(121) Results from over 800 Transplant Recipients Enrolled in the Guardian Heart Registry

Purpose

The decades long gold standard for preservation of donor hearts in ice appears to be rapidly shifting to advanced hypothermic preservation. At the time of this abstract, over 25% of donor hearts in the US in 2022 have been transported in a Paragonix SherpaPak Cardiac Transport System (CTS). This controlled hypothermic technology in clinical use since 2018 preserving organ temperatures between 4 - 8°C. Real-world evidence on the clinical benefits of using CTS compared to conventional ice storage (ICE) is evaluated in the GUARDIAN Heart Registry to assess whether improved outcomes are achieved with this technology.

Methods

Data from 877 adults at 16 US centers receiving donor hearts preserved and transported in either CTS (n=487) or ICE (n=390) between October 2015-August 2022 were analyzed in the GUARDIAN-Heart registry. Propensity matching was performed to balance baseline differences to further evaluate outcomes between cohorts (see Table). Summary statistics were used for comparisons.

Results

The CTS cohort demonstrated reduced severe primary graft dysfunction (PGD) compared to ICE in the unmatched cohort (p=0.08) (Table). When propensity matched, CTS had significantly lowered severe PGD by 60% (10.0% vs 4.0%, p=0.01). Survival was similar (Figure). Further analysis with ongoing enrollment through December 2022 will be available for presentation.

Conclusion

Utilization of the Paragonix CTS for organ preservation is associated with lower rates of severe PGD. This finding continues to fundamentally challenge the decades-long status quo of using ice for transporting donor hearts.