GUARDIAN Registry data presented at ISHLT 2022 has shown a 72% reduction (p=0.005) in Severe PGD (primary graft dysfunction) and a 39% reduction (p=0.03) in Mechanical Circulatory Support, in addition to improvement in 1-year survival1,2
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Paragonix Technologies, Inc., a leading organ preservation provider, announces today groundbreaking research from a multi-center study on one-year transplant patient outcomes following heart transplant surgery. The study compared the use of the Paragonix SherpaPak Cardiac Transport System, an FDA-cleared and CE-marked donor heart transport and preservation device, to the use of conventional cold storage using ice in the preservation of donor hearts destined for transplantation. Presented at the 2022 Annual Meeting of the International Society for Heart and Lung Transplantation on April 27, the study 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 p=0.005) in Severe Primary Graft Dysfunction (PGD) rates.1,2 The one-year survival rate in patients where traditional cold storage was used was 88.7%.1 In contrast, the one-year survival rate in patients where the SherpaPak was used was 96.4%. This finding represented an 8.7% increase (p=0.03) in one-year survival when using the SherpaPak for donor heart preservation.1
Additionally, several other post-operative improvements were noted by the propensity matched study in favor of the SherpaPak cohort:
- 38.5% reduction in all post-transplant MCS (mechanical circulatory support) (p=0.03).1
- 66.3% reduction in Post-transplant ECMO (extra corporeal membrane oxygenation) /VAD (ventricular assist device) (p=0.02)1
- 59.7% reduction in newly placed IABP (intra-aortic balloon pump) (p=0.02)1
- 71.9% reduction in Severe PGD (primary graft dysfunction) (p=0.005)1,2
“Our multi-center registry study was intended to assess the benefits of advanced heart preservation. We report a 1-year post transplant survival in matched cohorts from 89% in the traditional cold storage to 96% (p=0.03) in the SherpaPak cohort,” said Dr. Marzia Leacche, Richard DeVos Endowed Chair for Heart Transplant and MCS, Surgical Director, at Spectrum Health, MI, who presented the results of the study at the ISHLT 2022 Annual Meeting. “Innovations in patient care are rarely this impactful. We hypothesize that the survival benefit is due to reduction in the incidence of severe PGD (from 12% vs 3%, p=0.005)1,2 and reduced need for mechanical circulatory support after transplant.”
“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.”
“I look forward to contributing more to this important research as the GUARDIAN-Heart registry continues to grow, and as the trends we see within the data continue to point toward an improvement in care,” said Dr. David D’Alessandro, US Principal Investigator of the GUARDIAN study, Associate Chief of Clinical Operations in Cardiac Surgery, and Associate Professor of Surgery at Massachusetts General Hospital.
“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.
To visit with Paragonix Technologies and meet members of their team at ISHLT 2022 Annual Meeting, visit booth #211. For more information about Paragonix, visit www.paragonix.com.
About Paragonix Technologies
Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted cold preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Paragonix is a leading provider of FDA cleared and CE marked transport devices for organ preservation.
About Paragonix SherpaPak®
Paragonix SherpaPak® Cardiac Transport System (CTS) has preserved over 1500 hearts since start of clinical use in 2018. The Paragonix SherpaPak CTS, an FDA cleared, and CE marked preservation device for heart preservation and transport, provides a sterile, temperature and pressure-controlled environment for organs traveling between operating rooms. This award-winning product is designed to be easy-to-use in stressful, clinically demanding environments where there is no room for mistakes.
For important safety information on the Paragonix SherpaPak® System please visit: Important Safety Information
Disclaimer
Comparison of Paragonix SherpaPak to Ice Storage, Paragonix data on file. GUARDIAN is a registered clinical study (NCT04141605) funded and administered by Paragonix Technologies. At the time of this analysis, GUARDIAN contained data from 17 sites on 849 patients (384 ice transports and 465 Paragonix SherpaPak CTS transports). The data from the registry is descriptive, not statistically powered, and not pre-specified. The information should be interpreted accordingly. In this analysis, US adult cohorts were matched using statistical propensity matching to create cohorts of equal baseline characteristics (149 ice transports and 149 Paragonix SherpaPak CTS transports) with a matching propensity score allowable difference of 0.025.
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References
- Leacche et al., ISHLT Presentation 2022, Data on file
- Kobashigawa et al, Journal of Heart and Lung Transplantation, 2014
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Contacts
Adam Lafreniere, Director, Marketing Operations
marketing@paragonixtechnologies.com
