1. Proposal to Modify the Adult Heart Allocation System
Thoracic Organ Transplantation Committee
Spring 2016
Hi, my name is _________ and I’m here to present the Thoracic Committee’s proposal to modify the adult heart allocation system.

2. Current Allocation Policy
Zone A
500 Miles
Zone B
1000 Miles
Zone C
1500 Miles
Adult Candidate Prioritization:
Status 1A
Status 1B
Status 2
Geographic Allocation
Local: Status 1A, Status 1B
Zone A: Status 1A, Status 1B
Local: Status 2
Zone B: Status 1A, Status 1B
Zone A: Status 2
Zone B: Status 2
Etc…
For those of you who are not familiar with the current adult heart allocation scheme, I’d like to present a quick overview. The current system stratifies active adult candidates into three medical urgency statuses: status 1A; status 1B, and status 2. Candidates qualify for status 1A, if:
they require continuous infusion of a single high-dose intravenous inotrope or multiple intravenous inotropes and continuous hemodynamic monitoring
they are supported by a total artificial heart, an intra-aortic balloon pump (IABP), extracorporeal mechanical oxygenation (ECMO), mechanical ventilation, or a ventricular assist device (VAD) (for a 30 day discretionary period)
they are implanted with a MCSD and are experiencing a device-related complication
they have an approved exception
Candidates that are stable but supported by a VAD or that require continuous infusion of intravenous inotropes and do not meet the criteria for status 1A qualify for status 1B. Candidates that are in need of a heart transplant but do not meet status 1A or 1B qualifying criteria qualify for status 2.
Geographic allocation depends on the location of the donor. In the current allocation system, organs recovered from deceased donors aged 18 years or older are first offered to status 1A candidates “locally” within the donor hospital’s DSA and then to status 1B candidates locally. If not accepted locally, the heart is then offered to status 1A candidates in Zone A, and then to all status 1B candidates in Zone A. Only after offers are made through Zone A status 1B candidates is the heart then offered to a local status 2 candidate. Allocation then continues through subsequent geographic zones.

3. What problems will the proposal solve?
Status 1A candidates are 3x more likely to die on the waiting list than candidates in any other status
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Policy out of date re: increased use of mechanical circulatory support devices (MCSD) and associated complications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
Since the last significant revision to the adult heart allocation system in 2006 there has been an overall decline in waiting list mortality rates among adult heart transplant candidates, and specific patient groups intended to benefit from the previous policy changes experienced the most substantial decline in mortality rates. Despite these successes, there are four major problems with the current system.
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.
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. Depending on exceptions is less optimal for the patient, because exception requests must be approved by a regional review board, leading to the possibility of different outcomes for similar requests depending upon the region in which the request was made.
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 the MCSDs, 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.

4. What are the goals of the proposal?
Reduce waiting list mortality rates amongst most urgent adult heart candidates
Reduce the use of exceptions to qualify for a status
Ensure qualifying criteria for statuses are based on objective physiological indications
Improve overall access to transplantation by modifying geographic distribution to ensure maximum utility of donor hearts
Our goals in modifying the adult heart allocation system are to:
Reduce waiting list mortality rates among adult heart transplant candidates
Reduce the use of exceptions to qualify for a status by better accommodating all candidate groups within the heart allocation system
Ensure that qualifying criteria for the statuses are based on objective physiological indications rather than therapeutic intervention
Improve overall access to transplantation in the heart allocation system by modifying geographic distribution to ensure maximum utility of donor hearts

5. How does the proposal address the problem statement?
Adds more urgency stratifications based on relative waiting list mortality rates for all adult heart candidates
Modifies geographic sharing scheme to provide most urgent candidates access to donors from a broader geographic area
The proposal includes two significant changes to the current adult heart allocation policy.
First, we propose adding more urgency statuses to better stratify candidates based on medical urgency. The proposed system includes 6 urgency statuses, as compared with the current 3-status system.
Second, we propose adopting broader sharing for the most medically urgent candidates. In the proposed system, candidates registered in statuses 1 and 2 through Zone B would have access to the broadest range of donors.
I’ll explain each of these solutions in the following slides.

6. Proposed New Statuses: High Level
Current Status
Proposed Status 1A 1 2 3 1B 4 5 6
To develop additional statuses, we compared the waiting list mortality rates and post-transplant mortality rates of all heart candidates in each criteria, with a particular focus on better stratifying candidates currently in status 1A. We also compared risk based on candidates’ diagnoses at listing and at transplant within each urgency status. We also analyzed all status 1A and status 1B exception requests submitted for heart and heart-lung candidates between July 2009 and June 2011 to identify common categories of exception requests. We learned that current status 1A candidates have disparate waiting list mortality risks.
After reviewing these data, we drafted a “straw man” version of the proposed statuses. The straw man statuses primarily grouped candidates together by similar waiting list mortality rates, but also considered post-transplant mortality risk, as well as our own experience with candidates in these groups. You may have seen this straw man draft presented at earlier regional meetings. Generally, Proposed statuses 1-3 are defined by current status 1A criteria; Proposed status 4 is generally defined by current status 1B criteria; and Proposed statuses 5-6 are generally defined by current status 2 criteria.
After confirming the straw man groups, the Committee requested the SRTR perform a thoracic simulation allocation model (TSAM) to show the projected impact of the straw man statuses. The TSAM request was designed to mirror current allocation rules as closely as possible, including the intermingling of adult candidates and pediatric candidates, in order to verify that the modeled outcomes reflect the impact of the straw man itself, and not any other inadvertent changes to the allocation system. The TSAM results were encouraging, and we agreed that the straw man did a great job of grouping together similar candidates.
The proposed statuses, based on the straw man, are included on the following slides. Please note, within each status, candidates are grouped together regardless of how they qualified for the status. Offers will be made in order of waiting time within the status.

7. Proposed Statuses 1-3 Status Criteria 1 ECMO
Continuous Mechanical ventilation
Non-dischargeable (surgically implanted) VAD
MCSD with life-threatening ventricular arrhythmia 2
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
Acute circulatory support 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
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.

8. 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.
And again remember, within each status, candidates are grouped together regardless of how they qualified for the status. Offers will be made in order of waiting time within the status. It is also worth mentioning that candidates likely qualify for more than one status. For example, a candidate could have restrictive cardiomyopathy but also be treated with multiple inotropes with continuous hemodynamic monitoring. That candidate would qualify for status 3 and status 4. The patient should always be registered in the most urgent status for which they qualify. This same principle applies to status 5: combined organ transplants. If a candidate is registered for a heart and another organ, the lowest status for which they qualify would be status 5. But if the candidate’s heart condition qualifies him or her for status 1-4, then the candidate would appear the highest of those statuses, not status 5.
*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

9. Proposed Broader Sharing Sequence
Candidate Status
Location
Status 1A ped + Status 1 adult
Local + Zone A
Zone B
Status 2 adult
Status 1B ped + Status 3 adult
Local
Status 4 adult
Zone A
Once we finalized the statuses, we asked the SRTR to model a few different allocation sequences incorporating broader sharing. We determined that broader sharing of adult hearts to the most urgent candidates first, as well as minimizing the impact of “local” sharing based on DSA, may help to ensure that the candidates most in need of transplant have access to the broadest range of available donors. We debated which urgency statuses required the broadest sharing, as well as how far the first geographic allocation unit should be. Ultimately, we determined that statuses 1 and 2 should benefit from the broadest sharing, as these candidates are very urgent and would benefit most from exposure to more donors. The number of candidates that will qualify for status 1 and status 2 is also relatively small and therefore will have a smaller impact on candidates waiting in other statuses. The truncated sequence shown on this slide is the one we decided to propose after reviewing the results of the modeling.
[OPTIONAL, if asked about potential negative impact of broader sharing]
We debated the merits of sharing with the most medically urgent candidates against the safety of shipping organs further, as broader sharing could lead to less optimal outcomes because more urgent candidates would be transplanted with organs with more cold ischemic time. But, we also acknowledged that an organ with a longer ischemic time may be appropriate for very urgent candidates , and a preferable strategy to waiting for a local donor organ. To compromise, we determined that the most urgent candidates in the DSA and Zone A should have the first opportunity, then Zone B urgent candidates.
[OPTIONAL, if asked about eliminating local sharing] We also debated whether to eliminate local sharing altogether. Some of us believe that local sharing is based on arbitrary boundaries, thus violating the Final Rule, while some of us believe that minimizing or eliminating local sharing will impact donation rates, asserting that people may be more willing to donate if they know their organs are going to be shared with their local community. Even though data have shown this not to be the case, the Committee determined the best compromise is to keep local sharing as the first geographic unit of allocation, but to combine it with Zone A, so that all urgent candidates registered locally and within Zone A are grouped together, rather than sequentially.

10. Waitlist mortality rates by simulation and new status groups, adult candidates
I mentioned that the SRTR performed thoracic simulation allocation model (TSAM) analyses to help us determine the impact of the proposed 6-tiered system, including broader sharing. Note that in the following slides, simulation results show a range of outcomes across the ten runs, as well as a point estimate of the average across the runs. The ranges do not indicate confidence limits. Please note the ranges are wide in some results, and the reason is that the sample size is small.
We’re looking at the patient’s risk for dying (mortality rate) of people on WL. On vertical axis, values are very different. On the left side, scale goes from 0-450, on right side it goes from Along the horizontal axis there are numbers/verbiage. There are the 6 proposed statuses, and within each there are 3 different analyses. Modeling of the current rules, modeling of the 6 statuses, and modeling of the 6 statuses + broader sharing. We ran the models 10 times, which is why you see a point with points above and below – those show the range of outcomes out of the 10 times we ran the model.
For this slide, the data are compelling that we stratified the patients correctly. If you look at their risk of dying, the status 1 patients have a much higher risk than status 2, who have a higher risk than 3, 4s and 5s are about the same, and status 6 have the lowest risk.
This also shows there is a little variability here. For example, if you look at status 1 analyses, perhaps the 6 status system would result in an increased mortality. However, if you look at the next slide you might agree that’s not true.
Current Rules
6 Status
6 Status + Share
Current Rules
6 Status
6 Status + Share
Current Rules
6 Status
6 Status + Share
Current Rules
6 Status
6 Status + Share
Current Rules
6 Status
6 Status + Share
Current Rules
6 Status
6 Status + Share
6 Statuses
Current Rules
6 Status + Share 2 3 4 5 6
Inactive
Simulation results show a range of outcomes across the ten runs, as well as a point estimate of the average across the runs. The ranges do not indicate confidence limits.

11. Number of Waitlist Deaths by Simulation and Status
Current Rule
Broader Sharing
Status
Ave
Min
Max 1 16 11 19 6 4 9 2 12 18 5 3
In the previous slide, the waiting list mortality rate point estimates for "6 statuses" and "6 statuses with broader sharing" are higher among proposed status 1 & 2 candidates vs. current rules. You might be wondering: "if current rules are better for the most urgent statuses, why are we changing?" Rates are based on the number of deaths that occur against the time people spent on the waiting list. So if you think about the number of people that are likely to die, on the right side of the table you see that we have reduced the number of people who are likely to die in this system because they are spending less time on the waiting list. So, we believe we have reduced the risk of mortality, particularly for people in the two most urgent statuses.

12. Transplant rates by simulation and new status groups, adult candidates
On this slide, I’d like to again highlight the differences in the values in the vertical axes. The proposed system is intended to ensure that the most urgent candidates are transplanted more quickly, and the proposed geographic sharing schemes appear to achieve this goal. Broader sharing is projected to increase the transplant rates in status 1 and 2 because there are increased transplant counts and decreased waiting times for these patients, which contribute to higher rates. Note that the transplant rates are going to dramatically increase for status 1 and status 2 candidates. The increase is less pronounced for status 3 and 4.
NOTE TO SPEAKER: If asked to see the overall transplant rates, the slide is included in the “extra slides” section.
6 Statuses
6 Statuses
6 Statuses
6 Statuses
6 Statuses
6 Statuses
Current Rules
Current Rules
Current Rules
6 Status + Share
6 Status + Share
Current Rules
6 Status + Share
Current Rules
Current Rules
6 Status + Share
6 Status + Share
6 Status + Share
Simulation results show a range of outcomes across the ten runs, as well as a point estimate of the average across the runs. The ranges do not indicate confidence limits.

13. Two-year post-transplant mortality rates by simulation and tier, adult recipients
And finally, you might wonder if we’ll have a negative impact on post transplant survival if we take this approach. This slide suggests there really won’t be a major difference in post-transplant survival, except for status 5 candidates. However, it’s worth noting that the status 5 death rates were based on relatively few deaths.
I’d like to pause here and talk briefly about status 5. Remember, these are the candidates who are registered for a heart and for another organ. These candidates are heterogeneous and have multiple co-morbidities. Remember what I previously said - Status 5 is a catch-all for them -- they will only end up in status 5 if they don’t qualify for any of the other, higher statuses.
Current Rules
6 Statuses
Current Rules
6 Statuses
6 Statuses
Current Rules
6 Statuses
Current Rules
6 Statuses
Current Rules
6 Statuses
Current Rules
6 Status + Share
6 Status + Share
6 Status + Share
6 Status + Share
6 Status + Share
6 Status + Share
Simulation results show a range of outcomes across the ten runs, as well as a point estimate of the average across the runs. The ranges do not indicate confidence limits.

14. Impact on Pediatric Candidates
No negative impact anticipated
Potential for positive impact on pediatric candidate access to transplant
Modeling results for 6 urgency statuses with broader sharing:
Increased transplant counts for pediatric candidates
Increased transplant rates for status 1A pediatric candidates
Overall death counts decrease slightly
This proposal mainly impacts adult heart candidates, and the Committee does not anticipate this proposal to have a negative impact on pediatric candidates, and may even have a positive impact on pediatric access to heart transplant. Though the number of pediatric candidates is small and therefore more difficult to analyze, the TSAM analysis shows total increased transplant counts for pediatric candidates under the 6 urgency status with broader sharing scheme, and the transplant rate for pediatric status 1A candidates increased. The overall death counts also decrease slightly.

15. How will members implement this proposal?
Update data for candidates registered at the time of implementation
UNOS will provide a window of time during which members can update data
Members will need to verify the information after implementation date
Submit candidate CPRA values at time of registration and removal
CPRA already collected at time of transplant
Prior to implementation, UNOS will provide all heart transplant programs with a window of opportunity during which you must update the information for all of your heart candidates to meet the new statuses. On the day the new proposal becomes effective, the system will allocate based on the new statuses, so it is important that transplant programs verify their candidates’ information immediately before the new policy is active, and immediately after. Some of the statuses will require programs to report additional data that they don’t currently submit. UNOS will provide educational opportunities and plenty of communication regarding this transition period.
Note to speaker: there are additional slides in the extra slides section if people ask more questions about the transition plan.
Additionally, on multiple occasions we discussed how to identify and prioritize sensitized patients, but the problem remains that the OPTN does not collect enough data for heart patients to strongly support a policy solution at this time. We decided to focus on collecting data so that in the future we can make a more informed, evidenced-based decision on how policy should treat sensitized candidates. We propose collecting CPRA at the time of candidate's registration in Waitlist, and at the time of removal from Waitlist. Capturing CPRA at two discrete times will help us track a candidate's course while waiting for an organ. Capturing CPRA at removal for all candidates will help the committee understand how sensitization affects all candidates registered for a heart, not just those who actually receive a transplant.

16. How does this proposal support the OPTN Strategic Plan?
Strategic Goal – Improve Equity in Access to Transplants
More equitable access to transplants based on medical urgency and on geographic location
This proposal primarily impacts the strategic goal of improving equity in access to transplants. Revising the heart allocation system will provide more equitable access to transplants based on medical urgency and on geographic location.

17. Questions? Joe Rogers, MD Committee Chair Joseph.rogers@duke.edu
Liz Robbins Callahan, Esq.
Project Liaison

18. Extra Slides

19. Overall waitlist mortality rates by simulation
In this figure, the middle column, “6StatGrps” refers to the modeling results using the 6 tiered system based on our current geographic sharing scheme. The column on the right, 6 Grp Share, shows the modeling results combining the 6-statuses with the proposed broader sharing scheme. As you can see, the overall waiting list mortality rates in the proposed system are likely to decrease because organs will be allocated to sicker patients more quickly. Candidates that are less urgent might not be transplanted as quickly, but they are also less likely to die while waiting.

20. Overall transplant rates by simulation
Overall transplant rates by simulation appeared to be slightly lower in the proposed sharing schemes than in the current rules. However, the ranges of some sharing rules overlapped with the ranges exhibited in the current rules simulation. It is also important to remember that the bars in this graph represent the minimum and maximum results of the ten simulated runs; they are not the 95% confidence limits.

21. Anticipated Controversies
Preference for heart allocation score
Should ECMO be prioritized in the highest tier?
Should TAH be placed in Tier 2?
How can revision impact the highly sensitized and encourage data submission to inform future change?
Should we extend or eliminate 30-day elective VAD times?
Will the community agree upon the selected physiological principles that qualify a patient for inotrope use?
Is the “lumping” of CHD and restrictive CM and amyloidosis in same status criterion acceptable?
How will broader sharing be viewed by the public?
Transition candidates from old system to new system

22. Heart Allocation Score
OPTN does not collect enough data to develop a score
Inflexible solution
Changes in heart transplant technology occurring too quickly
We debated the merits of developing a heart allocation score (HAS). Though a HAS may be the best method for accounting for post-transplant survival and net benefit, the OPTN does not currently collect all the data necessary to develop a HAS at this time.
Additionally, we were concerned that the HAS is not a flexible solution. In our experience with the Lung Allocation Score (LAS), covariates have become outdated frequently. This would be particularly problematic for the heart transplant community, as technology is changing quickly and may affect the outcomes of subgroups of patients and invalidate the HAS. We agreed that VAD technology is evolving rapidly and may exceed the ability of a HAS to account for new devices and complications.
Based on these considerations, we ultimately opted to develop additional statuses to better stratify heart transplant candidates while prospectively collecting additional data that may be necessary for developing a heart allocation score in the future, if the we decide to do so. We agreed that adding more statuses to the current system may better accommodate the speed at which technology changes, because if a patient group is suddenly doing much better or much worse, moving those patients among the statuses can be done more quickly than changing a HAS system.

23. ECMO Priority
Will ECMO in highest priority incentivize increased use of ECMO?
If so, will post-transplant outcomes be worse?
Is there potential for outcomes to be better if ECMO patients are transplanted quicker?
The Committee determined that ECMO candidates should be in status 1 because of their high waiting list mortality rates, and because the number of candidates supported by ECMO prior to transplant is relatively low. For example, the TSAM analysis projected that under the proposed six-status system and broader sharing scheme, an average of 31 candidates were predicted to be transplanted on ECMO. Additionally, though it cannot be determined until the policy is in place, some hypothesize that rapid transplantation of ECMO-supported patients may be superior to durable MCSDs and may reduce ECMO-related complications and post-transplant mortality.
Committee members heard some reservations in the community about including ECMO in the highest urgency status, because data reveal that ECMO patients tend to have worse post-transplant outcomes than some other candidates that qualify for status 1. Additionally, some were concerned that including ECMO in the highest urgency status may inadvertently encourage transplant teams to opt for ECMO support simply to ensure their candidate qualifies for status 1. Recognizing this concern, but also recognizing that physicians would not use ECMO if it were not clinically indicated and not in the best interest of the patient, the Committee decided to keep ECMO in status 1.
Based on these concerns, however, the Committee determined the criterion for ECMO should be limited to those candidates supported by veno-arterial (VA) ECMO. It agreed that veno-venous (VV) ECMO is the ultimate form of respiratory failure and is not generally an appropriate indication for heart transplant. The Committee will closely evaluate the effect of allowing VA ECMO candidates to qualify for status 1A.’
Alternative Talking Points:
It is difficult to imagine that centers will be placing patients on VA ECMO who do not require a high level of support
It is not clear that using ECMO in this manner is bad.  Perhaps it will reduce the number of VADs implanted.  Ultimately that may not be a bad thing
One of the challenges to centers will be to avoid the patients who are too sick to transplant (end-organ dysfunction, etc).  Ultimately the check on this is that they will need to stand behind their outcomes.
We will be watching ECMO utilization. 
The time to transplant should be much shorter.   As a result, there should be fewer long-term ECMOs with the consequent complications
If ECMO isn’t placed in status 1, where should it belong?
This was a very data-driven process.

24. Total Artificial Heart (TAH)
Proposal: all TAH candidates grouped together in status 2 (hospitalized and not hospitalized)
Debate about whether outpatient TAH are more stable (should they be in a lower status?)
Debate about whether inpatient TAH are less stable (should they be in a higher status?)
This status is intended to apply to all candidates supported with a TAH, regardless of whether they are admitted to the hospital. Though data revealed that candidates implanted with a TAH have similar waiting list mortality rates to other candidates in status 2, there is still debate regarding whether all TAH candidates should be grouped together. Though there is an assumption that outpatient candidates supported by TAH are more stable than some other candidate groups in status 2, the Committee also recognized that outpatient or not, TAH can be a challenging support technology.
Additionally, regardless of hospital admission, TAH failure tends to be extremely urgent due to lack of backup circulatory support from the native heart. The Committee also recognized that it is the candidate’s disease process, more than the therapy, that should determine the status for which a candidate qualifies, and for TAH candidates, their disease process is most similar to candidates supported by a biventricular assist device (BiVAD).

25. Sensitized Candidates
Committee considered:
How to prioritize sensitized heart candidates
Definition of sensitization for heart candidates
Problem: can’t define sensitization for heart candidates because of insufficient OPTN data
Solution: collect more data
CPRA for each candidate upon registration and removal
On multiple occasions, we discussed how to identify and prioritize sensitized patients. Though the Committee discussed multiple solutions, including review board exceptions or prioritization for candidates with a Calculated Panel Reactive Antibody (CPRA) of 80 percent and with three positive prospective crossmatches, the problem remains that the OPTN does not collect sufficient data on heart patients to strongly support any of these solutions. The Committee decided instead to focus on collecting data so that in the future the Committee can make a more informed, evidenced-based decision on how policy should treat sensitized candidates. The Committee proposes collecting CPRA at the time of candidate's registration in Waitlist, and at the time of removal from Waitlist. Capturing CPRA at two discrete times will help the committee track a candidate's course while waiting for an organ. Capturing CPRA at removal for all candidates will help the committee understand how sensitization affects all candidates registered for a heart, not just those who actually receive a transplant. CRPA at time of transplant is already collected as of March 2015.
Transplant programs will be required to report CPRA at time of registration by entering the candidate's CPRA on the registration form. The CPRA will not be calculated by the system; the transplant hospital will obtain the candidate's CPRA from the histocompatibility lab and complete this section on the form. Upon removal, the same field will appear. Again, the system will not calculate the patient's CPRA at time of removal; the hospital will be responsible for obtaining this value from the lab and reporting it to the OPTN.

26. LVAD for 30 Days
Debate:
Eliminate 30 day time
Candidates are at lower risk of developing adverse events when using this criterion
Candidates using this criterion have lower WL mortality risk than others in same status
Retain 30 day time
Candidates shouldn’t have to risk becoming unstable to get priority for transplant
Proposal: retains elective 30 day time for stable LVAD patients in status 3
Represents compromise because 30 day time is mitigated by:
the proposed sharing scheme
Limitations on use with multiple registrations
Current policy permits stable candidates supported by a VAD to use be registered as status 1A for 30 days at the transplant program’s discretion. The Committee discussed whether the 30 day optional period should continue as a policy at all. Those who oppose the discretionary 30 day time cite studies that show that stable LVAD patients are at a much lower risk of experiencing adverse events while waiting for transplant, and are therefore not nearly as urgent as other candidates in status 3.,
Those who supported the optional 30 day period believe the TSAM analysis reveals that the candidates using the LVAD for 30 days discretionary time have lower waiting list mortality rates than others in status 3 as a direct result of an intentional compromise that provides candidates with a priority for a limited time without forcing them to risk developing a device complication in order to move up in urgency. It is an acceptable compromise that provides candidates supported by an LVAD with an opportunity for transplant while stable, which likely increases the opportunity for successful transplantation.
Ultimately, the Committee determined that the discretionary LVAD for 30 days policy should continue.
Mitigating factors:
Sharing scheme: The Committee’s decision to propose this particular broader sharing scheme, rather than the similar scheme (described in the TSAM analysis as Share 1/2B), centered largely on the distinction between the way in which status 3 and status 4 candidates are impacted by broader sharing. Under the proposed scheme, local status 4 candidates are prioritized before status 3 Zone A adults, whereas under the other scheme, status 3 Zone A adults are prioritized ahead of local status 4 adults. LVAD patients using the discretionary 30 day status 3 time exhibit a lower waiting list mortality rate than the other groups that qualify for status 3, though the mortality rate for LVAD for 30 day patients appeared similar to candidates with some device complications and infections. Additionally, these candidates have similar waiting list mortality rates to candidates on inotropes without hemodynamic monitoring, who fall into status 4.
Multiple registration: The Committee also clarified that candidates that are supported by a dischargeable LVAD and registered at more than one hospital nevertheless only receive 30 days of discretionary time total.  This means that if two hospitals register the candidate as status 3 at the same time, the candidate would only get 15 days of status 3 time at each of the hospitals, as both hospitals would have drawn from the same pool of discretionary time. If the candidate was registered as status 3 by the first hospital for 20 days and then registered at status 4, and the second hospital at which the candidate is registered decided to list the candidate as status 3, the candidate could only be registered at status 3 for 10 more days. The Committee believes this is the fairest way of permitting candidates simultaneously registered at multiple hospitals to have access to status 3, while not disadvantaging other candidates that are not capable of multiple listing. If a candidate’s device is replaced, then the candidate is eligible for another 30 day discretionary period, and any remaining 30 day time from the previous device does not carry over to the new device.

27. LVAD for 30 Days Example
Here, Hospital A registered Candidate 1 for 30 days under the discretionary status 3 criterion, and therefore Hospital B may not register Candidate 1 as status 3 under this criterion. Hospital A and B simultaneously registered Candidate 2 as status 3, so the candidate can only be registered for 15 days of status 3 time at each of the hospitals. Hospital A registered Candidate 4 as status 3 for 20 days, so Hospital B can only register Candidate 3 as status 3 for 10 more days. Finally, Hospital A only registered Candidate 4 as status 3 for 5 days under this criterion, so Hospital B can register Candidate 4 for up to 25 days of discretionary status 3 time. The Committee believes this is the fairest way of permitting candidates simultaneously registered at multiple hospitals to have access to status 3, while not disadvantaging other candidates that are not capable of multiple listing. If a candidate’s device is replaced, then the candidate is eligible for another 30 day discretionary period, and any remaining 30 day time from the previous device does not carry over to the new device.

28. Plan to Transition Adult Heart Candidates
Proposal for:
Transferring statuses from old system to new
Transferring waiting time from old system to new
Handling approved and “in flight” exception requests
We have a plan to transition patients from the old system to the new without harming patients that have been waiting for a heart transplant prior to implementation of the new system. The plan covers transferring candidates that are currently waiting from the old system to the new system, transferring their waiting time from the old system to the new system, and how to handle exceptions that are approved or in flight at the time of implementation.

29. Adult Heart Allocation Proposal – Status Transition Plan
Window of opportunity to update data
TBD: how big of a window?
Date of implementation
Allocation based on information submitted during window of opportunity
Candidates w/o updates fall into status 6
Programs must check info within 24 hours of transition
Candidates without updated records will appear in status 5 or 6
Prior to implementation, the OPTN will provide transplant programs with a timeframe in which to update current candidates’ information in UNet according to the new policy requirements. On the day of implementation, UNet will allocate organs using the new information. According to existing policy, within 24 hours of the implementation date, transplant programs should verify that their candidates’ information is up-to-date in UNet, to ensure that their candidates are registered in the appropriate new urgency status. Candidates whose records are not updated by the time of implementation will appear in status 6 (or status 5 if the candidate is registered at the same transplant hospital for another organ).

30. Adult Heart Allocation Proposal – Waiting Time Transition Plan
New Status
Waiting Time Calculated As
Status 1 
Accumulated time at New Status 1
Plus accumulated time at Status 1A*
Status 4
Accumulated time at New Status 4
Plus accumulated time at New Status 3
Plus accumulated time at New Status 2
Plus accumulated time at New Status 1
Plus accumulated time at Status 1B
Status 2
Accumulated time at New Status 2
Plus accumulated Time at Status 1A*
Status 5
Accumulated time at New Status 5
Plus accumulated time at New Status 4
Plus accumulated Time at Old Status 2
Status 3
Accumulated time at New Status 3
Status 6
Accumulated time at New Status 6
Plus accumulated time at New Status 5
The OPTN will ensure that waiting time accumulated under the old system will transition to the new system so that candidates already waiting will not be disadvantaged on the date of implementation.

31. Adult Heart Allocation Proposal – Exception Transition Plan
Approved exceptions
Exception requests pending approval
Invalid upon implementation
Exceptions that are approved prior to implementation and exception requests that are in progress at the time of implementation will be ineffective upon implementation. Many of the exception requests are expected to be unnecessary upon implementation, because the proposed policy is intended to accommodate the conditions of many candidates who previously needed an exception.

32. 6 Statuses + Broader Sharing
Current Rules
6 Statuses + Broader Sharing
Metric
Zone
Avg
Min
Max
TX count
Local
2591
2563
2647
1852
1790
1892 A
1703
1660
1746
1624
1583
1694 B
321
301
347
1047
1011
1089 C 58 45 70
124
104
139 D 11 9 20 13 19 E 1 2 3
1Y PT deaths
294
252
315
221
200
253
203
183
231
192
170
224 42 35 57
150
129
166 4 14 27 5 8
1Y PT death
rates
12.3
10.5
13.3
13.0
11.8
14.8
11.3
15.2
12.8
11.6
15.6
14.6
12.4
20.0
16.0
13.6
18.4
17.1
8.0
29.0
25.3
16.3
36.8
35.5
9.9
67.9
40.3
6.7
81.7
0.0
53.1
424.7
2Y PT deaths
383
343
421
287
269
313
260
243
285
250
274 55 43 66
193
172
213 6 17 34 26
2Y PT death
8.3
7.4
9.2
8.7
8.1
9.5
8.6
7.7
9.7
7.9
11.9
10.7
9.4
11.7
6.2
20.1
17.0
12.6
24.6
23.6
5.5
37.4
25.8
53.3
27.6
55.3
65.7
Transplant counts and posttransplant outcomes by simulation and zone