Guidance and Policy Addressing Adult Heart Allocation

At a glance

What is current policy and why change it?

In 2018, adult heart allocation policy was changed to better sort candidates based on their medical urgency. The Heart Committee (formerly the Thoracic Committee) monitored the impact of the changes and identified opportunities for improvement. This proposal will provide clearer information for transplant programs submitting exception requests. It also gives improved guidance to regional review board members who evaluate these requests. Additionally, it changes policy to make clear when certain data need to be submitted and provides more consistent timeframes for how long statuses last. The goal is to further clarify current adult heart status criteria.

Guidance and Policy Clarifications Addressing Adult Heart Allocation Policy

Dr. Shelley Hall, Chair of the OPTN Heart Transplantation Committee, reviews the Guidance and Policy Clarifications Addressing Adult Heart Allocation policy proposal.

Terms you need 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.

Click here to search the OPTN glossary

What’s the proposal?

Guidance for transplant programs and heart regional review board members
- Addresses Status 2 adult heart candidates experiencing cardiogenic shock
- Provides a template for transplant program staff on what information to submit for a Status 2 exception
Updates policy
- Clear deadlines for submitting certain data for Status 4 candidates
- More consistent timeframes for the length of time a candidate can remain at an approved status

What’s the anticipated impact of this change?

What it’s expected to do
- Help ensure that candidates with similar medical urgency are treated equally
- Provide transplant programs more information on what they need to include in their exception requests
- Create more consistency with Review Board decisions on exception requests

Themes to consider

What the volume of Status 2 exception requests suggests about adult heart statuses in policy
Usefulness of guidance for Status 2 exception requests
Appropriateness of proposed timeframes within adult heart statuses

Comments

Region 7 | 10/02/2020

Region 7 vote: 6 Strongly Support, 10 Support, 1 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose Region 7 supported the proposal and had the following comments: • Attendee stated that they agree with thoughtful proposal. • Attendee asked committee to please consider emphasizing placement efficiency for DCD and marginal hearts. • Attendee stated that decreasing extension timeframe to 7 days may be impractical.

Sam Dey | 10/01/2020

Strongly Support

Region 11 | 10/01/2020

Region 11 vote: 4 strongly support, 16 support, 4 neutral/abstain, 1 oppose, 0 strongly oppose

Region 9 | 10/01/2020

Region 9 vote: 3 strongly support, 11 support, 4 abstain/neutral, 0 oppose, 0 strongly oppose. Comments: No comments

Transplant Coordinators Committee | 10/01/2020

The Transplant Coordinators Committee thanks the Heart Transplantation Committee for the opportunity to comment on the proposal and guidance. The committee noted that the change to 7 days for Status 1 patients may increase administrative burden since those patients will need extensions or new justification forms frequently. However, the committee acknowledged that Status 1 patients are the most medically urgent and need to be reevaluated frequently. The committee also supported the Status 2 guidance and agreed that many exception requests may be inappropriate. It was also noted that a standard exception request form will be very helpful and time saving for transplant programs. Lastly, the committee noted that it is important that the adult heart allocation changes that were recently implemented need to be frequently evaluated and adjusted to best serve the community. The committee indicated the following sentiment for the guidance document: 3 Strongly Support, 8 Support, 1 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose

Cleveland CLiinic | 10/01/2020

Region 10 Cleveland Clinic: We support the suggested changes and really appreciate efforts to reduce UNOS Status 2 exceptions. We agree that these exceptions create disparities in the transplant process and that temporary devices, as Dr. Hall stated, were meant to stabilize with the intention for centers to then proceed to durable devices. Current criteria for IABP, percutaneous endovascular MCSD criteria and VT are very clear and define a very high risk group. Below were common UNOS Status 2 requests that Region 10 Board reviewed last term that should be specifically addressed to prevent disparities: 1. SBP >90 mmHg (but all other criteria met for temp support). We do believe there is a distinction between a pt w/ SBP

Association of Organ Procurement Organizations | 10/01/2020

The Association of Organ Procurement Organizations (AOPO) supports the modifications to clarify components of the existing adult heart allocation policy related to definitions for certain data submission and measures to assure consistency in timeframes for the length of status approvals. AOPO defers to the expertise of the Heart Committee who has monitored the impact of changes to adult heart allocation in 2018 and supports the recommended guidance for exception requests by identifying certain standard information that should be included with each request submitted by a transplant program and evaluated by the regional review board members thus ensuring that candidates with similar medical urgency are treated equally.

NATCO | 09/30/2020

NATCO supports this proposal as written. Patients should not be weaned from inotropes to measure cardiac index to meet current requirements. It is medically appropriate to extend timeframes up to 180 days for patients on inotropes without hemodynamic monitoring. It is reasonable to shorten timeframes to 7 days to better reflect high medical urgency of Status 1 candidates. These changes will provide further clarification on data submission for coordinators and ultimately improve guidance when caring for our patients.

Tampa General Hospital | 09/30/2020

Re: Timing of Obtaining Hemodynamic Data Associated With Policy 6.1.D.ii: Inotropes Without Hemodynamic Monitoring 1)Change in timing of measured CI from submission to that at initiation of inotropes: The stated goals of this change are admirable and sensible. We do not see any disadvantage to utilizing the measured Cardiac index (CI) at the time of inotrope initiation as the CI metric for initial listing. We are in favor of this change and feel it aligns with real world clinical practice. We commend the committee on recognizing this flaw in the current policy and for proposing the stated change as it pertains to inotrope initiation and listing. 2)In regards to the proposed extension in the length of both the initial qualifying period and the extension from 90 to 180 days: While this obviously decreases the number of required invasive procedures it also creates a 6 month window during which hemodynamics are not reassessed. We see this as potentially problematic from a standpoint of pulmonary vascular resistance surveillance. We favor hemodynamic assessment with right heart catheterization on all of our actively listed patients at a 90 day interval to ensure we have up to date hemodynamic data to help guide donor selection and perioperative management. Given the progressive nature of end stage heart failure we have concerns regarding potential poor outcomes in patients who undergo cardiac transplantation without recent hemodynamic data. It appears for many programs their standard is to measure hemodynamics at 180 day intervals. If the above changes are adopted we suggest the committee follow the outcomes of these patients post-transplant to ensure a 180 day time frame is deemed efficacious as it pertains to hemodynamic monitoring in inotrope dependent patients. We find this change to be reasonable although conservative comparatively to our internal programmatic standards. We can support this change with appropriate oversight by the committee. It would not likely change our internal practice. Re: Aligning Extension Timeframe for Policy 6.1.A.ii: Non-dischargeable, Surgically Implanted, Non-Endovascular Biventricular Support Device with Other Status 1 Conditions We agree with the proposed change to align the extension time frame for all status 1 listing criteria to 7 days. This patient population is clinically very dynamic and fluid and re-evaluation of the appropriateness of their status 1 listing on a weekly basis is reasonable. Re: Reordering Listing of Evidence of Device Infections We agree with this change. Re: Guidance document for status 2 exceptions We strongly agree with developing a standardized methodology for status 2 exceptions. We feel strongly that there should be minimal variation between programs in regards to the utilization of temporary MCS devices as a BTT. Currently there appears to be significant variation between programs which is likely driven by variation in programmatic thresholds to seek a status 2 exception. Variation in practices has the potential to advantage and disadvantage patients at different programs. We welcome and support the committees efforts to standardize status 2 exception criteria.

Donna Campbell | 09/30/2020

do not have enough experience in this area to have opinions

Anonymous | 09/30/2020

I believe the changes to the status 4 submission forms to be beneficial for our patients, specifically related to the change of criteria and the time frame of resubmission. While some exception forms may still be required for certain patients, I believe this will greatly decrease the amount of forms needed and also provide a more similiar process for all statuses. It has been very confusing that most other statuses require hemodynamics prior to initiation of therapy, while status 4 requires it within 7 days of form submission. If we can streamline the requirements to be consistently all prior to initiation of therapy, it would greatly decrease confusion among clinicians and better fulfill the goal of standardizing patient care. This also has the potential to decrease the amount of time patients wait to be listed, as the information can all be obtained ahead of time. I believe this to be very beneficial for patients, thank you for all of the work being put in to this.

American Society of Transplant Surgeons | 09/29/2020

The American Society of Transplant Surgeons (ASTS) supports this proposal as written. The ASTS acknowledges the need for clarifications of the Adult Heart Allocation Guidance and Policy and appreciates the work and effort of the OPTN Heart Transplantation Committee in formulating the proposal currently available for public comment. We suggest that UNOS re-emphasize the data requested supporting Adult Heart Status 4 is to be collected within 7 days of implementation of inotropes (versus a time period with respect to the date of submission). We support the effort to clarify and standardize exception requests for Adult Heart Status 2 candidates supported by Percutaneous Endovascular MCSD or IABP. We suggest that UNOS consider a templated electronic exception request form in these settings that require the critical fields of entry to ensure standardization for both those programs submitting exception requests and for those RRB members reviewing them.

Anonymous | 09/29/2020

Region 10 vote: 1 Strongly Support; 14 Support; 8 Neutral/Abstain; 2 Oppose; 0 Strongly Oppose. Comments: • An attendee noted that their program believes that Status 1 should be at 14 days. Status 1 patients are very sick and would more than likely get a transplant quickly. • Another attendee commented that RV failure is a clinical judgment made by the treating providers at the bedside. Despite best efforts of developing predictive hemodynamics and assessing echo parameters, the development of RV failure is unpredictable. There are many factors that go into the clinical “gestalt” that RV failure will occur. Therefore, they would be uncomfortable having specific hemodynamics needed for exception approval. It would be acceptable if they serve as a guide, but some reviewers may not interpret it that way. • An attendee agreed with extending to 180 days for patients on inotropes without hemodynamic monitoring. • Another attendee asks that the committee consider unintended consequences of going from 90 days to 180 days for patients on chronic inotropes. Does the committee think there might be a group of patients that are disadvantaged, who may have missed deterioration? Long-term outcomes are poor for patients on Milrinone for extended time periods. In terms of deterioration that might be missed – pulmonary hypertension can be quiet and subtle. • An attendee expressed concern about the long-term use of short-term devices since they were not designed to be used for more than a week and it is unknown if the thromboembolic complications or other impacts that can occur when used for longer term periods. Unfortunately, under the new system a VAD is very hard to transplant unless the candidate has a complication. Technology for VADs is relatively new so there should be fewer complications but there is long-term data available to support that. There are a lot of exceptions and that’s concerning. Why are so many people requesting exceptions from the criteria? • Another attendee added that there are newer devices coming out, like the Impella 5.5, and it is unknown how that will change things. It may be detrimental in terms of clinical outcomes that members have to demonstrate for the purposes of policy that a candidate can’t be weaned from a balloon pump. The committee needs to identify whether there are specific disease states or cardiomyopathies that may not be well-served by the current policy language. • The comment was made that the struggle between the new and old system is that in the old system, a durable LVAD could be used and the patient would still get transplanted. In the new system, it is very difficult to get a transplant for those patients unless they have major complications, and those complications could take away their opportunity to get a transplant. There needs to be better criteria for VAD patients so that they can get transplants. • One commenter noted that the proposed policy and guidance is not going in the correct direction.

Anonymous | 09/29/2020

Region 6 vote: 6 strongly support; 27 support; 8 neutral/abstain; 0 oppose; 1 strongly oppose. Comments: One attendee said 14 days approval timeframe for higher status is appropriate. Decreasing that to 7 days will force additional testing for extension and subject patients to unnecessary procedures. The attendee also said that 90 days for inotropes is appropriate, and that pushing it to 180 days is a bit too much time, but programs will continue to test. Another member said that it would be important to have more widely disseminated information regarding the impact of this policy post implementation.

Gerin Stevens | 09/25/2020

Strongly Support

Anonymous | 09/25/2020

Region 2 vote: 7 Strongly Support, 18 Support, 8 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose Comments: An attendee asked if the committee considers 20% of all cases an appropriate amount of exception cases for cardiac failure patients.

Region 1 | 09/24/2020

Region 1 vote: 4 Strongly Support, 3 Support, 5 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose Comments: Region 1 supports this proposal and had no comments.

American Society of Transplantation | 09/24/2020

The American Society of Transplantation supports this proposal in concept and offers the following thoughts for consideration: The current policy for Status 4 justification was clinically questionable and therefore this change is welcome. In particular, patients will no longer need to be weaned from inotropes to prove they are in cardiogenic shock to satisfy the current requirements. The status extension to 180 days is also reasonable given the median wait time and lack of restrictions on prior 1B status. The Committee does, however, need to clarify how hemodynamics may be obtained. CI may be obtained non-invasively and while the policy requires documentation of PCWP>15 mmHg there may be exception requests to provide PAD values from patients with implantable monitors (CardioMEMS). The Committee is anxious to reduce exception requests (see below). Regarding the Status 1 change from 14 days to 7 days, as the median days to transplant for Status 1 is 4 days, this change appears reasonable and provides equity with patients on VA-ECMO. Regarding the Status 2 guidance document, this proposal will go a long way at addressing some of the challenges faced by RRB with the deluge of requests they receive for exception for this particular status. The template is a nice idea to ensure relevant data is included with the application. It will improve the current process towards an attempt to “standardize” such request to ensure all programs are playing by the same rules. However, there is still much room for “gaming” in the criteria for contraindications to LVAD section and some members of the council suggest more concrete definitions or an emphasis that the narrative should be extensive on the item proposed since there is substantial center to center variability. Some examples are listed below: Severe TR - TAPSE - (1) this was felt to be too easy to game the system by repeating TAPSE, particularly as it is not a core lab; (2) this would make anyone with a TV annuloplasty qualify, even if RV had recovered (3) RV/LV size - fraught with arbitrary measurements. Surgical contraindications: • We don't believe either of the mechanical valves listed are contraindications without additional details of (1) why a Cohn sandwich for Mechanical AVR couldn't be performed and (2) not as clear that mechanical MVR is a contraindication • "Small LV cavity" – we think it would benefit from having a number. 5.0 cm seems to be dichotomous, down from 6.0 cm. • VSD – this would benefit from specifying why it couldn't be repaired. • Multi-organ transplant – We are not sure that would be a status 2 justification – we believe this may best fit as a status 5. • Thrombocytopenia – We believe this is too broad and too dynamic. We suggest that it would be important to know baseline platelet counts, as there are many ways that platelet counts could decrease transiently. • Hypercoagulable – We agree, but suggest that additional details should be specified Contraindications to warfarin – We suggest that additional detail regarding why it is contraindicated should be required Recent CVA - Wouldn't this be a contraindication to pump run OHTx or LVAD? • Recurrent refractory ventricular arrhythmias – this is addressed by the policy elsewhere

Anonymous | 09/22/2020

Region 8 vote: 5 strongly support, 8 support, 7 neutral/abstain, 1 oppose, 0 strongly oppose Comments: Proposed changes are sound and needed.

Region 3 | 09/15/2020

Region 3 vote: 3 Strongly Support, 20 Support, 3 Neutral/Abstain, 0 Oppose, 1 Strongly Oppose: Comments: One member commented that medical management is not considered with the 180 day timeframe. 180 days may be a long time to wait to check pulmonary pressures and whether the candidate would do well with a transplant. The committee should look at outcomes in recipients that would be affected by this change. There was a follow up request for clarification as to how the system would work if new hemodynamics were obtained prior to the 180 days. An additional comment opposed status one extension and qualifying redefinition and shortening time to 7 days as it would needlessly increase work for the coordinators of these critically ill patients. Additional comments submitted online during meeting: • Is there any consideration for removing or adjusting the systolic blood pressure requirement of < 90mmHg for status 2 listing? In section 2 of guidance proposal, one of the requirement is MAP to justify inability to wean, however MAP is not a requirement for status 2 listing. Is the committee suggesting a change to the blood pressure requirements for status 2 listing? • Need to streamline the status 1-3 to decrease variability and exceptions and decrease work load on coordinators

Region 7 | 09/10/2020

Univ of Alabama at Birmingham | 09/02/2020

The requirement for 7 days on ECMO support requiring proof on stability on ECMO after that time is a burden on the center that is not necessary. If a patient requires VA EMCO, they're requiring that support for adequate perfusion. Historically ECMO outcomes are terrible and the need for a center to make the decision for place a patient on ECMO means the need is dire and the limited days implies that improvement is expected when this is unlikely.

University of Alabama at Birmingham | 09/02/2020

Agree with the timeframe for patients on inotropes and the creation of criteria/document for status 2 patients. In regards to Status 1 patients and changing the time frame to 7 days. These are the sickest of the sick, usually on ECMO or biventricular support. There is very little chance that their condition would improve in 7 days without transplantation, to the point of being downgraded. Therefore, having the timeframe decreased to 7 days would only add additional work on the transplant center instead of truly benefitting or even increasing the patient’s chances of receiving an acceptable offer, especially in patients with O blood group.

Region 5 | 08/28/2020

Region 5 vote: 4 Strongly Support, 22 Support, 7 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose. No comments

Region 4 | 08/26/2020

Region 4 vote: 6 Strongly Support, 11 Support, 7 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose Region 4 supported the proposal. During the discussion, one attendee asked if this proposal should address weaning the MCS criteria. Another attendee commented that once an individual is listed, centers should not have to prove MCS dependency on a recurring basis. One attendee supported the proposal but thought the committee could go further to limit extensions. Another attendee suggested there be a standard format of data required for submission of a status 2 exception so that the data provided to the RRB is consistent.