GUARDIAN Clinical Donor Organ Registries
The objective of GUARDIAN is to collect and evaluate various clinical effectiveness parameters in patients with transplanted donor organs that were preserved and transported within the Paragonix SherpaPak® Transport Systems
GUARDIAN Clinical Donor Organ Registries
The objective of GUARDIAN is to collect and evaluate various clinical effectiveness parameters in patients with transplanted donor organs that were preserved and transported within the Paragonix SherpaPak® Transport Systems
The only and largest registries focused specifically on donor organ preservation
GUARDIAN-HEART
Registry Details
Established February 2020
19 Transplant Centers – 1300+ Patients
GUARDIAN-PEDIATRIC
Registry Details
Established June 2021
Enrolling Transplant Centers Now
GUARDIAN-LUNG
Registry Details
Established July 2021
Enrolling Transplant Centers Now
GUARDIAN-LIVER
Registry Details
Established October 2021
Enrolling Transplant Centers Now
GUARDIAN-HEART Clinical Summary
US Multi-Center Analysis Of The Global Utilization And Registry Database For Improved Heart Preservation (GUARDIAN) Registry: 1-year Transplant Survival Analysis1
M. Leacche, J. Philpott, S. Pham, Y. Shudo, M. Kawabori, J. Jacobs, S. Silvestry, J. Schroder, E. Molina, D. Meyer, D. D’Alessandro
KEY FINDINGS
1-year post transplant survival in matched cohorts (from 89% to 96%, p=0.03) is superior in the SherpaPak cohort
- This survival benefit is potentially due to reduced the incidence of severe PGD (from 12% vs 3%, p=0.005) and reduced need for mechanical circulatory support after transplant
- Advanced hypothermic preservation of the donor heart should be strongly considered as an important factor contributing to a center’s post transplant and 1-year outcomes
Clinical Results
Comparison of Paragonix SherpaPak to Ice Storage, Paragonix data on file. GUARDIAN is a registered clinical study (NCT04141605) funded and administered by Paragonix Technologies. At the time of this analysis, GUARDIAN contained data from 17 sites on 849 patients (384 ice transports and 465 Paragonix SherpaPak CTS transports). The data from the registry is descriptive, not statistically powered, and not pre-specified. The information should be interpreted accordingly. In this analysis, US adult cohorts were matched using statistical propensity matching to create cohorts of equal baseline characteristics (149 ice transports and 149 Paragonix SherpPak CTS transports) with a matching propensity score allowable difference of 0.025.
ICE | PARAGONIX SHERPAPAK | p-value | ||
|---|---|---|---|---|
SURVIVAL | 1-year Survival (%) | 88.7% | 96.4% | 0.03 |
PGD | PGD (%) | 18.1% | 11.4% | 0.10 |
PGD Severe (%) | 12.1% | 3.4% | 0.005 | |
POST - TRANSPLANT MCS | All Post-transplant MCS (%) | 26.2% | 16.1% | 0.03 |
Newly Placed IABP Post -transplant (%) | 10.2% | 3.4% | 0.02 | |
Newly Placed ECMO/VAD Post -transplant (%) | 13.4% | 5.4% | 0.02 |
1300+ Enrolled Patients
19 Transplant Centers Currently Enrolling
Multiple Published Clinical Reports
Advanced Preservation. Advanced Care.
Figures represent the percentage difference observed between transplant recipients of donor hearts preserved by Paragonix SherpaPak CTS and ice storage, as reported in the GUARDIAN registry
1-YEAR SURVIVAL
+8.7%
1-year Survival
P value = 0.03
PGD
-37%
PGD*
P value = 0.10
SEVERE PGD
-72%
Severe PGD
P value = 0.005
POST TRANSPLANT
MCS
-39%
All Post-Tx MCS
P value = 0.03
IABP
-66%
Newly Placed IABP
P value = 0.02
ECMO/VAD
-60%
Newly Placed ECMO/VAD
P value = 0.02
1. Leacche et al. 2022 ISHLT Presentation. Data on file.
2. Data on file
*Numerical trend, does not achieve statistically significance, p=0.10
