Thoracic Organ Transplantation Committee Spring 2015 Proposal to Collect Ex Vivo Lung Perfusion (EVLP) Data for Transplant Recipients Thoracic Organ Transplantation Committee Spring 2015

Use of EVLP not reported to OPTN The Problem Use of EVLP not reported to OPTN Number of lungs perfused and transplanted unknown Ex Vivo Lung Perfusion – or EVLP for short - is an emerging technology that OPOs and transplant hospitals are starting to use to assess, condition, and sometimes transport lungs prior to transplant. EVLP use is not reported to the OPTN. Starting this spring, OPOs will answer a question on the updated Deceased Donor Registration forms regarding whether the lungs were accepted by a transplant hospital with the intent to perfuse them prior to transplant. However, there is no corresponding question on the Transplant Recipient Removal form that the transplant hospital completes, to report whether the lungs were actually perfused prior to transplant. Without this information, the OPTN cannot track the number of lungs perfused and transplanted. Without that information, the OPTN can’t determine whether perfusion is effective, whether it poses any safety risks, or whether it affects transplant outcomes.

Goals of the Proposal Data may help inform future policy and risk-adjustment Enable OPTN to monitor EVLP use for: Compliance with policies Patient/recipient safety Patient/recipient outcomes Require transplant programs to report EVLP use for transplanted lungs The goal of this proposal is to modify the Transplant Recipient Registration form so that transplant hospitals will be required to report whether a transplanted lung (or heart-lung) was perfused. The perfusion section of the form will also ask a few more detailed questions to determine what type of perfusion was used, and how long the lungs were perfused. In changing the forms to require this information, we believe we will capture enough information to allow the OPTN to monitor compliance with allocation policies, ensure patient safety, and track transplant recipient outcomes. We believe these data will help provide the Thoracic Committee with ample information for future policy development and risk-adjustment.

How the Proposal will Achieve its Goal Modeled after Kidney TRR Modify lung and heart/lung Transplant Recipient Registration Form (TRR) If lungs were perfused prior to transplant Where the lungs were perfused Who perfused the lungs Total perfusion time Total ischemia time (question modified) Transplant programs will report: The proposal will achieve its goal by modifying the lung and heart-lung TRRs to include a section of questions about EVLP. These questions were modeled after the current kidney TRR, which also includes a section of questions regarding perfusion. On the next slide I’ll show you a mock-up of our proposed questions, but generally the form will ask whether the lungs were perfused prior to transplant, and if so, who perfused the lungs, where the lungs were perfused, and total perfusion time. We believe this information will provide us with ample information to analyze EVLP from different perspectives. For example, we will be able to see whether perfusion at an OPO by an OPO results in different outcomes than perfusion during transport. We don’t think it’s necessary to drill down into more detail at this time. We’re wary of the data-entry burden and don’t think additional information is necessary to help the Committee achieve its goals. Total ischemia time is already on the lung and heart-lung TRR, but we are proposing a slight modification to the question’s description from “Total Organ Ischemia Time (include cold, warm and anastomotic time)” to “Total organ ischemia time from cross clamp to in situ reperfusion (include warm and cold time).” The Subcommittee believes the modified question more clearly communicates the information the transplant center should report.”

Proposed TRR Form Here is a screenshot of what the proposed form will look like if the transplant center answers “yes” to the “Were lungs perfused prior to transplant” question. If the transplant center were to answer “no” to that question, they would not be required to answer the additional questions related to perfusion. If the transplant program answers yes, they must report where the perfusion occurred (at the recovery site, at the OPO, at a transplant hospital – transplant site, at a transplant hospital – non-transplant site, or other). They’ll also have to report who performed the perfusion: the OPO, the transplant program, or other, and the total perfusion time. Finally, they’ll have to report how the organ arrived at the transplant center: whether the lungs arrived on ice or whether they arrived on a pump, and if they arrived on a pump, for each side, whether the lung stayed on the pump or was put on ice.

Supporting Evidence FDA approved use of one perfusion machine for Humanitarian Device Exemption Proliferation appears likely Provides transplant surgeon longer assessment time Improves “marginal” lungs prior to transplant Warm perfusion during transport Functional outcomes comparable to “conventional” lungs Benefits of EVLP use We believe now is the appropriate time to start collecting these data, because the FDA recently approved use of one form of EVLP under a humanitarian device exemption. Based on a lot of literature, EVLP appears likely to proliferate the market soon. Multiple studies and peer-reviewed articles tout the benefits of using EVLP to provide the transplant team with longer assessment time for lungs that were perhaps questionable when procured. Perfusion of so-called “marginal lungs” prior to transplant appears to achieve outcomes equal to recipients transplanted with “conventional lungs.” Some perfusion techniques permit the transplant team to perform “warm perfusion” on the lungs during transport prior to transplant. We believe that the questions we have proposed will be sufficient to permit the Thoracic Committee to discern the type of perfusion technique used for the lungs and observe patterns associated with each approach.

What Members Will Need to Do Report information on TRR for lung and heart-lung transplant recipients If the Board of Directors approves adding these questions to the form, they will also be required to go out for public comment through the Federal Register process. Therefore, the modified form will likely not be implemented for a while. However, when the new form is implemented, lung and heart-lung transplant programs will be required to answer the questions in the perfusion section of the TRR after the recipient is transplanted and removed from the Waitlist.

Questions? Joe Rogers, MD Committee Chair joseph.rogers@duke.edu Liz Robbins Callahan Committee Liaison liz.robbins@unos.org