At a glance Current policy Primary Graft Dysfunction (PGD) is the leading cause of patient death in the first 30 days after a heart transplant. Currently, the Organ Procurement and Transplantation Network (OPTN) does not collect some of the information that could help identify patients who are more likely to develop PGD. Supporting media Presentation View presentation Proposed changes Collect post transplant graft data Monitor outcomes for patients who receive a heart transplant Allow program-level comparisons of PGD incidences Anticipated impact What it's expected to do Collect post-transplant data to help identify PGD Monitor how often PGD occurs in patients who receive a heart transplant Help the Committee monitor outcomes for patients with PGD Provide data to guide future policy development What it won't do The proposal does not change heart policy or allocation Themes Data elements Timing of data collection Inotrope and vasotrope reporting 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 Provide feedback Comments Region 1 | 09/24/2021 Region 1 sentiment: 2 Strongly Support, 2 Support, 4 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose. Comments: Overall, the region supports the proposal. There were no additional comments made. Region 6 | 09/23/2021 Region 6 sentiment: 4 Strongly Support; 15 Support; 3 Neutral/Abstain; 1 Oppose; 0 Strongly Oppose. Comments: An attended recommended the Heart Committee ask the Pediatric Committee for additional input. Region 8 | 09/22/2021 Region 8 sentiment: 4 strongly support, 15 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose. Comments: Region 8 supports this proposal. A member supported the proposal and suggested to also look at donor data, ischemic time, and distance travelled. A member stated that the need for this information is understandable but the impact on programs to collect this data should not be underestimated. He stated that there will be a significant increase in the time required to complete this form. Region 7 | 09/15/2021 Region 7 sentiment: 5 strongly support, 6 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose. Comments: During the meeting, there was discussion regarding pediatric candidates, DCD related data, and the definition and utilization of surgical complications data. An attendee suggested replacing, "Flolan following transplant" with the generic term "inhaled prostacyclin following transplant.” One attendee suggested making recommendations for the dose of pressors/inotropes along with hemodynamics carefully to define primary graft dysfunction however would not clearly make it’s a requirement, in the end, it should be the treating physician/surgeon to define graft failure. The attendee also expressed concern that vasoplegic patients who may get ECMO despite normal heart function could get mixed into "primary graft dysfunction" definition. Another attendee suggested that the Committee provide specific examples of “surgical complications” within the definition for PGD to provide direction and more standardization for these exceptions. Region 9 | 09/14/2021 Region 9 sentiment: 1 Strongly Support; 5 Support; 5 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose. Comments: Overall Region 9 is supportive of this proposal. There were comments regarding the ranges of epinephrine, including that the three ranges were not granular enough and that the upper range was too high. OPTN Transplant Coordinators Committee (TCC) | 09/14/2021 The Transplant Coordinators Committee (TCC) appreciates the work of the Heart Transplantation Committee in developing this proposal and for the opportunity to comment on it. Members voiced support for the proposed data elements and believed the requirements at 24 and 72 hours after patient arrival were reasonable because the care team would likely conduct those tests anyway. There is concern about the burden the forms would place on large transplant centers if taking 30 – 60 minutes to complete and suggested sending an automated email that reminds coordinators to check for those fields in real time throughout the day. This could cause undue burden when coupled with the increased workload from COVID-19, but with a yearlong implementation timeline this burden will likely decrease by the time of implementation. There was also a suggestion to provide additional details to explain why this data is not available for pediatric candidates. Overall, the TCC is supportive of the Heart Committee’s proposal and is appreciative of the opportunity to provide the transplant coordinator perspective. Maryl Johnson | 09/12/2021 I am strongly supportive of increasing the collection of data elements to better define the incidence, predictors, and outcomes of PGD. However, I would suggest that information regarding whether or not the donor was DCD, and, if so, whether the method was ex vivo perfusion or normothemic regional perfusion, should be collected. It is true that the ex vivo study has been completed, however, as stated by Dr. Jason Smith during the Region 7 meeting, FDA approval for the use of the ex vivo device is in process and many centers are proceeding with DCD heart donors using normothermic regional perfusion (recent case series from the Vanderbilt group has been published on line in JHLT). As adding data elements to collect always takes some time it would seem appropriate to start collecting DCD information now so we don't miss the opportunity to have information available in this rapidly developing field. Region 3 | 09/10/2021 Region 3 sentiment: 3 strongly support, 9 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose. Region 3 supported this proposal. One attendee believes the dosing scheme is appropriate; and the proposal will not overburden coordinators. Another attendee expressed concern the dosing for vasopressin does not include per Kg, which may be problematic for pediatrics. A third attendee commented dosing per IU vs mg of vasopressin needs to be considered. Region 2 | 09/10/2021 • Region 2 sentiment: 10 Strongly Support, 10 Support, 6 Neutral/Abstain, 1 Oppose, 0 Strongly Oppose • Comments: Overall, the proposal was supported by members in the region; however, members in the region raised concern over the added data burden being proposed. The proposal states that each form will require an extra 30-60 minutes worth of data collection and entry, which is a significant amount of work for transplant coordinators. Another member noted that it would be very helpful for transplant program staff if there was a way to track Primary Graft Dysfunction using fewer data points. Region 5 | 08/30/2021 Region 5 sentiment: 8 strongly support, 12 support, 4 neutral/abstain, 2 oppose, 0 strongly oppose. Region 5 supports the proposal for Reporting Primary Graft Dysfunction but points out the need for clarification on data collection and potential burden of the data collection. There were two oppositions for this proposal. A member suggested that the committee figure out what are the acceptable modalities and what values you are looking for. Regarding cardiac output, the member suggested to look at the desired methods. A member asked whether the 24-72 hours data was needed Several members cautioned on the committee on the large amount of data collection the proposal requires. Another member thought the data elements and type were reasonable. Another member stated they support this concept but oppose it in its current state due to the data burden and lack of specificity regarding the data points. Another member wants to see more clarity on the data collection end points and asked the committee to streamline the data collection measures to lessen the burden on transplant programs A member wants clarification of variable definition prior to implementation. Region 4 | 08/27/2021 3 strongly support, 10 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose. Region 4 supported this proposal and had the following comments. One attendee commented that primary graft dysfunction remains highly important for every center. They went on to comment that reporting inotropes that are used is variable between centers, and even within centers from cardiologist to cardiologist and surgeon to surgeon. They were also concerned that data could affect individual practice or center practices. The attendee recommended collecting data on whether the patient has primary graft dysfunction: yes or no. They went on to add that collecting hemodynamic data may add to the paperwork and data entry burden of each center, but supported acknowledging the presence of primary graft dysfunction and which device has been used to support. Another attendee commented that the lung TRR forms ask for specific information at 72 hours, adding that as long as the descriptions are as clear as possible, it will not be a big burden for the transplant centers. One attendee commented that this will require clear definitions and timeframes to ensure consistent, meaningful data. Finally, one attendee commented that more data entry is always a problem and was in favor or eliminating data submission when possible. Jondavid Menteer | 08/18/2021 I strongly support the proposal. There are a couple of details of the data collection that I think could be improved before this is fully approved. 1) primary graft dysfunction Yes/no should be changed to "Is primary graft dysfunction present?" yes/no. This would help in cases where PGD was present but resolved by day 3. This way, if resolved at day 3, the form would say yes at day 1 and no at day 3, reflecting this milder form of PGD. 2) After the data element primary graft dysfunction is selected, I would propose that a "yes" response causes the appearance of two more questions; LV dysfunction and RV dysfunction. If the response is PGD:no, I think these questions should not appear. 3) For clarification, the LV dysfunction and RV dysfunction should be changed to "PGD: left ventricular dysfunction" and "PGD: right ventricular dysfunction" 4) I agree that LV EF should be left for collection on all transplants. I would propose noting on the 24 hours form, that EF from any modality can be reported since transplant (e.g from the postop TEE); and that at 72 hours, EF from any modality performed AFTER 24 hours can be reported (e.g. not from the same study as on the first day, but anything since then). I feel strongly that the EF does not need to be from within the +/- 4 hour window, as this will severely diminish the number of data points we receive in the database. 5) For the elements nitric oxide following transplant. The element on the 24 hour form should read "inhaled nitric oxide after transplant (any time 1st 24 hours)" and on the 72 hour form it should read "inhaled nitric oxide after transplant, still in use". This will help clarify the data and also provide greater utility by specifying whether this was a brief therapy or needed for longer. 6) Same for Flolan, but importantly it should be labeled "epoprostenol", not brand Flolan. The element on the 24 hour form should read "epoprostenol after transplant (any time 1st 24 hours)" and on the 72 hour form it should read "epoprostenol after transplant, still in use". 7) for inotrope dosing, epinephrine dose should read "0.1" not "1.0" in the moderate and high doses. 8) Vasopressin should be in Units per min 9) For vasopressors consider allowing equivalent completion of the doses by allowing mcg/hour and per minute. It seems this should be simple programming. Thank you for doing this critical work to collect this data! Anonymous | 08/17/2021 As a heart transplant recipient, I believe this change will help care be more consistent with recipients experiencing PGD and possibility the information learned from the additional testing help predict this complication's occurring. I believe an informed patient - with both the good and the bad risks is important in having confidence in the team and decisions made in the care. Anonymous | 08/13/2021 The fact that there is not a standard definition for primary graft dysfunction is concerning - it seems that this is a wide swath attempt to have heart transplant centers collect data for someone to do a research study. I have concerns that if the initial answer is no to primary graft dysfunction, the center is required to complete the rest of the data. Of particular concern from a cost standpoint is the EF required at 24 and 72 hours. The addition of 2 echo measurements, of which the patient might not need, is concerning. It places a burden on the staff assessing EF, and for those patients with a global payment rate who don't need the test, will cause the center to have to absorb those costs. This is a significant amount of data that will not take a small amount of time to collect and enter. I don't disagree with the concept, but I think the reality needs more work. Bryan Barrus | 08/12/2021 This data collection has been missing for years and will be very helpful especially as we move toward increasing DCD donors in the country. The time frames for reporting at 24 and 72 hours seem appropriate. The epinephrine range limits seem a little high at >1 mcg/kg/min. If the goal is to detect at what doses of inotropes/vasopressors there is a risk of PGD, lowering the limits to something like 0.5 mcg/kg/min might improve the sensitivity of the analysis. Please make more clear if the committee looking for the max dose of drugs in the first 24 hours or just the dose at the 24 hour time mark post-transplant. Robert Goodman | 08/04/2021 I agree with the recommendations of the committee as presented in the report.