Transplant Center FAQ
If you are a lung transplant program interested in participating in our trial program, please read over the following list of frequently asked questions. We hope that these will explain the process and provide a jumping off point for you to get involved.
Q: Who is available from the study to assist us with questions as they come up for the protocol?
In general, study centers should first consult with Lung Bioengineering when questions about the protocol arise. The Lung Bioengineering medical directors will be available to consult with study center physicians/surgeons about suitability criteria for lungs undergoing EVLP or post-EVLP suitability for transplantation. Lung Bioengineering staff will be available to provide information on issues related to inclusion/exclusion criteria and EVLP-related procedures. When necessary, Lung Bioengineering may ask study centers to work with its clinical study manager, CTI, for questions related to data collection and/or analysis and adverse events.
Q: How long can Total Preservation Time (TPT) be per stage?
CIT-1, from donor aortic cross clamp to the start of the EVLP process at LB-1 is required to be 10 hours or less.
EVLP time, from initiation to completion of EVLP procedure is required to be between 3 and 6 hours.
CIT-2, from completion of EVLP to the removal of the first lung from cold storage must be less than or equal to 6 hours. For sequential bilateral procedure, CIT-2 for the second lung from cold storage must be less than or equal to 10 hours
Q: What is the start time of the EVLP process?
EVLP begins once the lung is connected to the perfusion circuit. The EVLP procedure runs for a minimum of 3 hours up to a maximum of 6 hours.
Q: Will the study centers receive an alert when a lung is sent for EVLP?
Because the study centers request the EVLP procedure to be performed, it is not necessary to “alert” a center when a lung is sent for EVLP. However, the involved transplant program will receive electronic alerts when a lung arrives at LB-1. At the conclusion of the EVLP procedure, the study center must indicate the disposition of the lung (accept or decline for transplant) in the client portal.
Q: Is there any protocol that needs to be followed for procuring the lungs for this study?
There are no changes to the way that the lungs are procured. However, we do have a “Lung Retrieval and Preservation for EVLP” protocol that has recommendations for best practices for lung retrieval specifically for EVLP. It is recommended to review this protocol and to share it with your colleagues who perform the lung retrieval. Technique of Lung Retrieval and Preservation for EVLP
Q: Who is responsible for transportation arrangements to and from LB-1?
The air and/or ground transportation cost involved with the import of lungs to LB-1 from the donor location are paid for by LBE regardless of EVLP outcome to transplant. Air and/or ground transportation cost for exporting lungs to an accepting clinical trial site are also paid by LBE. Transportation cost reimbursement requires that LBE is aware of the method of transportation in advance of any lung import/export activity, and the cost to be paid by LBE must be reasonable. An EVLP Specialist will be in contact with the appropriate trial site personnel to ensure that lungs are imported and exported as quickly as possible.
Q: Can single lungs be perfused on your system?
Yes. Single lungs can be perfused on the Toronto EVLP system.
Q: Is ECMO an exclusion criteria?
If the potential recipient is on ECMO at the time of referral, they are excluded from participation in the study and control groups. The decision to place the recipient on ECMO or other ECLS for post-transplant prophylaxis at time of or immediately prior to transplant is not considered an exclusion.
Q: If a patient previously had a right single transplant and then needs a transplant on the left, are they eligible for the study?
Yes, they are eligible for the study because it is NOT a same side re-transplant.
Q: What is the definition of PGD for double lungs and single lungs?
PGD is a primary safety endpoint for the Lung Bioengineering study. As specified in the protocol, PGD is defined using the 2005 ISHLT guidelines in the following manner:
PGD will be defined in a similar manner for patients undergoing single and double lung transplantation, however, because of the difficulty in applying the current PGD standard in the single lung transplantation population, these patients will be evaluated as a separate study arm and outcomes compared to control group.
Q: What type of training do the Specialists have?
The EVLP specialists have completed a competency-based EVLP-specific training program developed by Lung Bioengineering and conducted for 6 months at Toronto General Hospital. This extensive didactic curriculum included lung transplantation, lung allograft donation and procurement, U.S. procurement/transplant legislative framework, lung anatomy and physiology, perfusion concepts, ventilation strategies, and the Toronto EVLP system.
The EVLP specific training included bronchoscopy, performing and interpreting EVLP x-rays, cardiac pump operation, blood gas analysis, and ventilator management. In addition to being on call for all clinical cases at Toronto General Hospital, they assisted in procurements in the U.S., participated in animal procurements and EVLP procedures for thoracic surgery fellows, completed an independent pig lung procurement and EVLP project in the lab, conducted an EVLP research project, and completed a three part evaluation/assessment of clinical skills and EVLP competency. Each specialist has been certified for three years in Ex Vivo Lung Perfusion by the University Health Network. Specialists must undergo annual training to demonstrate competency.