GUARDIAN-Liver Registry

Largest Real-World Multi-Center Study Outcomes Reported with Controlled Moderate Hypothermic Preservation of Donor Livers

[.c-text-4]K. Dhanireddy, V. Subramanian[.c-text-4]
‍[.c-text-4]WTC 2025 Presentation[.c-text-4]

The results of an extensive clinical study presented at the 2025 World Transplant Congress comparing conventional ice storage to the Paragonix LIVERguard System in various use case scenarios revealed that advanced liver preservation technology with the Paragonix LIVERguard System to preserve donor livers demonstrated significant advantages in some post-transplant outcomes while taking on more risk such as longer recovery distances, longer cold ischemic times, and a higher portion of DCD livers.

The GUARDIAN-Liver data was collected from June 2021 through March 2025, including 898 patients (483 ice storage patients, 415 LIVERguard System patients).

As the complexity of liver transplantation evolves nationally, donor liver preservation with LIVERguard System demonstrated a reduction in the incidence of EAD and AKI, despite a higher risk population compared to ICE.

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

Propensity Matched:
    • 410 patients were identified as statistical matches based on a propensity matching methodology (205 ice storage patients, 205 LIVERguard System patients)
       • 51% reduction in EAD (p<0.001)

•  Static Preservation + Back-to-Base NMP:
    •  259 patients received a combination of static preservation and Back-to-Base NMP (45 ice storage+NMP patients, 214 LIVERguard System+NMP patients) 
        • 45% reduction in peak AST (p=0.019)
        • 85% reduction in peak ALT (p<0.001)
        • 32% reduction in EAD (p=0.045)