WALTHAM, Mass. — A new study presented at the 45th Annual Meeting of the International Society for Heart and Lung Transplantation (ISHLT) has found that heart transplant recipients whose donor hearts were preserved using the Paragonix SherpaPak® Cardiac Transport System experienced significantly improved survival rates and fewer post-transplant complications compared to those whose hearts were preserved using traditional ice storage.
The study, based on data from the GUARDIAN-Heart Registry, compared outcomes over four years in U.S. adult heart transplant recipients. Researchers found that the use of the FDA-cleared and CE-marked SherpaPak system led to a 54% reduction in mortality over four years. Survival improved at every annual interval, with particularly strong outcomes in the first two years post-transplant. One-year mortality was reduced by 72%, and two-year mortality dropped by 68% for patients whose organs were preserved using the SherpaPak system.
Beyond survival, the study highlighted notable reductions in post-transplant cardiac complications. Use of the SherpaPak system was associated with a 50% decrease in severe primary graft dysfunction and a 63% reduction in severe right ventricular dysfunction. These results underscore the potential of controlled hypothermic preservation to improve patient outcomes following transplantation.
Researchers also presented findings showing that the SherpaPak system may reduce the risk of long-term complications such as cardiac allograft vasculopathy (CAV), a common cause of late-term graft failure. By the fourth year post-transplant, patients in the SherpaPak group had a significantly lower rate of CAV development—17.7% compared to 23.6% in the ice storage group.
In a subset of transplants involving extended criteria donors, the SherpaPak system was linked to reductions in several major complications, including a 26% decrease in the need for post-transplant mechanical circulatory support, a 31% drop in primary graft dysfunction, and a 61% reduction in severe right ventricular dysfunction.
A separate analysis of hospital readmissions found that transplant recipients whose hearts were preserved using the SherpaPak system were more likely to avoid rehospitalization in the first year after surgery, including for cardiovascular-related causes.
Dr. David D’Alessandro, Director of Heart Transplantation and Ventricular Assist Devices at Massachusetts General Hospital, noted that the research validates the impact of controlled, moderate hypothermia in improving transplant outcomes. “Our research indicates that the use of moderate, controlled hypothermia not only significantly reduced the risk of severe PGD and RVD, but also significantly reduced mortality through four years post-transplant,” he said.
Lisa Anderson, Ph.D., President of Paragonix Technologies, described the findings as a major advancement in transplant care. “These landmark findings represent monumental progress in heart transplantation technology and research,” she said. “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.”
Paragonix Technologies, which specializes in organ transplant technologies and organ preservation solutions, continues to expand the global use of the SherpaPak system. The device is now used in more than 130 transplant programs worldwide, as the company works alongside healthcare providers and organ procurement organizations to increase access to its advanced preservation technology.
