Presentation
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Anticipated impact
- What it's expected to do
- Provide a more equitable approach to matching candidates and donors
- Remove hard boundaries that prevent candidates from being prioritized higher on the match run
- Establish a system that is flexible enough to work for each organ type
- What it won't do
- This request for feedback is not a proposed policy change, but will help the Heart Transplantation Committees develop a future policy proposal
Terms to know
- Attribute: Criteria used to classify then sort and prioritize candidates. For example, in heart allocation, suggested criteria include medical urgency, candidate biology, patient access, and placement efficiency.
- Values Prioritization Exercise (VPE): An exercise that asks participants to rate the importance of an attribute when it is compared to another attribute.
- Composite Allocation Score: Combines points from multiple attributes together. This request for feedback proposes the use of composite allocation scores in a points-based framework.
- Rating Scale: Describes how much preference is given to candidates within each attribute.
- Weights: Reflect the relative importance or priority of each attribute toward the overall goal of organ allocation. Combined with the ratings scale and each candidate’s information, this results in an overall composite score for prioritizing candidates.
Click here to search the OPTN glossary
Read the full proposal (PDF - 1009 KB)
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
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:
- 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.
- 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?
- 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.
- 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.
- 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:
- biventricular assist device (BiVAD) 55.64,
- Ventricular fibrillation (VF) or ventricular tachycardia (VT) 25.81,
- MCSD + RV failure 23.92,
- percutaneous endovascular LVAD 18.73, and
- 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.
References
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
BrioHealth Solutions | 03/19/2024
Attachment
View attachment from BrioHealth Solutions
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.
View attachment from International Society for Heart and Lung Transplantation
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
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
Khadijah Breathett, MD, MS, FACC, FAHA, FHFSA | 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
NATCO | 03/18/2024
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
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
View attachment from American Society of Transplant Surgeons
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
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
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
Anonymous | 03/13/2024
Luke Preczewski | 03/12/2024
Robert Kormos | 03/11/2024
Kiran Khush | 03/11/2024
Anonymous | 03/11/2024
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
Joseph Maniaci | 03/10/2024
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 (PDF - 3 MB), as well as published, peer reviewed analyses referenced herein.
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
- 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.
- 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).
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).
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.
- 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.
- 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
Anonymous | 03/06/2024
Anonymous | 03/06/2024
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
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
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
Anonymous | 02/22/2024
Anonymous | 02/21/2024
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:
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
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
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
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:
- 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)
- 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.
- I don't think other attributes need to be included in this first draft
- 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?
- 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
Anonymous | 02/08/2024
I applaud the work to date of the heart committee but would advocate for more.
- 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
- 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
- We are supportive of time on VAD concept
- 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