Guardian 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 1

  • 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
SherpaPak Cardiac Transport

Initial Clinical Results1

ICE

PARAGONIX SHERPAPAK

p-value

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 124 Paragonix SherpaPak® CTS transports).  The data from the registry is descriptive, not statistically powered, and not pre-specified. The information should be interpreted accordingly.

Total-Ischemic-Time

GUARDIAN REGISTRY CLINCAL RESULTS1

Patients With >3 Hours Total Ischemic Time

Cases utilizing the Paragonix Sherpapak CTS showed a significant decrease of proportion of patients discharged from the ICU in 2 weeks or more (p=0.048) and significantly increased the number of patients discharged in under a week (p=0.0002)

GUARDIAN REGISTRY CLINCAL RESULTS1

Ischemic Time Analysis

Data demonstrated that a controlled hypothermic transport system provides reliable preservation for cardiac allografts especially when longer ischemic times are required

KEY FINDINGS

  • Significantly longer ischemic time (31 minutes longer median) in Paragonix cohort

  • Significantly shorter ICU stay (3 days shorter median) in Paragonix cohort

Ischemic Time

ISO-1

ICU LOS

ISO-2

ABOUT THE GUARDIAN STUDY

400+ Enrolled Patients and Growing

8 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.1,2   These results are based on analysis of the first 223 patients (99 ice transports and 124 Paragonix SherpaPak CTS transports) enrolled in GUARDIAN across 5 transplant centers.

WAITLIST

-54%

Waitlist Days2

P value = 0.0095

TRANSPORT

+18%

Total Ischemic Time1

P value = 0.0003

TRANSPLANT

-41%

Cardioversion*1

P value = 0.062

POST TRANSPLANT

SEVERE PGD

-54%

Severe PGD**1

P value = 0.071

ICU STAY

-28%

ICU Days1

P value = 0.009

LVEF

+4%

LVEF (Heart Output)1

P value = 0.032

GUARDIAN REGISTRY CLINCAL RESULTS2

Post-Operative Cost Benefit Analysis

GUARDIAN registry data was analyzed to evaluate post-operative cost differences from improvements in clinical outcomes and their associated reductions in clinical interventions.  These results are based on analysis a statistically matched population of 171 US patients (72 ice transports and 99 Paragonix SherpaPak CTS transports) enrolled in GUARDIAN across 4 transplant centers. Cost data was analyzed from publicly available Medicare cost report data applied to the respective data sets.

$20,000
in average saving per patient (P=0.046)

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