The Journal of Heart and Lung Transplantation has published the world’s first multi-center report demonstrating a digitally connected preservation system utilizing controlled hypothermic storage that increases transparency of preservation conditions to extend the interval between organ procurement and implantation beyond fifteen hours.
WALTHAM, MA. March 12, 2024 - Paragonix Technologies, Inc., a pioneer in organ transplant products and services, announces the landmark publication of the first clinical manuscript assessing the use of FDA-cleared advanced organ preservation technology to significantly extend ischemic times, a term referring to the sensitive window of time between organ recovery and transplantation. Prolonged periods of uncontrolled preservation can risk detrimental effects on the viability of the tissue or organ; however, safely extending ischemic times beyond fifteen hours can facilitate potential new avenues that surgeons can harness to significantly enhance access to life-saving transplants for patients. This milestone publication lays a strong foundation for future clinical applications in organ preservation and transplantation. For example, presenting a means to better accommodate longer transportation times, overnight bridging, or optimize case scheduling during the day.
The retrospective analysis was conducted by three internationally recognized lung transplantation centers, including UZ Leuven Hospital (Belgium), Motol University Hospital (Czech Republic), and Massachusetts General Hospital (United States). During the six-month study period, the LUNGguard® Donor Lung Preservation System was utilized to preserve donor lungs for over 15 hours in 13 separate instances. The standard of care for preserving donor lungs typically utilizes a conventional cooler of ice, with an ischemic time over 6 hours often considered a higher risk factor for transplant outcomes Longer ischemic times increase the risk of primary graft dysfunction, a serious complication that can occur after lung transplantation. Given the historically acknowledged risks associated with prolonged ischemic times on uncontrolled ice storage, the clinical investigators analyzed the outcomes of the qualified 13 patients to examine the impact of utilizing controlled hypothermic storage.
Despite the prolonged preservation times and complex case dynamics including high-risk recipients and extended criteria donors, the study reported 0% instance of PGD-3 at 72 hours. The use of the controlled hypothermic device allowed the teams to remotely monitor the preservation temperature throughout the entire period, reporting an average probe temperature of 7°C across all 13 donor lungs. The device’s proprietary cooling technology and data reporting capabilities allowed full transparency into critical case insights, ensuring a reliable and consistent thermal environment within clinically recommended and FDA-cleared parameters.
“The use of controlled hypothermic storage in scenarios that extend beyond fifteen hours has demonstrated significant promise with favorable short-term outcomes,” said Professor Laurens Ceulemans, Assistant Professor of Surgery and Deputy Head of Clinic in the Department of Thoracic Surgery at UZ Leuven. “Through the provision of optimal preservation conditions, we can effectively extend ischemic time, thereby unlocking new possibilities and potentially reaching a broader spectrum of patients.”
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Reference
1. Ceulemans, L. et al. Extended ischemic time (>15 hours) using controlled hypothermic storage in lung transplantation: A multicenter experience. Journal of Heart and Lung Transplantation, (2024)