Lung Preservation System Safe for Donor Lungs

Doctors at Baylor College of Medicine have confirmed that the use of the portable Organ Care System (OCS), or "breathing lung" technology, boosts long-term survival for transplant patients. This discovery offers new hope for people currently awaiting lung transplantation.

This cutting-edge technology significantly expands the pool of donors whose lungs can be effectively used for transplant. The new findings show that the long-term results for lungs from "Extended Criteria" donors, or donors who are not typically accepted for lung transplantation, are as good as standard donors thanks to the breathing-lung technology. This comes in addition to prior findings that the breathing lung improves short-term outcomes for extended criteria transplants to the level of standard transplants.

The five-year, follow-up study, published in the current edition of The Lancet, followed participants from the international EXPAND Lung Trial, the first prospective, multicenter clinical registry of its kind to evaluate donor lungs considered to be increased risk because of donor features that are outside of standard acceptance criteria. These lungs come from donors who are older individuals, those with lower oxygenation, and donations after circulatory death. In addition, extended criteria donor lungs include those that require a longer than usual period of time outside the body due to long travel time or logistical issues. Standard practice limits lungs to 6-8 hours outside the body.

Extended criteria donor lungs often are underutilized due to concerns about post-transplant outcomes. Lungs considered extended criteria donor lungs are normally declined 33 times more than what is considered a standard organ donor.

The OCS Lung is a portable perfusion system that keeps the organ functioning outside the body until time of transplant, which preserves the organ. The standard way of preserving lungs for transplant is cold preservation.

"Donor lungs once seen as marginal can be safely used with this technology - expanding the donor pool without compromising outcomes," said Dr. Gabriel Loor, associate professor of surgery at Baylor and surgical director of the lung transplant program at Baylor St. Luke's Medical Center. "The device allows donor lungs to have blood and oxygen continuously pumped through them during transport. This also extends travel time if needed. Our findings underscore the system's role in rescuing otherwise unused organs."

With the OCS system, the five-year survival among recipients is 68%, with 60% surviving without severe chronic lung rejection. These results compare favorably to the expected national average for standard lung transplantation in the US.

"Our work not only supports the technology's safety but also opens the door for broader, more equitable access to transplant. We can say yes to more donors and save more lives," Loor said.

He adds that there are other similar devices being tested at other institutions; however, the OCS Lung is one of only two FDA-approved devices of its kind in the United States, and the only portable platform currently in widespread use in the U.S.

"While other studies have looked at similar devices in retrospective or in single-center settings, this is the first large-scale, long-term, international evaluation focused on extended criteria donors," he said.

Researchers anticipate wider adoption of portable "breathing lung" devices as new-generation devices are developed and cost-effectiveness improves.

"With Baylor now leading Texas in lung transplant volume and ranking among the top three centers nationally, we're proud to be part of shaping the future of transplant care," Loor said.

Others who contributed to the study include Gregor Warnecke, Mauricio A. Villavicencio, Michael A. Smith, Xiang Zhou, Jasleen Kukreja, Abbas Ardehali, Matthew G. Hartwig, Mani Ali Daneshmand, Marshall I Hertz, Stephen J Huddleston, Axel Haverich, Joren C. Madsen, Arne Neyrinck, Dirk Van Raemdonck. For a list of affiliations please see the publication.

Funding for this study was provided by TransMedics, Inc. For a list of disclosures associated with this study and funding, please see the publication.

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