GUARDIAN-Lung Registry

Real-World Outcomes Using Controlled Moderate Hypothermia at 4-8°C for Lung Transplant: An Update from the GUARDIAN-Lung Registry

[.c-text-4]N. Langer, J. Kukreja, P. Carrott, L. Ceulemans, P. Sanchez, S. Forest, E. Bush, G. Schwartz, N. Shigemura, H. Huang, M. Hartwig[.c-text-4]
‍[.c-text-4]ISHLT 2025 Presentation[.c-text-4]

The results of an extensive clinical study presented at the 45th ISHLT Annual Meeting and Scientific Sessions comparing conventional ice storage to the Paragonix LUNGguard System. The analysis revealed that advanced lung preservation technology with the Paragonix LUNGguard System to preserve donor lungs demonstrated comparable early post-transplant outcomes but resulted in significant advantages in medium and long-term outcomes, including lower rates of acute rejection and fewer hospital readmissions.

The GUARDIAN-Lung data was collected from April 2017 through November 2024, including 1160 patients (548 ice storage patients, 612 LUNGguard System patients), of which 608 patients were identified as statistical matches based on a propensity matching methodology (304 ice storage patients, 304 LUNGguard System patients).

Investigators discovered notable statistically significant improvements in the controlled hypothermic preservation group, including:

•  21% reduction in Post-Trasnplant Pulmonary Vasodilators (p = 0.011)

•  26% reduction in Acute Kidney Injury Post-txp to Discharge (p = 0.047)

•  23% reduction in Hospital Readmissions Discharge to 3 months (p = 0.023)
   •  53% reduction in Hospital Readmission Due to Graft Dysfunction to 3 months (p = 0.005)

•  14% reduction in Hospital Readmissions Discharge within 1 year (p = 0.007)
  •  32% reduction in Hospital Readmission Due to Graft Dysfunction to 1 year (p = 0.008)

•  50% reduction in Acute rejection within 3 months
(p = 0.041)

•  56% reduction in Acute rejection within 6 months
(p = 0.008)

•  71%reduction in  Bronchoscopic Intervention at 6 months (p = 0.010)

[.c-text-4]1. Langer et al., ISHLT Presentation 2025, Data on file[.c-text-4]
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[.c-text-4]Comparison of Paragonix systems to Ice Storage, Paragonix data on file. GUARDIAN is a registered clinical study funded and administered by Paragonix Technologies. The data from the registry is descriptive, not statistically powered, and not pre-specified. The information should be interpreted accordingly.[.c-text-4]