GUARDIAN-Heart Registry

1900+

Enrolled Patients

Transplant Centers

25+

Clinical Reports

Clinical Results

		Ice (n=362)	Paragonix SherpaPak (n=362)	p-value
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

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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

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1) Voight et al., ASAIO Journal 2022

GUARDIAN-Heart 2-Year Clinical Summary

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

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
ISHLT 2024 Presentation

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

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1) Silvestry et al., ISHLT Presentation 2024, Data on file

See more initial GUARDIAN-HEART results

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.

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+5%

2-year survival

p value = 0.04

-32%

All mechanical circulatory support

p value = 0.006

Post transplant

-50%

Severe primary graft dysfunction

p value = 0.010

+19%

Right ventricular normal

p value = 0.028

24 hours post transplant

-44%

Severe right ventricular dysfunction

p value = 0.05

-39%

Newly placed extracorporeal membrane oxygenation / ventricular assist device

p value = 0.036

Post transplant

No items found.

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