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Modify Heart Policy to Address Patient Safety Following Device Recall

eye iconAt a glance

Current policy

On July 14, 2022, the Organ Procurement and Transplantation Network (OPTN) implemented an emergency policy to create an exception pathway for non-hospitalized heart candidates who have an FDA recalled mechanical circulatory support device implanted. Previously these candidates had to have been hospitalized to apply for an exception for a Status 3 or above. This emergency policy is being submitted for retrospective public comment. The OPTN Board of Directors will vote on the proposal in December and decide if this policy should be made permanent.

Supporting media

Presentation

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Changes

Add option for status exception for Statuses 1, 2 or 3 for candidates not hospitalized:

  • Must have an implanted mechanical circulatory device (or internal component) that:
    • Is subject to an FDA recall
    • Poses a risk to patient safety
    • Cannot be mitigated without replacement of the device or internal component
  • Exceptions will be retrospectively reviewed by the heart review board
  • Candidates with approved exceptions will remain at status for 14 days
  • After 14 days, programs can apply for a 14 day extension for the candidate, which also must be approved by the review board

Anticipated impact

  • What it's expected to do
    • Promote patient safety for candidates with qualifying recalled devices

  • What it won't do
    • Provide an exception pathway for a status 1, 2 or 3 for all non-hospitalized patients
    • Provide an exception pathway for a status 1, 2, or 3 for all FDA recalls

Terms 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.
  • Mechanical Circulatory Support Device: A device use to treat end-stage chronic heart failure (ex. Ventricular assist devices (VADs), total artificial hearts (TAH), etc.)

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eye iconComments

UC San Diego Health Center for Transplantation | 09/29/2022

The UC San Diego Health Center for Transplantation (CASD) appreciates the opportunity to provide public comment on the proposal to Modify Heart Policy to Address Patient Safety Following Device Recall. CASD strongly support this proposal and commends the Committee for recognizing the need for this important patient safety improvement. With regards to the feedback explicitly requested: • Should the approved emergency policy changes be considered for permanent policy by the OPTN Board of Directors? Yes, we would urge the Board to formally adopt this emergency action as permanent policy. While we anticipate there to be a relatively small number of patients expected to be eligible for the proposed exception pathway, it is an essential step in expediting effected candidates who have limited alternative treatment options but risk harm and death associated due to an unsafe device. • What, if any, data analyses, peer-reviewed literature, or evidence-based medical judgments, provide evidence demonstrating that a patient with FDA-recalled heart device should be assigned to adult heart status 2 or adult heart status 3 by policy criteria, rather than a candidate’s transplant physician determining whether assignment to status 1, 2, or 3 by exception is appropriate? We agree that the the candidate’s transplant physician is the most appropriate individual to determine whether assignment to status 1, 2, or 3 by exception is necessary. Based on recall, status 3 is supported by the Medtronic press release that identified increased risk of pump stoppage, stroke, etc with the device. Given this, we would urge the Committee to consider adopting an automatic exception approval as opposed to requiring review by the Regional Review Board for candidates meeting this criteria. For status 1 or 2, we are unaware of any peer-reviewed literature that places these specific patients in a higher risk category. The standard high risk features such as arrhythmias, GIB, stroke or evidence of hemolysis, or RVF would suggest need for a higher status than the standard allowance for status 3 in those with the recalled device. We would agree that absent this peer-reviewed literature, centers requesting an exception assigning status 1 or 2 should follow the established request pathway justifying similar mortality in absence of transplant as a traditional status 1 or 2. • Is 14 days the appropriate amount of time for a candidate impacted by a FDA-recalled device to be initially assigned to status 1, 2, or 3 under the approved policy? Why or why not? Given that candidates impacted by an FDA-recalled device are unlikely to clinically improve and the safety risks remain until the device is replaced with an alternative MCDS or donor heart, we would urge the Committee to consider extending the duration for the exception approval, at minimum adopting the 90-day duration applicable to Status 4 Exceptions, if not a duration to transplant. Requiring re-application in short intervals will simply create additional undue administrative burden on the centers. • Is 14 days the appropriate amount of time for an extension of the assignment by exception? Why or why not? See above response. • In addition to the Member Compliance and Policy Evaluation actions identified in the proposal, what other actions can be taken to ensure the new exception pathway is only used for appropriate purposes as intended by the Heart Committee? Considering the stringent process associated with FDA recalls of medical devices, which include explicit recall classifications codifying the relative degree of risk associated with the product we do not share the Committee’s concerns about the potential for abuse. We are in fact, more concerned about centers not appropriately requesting a higher status via the approved emergency exception pathway as there remain patients with the recalled device listed as a status 4. • Are there any types of implanted devices that could be subject to a FDA device recall that should not qualify under the policy modifications? Describe why. Research and development continues on the next generation of MCSDs. As such, we would urge the Committee not to explicitly limit which types of implanted devices would qualify under the proposed policy at this time, as newly issued recalls would require policy modification before patients would be eligible for exception approval. The Committee is charged with continuing to monitoring policy impact and has the opportunity to consider the need for modification or refinement at a later date. • Are there any types of devices that are not implanted that should be permitted to qualify under the policy modifications? Describe why. None that we are am aware of. • Are the proposed data element and the associated data definition clear and understandable? The proposed data element and it’s definition are clear and understandable. • Are the acceptable forms of documentation regarding the recall of the device identified in the proposal widely available? Yes, the acceptable forms of documentation regarding the recall of the device are widely available and should not create additional burden for the program’s caring for these patients.

Attachment

Region 6 | 09/28/2022

Sentiment: 5 strongly support, 13 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose

Region 10 | 09/28/2022

Sentiment: 6 strongly support, 7 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose

OPTN Data Advisory Committee | 09/28/2022

The Data Advisory Committee thanks the Heart Committee for the opportunity to provide comment on their proposal Modify Heart Policy to Address Patient Safety Following Device Recall. The Committee is supportive of the inclusion of a new data element capturing whether the exception request is related to a device recall as part of the policy change approved by the Executive Committee. The Committee noted that the new data element seemed well-designed and was clear about which devices would be impacted due to the recall.

NATCO | 09/28/2022

NATCO appreciates the opportunity to provide feedback on modifying heart policies to address patient safety following a device recall. We agree that patients who have implanted mechanical circulatory support devices (MCSD) that are affected by an FDA recall should have higher status assignment for listing. Regarding whether a 14 day approval time should be extended to 30 days, NATCO believes it would be labor intensive to re-justify every two weeks. NATCO believes these changes will allow patients who have a potentially life-threatening malfunctioning device to be expedited to transplant.

Region 8 | 09/27/2022

Sentiment: 4 strongly support, 11 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose

International Society for Heart and Lung Transplantation | 09/27/2022

Please see attachment for comment from AHFTX IDN.

Attachment

Region 7 | 09/27/2022

Sentiment: 4 strongly support, 9 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose | This was not discussed during the meeting, but OPTN representatives were able to submit comments with their sentiment. One member noted that these patients must be prioritized. Additionally, this places patient safety first and will alert the community when a device recall happens. Which will allow a program to ensure the best outcome for patients by allowing exceptions to statuses. This is the right thing to do to take care of patients.

American Society of Transplantation | 09/27/2022

The American Society of Transplantation provides the following comments for consideration in response to the questions posed in the proposal: Should the approved emergency policy changes be considered for permanent policy by the OPTN Board of Directors? Yes, a permanent policy would support a transplant program’s ability to protect the safety of its patients. What, if any, data analyses, peer-reviewed literature, or evidence-based medical judgments, provide evidence demonstrating that a patient with FDA-recalled heart device should be assigned to adult heart status 2 or adult heart status 3 by policy criteria, rather than a candidate’s transplant physician determining whether assignment to status 1, 2, or 3 by exception is appropriate? Currently, there is a lack of available evidence (i.e., waiting list mortality analysis) to support adult heart status 2 or 3 for patients listed under FDA-recalled heart device support. Therefore, prioritizing listing status should be maintained by appropriate, device recall-specific exception. Is 14 days the appropriate amount of time for an extension of the assignment by exception? Why or why not? Those patients carry high risk of serious pump malfunction, severe injury, or death; therefore, 14 days is an appropriate time for initial assignment and extension for a device recall-specific exception. In addition to the Member Compliance and Policy Evaluation actions identified in the proposal, what other actions can be taken to ensure the new exception pathway is only used for appropriate purposes as intended by the Heart Committee? Initial requests, as well as any subsequent extensions, should be reviewed by adult heart regional review boards for approval. Are there any types of implanted devices that could be subject to a FDA device recall that should not qualify under the policy modifications? Describe why. Any FDA-approved implanted LVAD device subject to an FDA device recall should be included. Are the proposed data element and the associated data definition clear and understandable? Yes Are the acceptable forms of documentation regarding the recall of the device identified in the proposal widely available? Yes

Attachment

Region 11 | 09/26/2022

Sentiment: 4 strongly support, 10 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose

American Society of Transplant Surgeons | 09/26/2022

The American Society of Transplant Surgeons (ASTS) is pleased to provide the following feedback on modifying heart policies to address patient safety following a device recall. Should the approved emergency policy changes be considered for permanent policy by the OPTN Board of Directors? No, the policy should not be permanent. The recall should not automatically enable an MCS recipient with functioning pumps, without any issues, circumvent the current policies that would facilitate a status 3 or status 2 listing that are currently in place. What, if any, data analyses, peer-reviewed literature, or evidence-based medical judgments, provide evidence demonstrating that a patient with FDA-recalled heart device should be assigned to adult heart status 2 or adult heart status 3 by policy criteria, rather than a candidate’s transplant physician determining whether assignment to status 1, 2, or 3 by exception is appropriate? To our knowledge, there is no evidence that a patient with an FDA-recalled heart device should be assigned to adult heart status 2 or heart status 3; it appears to be a fear of patient risk. It is difficult to justify a status 1 exemption with a pump that has demonstrated no errors/malfunctions. This “risk” of pump stoppage is there with all MCS in principle. Is 14 days the appropriate amount of time for a candidate impacted by an FDA-recalled device to be initially assigned to status 1, 2, or 3 under the approved policy? Why or why not? Is 14 days the appropriate amount of time for an extension of the assignment by exception? Why or why not? The counterargument is that the morbidity of an exchange would outweigh the risk of transplant. A better use of extending an exception time should be reserved to those candidates who have had pump alarms or malfunctions. In addition to the Member Compliance and Policy Evaluation actions identified in the proposal, what other actions can be taken to ensure the new exception pathway is only used for appropriate purposes as intended by the Heart Committee? This appears to be a small number of the overall heart cohort and regional review or MPSC review would seem appropriate on all cases. Are there any types of implanted devices that could be subject to an FDA device recall that should not qualify under the policy modifications? Describe why. This question depends on the specific recall, the scope of the remedy (if any) and the risk of a poor outcome if an adverse event occurs. Are there any types of devices that are not implanted that should be permitted to qualify under the policy modifications? Describe why. No, temporary non-durable support should not be included as they are intended to be short-term and disposable. If a center is using a short-term device off label for longer than the prescribed policy, then they should proceed to durable MCS or other medical measures. Those policies are in place and appropriate. Are the proposed data element and the associated data definition clear and understandable? Yes. Are the acceptable forms of documentation regarding the recall of the device identified in the proposal widely available? Yes.

Attachment

Region 1 | 09/21/2022

Sentiment: 1 strongly support, 3 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose

Region 3 | 09/20/2022

Sentiment: 2 strongly support, 12 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose

Region 2 | 09/13/2022

Sentiment: 8 strongly support, 10 support, 6 neutral/abstain, 0 oppose, 0 strongly oppose This was not discussed during the meeting, but OPTN representatives were able to submit comments with their sentiment. It was noted that patients affected by the recall should be at least status three without requiring exception letter, or consider status 2 depending on wait time.

Region 9 | 09/12/2022

Sentiment: 3 strongly support, 5 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose

Region 5 | 09/08/2022

Sentiment: 10 strongly support, 14 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose

Region 4 | 08/26/2022

Sentiment: 4 strongly support, 12 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose | Comments: One commenter supported notifying patients of the change in policy.

Anonymous | 08/11/2022

This is an excellent modification and provides appropriate expedited transplant pathways to patients who have a potentially malfunctioning device.