GUARDIAN-Heart Registry

Enrolled Patients
Participating Transplant Centers
Clinical Reports

Clinical Results

    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

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 interventions1

[.c-text-4]1) Voight et al., ASAIO Journal 2022[.c-text-4]

GUARDIAN-Heart 1-Year Clinical Summary

US Multi-Center Analysis Of The Global Utilization And Registry Database For Improved Heart Preservation (GUARDIAN) Registry: 1-year Transplant Survival Analysis

[.c-text-4]M. Leacche, J. Philpott, S. Pham, Y. Shudo, M. Kawabori, J. Jacobs, S. Silvestry, J. Schroder, E. Molina, D. Meyer, D. D’Alessandro[.c-text-4]

1-year post transplant survival in matched cohorts (from 89% to 96%, p=0.03) is superior in the SherpaPak cohort1,2This 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 transplant1,2Advanced 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

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.

1-year survival
p value = 0.03
All mechanical circulatory support
p value = 0.03
Post transplant
Primary graft dysfunction
p value = 0.10
Newly placed intra-aortic balloon pump
p value = 0.02
Post transplant
Severe primary graft dysfunction
p value = 0.005
Newly placed extracorporeal membrane oxygenation / ventricular assist device
p value = 0.02
Post transplant
Study Synopsis
Study Product
Regulatory Status
Study Objective​
Study Design​​
Study Center​​
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Primary Outcome Measures​​​
Safety Measures​​
Lead Investigators​​
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