Amend Status Extension Requirements in Adult Heart Allocation Policy At a glance Current policy In 2018, adult heart allocation policy was changed to better sort candidates based on their medical urgency. Specific medical conditions must be present to qualify for each status and each status is valid for a certain amount of time before new information is required for an extension. Transplant programs have had questions about what specific information is required for patients to stay at their medically urgent status. Supporting media Presentation View presentation Proposed changes Clarify when a patient can remain at an assigned status beyond the first qualifying period Specify the criteria that must be met for a patient to qualify for a status extension Clarify Policy 6.1.C.iv: Mechanical Circulatory Support Device (MCSD) with Pump Thrombosis Anticipated impact What it's expected to do Address gaps and inconsistencies in heart allocation policy Ensures extension requirements are consistent and clear Ensure that similar patients have similar opportunities to receive an organ offer What it won't do This proposal does not incorporate the new continuous distribution framework to heart policy This proposal is not a substantive change to heart policy nor the heart allocation system Themes Criteria for extension Clarifies extension policy language Terms to know Exception Request: When a candidate does not meet the requirements for a particular status, but their transplant program believes they are at a similar risk of death while waiting for transplant and have a similar potential for benefit after receiving a transplant, they may ask that the candidate be placed at that higher status. These requests are reviewed retrospectively by the review board. Medical Urgency: Amount of risk to a candidate’s life or long term health without receiving an organ transplant. Mechanical Circulatory Support Device (MCSD): Device that helps pump blood through the body when the heart is not properly working. Click here to search the OPTN glossary Comments Region 11 | 09/30/2021 Region 11 sentiment: 2 strongly support, 10 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose Region 11 supported the proposal with no comments. NATCO | 09/29/2021 NATCO supports the exception criteria for pump thrombosis but questions that a 90 day extension might be too long. While we understand that pump thrombosis is life-threatening and that increased prioritization is justified, we also understand that despite higher status an individual may not be transplanted in a timely fashion for several reasons (i.e. BMI, PRA’s, blood type) and that device exchange should be considered as an alternative. NATCO proposes that the Heart Transplant Committee should consider a shorter exception period. In addition, NATCO supports a consistent extension timeline but expresses concern over the amount of work this will place on a transplant center for 7 day re-justification and suggest that the committee consider extending this to 14 days. NATCO also supports Life Threatening Ventricular Arrhythmias to remain at Status 1 until the time of transplant. American Society of Transplant Surgeons | 09/29/2021 The American Society of Transplant Surgeons (ASTS) strongly supports this policy proposal. The ongoing assessment to define and align listing status with the medical urgencies, balancing transplant and alternative strategies (e.g., inotropes and mechanical circulatory support) is beneficial and appropriate. This alignment would help minimize “gaming” of the status levels and the use of temporary mechanical support. As requested, we provide feedback on the following questions from the OPTN Heart Transplantation Committee. 1. Should the proposed changes to Policy 6.1.C.iv: Mechanical Circulatory Support Device (MCSD) with Pump Thrombosis include a temporal relationship when a patient experiences the medical conditions described and when the treatments are provided? Yes, a temporal component should be included. Additionally, one could propose adding the placement of temporary mechanical support was an elective decision (e.g., admission from home not in shock) or as a result of progressive decline and end organ malperfusion. 2. Are the medical conditions and treatments included in the proposed changes to the above mentioned policy described so that they may be easily understood and consistently interpreted by transplant program staff? Yes, the conditions and treatments are easily understood and should be interpretable. 3. Is Status 3 the appropriate status to transition a patient who was assigned to, but no longer meets, the eligibility criteria established for Policy 6.1.A. iii? Yes, assigning status 3 for a history of a recent life threatening arrhythmia is reasonable though the addition of a time limit of status 3 eligibility should be added. Then the candidate should revert back to a status 4 listing if there are no further life threatening arrhythmias. 4. Are the other requirements and/or criteria to extending a candidate's assignment at an adult heart status unclear in terms of what information must be submitted? No, this is not unclear. 5. Are there other requirements and/or criteria related to extending a candidate's assignment at an adult heart status that are inconsistent in terms of treating patients with similarly situated medical urgencies? No, the requirements and criteria are not inconsistent with treating patients with similar urgencies. 6. Should all adult heart policies require submission of objective evidence of a candidate's medical condition demonstrating a continued need for the established therapy in order to extend the candidate's assignment to the status? Yes, the adult heart policies should require submission of objective evidence of medical condition in order to extend the status upgrade assignment. 7. Should the Committee have considered changes to extension requirements/criteria in other specific adult heart policies? If yes, which policies and why? No, the current policy is appropriate for the “Status Extension Requirements in Adult Heart Allocation Policy.” Attachment Association of Organ Procurement Organizations | 09/29/2021 AOPO supports the Heart Transplantation Committee proposal to clarify status requirements to eliminate questions raised by transplant programs. This proposal aims to eliminate gaps and inconsistencies in listing criteria which is essential to allocating organs in a fair and trustworthy manor. American Society of Transplantation | 09/29/2021 The American Society of Transplantation supports this proposal in concept. We acknowledge that as proposed, this policy is designed to ensure that candidates at the highest status remain qualified beyond the initial period of time. For candidates who cannot be treated with other means, such as durable ventricular assist devices, the additional detail on justification forms will be straightforward to enter. The changes to the MCSD with thrombosis policy are also welcome. Increasing the length of time of extensions but requiring hospitalization will reduce paperwork while maintaining equivalent medical urgency. Region 10 | 09/28/2021 Region 10 sentiment: 2 Strongly Support; 9 Support; 7 Neutral/Abstain; 1 Oppose; 0 Strongly Oppose Comments: The members of the region are supportive of the proposal. One member commented that the committee needs to look in to the increased use of balloon pumps to increase a patient’s status. With the new heart statuses policy, they have noticed that transplant programs are using balloon pumps as a strategy to increase a patient’s status. There was a suggestion to give patients with ventricular assistance devices priority over balloon pump patients to deter the use of balloon pumps. Another member asked that the committee consider a contingency for HVAD patients, specifically those with infections or thrombosis, because device exchange options are challenging. Another member suggested that this proposal be broken into separate proposals, with the infection status criteria being separate from the rest of this proposal. Another member noted that there needs to be more clarification on the Status 3 criteria, specifically for the GI bleed qualifications. Another member agreed with the need for clarification on all adult heart statuses because it is often confusing; their specific suggestion is that pump thrombosis and MSCD should be a temporal relationship. Some programs are allowing pump thrombosis to go on for nine months, which the pump should be exchanged before that. The committee needs to figure out what the appropriate timing should be for pump thrombosis and how to associate it to the patient’s medical condition. Region 1 | 09/24/2021 Region 1 sentiment: 2 Strongly Support, 3 Support, 3 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose. Comments: Overall the region supports the proposal. There were no additional comments made. Region 6 | 09/23/2021 Region 6 sentiment: 1 Strongly Support; 7 Support; 1 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose. No comments. Region 8 | 09/22/2021 Region 8 sentiment: 5 strongly support, 12 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose. No comments. Region 8 supports this proposal. A member commented that informing other members about the need and use of this this proposal will be critical because implementing this policy requires more data entry. Saint Luke's Hospital | 09/21/2021 I would like to mention a discrepancy in wording that our team noticed: 6.1.A.iii is a Status 1 for MCSD with life threatening ventricular arrhythmia. It has very similar wording to the VT requirements of status 2 - 6.1.B.vi. However, the status 1 criteria says that the patient has 3 episodes of VT "over the previous 14 days" and status 2 criteria says "within a 14 day period." We were told that status 2 says "is experiencing" (while status 1 says "has experienced"), which means it must be within the 14 days prior. However, it is very confusing when it is laid out so clearly in a very similar status and we are supposed to be making these qualifying decisions based on nuances such as past vs present tense. While our team is in agreement that the VT episodes should not be significantly historical, we do request that this be reviewed to make the qualifying criteria more consistent. Thank you. Region 7 | 09/15/2021 Region 7 sentiment: 6 strongly support, 4 support, 7 neutral/abstain, 0 oppose, 0 strongly oppose. Comments: There was discussion regarding consistency in exception criteria and concern that the 90 day extension for pump thrombosis might be too long. There was concern that pump thrombosis that persists for months suggests that the definition or initial diagnosis may not be accurate and prolonged prioritization may not be warranted. One attendee commented that for device thrombosis to merit escalation in status, there should be sufficient morbidity or pose enough risk that the increased prioritization is justified. Pump thrombosis that persists for months suggests that the definition or initial diagnosis may not be accurate and prolonged prioritization may not be warranted. While they stated that they support the idea of increased prioritization in the setting of device thrombosis or suspected device thrombosis, if a transplant is not forthcoming in a relatively short time frame (maybe a couple of weeks), an alternative management strategy, such as device exchange, should be considered. Accordingly, the proposed duration of 90 days before status is reevaluated is too long for this problem. Region 9 | 09/14/2021 Region 9 sentiment: 0 Strongly Support; 6 Support; 4 Neutral/Abstain; 1 Oppose; 0 Strongly Oppose. Comments: Overall, Region 9 is supportive of this proposal. Two members suggested that for extending patients who have a mechanical circulatory support device with a life-threatening ventricular arrhythmia, it might be more appropriate to allow them to apply for Status 2 instead of Status 3. OPTN Transplant Coordinators Committee (TCC) | 09/14/2021 The Transplant Coordinators Committee (TCC) appreciates the work of the Heart Transplantation Committee in developing this proposal and for the opportunity to comment on it. Members are in favor of a consistent extension timeline, but voiced support for increasing the number of days to 14 instead of reducing them. There was concern that increasing reapplication places an undue burden if a suitable donor does not become available. There was also support for patients with Life Threatening Ventricular Arrhythmias to remain at Status 1 until the time of transplant. Overall, the TCC is supportive of developing a consistent reapplication process and is appreciative of the opportunity to provide the transplant coordinator perspective. Region 3 | 09/10/2021 Region 3 sentiment: 2 strongly support, 8 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose Region 2 | 09/10/2021 • Region 2 sentiment: 4 Strongly Support, 14 Support, 7 Neutral/Abstain, 2 Oppose, 0 Strongly Oppose • Comments: None Region 5 | 08/30/2021 Region 5 sentiment: 3 strongly support, 17 support, 7 neutral/abstain, 0 oppose, 0 strongly oppose. Region 5 supports the proposal to Amend Status Extension Requirements in Adult Heart Allocation Policy. A member agreed with the clarifications to the proposed policy. The same member stated that it may be redundant to specify that the patient needs to continue to be on ECMO and continue to be hospitalized, or continue to have a non-dischargeable device and continue to be hospitalized, since these treatments already require hospitalization. A member commented that the system is complicated and needs better definitions. Region 4 | 08/27/2021 2 strongly support, 11 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose. Region 4 supported this proposal. Children's Hospital Los Angeles | 08/18/2021 We agree that the adult criteria need to be clarified and amended. There are a couple portions of the amended policy that we feels deserve further clarification. 1) regarding 6.1.c.iv MCSD with pump thrombosis, even the revised policy does not appear to require that the patient should be actively experiencing pump thrombosis. It deserves clarification whether an extension will be granted if the patient simply continues with IV treatment for a past thrombus, or if the patient needs to still demonstrate evidence of thrombosis in the VAD. 2) regarding 6.1.A.iii MCSD with life-threatening ventricular arrhythmia, the revised policy still says that "this status can be extended by the transplant program every 7 days by submission of another heart status 1 form if the candidate remains hospitalized on continuous IV antiarrhythmic therapy". Does this require that the patient is still experiencing arrhythmias, i.e. that the status 1 form will be completed based on arrhythmias since the initial status 1 listing? If not, then there is no reason for a patient to be decreased to status 3, as the requirements for the new status 3 (6.1.c.xiii) appear to be the same. 3) regarding 6.1.c.xiii MCSD with arrhythmias after 7 days, it states "... is supported by placement of biventricular mechanical circulatory support device for the treatment of sustained ventricular arrhythmias or receiving continuous IV antiarrhythic therapy..." - this would seem to justify a status 1 extension. So perhaps it would be clarifying to say this status 3 is intended for patients who were listed under status 1 for 7 days, but have been stabilized with biventricular support or continuous IV antiarrhythmics and no longer meet the criteria for a NEW status 1 listing. Thank you for your hard work and for clarifying these policies. Anonymous | 08/13/2021 The proposal makes overall sense. My concern is the amount of work that these complex regulations place on transplant centers. I understand that UNOS is trying to make the perfect system, but every change has unintended consequences. When you fix one problem, you move the disadvantage from one group to another.