Michael Barbella, Managing Editor11.06.23
Paragonix Technologies Inc. is sharing research from a clinical study on patient outcomes after heart transplant surgery.
The multi-center study compared the use of Paragonix SherpaPak Cardiac Transport System, a U.S. Food and Drug Administration-cleared and CE-marked donor heart preservation and transport device, to the use of conventional cold storage using ice in the preservation of donor hearts. Published in The American Society for Artificial Internal Organs, the study used data collected by the GUARDIAN-Heart Registry, the world’s largest clinical database dedicated to donor heart preservation, to analyze post-transplant outcomes and the impact on organ preservation methods on transplant patient health.
“The findings of this study should impact decision making related to the type of preservation method utilized for heart transplant surgeries at the highest levels as it fundamentally challenges the decades long status quo of using ice storage for transporting donor hearts,” said Dr.Yasuhiro Shudo, clinical assistant professor of Cardiothoracic Surgery at Stanford Medicine. “Particularly, in the post-allocation change era, with increasing travel distances and ischemic times, advanced hypothermic organ preservation is an important resource for transplant centers to consider.”
The U.S. multi-center analysis of GUARDIAN Registry data included 569 adult patients who received heart transplants between October 2015 and January 2022. A propensity matched analysis showed a statistically significant (67% reduction p=0.011) in Severe Primary Graft Dysfunction (PGD), a severe post-transplant complication, utilizing SherpaPak compared to alternative methods.1
Several other post-operative improvements were noted by the propensity matched study in favor of the SherpaPak cohort:
"Our investments in ongoing large data collection efforts and associated multi-center studies are paying off for transplant patients around the globe," Paragonix Technologies President/CEO Dr. Lisa Anderson said. "At Paragonix, our top priority is to improve patient care. With the vast body of clinical evidence reported out this year and the resulting broad adoption of our technology by the clinical community, it is clear that there is a new standard of care for heart transplant patients."
Paragonix Technologies is a developer, manufacturer, and service provider in the organ transplant industry, establishing a novel approach to organ preservation. It provides advanced organ preservation (AOP) devices that safeguard donor organs during the journey between donor and recipient patients. All Paragonix AOP devices are natively integrated with a novel digital app, delivering real-time organ tracking data and monitoring logistics for transplant teams seeking a secure and centralized solution.
Reference
1 Shudo,Y. et al. A Paradigm Shift in Heart Preservation: Improved Post-Transplant Outcomes in Recipients of Donor Hearts Preserved with the SherpaPak System. ASAIO2023
The multi-center study compared the use of Paragonix SherpaPak Cardiac Transport System, a U.S. Food and Drug Administration-cleared and CE-marked donor heart preservation and transport device, to the use of conventional cold storage using ice in the preservation of donor hearts. Published in The American Society for Artificial Internal Organs, the study used data collected by the GUARDIAN-Heart Registry, the world’s largest clinical database dedicated to donor heart preservation, to analyze post-transplant outcomes and the impact on organ preservation methods on transplant patient health.
“The findings of this study should impact decision making related to the type of preservation method utilized for heart transplant surgeries at the highest levels as it fundamentally challenges the decades long status quo of using ice storage for transporting donor hearts,” said Dr.Yasuhiro Shudo, clinical assistant professor of Cardiothoracic Surgery at Stanford Medicine. “Particularly, in the post-allocation change era, with increasing travel distances and ischemic times, advanced hypothermic organ preservation is an important resource for transplant centers to consider.”
The U.S. multi-center analysis of GUARDIAN Registry data included 569 adult patients who received heart transplants between October 2015 and January 2022. A propensity matched analysis showed a statistically significant (67% reduction p=0.011) in Severe Primary Graft Dysfunction (PGD), a severe post-transplant complication, utilizing SherpaPak compared to alternative methods.1
Several other post-operative improvements were noted by the propensity matched study in favor of the SherpaPak cohort:
- Significant 67% reduction in post-transplant ECMO (extra corporeal membrane oxygenation) /VAD (ventricular assist device) use in the first 24 hours post-transplant (p=0.011)1
- Trending 30% reduction in all post-transplant MCS (Mechanical Circulatory Support) (p=0.098) and trending improvements in one-year survival (88.4% conventional cold storage vs 94.0% SherpaPak, p=0.10).1
"Our investments in ongoing large data collection efforts and associated multi-center studies are paying off for transplant patients around the globe," Paragonix Technologies President/CEO Dr. Lisa Anderson said. "At Paragonix, our top priority is to improve patient care. With the vast body of clinical evidence reported out this year and the resulting broad adoption of our technology by the clinical community, it is clear that there is a new standard of care for heart transplant patients."
Paragonix Technologies is a developer, manufacturer, and service provider in the organ transplant industry, establishing a novel approach to organ preservation. It provides advanced organ preservation (AOP) devices that safeguard donor organs during the journey between donor and recipient patients. All Paragonix AOP devices are natively integrated with a novel digital app, delivering real-time organ tracking data and monitoring logistics for transplant teams seeking a secure and centralized solution.
Reference
1 Shudo,Y. et al. A Paradigm Shift in Heart Preservation: Improved Post-Transplant Outcomes in Recipients of Donor Hearts Preserved with the SherpaPak System. ASAIO2023