GUARDIAN-Heart Registry

Enrolled Patients
Transplant Centers
Clinical Reports

Clinical Results

Paragonix SherpaPak
Survival 2-year Survival (%) 89.5% 94.3% 0.040
PGD PGD Severe (%) 11.0% 5.5% 0.010
Post-Transplant MCS All Post Tx MCS (%) 27.9% 19.1% 0.006
  Newly Placed ECMO/VAD Post Tx (%) 12.7% 7.7% 0.036
RV Function RV Normal (24 hour post) 45.8% 54.5% 0.028
  RV Severly Diminished 9.8% 5.5% 0.050

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 2-Year Clinical Summary

Improved 2-Year Heart Transplant Survival with Moderate Hypothermic Donor Heart Preservation

[.c-text-4] S. Silvestry, D. Meyer, S. Pham, J. Jacobs, Y. Shudo, J. Schroder, M. Leacche, C. Sciortino, H. Copeland, M. Rodrigo, K. Takeda, M. Kawabori, B. Mahesh, L. Klein, A. Vidic, S. Patel, D. D’Alessandro[.c-text-4]
[.c-text-4] ISHLT 2024 Presentation[.c-text-4]

Investigators found that 2-year post transplant survival in matched cohorts (from 89% to 95%, p=0.04) is superior in the SherpaPak cohort1. This survival benefit is potentially due to reduced the incidence of severe PGD (from 11% vs 5.5%, p=0.01) and reduced need for mechanical circulatory support after transplant1. The study concluded that Advanced hypothermic preservation of the donor heart should be strongly considered as an important factor contributing to a center’s post transplant and 2-year outcomes.1

[.c-text-4]1) Silvestry et al., ISHLT Presentation 2024, Data on file[.c-text-4]

Comparison of Paragonix SherpaPak to Ice Storage, Paragonix data on file. GUARDIAN is a registered clinical study (NCT04141605) funded and administered by Paragonix Technologies. The data from the registry is descriptive, not statistically powered, and not pre-specified. The information should be interpreted accordingly.

2-year survival
p value = 0.04
All mechanical circulatory support
p value = 0.006
Post transplant
Severe primary graft dysfunction
p value = 0.010
Right ventricular normal
p value = 0.028
24 hours post transplant
Severe right ventricular dysfunction
p value = 0.05
Newly placed extracorporeal membrane oxygenation / ventricular assist device
p value = 0.036
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​​
No items found.
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