UF Health Shands Transplant Center testing new device for rehabilitating donated lungs

The UF Health Shands Transplant Center is testing a new approach that could improve the viability of many donated lungs, allowing more of them to be used and shortening the time patients have to wait for transplantation. The center is one of 15 nationwide participating in a study to continue evaluating the XVIVO Lung Perfusion System. This system allows donor lungs — about 80 percent of which are found unacceptable for transplant under the very high standards required for the organs — to essentially be kept alive and potentially improved to become eligible for transplant. Some of the lungs may have potentially reversible problems, such as pulmonary edema or impaired gas exchange, which, if addressed, make them excellent candidates for successful transplantation.

The machine, called XPS, which the Food and Drug Administration approved under the humanitarian device exemption in 2014, pumps a special preservation solution and oxygen into the lungs to maintain and possibly improve their health outside the body. The lungs actually contract and expand inside the XPS for hours, allowing transplant surgeons to assess them over time. The FDA’s approval of the device last year came with a requirement that the manufacturer continue studies involving the devices to collect additional information on their use.

“The function of most of these lungs can now be improved by use of the XVIVO Lung Perfusion technique now licensed by UF Health,” said Tiago Noguchi Machuca, M.D., Ph.D., a UF Health lung transplant surgeon who leads UF Health’s lung perfusion program. “This technique will help to expand the pool of acceptable donor lungs, hopefully shortening the waiting period for donor lungs and, more importantly, preventing deaths of those whose health condition cannot afford the wait time.”

Thomas Beaver, M.D., M.P.H., established UF Health’s work in lung perfusion with a research program that began several years ago.

“We have been working since 2010 in the laboratory with our own system and have been looking forward to finally seeing the clinical application of the FDA-approved system in the United States,” Beaver said. “We are excited to be one of the few centers that will be utilizing this technology with Dr. Machuca, who used it extensively both clinically and in research while training at the leading institution for XVIVO. And, we are in a better position than most because we will be rehabilitating our own lungs on site rather than having to fly them to a perfusion center. This is a major advance in the field of lung transplantation.”

Machuca now leads the clinical lung perfusion program after recently completing a thoracic surgery fellowship at the University of Toronto, where out-of-body lung perfusion technology was pioneered. He has published several scholarly articles on transplantation of organs outside of the body, including in the Journal of Heart and Lung Transplantation and the American Journal of Respiratory and Critical Care Medicine.

Physicians at UF Health have been seeking new options to increase the availability of acceptable donor organs. Traditionally, lungs considered for transplant are evaluated once by a surgeon at the medical center offering the lungs, while the organs remain inside the donor. Such assessments may not provide all the information the transplanting surgeon may desire, and conclusions about the organs’ viability can be difficult to reach.

Absent convincing proof of excellent lung health, the organs are sometimes rejected because doubt remains about their condition. With the XVIVO Lung Perfusion system, lungs that fail initial screenings may be improved enough for transplantation. UF Health lung transplant surgeons will bring lungs identified for perfusion back to Gainesville and attach them to the XVIVO machine, XPS, which keeps them “alive” and functioning under normal body temperature. Studies have shown that lungs treated in the XVIVO system and rated acceptable for transplant through numerous careful assessments are safe for transplant.

“With today’s increased awareness of lung transplantation as a therapeutic alternative for many end-stage lung diseases, waiting lists are growing quicker than our ability to offer a transplant with our current donor selection criteria and practice,” said Juan Salgado, M.D., medical director for the UF Health Lung Transplant Program and an assistant professor in the UF department of medicine’s division of pulmonary, critical care and sleep medicine.

UF Health transplant providers will be certified to begin using the new XVIVO technology in late April after a training process of several weeks. Once that occurs, the lung transplant team will be ready to help extend the lives of more patients.

“Dr. Machuca’s expertise will allow us to consider an expanded pool of donor lungs to be able to increase our patients’ chances of receiving new lungs,” said Salgado.