoise back toward BTT or BTC LVAD. There is little argument that the 2018 allocation decimated equipoise for durable LVAD. With a device offering 64% survival at 5 years in a sick population of patients (Jorde, ATS 2024), utilization should go up for bridge to transplant and at a minimum NOT decline. However, the 2018 policy shifted field equipoise for durable LVAD largely because there is no reasonable way to safely get an LVAD patient to transplant when complications arise. In addition to concerns re: criteria used for defining LVAD urgency when complications arise, this lack of equipoise for LVAD has fuelled the high level of extension-exception requests (ie. “not a candidate for VAD”). Since the same UNOS 2-4 backbone will apply to continuous allocation, the presently proposed policy has not sufficiently captured the “double jeopardy” of patients living on durable LVAD.

a. I agree that durable LVAD support days are helpful to shift equipoise and acknowledge risks inherent to time on support. As the duration of LVAD support increases, the hazard for AE development also increases (Harari JHLT 2022;41:161-70).

b. DOUBLE JEOPARDY is not acknowledged with present and proposed durable LVAD urgency statuses: Patients undergoing durable LVAD are largely INTERMACS 1-2 with an inpatient mortality of >40-50% compared with medical therapy. There are many reasons why a heart team may feel direct transplant is not, or is no longer, feasible (clinical risk, can’t find donor, other below) so undertake durable LVAD. This should be seen as just organ utilization and identifying the “right therapy for the patient.” Yet, the durable LVAD patient has to try to die TWICE (one at time of LVAD and once when complications onset). The LVAD patient must suffer sepsis and recurrent heart failure from AI and unit after unit of blood from GI bleeding. The present UNOS 2-3 MCS complication urgency criteria fail to adequately capture the impact of multiplicative, recurrent AEs. Even “annoying” AEs like GI bleeding are associated with worse outcome when recurrent (Hariri, above). For those alive and on support at 1 year, AEs influence survival MORE THAN PREOP characteristics. For those alive and on support at 3 years, AEs influence survival MORE THAN PREOP characteristics. There is no way to fight the argument that the LVAD patient walking around the general floor with a PIC in place for an LVAD infection or for home milrinone for RVF has a much lower instantaneous hazard for death as a patient on ECMO or a UNOS 2 on tMCS. But, that LVAD patient was high risk for mortality prior to LVAD, followed provider recommendations to undergo the procedure, and is suffering a complication with increased mortality.

To this end, the field should better engage the LVAD and nonLVAD patient in the value proposition. Does the general LVAD patient understand the policy as written? Are the open comments reflecting any LVAD or nonLVAD patient concerns? How do morbidly obese patients feel about future limitations to transplant candidacy when durable LVAD does not provide a feasible option to transplant even after weight loss? Have we considered all aspects impacting just organ allocation (see renal transplant below and total survival on LVAD+Transplant).

3) The new continuous allocation does not address the high wait list mortality nor facilitate the use of durable LVAD to reduce this mortality in those who are appropriate LVAD candidates: Even though time waiting as a UNOS 2-3 is growing across the US, extensions and exceptions are increasing because patients and providers don’t want their BTT or BTC patient “stuck” on an LVAD. However, in figure 7 of the 4 year report, UNOS 1 wait list mortality is 170 per 100 pt years, UNOS 2 is 27 per 100 patients per year (not including those who were inactivated). Given present LVAD survival (90 day mortality presently ~10-12% for Intermacs patients under 69), these are lost survival opportunities for those patients who are reasonable LVAD candidates. Importantly, patients who are not LVAD candidates will still be caught in the Urgency quagmire of extensions.

Kidney allocation for nonliving related donors relies on presence of dialysis for listing. Why has heart deprioritized durable LVAD support (for appropriate LVAD candidates) when outcomes on LVAD are in many ways better than dialysis? Both disease states have catheters to deal with, dialysis has more medical interface on a daily basis (MWF dialysis for 3-4 hours), etc. and mortality for ESRD on dialysis for those 65-74 is 35% at 180 days and 47% at 1 year (Watcherman, JAMA Internal Med 2019;179:987-88). Readmission and complication burdens are not low in the dialysis population. Patients with a durable LVAD in place have had time to rehab, improve their kidney function, improve nutrition, live life for several years before the “heart transplant” clock starts ticking. The response “my patient does not want LVAD”, while not to be ignored, does not necessarily capture what is best for the field as a whole: just organ utilization, broader sharing, improved outcomes, equity in transplant and fiscal responsibility. The “I don’t want dialysis” argument does not apply in renal organ allocation for similar reasons.

4) Economics of direct transplant under the present urgency criteria and exception burden: We should appreciate the rising costs of transplant. Patients remain inpatient for weeks, using critical care beds that could be occupied by other patients in need, swapping in and out costly tMCS, while on rising prices of intravenous medications (bivalirudin, inotropes), battling line sepsis and peripheral embolization, when a durable device may provide equal short-term outcome, potentially at lower lengths of stay (no data) and potentially allowing transplant of a less ill patient with overall longer total survival (LVAD + transplant). The new continuous distribution proposal is not designed to take these cost factors or combined long term survival into account. Durable LVAD is not cheap nor is it associated with low readmission rates. This is where linked data between LVAD and SRTR would help the field and meet CMS requirements.

5) Risk for inequities from the proposed system: Perhaps the most important concern herein is the impact of the proposed continuous allocation system on equitable heart transplant access. There should be real concern that the presently proposed allocation policy will continue to impart disparities in heart transplant access for multiple patient groups, especially those who rely on LVAD to become a transplant candidate. Recent peer reviewed analyses suggest there are access disparities to LVAD for Black patients, even after accounting for higher levels of social deprivation, rural location, and/or lower income (Cascino, JAMA Open 2022;5:e2223080; JAHA 2024;13:e031021) . It would be hopeful that the lower frequency of durable LVAD utilization in the Black population would be matched by an increased proportional frequency of heart transplant. Unfortunately, evaluation of heart transplant allocation has also demonstrated reduced access for individuals classified of Black race since the 2018 change (JAHA 2024;13:e031021; Defilppis, Circ HF 2023;16:e009946; Morris Circulation: Heart Failure. 2021;14:e008296). As a field, we do not have reproducible metrics that define “adequate social support” or “adherence” and these assessments are highly subject to bias. Minority patients and individuals in lower SES are more likely to have modifiable contraindications to immediate transplant (e.g. BMI, substance use/abuse, lack of adequate insurance, poorly treated comorbidities due to poor health care access) and the ability to modify contraindications and achieve transplant listing must remain present in the heart allocation policy. The only way this is easily feasible is if LVAD can support ill patients while barriers or perceived barriers to transplant are addressed. Women have also been found to have lower rates of heart transplant and higher rates of delisting for death, not fully explained by PRAs (Defilppis, Circ HF 2023;16:e009946). Women are more likely be denied access to advanced HF surgical therapies due to “poor social support.” If marginalized patients are more likely to be directed to LVAD, and LVADs have reduced access to heart transplant, this results in inequities to heart transplant access.

While I present a long list of comments, they are largely concentrated on a central theme. The heart committee, who I presume were not part of the 2018 allocation derivation, has certainly gone out of their way to present a proposal meant to address key limitations of the present system and outline critical considerations/attributes to further refine heart allocation. The data online within the the 1, 3 and 4 year reports are thorough and beautifully presented. There will be no perfect policy and the presented continous allocation system will be an improvement from present state. My appeciation of the time and effort put forth by the Heart Committee and the UNOS research department and associated staff (and the field in general) must not be lost in the comments herein.

The comments herein are representative of me, a clinician in the field of advanced heart failure, transplant and MCS. They do not represent those of my institution/employer or any major organization with whom I may collaborate. For these reasons, they are anonymous.

Andrew Sauer | 03/08/2024

Since the last allocation changes implemented in 2018, patients with durable LVAD have experienced increasing challenges getting to transplant without compiling significant complications. In reality, patients who go home with an LVAD as BTT expose themselves to the very real risk of not being offered a transplant for many years until they experience a complication severe enough to justify higher UNOS Status by limited conventional criteria or by exception which then exposes patient to great subjectivity that goes along with these regional review board decisions.

All of this continued trend has consequently contributed to the now pervasive believe that a durable LVAD patient will "never" get transplanted without major complications while waiting on the list. Some of these major complications (like devastating stroke, for example) can lead to a BTT durable LVAD candidate to find themselves de-listed by the transplant listing center. And if patient survives long enough after de-listing, there is no increased waitlist mortality shown on SRTR. Ultimately, this leads to a deflation of wait-list mortality among patients with such immediately non-lethal but devastating and often disabling durable LVAD complications. Furthermore, for what it is worth, post transplant outcomes appear to be less favorable for more recent durable LVAD candidates on the waitlist, in part related to LVAD complications going into transplant and also due to complications of many years on continuous flow support which contribute to coagulopathy and vasoplegia and primary graft dysfunction, along with a coinciding concern many of us have the CT surgeons are becoming less and less experienced with the "LVAD-dig-out-heart-transplant" operation that is being done less and less every year as BTT LVAD proportions have shrunk to lowest level in history.

So, my feedback to UNOS is that patients who are listed with durable LVAD should receive "credit" for "time-served": risk accumulating with time on the list with LVAD, even if the patient is considered stable and without complications. This is because complications involving durable LVAD patients such as VT/VF/SCD, VT storm, stroke, HeartWare LVAD thrombus or recalled device failure, embolic events originating from aortic root, sepsis, and others can happen suddenly and without prelude and patients may not always be so readily able to go forward safely with transplantation if complications are severe enough. Furthermore, de-listing is not-infrequently the outcome and UNOS likely does not have full appreciation of how often this is happening in our system.

Lastly, for what it is worth, while transplant volumes have been increasing, LVAD volumes have been decreasing as a likely consequence of all the concerns I have raised above. This has likely contributed to minimal total HTX/LVAD surgical volume growth over the past decade despite an expanding epidemic. Meanwhile, particular underrepresented minority groups, those with limited social support, and rural patients are seen by transplant programs as less favorable candidates for heart transplant listing initially and can be disproportionately shunted toward this very challenging BTT LVAD pathway which likely contributes to disparities in access to transplant, which is what UNOS wants to avoid.

American Association of Heart Failure Nurses | 03/08/2024

The American Association of Heart Failure Nurses (AAHFN) would like to thank the Heart Committee for the extensive work they’ve done to create an equitable and just system of allocation. The AAHFN is an organization with membership exceeding 2,700 nurses in the United States who function in roles across the heart failure continuum throughout the clinical, education and research spaces. As an organization, we advocate for access to advanced heart failure therapies including ventricular assist device (VAD) and transplant for patients who meet criteria.

Several iterations of an allocation system have been adopted over the years, all which eventually unmasked unintended disparities. A Continuous Allocation Model (CAM) seeks to address these disparities by providing a “point system” based on multiple attributes. “Stable” patients on durable Ventricular Assist Device (VAD) support are disadvantaged in the current allocation system as organ offers rarely get to them as a Status 4; these offers go to patients with higher status. While many patients on durable VAD support enjoy event-free longevity, longer length of therapy often translates into higher risk. Therefore, AAHFN supports including metrics in the proposed CAM that would advantage patients on durable VAD support, whether based on duration of therapy, adverse events, or both to create a more equitable system.

William Parker | 03/07/2024

Thank you to the OPTN heart committee for your thoughtful approach to continuous distribution. I request that the OPTN heart committee consider a multivariable prediction model like the US-CRS for the medical urgency attribute in continuous distribution.

Since 2018, the OPTN has directed centers to collect important laboratory data on candidates- specifically sodium, BNP, creatinine, bilirubin, and albumin- data that is highly predictive of death without a transplant in multiple studies. I led a team of researchers in developing the US-Candidate Risk Score (US-CRS), a multivariable prediction model for death without a transplant that utilized these important data (Zhang KC et al. Development and Validation of a Risk Score Predicting Death Without Transplant in Adult Heart Transplant Candidates. JAMA. 2024 Feb, doi: 10.1001/jama.2023.27029. PMID: 38349372). Inspired by the French CRS, we designed US-CRS to be parsimonious (like the Model for End-Stage Liver Disease). The US-CRS was significantly more accurate in rank-ordering candidates by medical urgency than the 6-status system and especially useful in identifying high-risk candidates currently prioritized at Status 3-6.

These results suggest that the OPTN committee should direct the SRTR to simulate both the 1) proposed mapping of the current criteria to waitlist mortality and 2) a multivariable prediction model like the US-CRS. Even if the decision ultimately maps the current criteria to a continuous scale, this exercise will lay the groundwork for the future multivariable prediction model into heart allocation.

Regarding durable LVAD priority, I agree entirely that these patients need a reliable path to transplantation to incentivize bridge-to-transplant LVAD use. I suggest the committee design these LVAD waiting time points in the “patient access” component of the composite allocation score to fit within the normative framework of continuous distribution.

Anonymous | 03/06/2024

Durable LVAD patients should have a higher priority. I think that priority should be based on duration of LVAD support. Patients with an LVAD of >5 years have a significant higher mortality rate than those patients with status 4 criteria. I do not feel that a VAD complication and/or malfunction should need to occur in order to be transplanted. The risk for stroke, infection, death and bleeding is significantly higher in this population and should be represented appropriately.

Anonymous | 03/06/2024

I would expect that the continuous distribution of hearts would eliminate the current policy that pediatric patients current listed status 1A are required to be an inpatient at the transplanting hospital. Correct?

Region 8 | 03/05/2024

An attendee requested that future updates include applicable statistics. A member institution said they need more clarity on the details and explained that predicting outcomes is difficult. They said the Lung Committee struggled with it as they incorporated post-transplant survival in CAS but felt that public comment supported the inclusion of longer-term outcomes in organ allocation schemes as a priority and this attribute (post-transplant survival) is consistent with NOTA and the Final Rule. The goal of this attribute is to have the highest number of patients surviving post-transplant at 1, 2 or 5 years. The member pointed out that SRTR does have post-transplant survival measures- for lung 1-year survivals are as predictive as 5 year survivals. While these predictions are difficult, they are a critical component of the CAS which is meant to consider the candidate wholistically. The presentation referenced that programmatic UNOS outcomes could be used as a surrogate for post-transplant survival attribute. While this has some validity, this approach would lead to disparate listing practices and thus inequitable organ access for patients at smaller programs. Smaller programs will be less willing/able to list patients while larger programs may be able to be more liberal. Moreover, this approach does not allow for a candidate to be considered wholistically, it applies to a program wide goal to individuals which could create inequity. Post transplant outcome is a necessary and important attribute to be included in all organ CAS. It is consistent with the principles of utility and equity and consistent with public comment priorities. Interim analysis can be utilized as well as prospective data collection to fine tune weights in organ specific cases. Imperfect data should not be used as a reason to not include post-transplant outcomes, one of strengths of CAS is that each attribute weight can be altered at regular intervals as we have seen in the lung implementation of CAS. An attendee expressed concern about the exclusion of a post-transplant survival metric. The member suggested data collection efforts to leverage preexisting data in electronic health records for future development of post-transplant metrics. Another said this is a good effort and inquired about the prospects of getting an EPTS equivalent for transplant. A member suggested that pediatric candidates should be prioritized every time. And explained that from a donor family perspective there is no better way to honor the gift.

Jennifer Hiller | 03/05/2024

Lvad therapy can be fantastic in first years giving a patient improved quality life and return functionality that heart failure has taken away

As years go by the chances of their survival decreases dramatically into years 3,4,5

We say no lvad is a “stable” vad as it takes one major complication that person may not recover from. Ideally we stabilize someone and get their bodies out from under the effects of heart failure with device and transplant them when they are stable and not when they are under such crisis as failing pumps or massive infection. Why put the transplant at jeopardy.

Lvad is major life support and without it for even a minute can cost the patient their life. This should be a high priority listed patient.

Region 2 | 02/29/2024

An attendee inquired about the committee’s decision not to include post-transplant survival in Continuous Distribution (CD). The reasons cited included logistical challenges, lack of available data, and concerns about program decision-making for candidate selection. Despite considerable public interest, it was deemed acceptable for the first iteration of the system to omit post-transplant survival measures. The attendee suggested that the committee revisit and possibly include post-transplant survival after a few years under the new system, allowing for more data collection and modeling. Concerns were raised about the absence of detailed information and data on post-transplant outcomes, emphasizing the importance of considering outcomes in transplantation decisions. One attendee added that this issue should be addressed before implementing any further changes to the allocation system. There was a call for simulations to contrast pre- and post-CD allocation to guard against unexpected disadvantages. Another attendee expressed the need to rapidly develop a system for assessing potential post-transplant survival metrics to strike a balance between medical urgency and post-transplant survival, especially given the inadequate number of organs for listed patients. Among the attendees there were varying opinions on the prioritization of patients with Ventricular Assist Devices (VADs), with suggestions to prioritize them based on complications such as right ventricular failure or infection. The overall sentiment was a recognition of the need for continuous improvement in transplantation allocation systems, a focus on data collection, and the inclusion of post-transplant outcomes in future iterations. Additionally, there was a suggestion to explore opportunities to utilize more hearts from DCD donors.

Region 11 | 02/29/2024

An attendee strongly encouraged the committee to consider including long term outcomes in continuous distribution. One member expressed support for the consideration of VAD patients. Another attendee stated that OPTN data collection is antiquated and needs to be modernized. A member strongly supports the continuous distribution of hearts project, as many patients do not fit the current status hierarchy, and a score would allow for other factors that are important to be considered. One attendee urged the committee to consider the scale for potential recipients developed in Europe.   

OPTN Histocompatibility Committee | 02/27/2024

The OPTN Histocompatibility Committee supports the OPTN Heart Committee’s work to transition heart allocation to continuous distribution, and strongly supports the proposed inclusion of sensitization as an attribute in the biologic disadvantages category. The Committee has previously discussed and supported using unacceptable antigens to prioritize difficult to match patients. In order to balance clinical judgment and personalized patient care, the Committee is opposed to attempting to standardize MFI values.

OPTN Pediatric Transplantation Committee | 02/27/2024

The OPTN Pediatrics Committee would like to thank the Heart Committee for the work they have done on Continuous Distribution, and for including members of the Pediatrics Committee in their discussions while developing the continuous distribution framework. The Committee supports and agrees with many of the components provided in this update, particularly the binary scale for all pediatric candidates that is being proposed. However, the Committee is concerned about certain attributes that were not included in this update.

While providing all pediatric candidates with a certain amount of points to ensure some level of priority is a good thing, there are certain attributes within heart policy that are unique to pediatric candidates that should be considered by the Heart Committee. Many pediatric candidates end up spending more time on the waiting list than their adult counterparts, so the Committee would like to see waiting time included as an attribute.

Pediatric candidates are often unable to benefit from many mechanical support devices because they weigh too little. This creates a scenario where the pediatric candidate’s urgency drastically increases and their options for care decreases. However, this is not accounted for in continuous distribution. The Pediatrics Committee recommends this be discussed by the Heart Committee for inclusion in the next continuous distribution update as a biological disadvantage.

In current heart allocation policy, pediatric candidates receive priority during allocation of pediatric donor organs. The Committee feels strongly this policy should be included in continuous distribution.  

Dylan Fiddes | 02/27/2024

To expedite the distribution of Hearts, it would be it would be useful to have the option to utilize the UNOS predicted heart mass calculation as a filter option. Similar to the current height and weight filters that are currently applied.

Region 4 | 02/26/2024

Members in the region offered several suggestions for the committee to consider as they move forward with continuous distribution. Two attendees recommended including post-transplant survival as a variable. They added that overall medical care of the patient is important, and the most medically urgent candidate should not always be prioritized if they are going to have a bad outcome. Another attendee said the data for post-transplant mortality will never be as good as we want, but there is an opportunity to think about it as we move forward. They added that this is an opportunity to improve how we care for patients, and we need to accommodate post-transplant outcomes, especially if we use devices to prioritize people. Devices are a decision we make, not a marker of urgency or illness. 

Manreet Kanwar | 02/26/2024

I agree that a Continuous Allocation Model (CAM) is an important and needed modification to the current status system. The intent of allocation attributes of Urgency, Reducing Biological Disadvantages, Optimizing Patient Access and Maximizing Placement Efficiency are well received. However, to be effective I hope the following concerns can be addressed:

1. My biggest concern is that use of temp MCS based on current criteria will continue to out-weigh all other metrics on a weighted scale. The current hemodynamic criteria do not consider any measure of hypo-perfusion (except for ECMO) – as a result of which it is not hard to ‘qualify’ an ambulatory patient not in cardiogenic shock for these devices since many of them will meet them. And if they don’t, folks submit an exception letter for the same. The 2018 changes to heart distribution policy achieved the goals of reducing the waitlist mortality, and shortening the time on support for the sickest. But that advantage is fast receding as more and more pts are being supported on temp MCS, creating a massive bottleneck for Status 2 – and I did not see how the CAM will address that.

2. Need to better address the adverse events on an LVAD that would qualify a pt for a ‘status upgrade’ in alignment with the contemporary INTERMACS Academic Research Consortium definition. Sequential adverse events should allow for sequential acceleration of status.

3. It was unclear to me how ‘exceptions’ are to be handled within the CAM, especially given the steep rise in them in the current system. Have they been evaluated for recent times to make sure they are addressed as a risk in CAM?

4. The current plan proposes to give a 5% increase in priority for every year on LVAD to a maximum of 6 years at 30 %. For a status 4 LVAD pt, when does the clock start for time accrued? At the time of listing or BTT LVAD implant?

5. I understand the rationale behind prioritizing a recipient of a living donor – but my concern is that as stated, it may encourage centers to have the ‘we can always re-transplant this pt’ mentality rather than careful consideration for an LVAD for a goal net prolongation of life.

6. I am curious to know how CAM will address the ‘post transplant survival’ metric. I think the goal for each transplant should be an addition of 10 of more years to a patient’s lifespan. Aiming for 1 year survival metric may be ‘short sited’

Robert Goodman | 02/22/2024

Full disclosure: I am a heart transplant recipient and I was a Visiting Board Member on the OPTN Heart Transplantation Committee for about a year and a half. I fully support the approach being taken and firmly agree that medical urgency is a key element. Recent literature suggests additional and other thinking on the matter, and should be evaluated. I would love to see the process take a much shorter period of time to get to implementation, but not just for the sake of speed. When I first learned about Continuous Distribution, probably 6 or 7 years ago, it made so much sense to me as a lay person that I couldn't understand why it should take such long time to make happen. I've become educated and understand it now, but would still prefer to find a way to streamline its implementation.

Anonymous | 02/22/2024

I agree that VAD wait time should be factored into CAS. I also agree that sensitization should be included.

Anonymous | 02/21/2024

I think this policy benefits the progress of heart transplants, though, I feel that more additional policies can be accomplished. There are a lot of difficult factors and boundaries facing heart transplants, but I think the project is flowing in a more reasonable direction. I also like how the policy has the donations and transplant buildings closer in proximity, as it reduces longer waits and other problems that may occur.

Juan Vilaro | 02/20/2024

First of all, I applaud the committee for their tremendous work in structuring this new system for heart allocation. A few comments from my end:

1. I DO agree that points for time on LVAD support should be weighed into the scoring system. In our current system, my impression is that length of temporary mechanical support is extended sometimes to the detriment of the patient because the decision to transition the patient to a durable LVAD implies extending the waitlist time considerably due to the transition to the lower status once they are no longer on t-MCS. Including this as part of the scoring system would incentivize transplant teams to transition patients to durable LVADs sooner, which is already known to be a more stable platform for these patients with better survival, but it is underutilized due to the desire to get people straight to transplant sooner

2. Need to make sure that complex congenital heart disease is given thoughtful consideration and appropriate points within this scoring system. Our current allocation system does not factor in the reduced donor pool these patients have because of sensitization, and requires cumbersome exemptions and in-hospital stays in order to reflect the urgency for transplant that many of them already have even if they are not in the hospital

3. I like the additional points for age under 18, but I also think that certain age ranges above 18 should be considered for additional points within the system (i.e. 18-40 with dilated or genetic cardiomyopathies in the absence of other comorbid conditions) I understand part of this may already be captured in the factor that aims to estimate survival with and without transplant for these recipients, as I would think this patient population has a high survival rate given younger age and lack of comorbidities.

Ewa Sztandera | 02/14/2024

I would like to comment on patients with a permanent LVAD and their listing status. Permanent LVAD patients are treated as if they are "less ill" than patients who have temporary VADs placed, even though the indication for both is heart failure. Durable LVAD patients are more stable and likely more optimized prior to surgery than those with a temporary VAD who are acutely ill. Durable VAD patients would likely have better outcomes after transplantation given that they are medically optimized prior to surgery. More so, the risk of currently having a permanent LVAD, and the prior high risk endured during placement of it, is not currently accurately represented. I would largely advocate for the review and amendment of listing for those with permanent VADs.

Andrew Kao | 02/13/2024

Thank you for your hard work on this very difficult proposal. I would like to answer the questions you posed and add a comment or two:

1. I think it is reasonable to given some prioritization to time on LVAD but not so much that programs would place LVAD to gain time - then we would be back to the same problem before the current 6-tier listing system - is 5% per year fair and they would potentially get up to 50% priority points? I don't know but the top priority should not be higher than that for the really medically urgent (i.e. ECMO)

2. I think the attributes chosen for the first iteration of the policy seems reasonable EXCEPT for the post transplant survival - I could not tell if this was in the VPE to gather information or because it will be included (some parts of the proposal stated it wouldn't be). I agree wholeheartedly we should gather information on post transplant survival but we have zero data to base any decisions on so please don't include this.

3. I don't think other attributes need to be included in this first draft

4. I think the committee is doing its best to determine weight given to each attribute - I would say that if we determine prior living donor and pediatric candidates should have priority, we would need to follow wait times for these candidates pre and post policy change to see if the intended effect is achieved (same with the high cPRA group, blood type O group). My concern is that the lung policy led to unintended decrease in blood group O transplants - how are we going to safeguard against that or other unforeseen consequences?

5. I already mentioned that post transplant survival should not be included but I don't think it is?

Finally, I would like to emphasize the importance of proximity - I am quite concerned that the lung policy led to a 160 nautical mile increase in median donor hospital distance - the October 18, 2018 allocation change already significantly increased all program's procurement distance - I am worried about staff and surgeon safety as we fly farther and farther (not to mention cost) - there has to be priority given to a donor heart in close proximity to the recipient (like < 250 nm) vs one that is very far away - not sure the current proposal of having the same priority for up to 500 nm and then linear decrease to 0 at 1500 nm makes sense - in reality, very few programs would ever go out to 1500 nm - maybe 800-900 nm but we have to worry about post transplant survival as well and early postoperative complications. In addition, for coastal programs or border states, much of their circle will be in another country or in the ocean. I would suggest making the scale of 0-250 nm getting 100% and then a linear decrease from 250 to 1000 nm. Thank you for your consideration and thank you for your hard work and dedication to this important project.

Anonymous | 02/11/2024

Strongly oppose

Anonymous | 02/08/2024

I applaud the work to date of the heart committee but would advocate for more.

1. There are inequities within statuses (especially status 2) and thus these should be teased out and spread across the CD risk - VT/VF patients are far more likely to die than patient on an IABP for example

2. We know that disease markers of hypoperfusion and end organ failure (Cr, Lactate, LFTs) are very powerful. We have five years of data gathered that we could analyze and, with appropriate data analytics resources, add to the medical urgency risk score

3. We are supportive of time on VAD concept

4. While supportive of getting post tx survival as a metric, our current data shows that the very patients we are trying to give priority to (Sensitized patients, VAD patients, congenital patients) are the poorest post tx outcomes. THe goal is by getting them organs sooner, the post transplant outcomes will be improved. If we also punish them for poorer post tx outcomes, we will simply erase the points they got for disdavantaged and place them back in the limbo status they often suffer from.

Déboralis Ramos | 01/31/2024

support

Anonymous | 01/24/2024

Continuous distribution burdens the screening staff. Suggest allocating brain dead organs different than dcd. Unet does not let you screen out different ages/distances or Neuro status so when there is a high Las too many offers come in to handle that would otherwise be screened out. Also go back to offering to three centers at a time. It’s too busy to be entering prov yes for pt with 100 people in front of them. Blind prov yes being entered as a result.