In the mission-critical world of transplantation, where there is no margin for error, advanced technologies are required to support transplant teams. The historic method of preserving and transporting organs uses plastic bags, ice, and consumer ice coolers. These non-FDA regulated devices provide un-controlled, un-monitored cooling that pose a risk of cellular injury to the transported organs and can affect transplant patient outcomes. Now, groundbreaking research from a recent study has found that patients receiving hearts transported using a novel preservation and transportation device had a superior one-year survival as compared to donor hearts stored on ice.

The SherpaPak Cardiac Transport System (CTS) from Paragonix Technologies, Inc. (Cambridge, MA, USA) is an FDA-cleared and CE-marked donor heart transport and preservation device that uses proprietary phase change technology prevent exposure to excessive temperature reduction. The rigid, pressure controlled, leak-proof dual-canister system protects the donor heart from physical and thermal trauma while Bluetooth connection and the Paragonix App ensure real-time monitoring, tracking, and communication.

The new multi-center study compared SherpaPak CTS to the use of conventional cold storage using ice in the preservation of donor hearts destined for transplantation. The study on one-year transplant patient outcomes following heart transplant surgery focused on post-transplant outcomes and survival, and utilized data collected by the GUARDIAN-Heart Registry, the world’s largest clinical database specifically dedicated to heart preservation.

The US Multi Center 1-year Transplant Survival Analysis of the GUARDIAN Registry included 569 adult patients who received heart transplants between October 2015 and January 2022. The analysis showed a statistically significant 72% reduction in Severe Primary Graft Dysfunction (PGD) rates. The one-year survival rate in patients where traditional cold storage was used was 88.7%. In contrast, the one-year survival rate in patients where the SherpaPak was used was 96.4%. This finding represented an 8.7% increase in one-year survival when using the SherpaPak for donor heart preservation.

Additionally, several other post-operative improvements were noted by the propensity matched study in favor of the SherpaPak cohort such as 38.5% reduction in all post-transplant MCS (mechanical circulatory support), 66.3% reduction in post-transplant ECMO (extra corporeal membrane oxygenation)/VAD (ventricular assist device), 59.7% reduction in newly placed IABP (intra-aortic balloon pump) and 71.9% reduction in severe PGD (primary graft dysfunction).

“The results of this study suggest that using ice to preserve and transport donor hearts is a potentially inferior method for organ preservation,” said Dr. Andreas Zuckermann, the EU Principal GUARDIAN Investigator, Director of Cardiac Transplantation, and Associate Professor of Surgery Medical University of Vienna. “A 96.4% 1-year survival rate in the propensity matched analysis utilizing the SherpaPak is an encouraging sign that this technology for advanced organ preservation is having an impact on the clinical outcomes of heart transplantation. Advanced preservation of donor hearts should be a seriously considered by all transplant centers when assessing the impact on clinical outcomes outlined in this research.”

“With advanced technology like the SherpaPak, we can now demonstrate that we provide advanced care and improved outcomes for the vulnerable patient population of heart transplant recipients. With over a third of all US transplant centers utilizing the SherpaPak device, we look forward to supporting transplant centers across the US and Europe as they transition to this innovative technology as the standard of care,” said Dr. Lisa Anderson, CEO and President of Paragonix.

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