Sterile, temperature-controlled preservation reduces long-term mortality after heart transplant by 54%
Donor hearts preserved with the Paragonix SherpaPak Cardiac Transport System are associated with significant improvements in heart transplant outcomes, according to new data presented at ISHLT 2025, the annual meeting of the International Society for Heart & Lung Transplantation.
The SherpaPak systems allows care teams to store donor hearts in a sterile, controlled environment as opposed to simply storing them in ice. It also provides real-time data on the case’s temperature and location. Paragonix, a Massachusetts-based medtech company acquired by Getinge in 2024, has received both FDA clearance and CE mark approval for the technology.
The study’s authors explored the GUARDIAN-Heart Registry, focusing on long-term mortality in more than 1,300 heart transplant patients. While 742 patients underwent a transplant that used the SherpaPak system, another 605 patients were treated using conventional ice storage. Propensity matching was performed to ensure similar patients were being compared to one another.
Overall, first author David D’Alessandro, MD, director of heart transplantation and ventricular assist devices at Massachusetts General Hospital, and colleagues found that heart transplants conducted using the SherpaPak technology were associated with a 54% reduction in mortality after four years. In addition, using SherpaPak was linked to a 72% reduction in one-year mortality, a 68% reduction in two-year mortality and a 52% reduction in three-year mortality.
The risks of severe primary graft dysfunction (PGD) and severe right ventricular dysfunction (RVD) were also dramatically reduced when using the Paragonix offering as opposed to traditional ice storage.
“These landmark findings represent monumental progress in heart transplantation technology and research,” Lisa Anderson, PhD, president of Paragonix Technologies, said in a statement highlighting the new data. “The GUARDIAN Registry research data clearly demonstrates that patients whose donor hearts were preserved with the Paragonix SherpaPak experience a statistically significant improvement in outcomes. At Paragonix, we remain committed to working alongside the transplant community to ensure every donor gift has the greatest chance to save and sustain life.”
The full study abstract is available here.