Paragonix Study Shows Improved Outcomes for Heart Transplant Patients

Paragonix Technologies is touting positive clinical results from its GUARDIAN study,¹ the largest multi-center, international registry specifically focused on donor heart preservation. Clinical investigators from the first five enrolling centers collaborated to pool their data and analyze the differences in clinical outcomes of 224 patients who received donor hearts preserved either in the Paragonix SherpaPak Cardiac Transport System or with traditional ice storage.
 
Dr. David D’Alessandro, Surgical Director of Heart Transplantation at Massachusetts General Hospital, summarized the study authors’ conclusions that, “Heart preservation utilizing the Paragonix SherpaPak CTS compares favorably to ice storage preservation in this registry analysis. Despite unfavorable donor and recipient characteristics in the [Paragonix] cohort of patients, early clinical outcomes including Intensive Care Unit (ICU) length of stay are improved.”
 
The investigators reported that the donor hearts preserved by the Paragonix SherpaPak had statistically significant increases in total ischemic time and travel distance.² Total ischemic time, the time a donor heart is out of the body before implanted in a recipient, is a known risk factor for negative outcomes. Despite this increased risk the authors found significant reductions in ICU length of stay, with median ICU durations reduced by three days, in the Paragonix SherpaPak cohort.
 
An analysis of patients with extended ischemic times, those greater than 3 hours, found even more pronounced favorable differences. In this group, the portion of patients in the ICU for two weeks or more was reduced by 50 percent in the Paragonix SherpaPak cohort, and the portion of patients in the ICU for only a week or less were more than double compared to ice storage.
 
“We are incredibly encouraged and gratified by the presentation of these results. We extend our gratitude to all clinicians and patients who are contributing data to the GUARDIAN registry as we pledge our strong commitment to a data driven approach in providing tools to the transplant community. Further, our ongoing data collection effort and the joining of many centers in the United States and in Europe during 2021 will make this database an important resource to help guide clinical practice. Our team is committed to advancing the science of donor heart preservation,” said Lisa Anderson, Ph.D., CEO of Paragonix Technologies.

Paragonix Technologies designs, produces, and markets organ preservation and transport devices that safeguard organs during the journey between donor and recipient patients. Its devices mitigate risk in an otherwise high stakes environment. The Paragonix SherpaPak systems incorporate clinically proven and medically trusted cold preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Paragonix SherpaPak CTS is the only commercially available U.S. Food and Drug Administration (FDA)-cleared and CE-marked transport device for heart preservation. Paragonix markets the only FDA-cleared and CE-marked hypothermic storage device for lungs, the LUNGguard system. Paragonix is also developing transport devices for the liver, kidney and pancreas—designed to improve donor organ quality and extend donor organ preservation time.

References 
¹ GUARDIAN is a registered clinical study https://clinicaltrials.gov/ct2/show/NCT04141605. At the time of this analysis, GUARDIAN contained data from 5 sites on 223 patients (99 ice transports and 124 Paragonix SherpaPak CTS transports). The data from the registry is descriptive, not statistically powered, and not pre-specified. The information should be interpreted accordingly.
² The Paragonix SherpaPak Cardiac Transport System is intended to be used for the static hypothermic preservation of hearts during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the heart. The intended organ storage time for the Paragonix SherpaPak Cardiac Transport System is up to four hours. Donor hearts exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.