Results from the GUARDIAN-Heart registry demonstrated statistically significant improvements in 2-year survival following heart transplantation. The analysis consisted of a total of 1,261 U.S. adult patients matched using statistical propensity matching. This created two cohorts of equal baseline characteristics to compare the SherpaPak system against traditional ice storage.
SherpaPak offers static hypothermic preservation for hearts during transportation and eventual transplantation. It utilizes cold storage solutions indicated for use with the heart.
Looking at the results from the Paragonix registry
The matched cohorts in this registry featured 362 patients each. Paragonix said its SherpaPak heart preservation system led to a 5% increase in two-year survival. That represents a 43% reduction in two-year mortality. Additionally, the study saw a 50% reduction in severe primary graft dysfunction within 24 hours post-trasplant.
Paragonix said it observed a 32% reduction in all post-transplant mechanical circulatory support (MCS). That includes MCS continued from pre-transplant throughout the post-transplant period. SherpaPak led to a 39% reduction in new extracorporeal membrane oxygenation (ECMO)/ventricular asisst device (VAD) post-transplant. Finally, the study recorded a 44% reduction in severe right ventricular dysfunction (RVD) with SherpaPak.
Dr. Scott Silvestry served as lead investigator for the study. Silvestry said the results highlight the possibility of saving 1-5 lives per year thanks to the survival difference with SherpaPak.
“For as long as heart transplant has been a discipline, we have been racing against the clock,” said Dr. David D’Alessandro, a lead investigator and surgical director of heart transplantation and ventricular assist devices at Massachusetts General Hospital. “This study indicates that the SherpaPak System can attenuate the risks of ischemic time through controlled hypothermic and isobaric preservation. Our findings showed that hearts performed better in a SherpaPak than on ice across all examined ischemic timeframes – whether it’s simply one hour or very long-distance procurements.”