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Develop Measures for Primary Graft Dysfunction in Hearts

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eye iconAt a glance

Current practice

Primary Graft Dysfunction (PGD) is the leading cause of death among heart transplant recipients within the first 30 days of transplant. The OPTN does not collect post-transplant information on recipients that could help identify those who are at risk for developing PGD.

Supporting media

Presentation

View presentation slides

Requested feedback

  • Heart Transplantation Committee suggests adding new data elements to the Transplant Recipient Registration (TRR) form to collect information that could inform PGD risk.
  • Committee is asking for community feedback about:
    • Data elements
      • Is the Committee suggesting the right elements?
      • Are there other elements that should be included?
      • Should information be collected on donors?
      • Should the focus be on both moderate and severe PGD?
    • Timing
      • How many hours after transplant should data collection occur?
    • Logistics
      • What challenges would programs have in collecting this data?
      • Is the TRR the best way to collect this data?
      • How can the Committee ensure consistency in this data collection across programs?
      • Are there differences between adult and pediatric PGD that should be considered?

Anticipated impact

  • What it's expected to do
    • Inform a future Heart Transplantation Committee data collection proposal
  • What it won't do
    • Will not change policy at this time

Themes

  • Data elements
  • Timing of data collection
  • Transplant program considerations

Terms to know

  • Primary Graft Dysfunction (PGD): life-threatening complication when a heart transplant recipient develops left, right, or biventricular dysfunction within the first 24 hours of transplant and a secondary cause is unknown.
  • Transplant Recipient Registration (TRR): The form completed and submitted by the transplant center when a patient is transplanted. The form contains patient status, pre and post-transplant clinical measures, transplant procedure, graft status, treatment, and immunosuppression therapies.
  • Click here to search the OPTN glossary

eye iconComments

Region 4 | 02/04/2021

During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. Overall, there was general agreement and support for this proposal. One member commented that a review at their center found worse mortality and prolonged hospitalizations for those identified with PGD. This member recommended using inotropic score to define PGD- this is validated in the literature, as it may be more useful and easier to pull from EHR. She added that hemodynamic data collection was not used as much in their study because it was too onerous and inconsistently collected. The attendee also commented that it would be beneficial to capture first biopsy or some other marker for hyper acute rejection in order to learn from this data. Another member commented that data collection will be challenging for transplant programs, but will help differentiate PGD Left ventricle (PGD-LV) and PGD-Right Ventricle (PGD-RV) RVPGD. He added that cross match data needs to be factored in since programs make decisions early in the transplant process about how to address highly sensitized candidates’ needs. The attendee also commented that such pre-transplant decisions may eventually play into who has PGD and should probably be considered as well as post-transplant metrics. Another attendee commented that defining PGD at 24 will be more critical when looking at moderate to severe cases as clinical teams are comfortable dealing with mild PGD. The attendee added that use of inotropic score is problematic as use of inotropes is variable, even within centers. The attendee also commented that reporting the use of devices will be a more definite method in defining PGD. The member also supported collecting data on predictive heart mass between recipient and donor for matching. Several members were concerned with data burden, with one reminding meeting attendees that the information the community would like to collect needs to be balanced against the requirements/challenges programs would face with performing the collection and reporting. One member suggested pulling data directly from the EMR to reduce data burden. One attendee commented that they were concerned about how the diagnosis is made and potentially used by centers to get organ offers. Finally, an attendee commented that the committee will need to ensure we have clear definitions that are documented.

Region 3 | 02/18/2021

During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. One member commented that data collection on DCD hearts could expand the donor pool. Another member commented that this is great and necessary work and believe the committee should look at moderate and severe PGD and stated that it is different in pediatrics and adults. They recommended the committee look at different ways to preserve it if supported by technology as well as looking at DCD vs traditional donors. They also suggest looking at data related to the donor including hemodynamic support, mode of death, CPR and duration, and time to retrieval. Several members commented that the data burden and cost to transplant centers needs to be considered. One of the members stated that it needs to be considered whether this data is for fair policy development or to answer a potential research question.

Region 5 | 02/19/2021

During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. Overall, there was general agreement and support for this proposal. One member agreed that collecting data from organ recovery is critical. In addition to the data elements mentioned, we should consider including time to standstill. Another member stated they are seeing this in addition to pre-donation warm ischemic time stating that it does make a difference and depends on the operator. The member did not know if this is something that can be measured stating that it is important to know what kind of pressure you have.