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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[.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

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

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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