Pediatric heart allocation policy and system changes

Published on: Tuesday, May 17, 2016

frequently asked questions

The Board of Directors approved policy changes in June 2014.

We are currently working to complete the second phase of a two-part project to decrease waiting list mortality for pediatric heart transplant candidates. In March, we implemented phase 1, which revised pediatric heart status 1A and 1B justification forms in Waitlist^SM to reflect the new status criteria.

We will make the following changes on July 7, 2016:

Increase the qualifying isohemagglutinin titer to 1:16 or less for Status 1A/1B candidates who are one year old or older, but registered before their second birthday, and who are willing to accept intended blood group incompatible heart offers.
Add a new the treatment question “Has candidate received any treatments within the prior 30 days that may have reduced titer value to 1:16 or less?”
Change the allocation priority of candidates under one year old, and candidates eligible to receive intended blood group incompatible heart offers.
Eliminate the option to register heart candidates as in utero.
Remove outdated policy language.
Modify reports in Waitlist.

Important: Transition plan for pediatric candidates at implementation

Please see notes and actions you may need to take when we implement the changes on July 7.

For candidates who are less than one year old on July 7:

If they have titers entered, the titer values will not be affected.
The response to the treatment question (“Has candidate received any treatments within the prior 30 days that may have reduced titer value to 1:4 or less?”) will not transition over to the new system.
The next time titer data are updated, members will have to answer the new treatment question (“Has candidate received any treatments within the prior 30 days that may have reduced titer value to 1:16 or less?”)

For candidates who are one or older on July 7, but less than two years old at the time of registration, the following actions are required for candidates to be eligible for intended blood group incompatible offers as of July 7:

The system will display the previously entered titer values but they will not be used.
- Action required: Members must reenter the titer values if they have not yet expired, or enter the new titer values.
The response to the treatment question (“Has candidate received any treatments within the prior 30 days that may have reduced titer value to 1:4 or less?”) will not transition over to the new system.
- Action required: Members will have to answer the new treatment question (“Has candidate received any treatments within the prior 30 days that may have reduced titer value to 1:16 or less?”)

Resources

View a toolkit of materials that explain the changes, including policy and system instructional recordings, frequently asked questions, and more. Read the policy notice for more information.

Questions?
If you have additional questions relating to policy, contact your UNOS Regional Administrator at 804-782-4800.

If you have questions relating to the system, contact UNOS Customer Service (UNet Help Desk) at 800-978-4334.

frequently asked questions

These questions and answers are from the March 14, 2016 webinar.

Status Qualifications

Define congenital heart disease. From one of the example questions, you do not consider restrictive or dilated cardiomyopathy patients on high dose inotropes to meet 1A criteria.

The following is the list of OPTN-approved qualifying hemodynamically-significant congenital heart diagnoses:

Double Outlet Right Ventricle
Atrial isomerism / Heterotaxy
Atrioventricular Septal Defect
Congenitally Corrected Transposition (L-TGA)
Ebstein’s Anomaly
Hypoplastic Left Heart Syndrome
Other left Heart Valvar/Structural Hypoplasia
Pulmonary Atresia with Intact Ventricular Septum
Single Ventricle
Tetralogy of Fallot
Transposition of the Great Arteries
Truncus Arteriosus
Ventricular Septal Defect(s)
Other (Specify)

For a cardiomyopathy patient on high dose inotropes, does an ASD qualify as a congenital heart defect for status 1A candidacy?

ASD is not on the list of significant congenital heart diseases diagnoses that qualify a candidate for status 1A under criterion 4.

We have a patient with idiopathic cardiomyopathy listed as 1A currently. Under the new criteria would we just report their diagnosis as other and is this still valid for 1A criteria? Pending all other criteria is met.

Transplant programs should not report diseases as “other” congenital heart disease diagnoses unless they are actually hemodynamically significant congenital heart disease diagnoses.

To clarify 1A status: they must be congenital heart disease AND admitted to the hospital. Therefore, they must remain in the hospital from listing as 1A until transplant as 1A, correct? In what scenarios can they be at home as status 1A? Only patients with a VAD?

Correct. To qualify for status 1A under criterion (4), the candidate must be diagnosed with a hemodynamically significant congenital heart disease, and must be treated with a high dose inotrope or multiple inotropes, and must be admitted to the hospital that registered him or her. The only status 1A criterion for which hospital admission is not required is status 1A (5) – the candidate requires assistance of a mechanical circulatory support device.

I understand the hospital admission, but are there any monitoring requirements?

With the exception of status 1A (5) (requires assistance of a mechanical circulatory support device), all status 1A candidates must be admitted to the hospital that registered them on the waiting list. There are no additional monitoring requirements.

Where do patients who have CAD and require a retransplant fall? Is this considered a congenital disease? What about a retransplant candidate, formerly with congenital heart disease, but whose failing transplant requires high dose inotropes only?

Candidates who require a re-transplant will qualify under the appropriate status for their current underlying medical condition. Coronary artery disease is not on the list of hemodynamically significant congenital heart disease diagnoses that qualify a candidate for status 1A under criterion 4.

When dealing with a re-transplant listing for a patient with severe rejection related coronary vasculopathy, what status is most appropriate? This is not addressed in status justification forms.

If the candidate does not qualify for a status under the policy criteria, then the transplant program may request an exception in the appropriate status if the transplant physician believes, using acceptable medical criteria, that the candidate has an urgency and potential for benefit comparable to that of other candidates in the requested status.

What about restrictive cardiomyopathy patients older than 1 year who aren't candidates for MCS or inotropic support? Risk of sudden death is very high. It's not likely they'd get a transplant in time as a status 2.

Status 1A Transition

For a patient who is currently listed as status 1A under old criteria and they are not due to be recertified until after the implementation date and they now do not qualify for 1A, do we change status on March 22 or do we change when they are due, for instance on March 28?

Candidates registered as status 1A prior to the date of implementation who are not due for a recertification until after March 22 will remain status 1A until their next scheduled status update. Therefore, if a candidate is registered as status 1A under current policy two days before the new policy becomes effective on March 22, the candidate will remain in status 1A until their next justification form is due 12 days after the new policy becomes effective.

For patients formerly listed as 1A who no longer qualify, how is 1B time calculated when their status changes? For example, for a patient at home on Milrinone listed status 1A now, will they lose all their 1A time as they transition to 1B? Or will their acquired 1A time be shifted to 1B? In patients who change from 1A to 1B with the new allocation scheme, will their 1A time be converted to 1B time to account for patients who have already been waiting? Or do they start at 1B, day 1?

Once the candidate’s status is updated, the candidate will begin accruing time at status 1B instead of status 1A. The candidate’s accrued status 1A time will remain, and when hearts are allocated candidates in status 1B are stratified by their combined total accrued status 1A and status 1B time.

What happens to the patients who are waiting at home with a high dose inotropic support?

Unless these candidates are being treated for a hemodynamically significant congenital heart disease and are admitted to the hospital while on high dose inotropic support, they will no longer qualify for status 1A under new policy. At the time of their next status update, you should submit a justification form for the status for which the candidate qualifies under the new policy criteria.

Status 1B Transition

A Patient is currently status 1B for failure to thrive. Must we change that to status 2 on March 22?

Patients registered under any criterion in status 1B on March 22 will not be required to update their 1B registrations. If the candidates’ medical condition changes, such that status 1B is no longer the appropriate status, then the candidate’s registration must be updated within 24 hours of the change in medical condition change.

If a baby less than 1 year of age is listed status 1B with RCM or HCM, do they remain 1B after turning 2 years of age, or do they change to status 2?

If the candidate was registered before turning 1 and has a diagnosis of restrictive cardiomyopathy or hypertrophic cardiomyopathy, the candidate will continue to qualify for status 1B under criterion 2, even after they turn 1.

For patients who have been approved by appeal as status 1B, then need to be changed to status 7 due to viral illness, can we reactivate them as 1B? Will they lose their "grandfathered in" status if we have to place them as status 7 and then reactivate them at 1B?

After March 22, if a candidate’s status changes for any reason, all subsequent status updates will follow the new policy criteria. Therefore, if a candidate is registered as status 7 after March 22, when they are ready to be reactivated they must meet the new status 1A or 1B qualifying criteria, or be registered as status 2. The candidate will not lose previously accrued time at status 1B.

Exceptions

If a patient meets criteria for status 1B, and we are requesting a status 1A by exception, what status is the patient until the retrospective review by the review board? If the review board rejects the exception, will there be a phone or other conference to discuss/review that rejection?

Because the review is retrospective, a patient is registered in the requested status once the exception form is submitted. Transplant programs can appeal or override any denials of exception requests. A conference call may be offered as an option if an appeal is also denied.

What happens if a patient is listed as status 1A by exception, and is then transplanted prior to the Review Board's retrospective review?

Even if a candidate receives a transplant prior to the Review Board’s retrospective review, the Review Board will review the case and make a decision. The appeals and override process will be the same regardless of whether the candidate is transplanted.

Are exceptions listed to be read as "AND" or "OR" statements?

The exception policies should be read as “and” statements. Therefore, to register a candidate as a status 1A by exception, the candidate must be admitted to the transplant hospital that registered him or her, and the transplant physician must believe, using acceptable medical criteria, that the candidate has an urgency and potential for benefit comparable to that of other candidates in status 1A.

How will the RRB notify transplant centers that they have reviewed the 1A status after the first 14 days and it has been extended?

Policy 6.1.C states that a candidate’s pediatric status 1A must be recertified by an attending physician every 14 days. This is accomplished through the submission of a new justification form. Forms that require review board evaluation will be submitted to the RRB. Transplant hospitals are only notified if the review board does not approve of the extension. The physician named on the form will be notified by email.

ABOi

What is the current isohemagglutinin titer cutoff for eligibility for ABOi offers for children less than 1 year of age? The anti A and anti B titers need to be less than 1:16 for patients older than 1 but registered before turning 2 years old, but for patient <1 year, they can still receive an incompatible heart at any titer--correct?

Currently, and under the new ABOi policy once it becomes effective later in 2016, there is no isohemagglutinin titer maximum for candidates less than 1 year old at the time of the match run.

For candidates who are older than 1 but registered before turning 2, the isohemagglutinin titer maximum will be raised from 1:4 under current policy to 1:16 under the proposed policy. However, this change will not be effective until phase 2 of the implementation plan, which will occur later in 2016.

Miscellaneous

Can you address the change in multiple site listings?

Policy will not change with regard to registrations at multiple hospitals. However, to qualify status 1A, with the exception of those candidates supported by a mechanical circulatory support device, candidates must be admitted to the hospital that registered them. Therefore, depending on the criteria under which a candidate is registered, the candidate may not be able to be registered as status 1A at multiple hospitals.

Has UNOS changed the letter (required to be given to the family) to include the admission requirement? If a patient is listed as 1A under the current policy but will be listed as a 1B after the policy change, do we have to notify the family of the status change via a letter?

There are no changes to the patient information letter or the policy requirements for notifying patients. Policy 3.5: Patient Notification requires transplant hospitals to contact patients when the patients are registered on the waiting list initially, if the patient is evaluated but not registered on the waiting list, or if the patient was removed from the waiting list for a reason other than transplant or death. The policy does not require transplant programs to update patients every time the patient’s status changes.

Education