GUARDIAN-Lung Registry

Enrolled Patients
Transplant Centers
Clinical Reports

Clinical Results

Paragonix LUNGguard
PGD PGD 3 at 24 hours 20.5% 12.7% 0.024
  PGD 3 at 72 hours 15.4% 9.7% 0.063
Post-Transplant MCS ECMO Post-Transplant 18.9% 11.6% 0.027
Renal Function Dialysis at Discharge 11.2% 5.5% 0.025
  Renal Dysfunction at Discharge 30.6% 18.0% <0.001

Latest Results from the GUARDIAN-Lung Registry

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

[.c-text-4]J. Haney, M. Hartwig, N. Langer, P. Sanchez, P. Carrott, H. Huang, L. Ceulemans, J. Kukreja, E. Bush[.c-text-4]
[.c-text-4] ISHLT 2024 Presentation[.c-text-4]

The results of an extensive clinical study presented at the 44th 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 favorably influences post-transplant outcomes, including reductions in primary graft dysfunction, the use of invasive MCS interventions, and improvement in renal function.

The GUARDIAN-Lung data was collected from August 2018 through January 2024, including 797 patients (389 ice storage patients, 408 LUNGguard patients), of which 259 subjects were identified as statistical matches based on a propensity matching methodology.

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

•  38% reduction of Primary Graft Dysfunction 3 (PGD 3) at 24 hours (12.7% LUNGguard vs. 20.5% Ice, p = 0.024)1
•  39% reduction of Extracorporeal Membrane Oxygenation (ECMO) post-transplant (11.6% LUNGguard vs. 18.9% Ice, p = 0.027)1
•  51% reduction in need for dialysis at discharge (5.5% LUNGguard vs. 11.2% Ice, p = 0.025)1

Further, a numerical reduction in primary graft dysfunction at 72 hours, an indication of severe post-transplant complications, was also observed in the LUNGguard group (9.7% LUNGguard vs. 15.4% Ice, p = 0.063).1

[.c-text-4]1) Haney et al., ISHLT Presentation 2024, Data on file[.c-text-4]

Comparison of Paragonix LUNGguard to Ice Storage, Paragonix data on file. GUARDIAN is a registered clinical study (NCT04930289) 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.

PGD 3 at 24 hours
p value = 0.024
PGD 3 at 72 hours
p value = 0.063 (trending)
p value = 0.027
Dialysis at discharge
p value = 0.025
Renal dysfunction at discharge
p value = <0.001
Study Synopsis
Study Product
Study Objective​
Study Design​​
Study Center​​
Treatment Plan
Inclusion Criteria
Exclusion Criteria
Follow-Up Period​
Study Duration​
Outcome Measures​​​
Safety Measures​​
No items found.
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