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.
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
Status: Public Comment
Sponsoring Committee: Heart Transplantation Committee
Strategic Goal: Improve waitlisted patient, living donor, and transplant recipient outcomes
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.
Region 5 | 08/28/2020
Region 5 vote: 4 Strongly Support, 22 Support, 7 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose. No comments
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.
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.
Region 7 | 09/10/2020
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.
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 8 | 09/22/2020
Region 9 vote: 5 strongly support, 8 support, 7 neutral/abstain, 1 oppose, 0 strongly oppose Comments: Proposed changes are sound and needed.
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
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.
Region 2 | 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.