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
13 Transplant Centers – 900+ Patients
GUARDIAN-HEART PEDIATRIC
Registry Details
Established June 2021
Enrolling Transplant Centers Now
GUARDIAN-LUNG
Registry Details
Established July 2021
Enrolling Transplant Centers Now
GUARDIAN-HEART Clinical Summary
First Report of the GUARDIAN Registry: An International Consortium Examining the Effect of Controlled Hypothermic Preservation in Heart Transplantation
D.D’Alessandro, J.Philpott, T. Boeve, S. Pham, A. Zuckermann.
KEY FINDINGS
Heart preservation utilizing the Paragonix SherpaPak CTS compares favorably to ice storage in this registry analysis
- Early clinical outcomes, including PGD rates and ICU length of stay are improved despite unfavorable donor and recipient characteristics
- Mid-term survival is maintained despite these important differences
- Additional patients and analysis are needed to understand the impact on survival of matched populations
Initial Clinical Results
ICE | PARAGONIX SHERPAPAK | p-value | ||
|---|---|---|---|---|
WAITLIST | Median Time on Waitlist (days) | 90 | 42 | 0.0095 |
TRANSPORT | Total Ischemic Time (min) | 176.5 | 208 | 0.0003 |
TRANSPLANT | Cardioversion (%) | 26.0% | 15.4% | 0.062 |
POST - TRANSPLANT | PGD Severe | 14.1% | 6.5% | 0.071 |
Post Tx ICU LOS (days) | 14.4 ± 22.1 | 10.4 ± 12.7 | 0.009 | |
LVEF at Discharge (%) | 61.9 ± 8.0 | 64.3 ± 8.2 | 0.032 |
GUARDIAN is a registered clinical study (https://clinicaltrials.gov/ct2/show/NCT04141605). At the time of this analysis, GUARDIAN contained data from 5 sites on 223 patients (99 ice transports and 123 Paragonix SherpaPak CTS transports). The data from the registry is descriptive, not statistically powered, and not pre-specified. The information should be interpreted accordingly.
900+ Enrolled Patients
13 Transplant Centers Currently Enrolling
First Results Report at 2021 ISHLT
Impact Multiple Stages of The Transplant Process
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
WAITLIST
-54%
Waitlist Days
P value = 0.0095
TRANSPORT
+18%
Total Ischemic Time
P value = 0.0003
TRANSPLANT
-41%
Cardioversion*
P value = 0.062
POST TRANSPLANT
SEVERE PGD
-54%
Severe PGD**
P value = 0.071
ICU STAY
-28%
ICU Days
P value = 0.009
LVEF
+4%
LVEF (Heart Output)
P value = 0.032
1. D’Alessandro et al., The Journal of Heart and Lung Transplantation 2021, Volume 40, Issue 4, Supplement , S127, April 01, 2021
2. Data on file
