GUARDIAN-Heart Registry

2600+

Enrolled Patients

Participating Centers

25+

Clinical Reports

Clinical Results

		Ice (n=243)	Paragonix SherpaPak (n=243)	p-value
Survival	1-year Survival (%)	90.5%	97.3%	0.003
PGD	PGD Severe (%)	14.0%	7.0%	0.017
Post-Transplant MCS	Newly placed ECMO/VAD Post Tx (%)	30.9%	20.6%	0.013
RV Function	RV Normal (24 hour post)	42.5%	57.0%	0.004
	RV Severly Diminished	12.1%	4.5%	0.007

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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 2023[.c-text-4]

GUARDIAN-Heart 4-Year Clinical Summary

Donor Heart Preservation Improves 4-year Survival in the US Guardian-Heart Registry

[.c-text-4]D. D'Alessandro, Y. Shudo, M. Rodrigo, S. Pham, K. Takeda, R. Loyaga-Rendon, C. Sciortino, J. Schroder, A. Zeeshan, J. Jacobs, D. Meyer, G. Couper, B.Mahesh, D. Morales, T. Nasirov, L. Klein, M. Urban, V. Scavo, S. Patel, H.Shah, S. Silvestry, A. Zuckermann[.c-text-4]
[.c-text-4] ISHLT 2025 Presentation[.c-text-4]

The results of an extensive clinical study presented at the 45th ISHLT Annual Meeting and Scientific Sessions comparing conventional ice storage to the Paragonix SherpaPak System. The study concluded that utilization of the Paragonix SherpaPak System’s advantages of both temperature and physical protection for preservation are increasingly important in an era of longer procurement distances with longer ischemic times occurring in contemporary heart transplantation.

Investigators found that 4-year post transplant survival in matched cohorts (from 90.5% to 97.3%, p=0.003) is superior in the Paragonix SherpaPak System cohort. This survival benefit is potentially due to reduction in incidence of severe PGD (from 14% vs 7.0%, p=0.017) and severe RVD (from 12.1% vs 4.5%, p=0.007).

See more initial GUARDIAN-HEART results

+7%

1-year survival

p value = 0.003

-50%

Severe PGD

p value = 0.017

Post transplant

-63%

Severe RVD

p value = 0.007

+34%

Right Ventricular Normal

p value = 0.004

24 hours post transplant

-33%

New MCS

p value = 0.013

Post Transplant

Improved Survival Annually Through 4 Years

1. D'Alessandro et al., ISHLT Presentation 2025, Data on file

Comparison of Paragonix systems to Ice Storage, Paragonix data on file. GUARDIAN is a registered clinical study 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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