1. Proposal to Modify the Adult Heart Allocation System: Round 2
Thoracic Organ Transplantation Committee

2. What problems will the proposal solve?
High waiting list mortality rates, particularly for the most urgent candidates
High # of exception requests indicates certain candidates not served well by current system
Policy out of date re: increased use of mechanical circulatory support devices (MCSD) and associated complications
Current geographic sharing scheme is inequitable and inconsistent with the Final Rule
This is the second time the Thoracic Committee is distributing this proposal for public comment (the first round of public comment was earlier this year). Though we are proposing some changes to our original proposal, the problems that we are trying to solve remain the same:
First, since 2006, the number of active heart transplant candidates more than doubled. Status 1A candidates are the most urgent candidates in the current system, and are three times more likely to die on the waiting list than candidates in any other status. Stratification by waiting list mortality amongst all heart candidates, and particularly the most urgent heart candidates, is necessary to attempt to reduce waiting list mortality rates.
Second, some candidate groups, such as candidates diagnosed with amyloidosis and congenital heart disease, are not served well by the current system and often must request exceptions. It is less than optimal to depend on exceptions because exception requests must be approved by a regional review board. And depending on the region where the request is made, the outcome could differ from other regions with similar requests.
Third, since 2006, the use of mechanical circulatory support devices (MCSDs) has increased significantly, though disparately depending upon geography. With increased use of MCSDs comes more complications associated with them, often requiring urgent transplantation. Current policy doesn’t adequately account for all of these complications.
Finally, the current geographic sharing scheme is not consistent with the OPTN Final Rule, which states that organ allocation policies “[s]hall not be based on the candidate's place of residence or place of listing…” The current geographic sharing scheme is inequitable, as it favors less urgent candidates locally in the DSA rather than more urgent candidates, sometimes as close as 25 miles away from the donor, in Zone A.

3. January 2016 Proposal
Added more urgency stratifications based on relative waiting list mortality rates for all adult heart candidates
Modified geographic sharing scheme to provide most urgent candidates access to donors from a broader geographic area
To attempt to address these problems, in January this year we proposed a major modification to the adult heart allocation system. The two major components of the proposal were 3 additional statuses to further stratify heart candidates on the waiting list; and we proposed broader sharing for the most urgent candidates to make sure they have access to donors from a broader geographic area. In the original proposal, we proposed that the most urgent candidates (status 1 and 2 candidates) should have access to donors as far as Zone B.
Our original proposal was supported by OPTN data and simulation modeling (TSAM) performed by the SRTR.

4. Feedback to January 2016 Proposal
Themes related to statuses
Distinguish between patient need and therapeutic preference
Define biventricular heart failure rather than treatment employed
Limit time for highest priority statuses to combat potential behavior changes
Better define qualifying devices for each status
Still split on VAD for 30 days
We received tremendous feedback during public comment, and some themes emerged that we considered after public comment closed.
Many people emphasized that the statuses should be focused more on a candidate’s underlying physical condition than the treatment they’re receiving. Commenters were concerned that otherwise, the design of the new system may encourage practitioners to employ certain treatments to ensure their patients qualify for a higher status, rather than more neutrally choosing the treatment that is clinically indicated for the patient. There was also a strong theme that patients suffering from biventricular heart failure should qualify for status 1. Additionally, the original proposal wasn’t quite clear on which devices qualified a candidate for each status. And, commenters were divided about whether or not to maintain the LVAD for 30 days discretionary period that’s currently in policy.

5. Feedback to January 2016 Proposal
Themes related to broader sharing
Support:
Don’t have to accept an organ from farther away just because it’s offered
Distance doesn’t necessarily translate to longer ischemic time
Current boundaries are arbitrary
Organs are a shared national resource
Oppose
Concern about cost/difficulty of more remote recoveries
Will increase ischemic time affecting outcomes
Harm to relationships between OPOs & hospitals
Zone B is too far
Policy changes should be made one at a time
As for broader sharing, the community was also split.
Those who support broader sharing emphasize that the current DSA boundaries are arbitrary and that organs are a shared national resource. They also noted that the proposed sharing scheme would be more equitable and simply provide the highest urgency candidates with the opportunities to receive an offer from as far as Zone B, but the proposal doesn’t require transplant programs to accept those offers if it would put their particular patient at risk. Additionally, they noted that distance doesn’t necessarily translate to longer ischemic times (a 2-hour flight can cover a farther distance than a 2-hour car ride).
Those who opposed broader sharing expressed a wide range of concerns: broader sharing may negatively impact the relationship between transplant programs and their OPOs and may make recoveries more costly and risky for OPOs and transplant programs. Sharing out to Zone B may be too far of a distance, and may increase ischemic times, leading to more risky transplants for candidates that are already very medically urgent. Some commenters suggested that changing the status system and the geographic sharing system in one proposal may be too much to do at once, and that these changes should instead occur sequentially in order to best monitor the impact of these changes individually.

6. Supporting Evidence
TSAM supports framework established in original proposal
Clinical consensus from public comment and post-public comment outreach informed proposed physiologic criteria used to refine statuses
Because the structure of the original proposal is largely intact, the supporting evidence we used the first time around largely informs this version of the proposal. However, in weighing whether to defer to clinical expertise, or instead to adhere strictly to the models and data, we determined that, particularly in matters of behavior (or where commenters suggested behavior would change in response to a proposed policy change), we should defer to clinical expertise. Therefore, the Committee reached out to the community to gain clinical consensus in establishing restrictions for the qualifying criteria for the most urgent statuses. This consensus also helped us determine where to draw the line for broader sharing.

7. Post-Public Comment Outreach
Forums at ISHLT (April 2016)
St. Jude Users Meeting (Spring 2016)
Session at ATC (June 2016)
Survey (June 2016)
After public comment, we engaged in a lot of formal and informal discussions with stakeholders in the community to really get a sense about specific changes that could improve the original proposal. We participated in and led forums at ISHLT, the St. Jude’s Users Meeting, and at ATC.
We also conducted a survey in June of heart transplant program administrators and directors, OPO executive directors, and some of the Committees. The survey developed to elicit additional feedback on VA ECMO, ACS, stable LVAD and geographic sharing. We received 169 responses.

8. Survey Results Summary
VA ECMO: ~80% supported VA ECMO in Status 1
Over half supported extension at Status 1
60% preferred requiring failed weaning for extension
Percutaneous devices: ~40% preferred 14 days in Status 2, though 30% preferred unlimited time
>60% of both groups of respondents preferred failed weaning for extension
Stable LVAD: 55% supported 30 days of elective Status 3 time for stable LVAD
Geography: >60% preferred sharing just through DSA + Zone A
Of these respondents, 55% preferred sharing only for Status 1 and 42% preferred both Status 1 and 2
The results helped inform our proposed changes, which I’ll review on the next few slides.
One interesting result from the survey was that most respondents supported leaving VA ECMO in the highest urgency status for a time-limited 14 day period. But, instead of allowing these candidates to continue to extend their time, they supported requiring transplant programs to show proof of failure to wean off of VA ECMO. Similar responses came in for acute circulatory support devices.
Notably, because more people in the survey than not supported keeping elective 30 day VAD time, and because public comment was also split on this topic, we decided to retain it in this proposal. And finally, most people supported sharing only out to Zone A, rather than out to Zone B.

9. What are the proposed solutions?
Topic
January 2016 Proposal
Current Proposal
Evidence of Cardiogenic Shock (for VA ECMO, IABP, percutaneous devices, and multiple inotropes with hemodynamic monitoring)
These therapies* were employed to treat cardiogenic shock, evidenced by a cardiac index < 2.2 L/min/m2
*Notably, Jan 2016 proposal didn’t apply cardiogenic shock definition to VA ECMO
These therapies are being used to treat cardiogenic shock, evidenced by ALL of the following:
Systolic blood pressure <90 mmHg
Cardiac index:
<1.8 L/min/m2 if the candidate is not supported by inotropes
<2.0 L/min/m2 if the candidate is supported by at least one inotrope
Pulmonary capillary wedge pressure >15 mmHg
If measures can’t be obtained, then at least one of the following must be true within 24 hours prior to use of that therapy:
CPR was performed on the candidate
Systolic blood pressure <70 mmHg
Arterial lactate >4 mmol/L
Aspartate transaminase (AST) or alanine transaminase (ALT) > 1,000 U/L
The structure of the current proposal is the same as the previous proposal. I’ll focus on statuses first. Like the original proposal, this proposal retains the proposed 6 statuses, largely intact, but with some significant differences:
VA ECMO remains a status 1 criterion, but we tightened qualifying criteria for candidates supported by VA ECMO, percutaneous circulatory support devices, IABP, and multiple inotropes
Transplant programs must show evidence that these candidat. are supported by these therapies for treatment for cardiogenic shock. The definition of cardiogenic shock is informed by the AHA definition, and all three conditions must be met. We also included a separate path for those candidates that are crashing whose hemodynamic measurements cannot be taken before therapy is employed.
Added restrictions on the duration for candidates to remain in statuses 1 through 3
Any candidate supported by these therapies are limited to 14 days in their status unless there are contraindications to using a durable device and they have failed a weaning attempt
RRB have to approve extensions, and RRBs will review cases outside of their region to eliminate some risk of bias in reviewing cases from their own region.

10. What are the proposed solutions?
Topic
January 2016 Proposal
Current Proposal
Continuous mechanical ventilation
Candidates qualify for status 1 if supported by continuous mechanical ventilation
Continuous mechanical ventilation is removed as a status criterion. Candidates must qualify under other options.
Non-Dischargeable VADs*
Candidates qualify for status 1 if admitted to the hospital and supported by a surgically implanted, non-dischargeable VAD.
Candidates qualify for status 1 if admitted to the hospital and supported by a non-dischargeable, surgically implanted, non-endovascular BiVAD.
Candidates admitted to the hospital and supported by non-dischargeable, surgically implanted, non-endovascular LVADs would qualify for status 2.
Acute/ Percutaneous devices
Status 2 – called “acute circulatory devices”
Status 2 – called “percutaneous endovascular mechanical circulatory support device without an oxygenator”
We propose eliminate continuous mechanical ventilation as criterion in status 1, because it is not typically an indication for transplant. These candidates are also likely to qualify under other status criteria.
We also propose limiting status 1 to candidates supported for biventricular failure with surgically-implanted, non-endovascular BiVADs. Compared to the original proposal, we limited this criterion only to BiVADs (instead of any non-dischargeable VAD) because we heard during public comment that status 1 should really be limited to candidates in biventricular failure. We also changed the terminology here to be more specific about what devices should qualify for status 1 under the sub-criterion. When we say non-dischargeable, we are clear in policy that we mean those devices that are not FDA approved for use outside the hospital. And, when we say surgically implanted, non-endovascular BiVADs, we mean those candidates whose devices were placed after undergoing a thoracotomy or median sternotomy. We created a separate criterion in status 2 for candidates with non-dischargeable LVADs.
We also changed the terminology for acute devices to be even more clear about what devices should qualify. In the original proposal we called them acute circulatory support devices. In this proposal we’ve changed that terminology to “percutaneous endovascular mechanical circulatory support devices without an oxygenator.”
*Non-dischargeable refers to devices that are not FDA approved for use outside the hospital

11. What are the proposed solutions?
Order
January 2016 Proposal
Current Proposal 1
Status 1 adult + Status 1A ped in DSA + Zone A 2
Status 1 adult + Status 1A ped in Zone B
Status 2 adults in DSA + Zone A 3
Status 2 adult in DSA + Zone A
Status 3 adult & status 1B ped in DSA 4
Status 2 adult in Zone B 5 6
Status 4 adult in DSA 7
Status 3 adult + Status 1B ped in Zone A 8
Status 5 adults in DSA
We’re also still proposing a degree of broader sharing, but scaled back from the original version. This proposal shares broadly for the most urgent candidates to DSA and Zone A, but rather than sharing out to Zone B for the status 1 and 2 candidates, offers would be made to status 3 adults/status 1B pediatrics before sharing to status 1 & 2 candidates in Zone B. This compromise ensures that high urgency candidates in a reasonably broad geographic area have equitable access to organ offers, while minimizing the potential increase in donor organ ischemic times (and possible consequent worsening of post-transplant outcomes).
We also realized that the original proposal might have unintentionally created a disadvantage for status 1B pediatric candidates. One of our overarching principles in developing the adult heart allocation scheme was that we did not want to negatively impact pediatric candidates, so when possible, the proposal should be neutral or should benefit them. Therefore, you’ll notice some changes in the pediatric donor allocation sequence in this version of the proposal that are intended to ensure that the pediatric candidates are minimally impacted by the adult heart allocation changes.

12. How will members implement this proposal?
Transplant programs:
Submit data for every candidate with every status justification form
Hemodynamic assessment results
Functional status or exercise testing results
Heart failure severity or end organ function indicators
Heart failure therapies
Sensitization risk, including CPRA and number of prior sternotomies
Current diagnosis
OPOs
No new requirements from policy, but broader sharing affects OPO practices
Histocompatibility Labs
Perform HLA testing for heart candidates and provide CPRA so transplant programs can report to OPTN
Transplant Programs will need to report a number of data elements in all the categories you see here, every time a candidate is due for a status update. See Appendix B in the proposal for the full list of potential data elements. These data touch on factors that are likely to influence waiting list mortality or post-transplant survival for heart candidates and recipients. For high urgency statuses, those updates would be due every 14 days. For the lower urgency statuses, the updates would be due every 3 months. However, we are seeking your input regarding all these data points, and how often to report them (especially for the lower urgency candidates). We are very aware of the increased resources it takes to report more data to the OPTN, but we will need to start collecting these data so we can create a heart allocation score in the future.
For OPOs, the proposal doesn’t include any explicit requirements, but broader sharing will likely impact OPO practices.
Finally, histo labs will perform more HLA testing for heart transplant candidates than current practice, and provide transplant programs with candidates’ CPRA scores, so the transplant program can report that information to the OPTN in the status justification forms.

13. How will the OPTN implement this proposal?
Target Board Date: Dec. 2016
Effective date depends on programming
UNOS will give members time to update their candidate data before implementation
Members will need to verify information after implementation date
Exceptions (approved and in flight) will be null upon implementation
Accumulated waiting time will transfer
Proposal does not affect methods for routine monitoring
We hope to bring this proposal to the Board for approval in December The effective date would depend on programming. The programming effort will be significant, so UNOS will give members plenty of notice and education before implementation takes place. There will be a transition period before the implementation date to allow programs to ensure that the information for candidates that are already on the wait list is up-to-date and can be used to place those candidates in the proper status post-implementation. Any exceptions that are approved but not expired, or exception requests that are in flight as of the implementation date will be ineffective. Also, candidates will not lose the waiting time they’ve accumulated under the current system, and we included a chart explaining how waiting time will transfer to the new system in the proposal.

14. Questions? Kevin Chan, M.D. Committee Chair kevichan@med.umich.edu
Liz Robbins Callahan, Esq.
Project Liaison

15. Supplemental slides

16. Proposed Statuses 1-3 Status Criteria 1 VA ECMO
Surgically Implanted, Non-Endovascular Biventricular Support Device
MCSD with life-threatening ventricular arrhythmia 2
Surgically Implanted, Non-Endovascular Left Ventricular Assist Device (LVAD)
Intra-aortic balloon pump
Ventricular tachycardia/ventricular fibrillation, mechanical support not required
MCSD with device malfunction/mechanical failure
Total artificial heart/Dischargeable BiVAD or RVAD
Percutaneous endovascular mechanical circulatory support devices without an oxygenator 3
Dischargeable LVAD for up to 30 days
Multiple inotropes or single high-dose inotropes with continuous hemodynamic monitoring
MCSD with device infection
MCSD with hemolysis
MCSD with pump thrombosis
MCSD with right heart failure
MCSD with mucosal bleeding
MCSD with aortic insufficiency
VA ECMO, percutaneous endovascular circulatory support device, or IABP after 14 days
Please note that the actual policy proposal includes much more detailed descriptions regarding the candidates that qualify for any of these statuses. As we developed the proposal, we recognized that the candidates that qualify for a status should be more specifically defined to ensure that the status comprises the patients that are truly urgent.
We also previously attempted to clarify the current “device complications” policy by publishing what is known as the Criterion (b) document. Many of the complications detailed in the guidance document were ultimately incorporated into the proposed policy to ensure that patients with severe device complications qualify for the most urgent statuses and to clearly convey our intent regarding which complications are truly urgent.
The public comment proposal contains a list detailing the rationale behind every single qualifying criterion for every single status, so if you have specific questions about the proposed statuses that is probably the best place to start.

17. Proposed Statuses 4-6 Status Criteria 4
Stable LVAD candidates not using 30 day discretionary period
Inotropes without hemodynamic monitoring
Diagnosis of congenital heart disease (CHD)
Diagnosis of ischemic heart disease with intractable angina
Diagnosis of hypertrophic cardiomyopathy
Diagnosis of restrictive cardiomyopathy
Diagnosis of amyloidosis
Retransplant 5
Combined organ transplants 6
All remaining active candidates
In addition to the qualifying criteria shown here, transplant hospitals will still be able to apply for exceptions for statuses 1-4. The exception process will be handled by the regional review boards just as it is in the current system.
*Candidates may qualify for more than one status, but their programs should register them in the most urgent status for which they qualify
**Transplant programs can request exceptions to register candidates in statuses 1-4 if they don’t qualify based on policy but are as urgent as other candidates in those statuses

18. AHA Definition of Cardiogenic shock
The definition of CS includes hemodynamic parameters: persistent hypotension (systolic blood pressure <80 to 90 mm Hg or mean arterial pressure 30 mm Hg lower than baseline) with severe reduction in cardiac index (<1.8 L/min/m2 without support or <2.0 to 2.2 L/min/m2 with support) and adequate or elevated filling pressure (eg, left ventricular [LV] end-diastolic pressure >18 mm Hg or right ventricular [RV] end-diastolic pressure >10 to 15 mm Hg).
Citation: Reynolds, H.R. and Hochman, J.S. Cardiogenic Shock: Current Concepts and Improving Outcomes. Circulation. February 5,

19. Proposed Data Elements
Refer to Appendix B for the full list of proposed data elements
We are seeking your input regarding all these data points, and how often to report them (especially for the lower urgency candidates).
These data will inform a heart allocation score in the future
As referenced in a previous slide, transplant Programs will need to report a number of data elements in all the categories you see here, every time a candidate is due for a status update. See Appendix B in the proposal for the full list of potential data elements. These data touch on factors that are likely to influence waiting list mortality or post-transplant survival for heart candidates and recipients. For high urgency statuses, those updates would be due every 14 days. For the lower urgency statuses, the updates would be due every 3 months. However, we are seeking your input regarding all these data points, and how often to report them (especially for the lower urgency candidates). We are very aware of the increased resources it takes to report more data to the OPTN, but we will need to start collecting these data so we can create a heart allocation score in the future.

20. Regional Review Board Changes
RRBs will review exceptions and extensions for Statuses 1-4
RRBs will review cases outside of their region to eliminate some risk of bias in reviewing cases from their own region
To ensure that transplant programs do not try to take advantage of this possibility, the Committee proposes giving the Thoracic Committee clear authority to review cases in which a candidate is transplanted at an unapproved status, and to determine whether the transplant program at which the candidate was registered should be referred to the Membership and Professional Standards Committee (MPSC) for further review.