Comments

Ashley S. | 09/19/2023

There appears to be a long wait for a heart transplant and as a direct family member of a potential heart transplant candidate with an LVAD, I hope that any revisions to the protocol will help patients with an LVAD make sure they are considered sooner for a heart transplant.

The Mended Hearts, Inc. | 09/19/2023

The Mended Hearts, Inc. (MHI), a non-profit founded in 1951 with a rich history of serving heart patients and their families, advocates for optimal care for all heart disease patients. Founded by heart patients for heart patients, our members and supporters are acutely aware of the challenges and intricacies of navigating the heart transplant journey. For over 70 years, MHI has served millions by providing support and education, bringing awareness to issues that those living with heart disease face, and advocating to improve quality of life across the lifespan. As such, we wish to strongly endorse and support the proposed changes to the Heart Status 2 Mechanical Device requirements as proposed by the Organ Procurement and Transplantation Network (OPTN).

In recent years, we've observed a troubling surge in intra-aortic balloon pump (IABP) utilization. This increase, occurring since the 2018 allocation policy update, has led to an alarming congestion of patients within Status 2. While these 2018 updates were an incredible step toward a fairer distribution of organs, as with any innovative policy change, certain unintended consequences may become pronounced. In this case, the 2018 allocation policy update has misplaced some candidates in inappropriate status levels that do not align with their health or observed mortality rates. One study found patients placed on IABP increased from just 3% in 2017 to 45% after the new priority system took effect.

The overutilization of IABPs not only stretches critical care resources by allowing some IABP recipients to be incorrectly placed in a higher status along with sicker patients on the waitlist, but it also mandates extended invasive treatments for patients, which are often not reflective of their genuine medical risk. This trend results from the misaligned incentives for medical providers to use IABP even when not clinically justified, compromising both the patient's quality of life and the integrity of the organ distribution process.

A heart patient's journey is already laden with physical and emotional challenges that take a toll on the patient and their family. It is unfair to further burden them with unnecessary and invasive procedures that result in overcrowding status levels and do not necessarily result in better patient outcomes. All heart transplant waitlist patients deserve a fair system that promotes the best clinical practices and prioritizes the sickest patients. Our vision is that patients can await their heart transplant without undergoing undue treatments in the comfort of their homes, if possible.

By necessitating a documented inotrope failure seven days before IABP usage, the proposed change emphasizes the exhaustion of medical treatments before device deployment. This recalibration promises to alleviate Status 2 congestion and reposition approximately 65%-83% of the current adult candidates in Status 2, aligning them more accurately with their clinical status.

The Mended Hearts, Inc. firmly supports OPTN's proactive approach to resolving the Status 2 congestion issue via the proposed amendments to the Heart Status 2 Mechanical Device requirements, and we applaud OPTN for proposing these critical changes. Furthermore, we are eager to witness the full rollout of a continuous distribution model, which promises a more equitable organ distribution. We applaud OPTN's plans to bring this model to fruition by 2027, and we remain hopeful that these changes will significantly elevate the patient experience and outcome in the heart transplant process.

View attachment from The Mended Hearts, Inc.

International Consortium of Circulatory Assist Clinicians (ICCAC) | 09/19/2023

See attachment

View attachment from International Consortium of Circulatory Assist Clinicians (ICCAC)

Region 8 | 09/19/2023

Sentiment: 2 strongly support, 6 support, 7 neutral/abstain, 4 oppose, 0 strongly oppose

Several members suggested the committee should consider lowering inotrope doses and believed the proposal is too restrictive and proscriptive. A member expressed concerns about the use of inotropes, explaining that some are really high especially if they are at home on inotropes. Candidates may have VT and increasing inotropes could accelerate or cause more issues. When the intent is to decrease the use of balloon pumps. VT can make people not a candidate for transplant anymore. The concern is gaming; when some people come into be qualified for IABP, they are really sick. If there is a bias to not put a balloon pump in that is going to hurt more candidates as well. The committee is trying to not choose one support device over another but decreasing the use of the balloon pumps will promote other mechanical support. Another attendee commented that they believe the proposal has merit but the committee should reconsider the inotrope levels. There is a lot of evidence to show that IABP is being used liberally and those candidates aren’t status 2.

·      A member explained that as a cardiologist there are a lot of pathways for how candidates end up on mechanical support, either permanent or temporary. He commented that it seems like this proposal is focusing on chronic heart failure patients who require inotropes, but it does not account for the more acute situations and those candidates may not have had a chance to meet the other requirements because they were resuscitated very quickly. Those candidates are very in between and haven’t had a chance to try high dose inotropes. The member expressed concern about the proposal being proscriptive for doses of medicines. He suggested to account for the patient’s mortality and we don’t want to jeopardize their care and our need for clinical discretion.

·      An attendee commented that the proposal seems to spread out the large number of patients in the group of category 2; and keeping some of the meds as established may disadvantage some patients who would be served well with earlier mechanical and may avoid VT. A member explained they support IABP or MCSD trials but not overall support the proposal due to failure to wean language. They explained that candidates don't do as well with increased shock if you wean support and end up needing to re-institute IABP or MCSD. A member supported the proposal, but noted it needs revisions using lower inotropic dose/levels and consideration of inclusion of all devices not just balloon pump. An attendee explained that the use of high dose inotropes will likely cause harm to patients, including VT. This proposal has the potential to harm patients by worsening their status by causing VT or worsening end organ function, such as Cr. IABP are placed in those patients who meet criteria and are sick enough to need this. Also, elevations in Cr are not evaluated in this requirement, which should be considered. IABP many times can improve overall function and prevent end organ dysfunction, which can be worsened by inotropes. In addition, if a candidate develops VT, they could have a complication from VT, rendering them ineligible for heart transplantation.

OPTN Transplant Administrators Committee | 09/19/2023

The OPTN Transplant Administrators Committee thanks the OPTN Heart Transplantation Committee for their dedication and work on this project. The Committee appreciates the necessity of this policy change and offers a few thoughts for consideration. There is some concern with requiring drugs to maintain compliance with the policy, as this could have a negative impact on patient well-being if utilized when not clinically necessary. Additionally, the Committee asks that unintended consequences, such as congestion of the Status 3, be considered with this policy shift.

Region 9 | 09/19/2023

Sentiment: 2 strongly support, 7 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose

A member expressed support for the proposal and wondered if there are status 2 patients that should really be status 1. An attendee remarked that the review boards should follow existing guidelines. One member was concerned about patients with arrhythmias that cannot tolerate inotropes under this policy. An attendee was concerned that this proposal could undermine patient trust if physicians are not allowed to use their best judgment regarding the treatment of their patient. The member also was not sure if it makes sense to undertake this change now if the committee is already working on moving heart allocation into continuous distribution. 

Houston Methodist Hospital | 09/19/2023

We commend the UNOS sub-committee for reviewing the data post implementation of the new allocation system. We agree with the overall premise of the proposed changes for status 2 justification. This is also in keeping with the SCAI stages of cardiogenic shock, which now have been validated in multiple studies. The proposed status 3 appears to mirror the SCAI stage C Shock and status 2 requirements mirror SCAI stage D shock. However, etiology of cardiomyopathy, intolerance to inotrope and reason for listing for transplantation have not been accounted for in the proposed changes.
We have a few concerns regarding the proposed changes:
1. Certain patients do not tolerate low doses of inotropes due to ventricular tachycardia or persistent atrial arrhythmias with rapid ventricular rates which may lead to ICD therapy or necessitate an IV anti arrhythmic. This contraindication will have to be built into the proposed criteria. In addition, for these patients, continuation of a high dose inotrope to justify status 2 listing is inappropriate.
2. Subgroups such as those with non-revascularized coronary disease, persistent angina, restrictive cardiomyopathy (such as amyloidosis), ESRD/Cirrhosis listed for multi-organ transplants may not tolerate high doses of inotropic therapy. In addition, these patients have a higher risk of waitlist mortality. IABP support in these circumstances is an appropriate treatment strategy and should suffice to warrant status 2 listing.
3. Would recommend including either MAP

Region 3 | 09/19/2023

Sentiment: 0 strongly support, 7 support, 8 neutral/abstain, 1 oppose, 0 strongly oppose

During the discussion one attendee raised concerns about extension criteria, specifically Mean Arterial Pressure (MAP) less than 60. They suggested that a more appropriate threshold would be MAP below 70, emphasizing the potential dangers of MAP dropping to 60. 

Spectrum Health | 09/19/2023

The Spectrum Health transplant team thanks the OPTN Heart Transplantation Committee (the Committee) for proposing these modifications. We offer the following comments for consideration.

We support the need for evidence of decompensated hemodynamics while on inotropic support prior to placement of a MCSD and status 2 listing. Regarding MCSD weaning trials, we do believe that the need for continued inotrope support following MCSD placement is important, but we do not feel that the pre-MCSD inotrope dose needs to match the post-MCSD dose. The clinical picture may change after MCSD insertion, and we would argue that using the lowest possible inotropic support needed is what’s best for the patient. In addition, a specific dose requirement would mean additional time for someone to review the pre and post device implant inotropes dosages. We believe that this would detract from direct patient care. We recommend just requiring a need for continued inotrope support, but not necessarily at the same dose as the pre-insertion therapy while on a weaning trial for MCSD.

Does this proposal sufficiently address the issue of IABP usage within status 2? Describe why or why not.
We believe that these modifications for IABP usage and status 2 listing are the right thing to do thereby saving an aggressive support option for the sicker patients as an additional differentiator on the waitlist. Inotropic support should be attempted first.

Is adult heart status 3 more appropriate for the IABP criterion currently in status 2? Is this also true for percutaneous endovascular MCSDs (mechanically circulatory support device) criterion in status 2?
The Spectrum Health transplant team believes that Impella CP and IABP are reasonable for a status 2 candidate and appropriate for attempts at weaning. However, we do not believe that Impella 5.5 is the same level of support. With Impella 5.5, you are committing to a surgically implanted device and there should be no need to wean every two weeks to prove eligibility. Typically, these patients are those that require longer term mechanical support without an option for a durable LVAD. Patients with Impella 5.5 should remain status 2 without weaning.
Are the prerequisite parameters for IABP and percutaneous endovascular MCSDs appropriate given the specific need of some candidates?

We believe the parameters are appropriate with inotropes and support this proposal.

Should the proposed policy changes to adult heart status 2 IABP and percutaneous endovascular MCSD criteria also define the amount of time a candidate must receive a continuous infusion of the inotropic therapy before the candidate would qualify for the status assignment?
The timeframe question is challenging. A crashing patient is well covered by the emergency parameters. Since the goal of the proposal is to ensure program integrity, we would recommend an 8–12-hour trial of inotropes prior to claiming hemodynamic failure. We recognize that the burden of data collection might be challenging and difficult to verify for accuracy.

Are the inotropic levels that are listed within the policy appropriate for use prior to the placement of an IABP? If not, what levels would be more appropriate and why?
The Spectrum Health transplant team recommends that Epinephrine not be included in the single-dose high-dose category. We believe it should remain in the dual inotrope category, but that the dose be increased to 0.02mcq/kg/min.

Should the duration of the initial assignment, and/or the extension, be reduced from 14 days? If yes, please describe why and what might be a more appropriate time period.
We support the current policy of 14 days.

Do members of the patient community feel this action is appropriate to give greater access to more medically urgent candidates?
We believe the patient community would agree that this action is appropriate to give greater access to medically urgent candidates.

Under the proposed transition plan, following implementation, a candidate would remain at the assigned status until the expiration of the justification form, at which point the transplant program would need to submit a new justification form. Is that the most appropriate way to address such adult heart status 2 candidates following implementation? Are there more efficient and effective options to ensure all candidates are assigned to the correct status following implementation?

The Spectrum Health transplant team supports this proposal.

Thank you very much for your consideration of our comments.

Sincerely,
The Spectrum Health Transplant Team

NATCO | 09/19/2023

NATCO would like to thank the committee for their efforts and appreciate the opportunity to comment. Overall, the membership views these modifications as a step in the right direction but is concerned that this eliminates the discretion of the physician to treat their patient as they deem medically necessary based on their patient’s history and severity of illness. In addition, not all patients are candidates for inotropic therapy and the risks of using inotropic medications could be detrimental to their outcome, i.e VT/VF, transplant vasculopathy, restrictive or hypertrophic cardiomyopathy patients. In addition, the burden that this will place on the healthcare team in regard to every 2 week wean attempts and re-submissions will increase.

Region 10 | 09/19/2023

Sentiment: 0 strongly support, 8 support, 6 neutral/abstain, 1 oppose, 0 strongly oppose

Members of the region support the proposed changes to adult heart status 2 mechanical device requirements, but raised concerns in regard to issues with contraindications, weaning processes, and the need for more thorough guidelines. Attendees noted the need for change due to the increasing number of patients at Status 2 with balloon pumps and the identified inequities in terms of mortality. Concerns were raised about the impact of arrhythmias, a common issue for patients in cardiogenic shock on inotropes, on appeals based on inotrope-driven arrhythmias. An attendee highlighted practical challenges, such as patients arriving at transplant hospitals already on devices and the potential need for a weaning attempt to apply for Status 2. Questions were posed about the definition of contraindications to inotropic therapy and the potential for numerous exception requests in the absence of clear guidelines. There was concern over the minimum time requirement for treatment with inotropes prior to assessment with hemodynamics, along with the potential for patients transferred to transplant hospitals while already on mechanical circulatory support (MCS) to face delays in listing due to the requirement for weaning. Lastly, an attendee expressed concern about the thoroughness of the proposal, suggesting that it might be rushed without adequately addressing known concerns. The need for careful and comprehensive policy development, rather than addressing issues as they arise, was emphasized.

Abbott Laboratories | 09/19/2023

Abbott appreciates the complex discussions surrounding their recommendation and commends the UNOS Heart Transplantation Committee (the Committee) for its thoughtful approach to heart distribution policy changes. Furthermore, we support the proposal as it is a positive step towards more equitable distribution of hearts. It also provides substantive guidance for clinicians to aid in the decision making about deploying Temporary Mechanical Circulatory Support (tMCS) to bridge a candidate to cardiac transplantation. We agree that this proposal is based on sound evidence-based medical judgment and ensures that it promotes the best use of donated organs by ensuring organs are allocated and transplanted according to medical urgency.

As the Committee noted, the 2018 changes to heart distribution policy achieved the goals of better delineating the methods of defining the acuity of a transplant candidate, reducing the waitlist mortality, and shortening the time on support before gaining access to a heart transplant. However, there was not a specific way to define the need for tMCS other than a clinically intuitive decision process. Thus, the waitlist status was defined by the need for tMCS therapy and not necessarily hemodynamic condition. This caused a significant increase in the use of IABP and other tMCS devices, followed by a significant decrease in the use of durable LVADs. We agree that the policy should move towards a system whereby a patient’s waitlist status is more defined by hemodynamic criteria at a specifically defined degree of pharmacological therapy, as opposed to a decision based on the presence of support devices themselves. We believe that the proposed policy amendment achieves this realignment.

With regards to specific questions asked by the Committee, Abbott supports the proposed 14-day duration of the initial assignment after hemodynamic criteria are met. Abbott also supports the proposed policy in which a transplant program must reapply for a Status 2 extension every 14 days by meeting the criteria outlined in the proposal and submitting a justification form to their regional review board. As noted above, we support the policy proposal as it prioritizes patients with the greatest medical need. Of greater concern in the past process is the allowance of a high number of exceptions to established criteria for determining listing status. A method should be proposed for proper control of the proliferation of rate of exceptions.

Since the 2018 changes in heart distribution policy, clinical teams have been reticent to use LVAD therapy as BTT because waiting time has increased significantly for patients in Status 4. This is despite recently published 2022 Joint AHA/ACC/HFSA guidelines for the management of heart failure. These guidelines resulted in a Class 1A indication for the use of durable MCS in patients on Inotropic or tMCS support based upon the 5-yr survival outcome data from the MOMENTUM 3 trial which showed that use of an LVAD is indicated for both bridge-to-transplantation (BTT) and destination therapy achieving a 5-year survival of 58.8%. The continuous distribution of hearts — with the inclusion of a risk adjustment factor for time on LVAD — will enable more equitable distribution. But since these changes will not be implemented for a few years, Abbott supports the interim step of adopting the Amend Heart Status 2 policy proposal as an important interim step to help with equitable distribution of donor hearts.

UC San Diego Health | 09/19/2023

The UC San Diego Health Center for Transplant appreciates the Heart Committee’s ongoing monitoring of the post-implementation impact of the 2018 heart allocation changes and generally supports the proposal to revise the eligibility criteria for IABPs and percutaneous endovascular MCSDs within adult heart status 2 to better reflect the high-level of medical urgency associated with the other adult heart status 2 criteria. While the rates of bridging to transplant increased significantly after the policy change, programs also realized improved waitlist outcomes and comparable post-transplant survival making it difficult to argue that these advanced therapeutic measures were deployed even in the absence of true medical necessity; particularly as baseline characteristics of pre- and post–policy change recipients remained similar. We do however, agree that this demonstrated experience also supports that these candidates, when stabilized using these therapies, largely do not demonstrate the same level of severity of illness as other Status 2 candidates and thus, the policy should be modified to better prioritize the most critically ill.

Members of the team did express concerns that this will create an additional administrative burden on programs given the additional data collection that would be required and the potential for an increase in exception requests; although overall, it is not felt that this additional burden is a sufficient cause to reject the proposal.

Additionally, we agree:
• It is sensible to apply these requirements to MCSDs as well as IABPs and the prerequisite parameters are appropriate
• The inotropic levels that are listed within the policy are appropriate for use prior to the placement of an IABP however, policy should not define the amount of time a candidate must receive a continuous infusion of the inotropic therapy before they would qualify for the status assignment
• Should not reduce the exception period from the current 14 days
• With the Committee’s proposed transition plan in which following implementation, a candidate would remain at the assigned status until the expiration of the justification form, then prompting a new submission.

Region 7 | 09/18/2023

Sentiment:  1 strongly support, 7 support, 5 neutral/abstain, 1 oppose, 3 strongly oppose

Attendees expressed concern that adding more criteria for determining Status 2 eligibility might result in more exception requests, complicating the allocation process further. They raised the issue of high inotrope levels, which they felt could limit physician flexibility and potentially run counter to the policy's intent. Additionally, the addition of more parameters and criteria could lead to an increase in exception requests, particularly for patients with a history of ventricular tachycardia (VT). In regard to handling current Status 2 candidate, an attendee questioned how the proposed policy changes would affect candidates who are currently listed as status 2 but may not meet the new criteria. There was discussion about the use of inotropes and intra-aortic balloon pumps (IABP) in managing heart transplant candidates, with some attendees questioning the evidence supporting the use of high-dose inotropes and the benefits of IABP, suggesting that the effectiveness of these interventions should be considered. An attendee noted that comparing waitlist mortality between Status 2 and Status 3 candidates is not entirely accurate, and the focus should be on specific subgroups within Status 2. In particular, candidates with surgically implanted non-endovascular LVAD devices should move to Status 1. An attendee raised concerns about the potential risks associated with the proposed parameters, especially in terms of weaning inotrope support, which could put patients at increased risk. The attendee emphasized the importance of patient safety and avoiding undue risk. Additionally, attendees proposed alternative approaches, such as requiring patients to meet Status 4 criteria before becoming eligible for Status 2 IABP criteria, to prevent patients from being upgraded from Status 6 directly to Status 2. An attendee noted concern over the complexity of the proposed changes and the potential increased administrative burden, including the need for more frequent status renewals. Lastly, and attendee suggested that the focus should be on understanding and addressing the reasons for the high number of exception requests, rather than adding more layers and barriers to Status 2 eligibility.

Region 1 | 09/15/2023

Sentiment: 0 strongly support, 3 support, 1 neutral/abstain, 1 oppose, 0 strongly oppose

Region 6 | 09/15/2023

Sentiment: 1 strongly support, 8 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose 

One attendee commented that it would be helpful to have regional data about how many candidates are at status 2 with devices, versus being transplanted at status 3 or 4 with inotropic escalation. Another attendee supported the proposal but cautioned the committee on getting too prescriptive with doses and timing of medications. Several attendees supported the intent of the policy but had concerns about patients with arrhythmias and the requirements to maintain high inotropes with percutaneous mechanical circulatory support (pMCS). One attendee commented that the committee needed to make sure the inotrope does are supported within the committee with input from cardiology. 

American Society of Transplantation | 09/15/2023

The American Society of Transplantation (AST) generally supports the proposal, “Amend Adult Heart Status 2 Mechanical Device Requirements,” and offers the following comments for consideration:

• The AST agrees the policy should be modified to better prioritize the most critically ill patients. Members commented their experience also supports that heart candidates with an intra-aortic balloon pump (IABP) or percutaneous endovascular mechanical circulatory support device (MCSD), when stabilized using these therapies, largely do not demonstrate the same level of severity of illness as other Status 2 candidates. The use of inotrope support should be pursued before the use of IABP or MCSD. Heart candidates with an IABP or MCSD should be required to demonstrate failed inotropic support to qualify for adult heart status 2; otherwise, these heart candidates should qualify for adult heart status 3.

• There is overall agreement in the inotropic levels (high dose single inotrope versus at least two lower dose inotropes); however, it remains unclear how to define the duration of inotropic therapy before it is considered a failure. The duration of time to define inotropic therapy failure is highly debatable and depends on several variables, including patient acuity and hemodynamics. Recognizing that this aspect of the proposal is consistent with requirements in status 3 OPTN Policy 6.1.C.ii Multiple Inotropes or a Single High Dose Inotrope Hemodynamic Monitoring, did the Committee consider including other criteria – including duration of inotropic support – to demonstrate that the patient’s condition did not improve with inotropic support?

• The proposal does not clearly address situations where patients can’t tolerate high-dose inotropes prior to MCSD support (e.g., ventricular tachycardia). The AST believes it is important to create a mechanism for these candidates to qualify as Status 2, either through policy or specific exception guidelines.

• Did the Committee consider whether the heart status 2 timing should be limited to less than 14 days, as well as shortening the time for future extensions? Potential pros to reducing these time frames include better timing and careful device choice; potential cons are an increased number of exception requests and a more tedious process.

• The AST agrees that if a patient’s condition improves on inotropes, then weaning off an IABP or MCSD should follow and correspond with adult heart status 3.

• The AST agrees with the proposed transition plan in which, following implementation, a candidate would remain at their assigned status until the expiration of their last justification form, then requiring a new justification form guided by the new policy.

View attachment from American Society of Transplantation

Anonymous | 09/14/2023

For candidates experiencing cardiogenic shock:
-Add a requirement to use certain medications within 7 days before using an IABP or percutaneous endovascular mechanical circulatory support device (MCSD)
- this is not taking in consideration the great number of patients that cannot be supported by certain medications due to experiencing arrythmias while on them - puts them more at risk for a worsening condition, including cardiac arrest.

-Add a requirement to report hemodynamic measurements within 7 days before implanting an IABP or percutaneous endovascular MCSD:
-this is a requirement already.

-When extending a candidate at this status, add a requirement that the candidate must continue to be on certain medications when attempting to wean them off IABP or percutaneous endovascular MCSD support:
-there should be an exception for those that do not tolerate inotrope support due to causing dangerous arrythmias, making the candidate more at risk for a cardiac arrest.

American Society for Histocompatibility and Immunogenetics | 09/14/2023

This proposal is not pertinent to ASHI or its members.

View attachment from American Society for Histocompatibility and Immunogenetics

Region 5 | 09/13/2023

Sentiment: 6 strongly support, 11 support, 5 neutral/abstain, 3 oppose, 0 strongly oppose

Many attendees supported the status 2 change and offered suggestions for the committee. An attendee suggested the Committee consider using machine learning, using criteria that aren’t “gameable”. They pointed out there are a lot of decisions that drive deciding who receives a heart transplant (such as choosing to wean or not to wean pressors, or choosing to implant an impella heart pump). The attendee suggested adding inotropic with an intra-aortic balloon pump (IABP). An attendee commented that with status 2, they are seeing a lot of stability with these therapies. They pointed out that status 2 patients are not all the same and has more granularity. Several attendees thought the proposed status 2 change will yield more exceptions and noted that inotropes are not safe for many high-risk patients. Several attendees suggested the committee tighten the criteria for status 2. An attendee suggested that allocation priority should be based on patient health status as opposed to treatment protocol. The attendee supported the proposal because it may reduce unneeded interventions, but suggested rethinking the approach. This proposal implies there is 'gaming' of the system by centers putting in IABP/Impella devices 'unnecessarily'. A center expressed concern that the committee is essentially dictating clinical care - sometimes in circumstances as noted by others where it may be dangerous to do so. (i.e. patients prone to arrhythmias in response to pressors). The proscription of clinical care and the determination of medical criteria based on the treatments candidates receive has many pitfalls. They thought better predictors of both short term and long term waitlist mortality ought to be substituted in place of simply ranking patients by the treatment of such patients. An attendee pointed out that inotropes are often not safe in many high-risk patients waiting for heart status where temp devices could be helpful when inotropes are not (for candidates prone to arrhythmias and candidates with already poor RVs).

Anonymous | 09/12/2023

There appears to be a long wait for a heart transplant and as a friend of the family that has an LVAD, I hope that any revisions to the protocol will help patients with LVAD make sure they be considered sooner for a heart transplant

Region 11 | 09/12/2023

Sentiment: 3 strongly support, 5 support, 5 neutral/abstain, 0 oppose, 1 strongly oppose

Anonymous | 09/12/2023

I am writing to express my heartfelt concerns about the proposed changes that are set to impact how we manage candidates experiencing cardiogenic shock. While I understand the need for continuous improvement in our medical protocols, I believe it is vital to critically assess the potential consequences of these changes.

The anticipated impact of these changes, as described, aims to make sure that Status 2 candidates with IABP or percutaneous endovascular MCSD receive the appropriate level of medical attention and urgency. While this goal is undoubtedly commendable, we must also weigh the potential drawbacks.

It is my concern that these changes may inadvertently introduce complexities and delays in patient care. Lives hang in the balance, and we must strike a careful balance between rigor and practicality.

Anonymous | 09/11/2023

There appears to be a long wait for a heart transplant and as a friend of the family that has an LVAD, I hope that any revisions to the protocol will help patients with LVAD make sure they be considered sooner for a heart transplant

Elaine Shepherd | 09/10/2023

Since we have a family member with a LVAD,it appears to take along time to receive a heart ❤️ I hope that any revisions to your protocol will help to ensure that LVAD patients be considered sooner,as every life is most precious.

David Shepherd | 09/09/2023

There appears to be a long wait for heart transplants and as a hopeful recipient that has Al VAD , I hope that any revision to the protocol will help patients with lead make sure that they are considered sooner for a heart transplant

Anonymous | 09/09/2023

There appears to be a long wait for heart transplants and as a (relative/friend)of the family of a patient that has an LVAD, I hope that any revisions to the protocol will help patients with LVAD make sure they be considered sooner for a heart transplant.

Vlad Cotarlan | 09/08/2023

It is a fact that the number of patients supported by MCS has exponentially increased.
It is also a fact that the number of exception requests has exponentially increased. This is mostly because we moved from a 3 tier priority system(1a, 1B, 2) to a 6 tier system (1-6).
Patients on temporary MCS are listed at higher priority(status 2) than patients on high dose inotrops(status 3). However, as others pointed out, the mortality on high dose inotrops is likely not lower that that on patients supported by temporary left MCS. If we agree on that, then patients on temporary MCS and those on high dose or multiple vasoactive drugs, should be listed with same priority.
I personally think that status 2 and status 3 patients should be combined as status 2. This would avoid many exception requests and also avoid the potential gaming the system. It is really up to the caring center/providers how to best manage patients with cardiogenic shock, whether it is with multiple inotrops, temporary MCS , or a combination.
What makes sense to me is this:
Status 1: Patients on ECMO, TAH or Biventricular support. Patients on RV support (Right Impella, Centrimag) might also be included here since these patients are usually very sick and there is no long term solution for them.
Status 2: Patients on LV mechanical support or multiple/high dose inotrops. This patients have similar mortality in my opinion, and others. At the end of the day, it is up to the individual center how to manage these patients. This will avoid many exception requests.
Status 3: Patients on home inotrops
Status 4: The rest.

Mitchell Psotka | 09/07/2023

The requirement to use certain medications within 7 days before using an IABP or percutaneous endovascular mechanical circulatory support device (MCSD) is not aligned with best practices in clinical care, is not patient-centered, and increases the risk of patient harm. Dictating clinical decision-making and requiring the use of inotropic (calcitropic) therapies that have associated adverse events such as ventricular arrhythmias, as well as which may not provide sufficient support to some patients, has no clinical purpose and will likely precipitate death in some patients by forcing clinicians into inappropriate care. Some patients can be managed with these inotropic medications, others cannot, and those that cannot often require temporary mechanical circulatory support. Mandating inotropic therapy use on the pathway to transplant does not improve patient care nor make the allocation policy more equitable, it is only a step backwards. In addition, although the stated intention of this proposal is to ensure medical urgency of Status 2 candidates and reduce the number of listed Status 2 candidates, this proposal is unlikely to achieve either of those aims. In the prior allocation model inotropic therapy use was shown to be even more arbitrary than temporary mechanical circulatory support, that is not likely to have changed in the intervening years. It remains more likely that patients will receive possibly unneeded inotropic therapies than unneeded temporary mechanical circulatory support. Rather, the oversimplistic proposal to require inotropic therapy use is most likely to lead to increased exception use surrounding the inappropriate mandate for inotropes, thus further harming the reliability of the current allocation system, in addition to impairing clinical decision-making. If the goal is to further stratify patients at increased risk of adverse events within the Status 2 stratum, then perhaps breaking out higher risk candidates is appropriate as opposed to attempting to determine which candidates are lower risk without sufficient data or means.

University of Utah Medical Center | 09/06/2023

We would like to thank the committee for their efforts. Overall, we view these modifications as a step in the right direction. We agree that IABP-supported patients are at no greater risk of waitlist mortality than patients supported by high-dose inotropes, as we recently published in the JHLT (PMID: 36369224). Our allocation system should restrict Status 2 tMCS criteria to those patients who are truly failing high-dose inotropes, while doing so in a way that remains agnostic to choice of tMCS. The proposed modifications meet both goals, and the allocation system will benefit. Nevertheless, we see two important areas where the proposed changes could be improved.

Theme #1: In addition to meeting HEMODYNAMIC shock criteria despite high-dose inotropes, use of endovascular tMCS should also require evidence of at least mild systemic MALPERFUSION. Patients who have hemodynamic shock WITHOUT malperfusion have a much lower mortality risk than patients with hemodynamic shock WITH malperfusion. This concept is supported by several large observational studies (see PMID: 33464952, 10759093, and 35835491). Consequently, hemodynamic criteria alone do not define a cohort who are sick enough to justify use of tMCS; such patients could, instead, remain on high-dose inotropes as status 3. We favor adding criteria for a malperfusion requirement for Status 2 tMCS as follows:

Patient meets ONE of the following malperfusion criteria despite use of high-dose inotropes for at least 24 hours:

• Arterial Lactate > 2 mmol/L
• Urine output < 0.5 mL/kg/hour or need for renal replacement therapy
• Increase in serum creatinine >= 1.5 x baseline from the prior 7 days
• Aspartate Transaminase (AST) or alanine transaminase (ALT) greater than 500 U/L

We note that these malperfusion criteria are less severe than the criteria used to justify tMCS use in critically ill patients missing hemodynamics (e.g., lactate 4, AST/ALT > 1000, cardiac arrest etc). This is by design. Moreover, we would require at least 24 hours of inotrope support, which is important to show that inotropes are unable to correct the underlying metabolic abnormalities. Together, these will restrict tMCS use to those patients with persistent hemometabolic derangements refractory to high-dose inotropes. Implicit in this is that providers may still elect to utilize tMCS without meeting malperfusion criteria, if they see fit, but patients would then remain at Status 3.

Theme #2: Some patients will be unable to tolerate inotropes due to ventricular arrhythmias, but the criteria for inotrope intolerance should be EXPLICIT in the allocation rules to avoid excessive use of exception requests. We anticipate that the new inotrope requirement, as written, will lead to a sizeable increase in exception requests for patients deemed “intolerant” to inotropes. Some of these exceptions will be justified, some will not. We believe that the allocation criteria should clarify what constitutes “intolerance” to inotrope therapy, as follows:

The requirement for high-dose inotropes is waived if patients had potentially life-threatening ventricular arrhythmias while on any dose of inotrope, as defined by at least ONE of the following:

1. Sustained ventricular tachycardia > 30 seconds requiring cardioversion, defibrillation, or anti-tachycardia pacing to terminate.
2. Sustained ventricular tachycardia > 30 seconds requiring intravenous antiarrhythmic therapy to terminate
3. Ventricular fibrillation

Note that these criteria are less stringent than the VT storm criteria, where patients would already qualify as Status 2. In this scenario, to meet shock criteria without inotropes, we should retain the previous non-inotrope cutoff of cardiac index < 1.8 L/min/m2. Review boards should be instructed to scrutinize closely any exception requests for inotrope intolerance that do not meet the above arrhythmia criteria.

Thank you for considering these comments.

Sincerely,

The University of Utah Heart Transplant Team
The Intermountain Healthcare Heart Transplant Team

Northwestern Memorial Hospital | 09/06/2023

This proposal
• Uses a non-evidence-based approach
• Will not reduce Status 2 exceptions, but rather increase exception requests due to more restrictive criteria, with q 2 week approval
• Creates a situation of greater potential for harm for patients with VT/VF, given the requirement of inotrope therapy prior to mechanical device placement
• Removes the cardiologist/cardiac surgeon from a decision-making role in patient care with these restrictive proposed changes
• Will increase burden on the healthcare team (e.g., q 2wk wean attempts, re-submissions, etc…)
• Does not prioritize patients needing higher support (eg Impella 5.5, etc…). The purpose of the proposal is stated as to “prevent future status 2 congestion” and “properly align medical urgency of the candidates”. Among the current status 2 patients, those with “recurrent sustained VT/VF”, “temporary surgical VAD (Centrimag)” and those with “TAH, BiVAD and RVAD” have expected waitlist adverse events similar to UNOS status 1 patients. An alternative solution to the stated problem is to move those patients from status 2 and give them higher priority.
• The requirement for extending status 2 not only lacks evidence but also is unrealistic and exposes the listed candidates to unwanted risk. In order to extend status 2, programs are required to demonstrate failure to wean off device every 14 days while on continued inotropic therapy. This requirement does not appreciate the fact that many patients who have IABP as status 2 have a surgically-implanted axillary device, and they have been previously deemed appropriate to receive IABP. Also, it does not appreciate that many patients after receiving IABP do not require high dose inotropes, and the inotropic therapy at times can be safely weaned off as clinically indicated. So, it is both dangerous and unrealistic to try high doses of inotropes and wean the IABP after 14 days, remove a surgical device if the candidate does not meet criteria, and place it back if the candidate fails inotrope therapy again.

Kambiz Ghafourian, MD; Duc Thinh Pham, MD; and Jane Wilcox, MD on behalf of the Northwestern Memorial Hospital Heart Transplant Program

Andrew Kao | 09/02/2023

1. I would like to first respond to the concern of overuse of temporary mechanical support - currently, there is no requirement for "high dose" inotropes so the fact that 65% of the current status 2 patients would not qualify under the new policy does not equate to 65% of these patients being inappropriately listed as status 2 - transplant professionals are listing patients under the current guidelines. Without further analysis, it will be difficult to ascertain the patients who are truly inappropriately listed at a higher status. For example, the number of ECMO supported patients now are much higher than under the previous status 1A listing guidelines, but no one would suggest that physicians are placing ECMO cannulation to "game" the system. The placement of IABP and Impella and other temporary devices is not without risks, and to suggest that programs are putting these catheters because they are "easy to place" disregards the real risks associated with these devices, including fatal thromboembolism and hemorrhage. The current requirement for low cardiac index and elevated wedge pressure with hypotension already selects out a sick population.

2. I applaud the hard work the committee has done to ensure all candidates are assigned to the correct listing status, but there are concerns listed in the points below.

3. I am concerned about the proscriptive use of "high dose" inotropes or combination inotropes. Inotropic use is not benign and increasingly, patients experience significant hypotension and ventricular arrhythmias on inotropes, and to mandate that patients have to "fail" these doses would be doing these patients a disservice. Also, to answer the committee's question about requiring a certain duration of the "high dose" or combination inotropes, I would also be concerned about policy inadvertently dictating clinical care of this complex group of patients. There is another avenue to list patients as status 2 based on having had CPR, but the patients who acutely decompensate during cath-lab based or surgical procedures are often resuscitated quickly before they need CPR and they may not have a chance to develop significant acidosis or hepatic injury to qualify but that does not mean these patients do not have poor prognosis and need a higher level of support.

4. Endstage heart failure patients with severe cardiorenal syndrome often benefit from augmentation of cardiac output and renal flow with a temporary mechanical support device and often do not respond well to inotropic therapy alone. This group of patients would necessitate to a lot of exception requests which this policy is meant to decrease.

5. The current policy proposal does not address patients with severe restrictive or hypertrophic cardiomyopathy who would not benefit from inotropic support.

6. The current policy proposal does not address re-transplant candidates with severe vasculopathy and ischemia without revascularization option - intra-aortic balloon pumping is often the last viable treatment option to augment coronary flow to the extent possible. Inotropes obviously have no role in their management.

7. If our patients cannot be upgraded to status 2 due to the policy change and end up dying before receiving a transplant, that will count against the program's waitlist mortality metric. Perhaps there would be a way to exclude these patients in the calculation of that metric?

8. Disagree with consideration of moving IABP supported and possibly temporary MCS supported patients to status 3 - this will just move the logjam from status 2 to status 3.

9. Disagree with reducing status 2 time or renewal time to less than 14 days - often patients do not have enough status 2 time until the end of the 14 day period (or beyond) and if they are allosensitized, that makes it even harder to obtain an appropriate donor organ.

10. Perhaps the policy proposal can include some "exceptions" or "pop-off valves" where if patients have VT (can use current VT exception listing language) or intractable hypotension with renal injury, or hemodynamically significant atrial dysrhythmias, that would preclude the "one-size fits all" criteria for status 2 upgrade qualification.

Thank you for your kind attention.

Region 2 | 09/01/2023

Sentiment: 2 strongly support, 6 support, 10 neutral/abstain, 1 oppose, 1 strongly oppose

Overall, members of the region support the proposal, but there was some opposition. An attendee highlighted that while some data suggests inotrope use is riskier than early use of Intra-Aortic Balloon Pumps (IABPs), their institution has achieved positive outcomes with IABPs. They emphasized that correlation does not imply causation and emphasized the importance of gathering more data from both sides before making changes to policy. They do not agree with the proposal. Another attendee expressed support for re-stratifying Status 2 patients to identify those who are sicker. A question was raised regarding the specific clinical parameters that would classify someone as sicker while on inotropes. Another attendee noted concerns about the potential impact of the change on patients. The concern was that the proposed criteria might not address the problem of gaming the system by using IABPs to increase status. There was a suggestion that patients on IABPs might not have comparable outcomes as those on inotropes, and better analytics like propensity matching were recommended to provide a clearer comparison. Lastly, there was support for better risk stratification of patients who receive temporary mechanical circulatory support (MCS) and fall into the Status 2 category with reservations. The concern was that certain issues like inotrope toxicity, ventricular arrhythmia, and deteriorating end organ function might not be captured by the proposed criteria. It was suggested that these issues could justify Status 2 without meeting the criteria. Additionally, potential impacts on waitlist mortality and outcomes post-surgery were highlighted.

Taiyeb Khumri | 08/31/2023

IN principle I do agree that most patients should be tried on reasonable doses of inotropes prior to escalation to temp MCS.
However, the purpose of the transplant listing criteria should be to classify the severity of illness of the waitlist patient, rather than the treatment being used by their physicians. To dictate prescriptive use of prespecified treatment option prior to being able to up titrate support to justify status 2 listing with temp MCS is too simplistic for a very complicated clinical status and does not incorporate clinical variables that may preclude the use of the specified therapies prior to escalation to temp MCS. An amendment like this is only going to substantially increase the number of status 2 exceptions request/listing.
I also disagree with the reasons that are prompting the need to amend the current requirements, ie Saturation of Status 2 with patients on IABP and the wait list mortality of patients as status 2 with IABP being similar to those listed as status 3.
Most transplant centers/physicians focus on using the least toxic therapies that will support a patient in cardiogenic shock to bridge them to transplantation. This is what has lead to an increased number of patients with IABP as status 2.
And the fact that patients with IABP and status 2 listing have similar mortality as those with status 3 listing is actually a testament to the success of that treatment strategy rather than a criticism.
At our institution, there was very uniform consensus regarding opposition to the proposed amendment.

Region 4 | 08/30/2023

Sentiment: 3 strongly support, 11 support, 8 neutral/abstain, 0 oppose, 0 strongly oppose

Region 4 supported this proposal. One attendee commented that the Heart Committee has conducted themselves with rationale thought, expertise and community engagement providing rationale solutions. They added that the balloon pump issue is somewhat controversial depending on the transplant center. There will be situations where balloon pumps are necessary and they would not advocate for balloon pumps to go away, but rather look at data and adjust the status according to mortality rate. Another attendee agreed that the change was thoughtful and commented that there are appropriate utilizations after looking at data. They went on to suggest that one point to consider is inotropic levels prior to placement and that it makes sense for status 2, but there is a disconnect because there is no criteria in status 3 for balloon pump unless you don’t meet status 2.  Using mechanical circulatory support is preferrable. They added that if you have a lower level of inotropes and fail weaning from the device, you could go in with status 2. They added that maybe there should be criteria for an initial listing at status 3. Another member commented that there are patient scenarios where balloon pump is clinically appropriate over inotropes and that’s the process for filling out data and explaining the request. They went on to comment that review boards did not effectively monitor this, which is why this is such an issue that now requires a policy change. They added that this isn’t a balloon pump policy, this is a status 2 policy. One attendee commented that this could result in more exception requests. Another attendee commented that the committee should consider status 3 criteria for candidates who move to mechanical device support after failing a single inotrope. One attendee commented that each time the requirements in policy change for a specific device, drug, or patient location, there is an increase in utilization of that device or drug. They went on to question if this change would have any effect on the behavior. Another attendee commented that while this proposal will not address all the issues, it is a reasonable solution while continuous distribution is developed and could provide data that can be used for continuous distribution.  

OPTN Transplant Coordinators Committee | 08/28/2023

The OPTN Transplant Coordinators Committee thanks the OPTN Heart Transplantation Committee for their work and for the opportunity to comment on this proposal.

A member said that this proposal is encouraging and sufficiently addresses the issue, is thoughtful, and will address the issues seen in their transplant center, specifically for pediatric and adolescent candidates. A member commended the OPTN Heart Transplantation Committee, saying that this proposal was readable, especially for the patient population and applauded the patient education video that was paired with the proposal. The member said they hope that other OPTN Committees will do something similar to assist patients in understanding proposals. The member continued saying that data supports this change and the OPTN Heart Transplantation Committee is doing their due diligence to follow up on the implementation, specifically addressing intended and unintended consequences and making appropriate changes.

Brett Sperry | 08/25/2023

I am posting this in opposition to the amendment to adult heart status 2 mechanical device requirements for transplant listing, as currently worded.

The purpose of this update, as stated, is to revise the criteria for IABP and percutaneous MCSD to reflect the high level of medical urgency associated with other adult heart status 2 criteria. The proposal also frequently states that IABP use has increased after the 2018 allocation change, and characterizes this changing practice as inherently problematic.

As stated in the proposal and per the "three-year monitoring of heart allocation" document on page 31, IABP patients do have low waitlist mortality that is similar to status 3 patients. However, Status 2 exceptions and MCSDs with malfunction also have low waitlist mortality, similar to status 3. In fact, other Status 2 criteria like VT/VF, BIVAD, and percutaneous MCS appear to have statistically similar waitlist mortalities to IABP. It appears that most of the increased waitlist mortality in Status 2 is related to non-dischargeable surgically implanted non endovascular LVAD devices. Perhaps instead of targeting IABP, the committee should consider moving this criteria up to Status 1. IABP at Status 2 is not holding back other Status 2’s from being transplanted, as evidenced by low wait times and low waitlist mortality (besides non-dischargeable surgically implanted non endovascular LVAD devices). Furthermore, IABP at Status 2 does not appear to be increasing waitlist mortality or waiting times for Status 3’s.

The committee in this proposal is asking heart transplant physicians to practice in a way that is currently only practiced 17% of the time. This proposal will incentivize transplant physicians to use high dose inotropes in scenarios where they do not do so currently, because it is the not the best, safest, or most appropriate strategy, based on risk/benefit ratio and clinical logic/insight. As occurred after the 2018 allocation change, these incentives may lead to similarly unintended consequences, such as high rates of arrhythmia and potentially increased waitlist mortality, among patients treated with high dose inotropes. Waitlist mortality for IABP is currently low because of the way it is being used to stabilize cardiogenic shock patients who are sliding. This proposed allocation change will undoubtedly increase waitlist mortality for these patients, which would be alarming and, obviously, undesired.

Finally, we can assume that all transplant physicians are going to advocate for their patients, and that the already-high rate of exceptions is only going to further increase, as a consequence of the changes that would occur if this proposal passed. This proposed change will further contribute to disparities in donor organ access/availability seen between programs and regions that are willing to make and grant exceptions, versus those that are not.

Overall, the 2018 change has successfully reduced waitlist mortality and waiting times for the sickest patients, which should be celebrated. While there are going to be problems with any allocation system for such a scare resource, this proposal of moving IABP/tMCS to Status 3 seems to relate to the feeling among some that IABPs are being overused, as opposed to being a product of solid evidence that a problem exists within the current system. I would argue that the potential unintended consequences of this change would end up outweighing any potential benefits.

Anonymous | 08/24/2023

The proposed changes will ensure that before implementing MCS there is real or close to real time data to help guide the decision making process.

Luke Masha | 08/15/2023

I generally oppose the proposal as written. I agree with what its trying to do but think the current language is too restrictive. In summary i agree that high dose inotropes must be tried before going to MCS. I don't agree with ongoing high dose inotropes as necessary to maintain MCS. I think there are other ways to separate out status 2 from status 3 in that situation which are more fair and clinically relevant.

In brief:
Firstly, overall the proposal's aims are reasonable as the status 2 designation is becoming saturated currently and many physicians use it as a fast track pathway to avoid durable LVADs and inotropic support as an ambulatory status 4. I fully understand the logic of the proposal and generally agree with the aim (requiring physicians to escalate care appropriately and trying to decongest the status 2 designation so we don't end up with what we had prior to the 2018 allocation change where everyone was basically status 1a).

I think that the language is too restrictive. The new extension however requiring ongoing high dose inotropic support to warrant maintaining a status 2 seems unreasonable and poorly contrived. Many patients (who are not VAD candidates) have substantial reductions inotropic support after pMCS implementation. This proposal would have such patients drop down to status 3 (or even status 4) even with high risk devices like impella 5.5, devices which are a real commitment to place and provide substantial daily risk to the patient. This would lead to lengthy hospitalizations with high risk devices for patients with no other options due to the lower status which seems unreasonable (these are patients who received an impella because they are failing inotropes). Sitting on am impella 5.5 or a femoral impella CP as a status 3 for weeks on end seems undesirable and many patients (large patients, blood group O, or sensitized patients) would suffer (bleeding events, stroke, etc).

I agree that inotropic support prior to receipt of a pMCS should be required. I would recommend eliminating the new extension criteria that require ONGOING high dose inotropic support after the pMCS device has been placed. I would simply keep the current extension criteria in place, particularly for patients with high risk pMCS devices. IABPs should all be status 3 devices after 2 weeks as they are not nearly as high risk as Impellas/tandems, provide lower degrees of cardiac support (suggesting the patient is less sick), and portend a generally good waitlist survival outcome (data that looks out MCS outcomes in transplant always have IABP patients doing the best, and other devices not as well). I would also significantly strengthen (i.e. make it harder to pass) exception requests rules for avoiding inotropes due to concerns of VT as some of these exception requests can be superficial (i.e. patient had VT 3 years ago, received an ablation and is on amiodarone, and thus we cannot use inotropes today)

Anonymous | 08/09/2023

how long does pt need to be trialed on inotropes before temp mcs is provided?

Anonymous | 08/07/2023

Why replace one non evidence based approach with another non evidence based approach.
Just 'winging it' as we go seems to be quite an ineffective strategy to gain support for such policy changes.
Also LVAD IS NOT EQUIVALENT TO TRANSPLANT. Offering LVAD over transplant because RV function can handle it is an ethical travesty.

JEnnifer Cowger | 08/03/2023

The new UNOS revision will hopefully help address concerns that patients who are receiving tMCS (esp IABP) without clinical need are reducing intended risk stratification of the UNOS 2 status. While many may advise moving iABP to status 3, as a field, we still must consider that some patients with chronic HF shock can be well supported with an IABP and do not need tMCS with a 3.5L device. There are NO data to support a 3.5L device is better than an IABP. Rather, small BSA patients (women for example) could be at greater harm from larger bore devices. In the end, the devices used should NOT dictate UNOS urgency. Rather, the clinical condition should define a patient's urgency (oxygenation, perfusion etc) and the team should the decide management needed to achieve transplant.

However, we still have an unacceptable level of UNOS 2 (and UNOS 1) exceptions and this will not likely improve with the proposed revision.

1) Shock has various levels of illness, leading to SCAI classification. UNOS 2 does not really capture that. Again, using device selection to define shock severity is erroneous. Whether herein or for continuous allocation, the field needs to capture the shock trajectory in the allocation of hearts. Most will argue that a patient who needs a 5.5L tMCS devise is likely to be sicker than those on less support but we need criteria to show that, and the criteria should NOT include the device itself.

2) How long does one need to be on inotrope support to "fail"- 5 minutes or 3 hours or 12 hours?

3) How long does the SBP and/or cardiac index need to be reduced?

4) If VT results on inotropes, yet the cardiac index does not meet requirements, will this lead to a UNOS 2 exception? What defines VT?

5) What is the consequence for transplanting across an exception denial? With such a high rate of exceptions, I imagine it is hard for reviewers to keep up

6) Does UNOS/OPTN have a guidance plan for board reviewers of upcoming UNOS 2 exception requests so policy is enforced according to the aims and mission of UNOS/OPTN. The regional review board members seek guidance.

Jamie Kennedy | 08/02/2023

With this change, I expect a significant increase in status 2 exception requests based on arrhythmias limiting inotrope use. I think this change should be accompanied by clear guidance regarding arrhythmias.

Anonymous | 07/28/2023

Oppose without further criteria:
Many patients with worsening heart failure also have substantial ventricular tachycardia. Requiring utilization of inotropic therapy prior to a mechanical device for all patients would expose that patient population to undue risk and inappropriately dictate care decisions that could harm patients.