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

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.

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 Analysis1,2

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 cohort1,2
  • 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 transplant1,2
  • 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 outcomes1,2
Clinical Results1,2

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

1100+ Enrolled Patients

17 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 registry1,2

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

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 interventions2

$28,597
in average saving per patient (P=0.024)
Cost Differences_1024

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

*Numerical trend, does not achieve statistically significance, p=0.10

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