Expansive Clinical Study Demonstrates Improved Clinical Outcomes in Heart Transplantation with the Paragonix SherpaPak
Paragonix Technologies, Inc.
Paragonix® markets medical devices that safeguard organs during the journey between donor and recipient.
A recent clinical study published in the Journal of Heart and Lung Transplantation concludes that the Paragonix SherpaPak significantly reduced the likelihood of severe Primary Graft Dysfunction, a life-threatening complication shown to diminish patient survival rates.
Clinical investigators of the GUARDIAN-Heart Registry, the largest post-market, observational registry of adult and pediatric heart transplant recipient patients, have published extensive findings detailing the positive impact of advanced donor heart preservation. The study, published in the prestigious Journal of Heart and Lung Transplantation (JHLT), found statistically significant clinical benefits in transplant recipients whose donor heart was preserved and transported with the use of the Paragonix SherpaPak Cardiac Transport System as opposed to ice storage. The conclusions of multiple research presentations have highlighted that the use of a Paragonix SherpaPak System has been associated with an overall reduction in many common post-transplant complications.
Notably, the most impactful results consistently demonstrated that advanced organ preservation was associated with a significant reduction in severe Primary Graft Dysfunction (PGD), a life-threatening post-transplant complication defined in this study as the use of MCS (excluding balloon pump) within 24 hours post-transplant. When the patient cohorts were propensity-matched, investigators discovered that severe PGD was reduced by 50% (6.0% (17/281) versus 12.1% (34/281) respectively; p=0.018).
Investigators stated that PGD occurs in an estimated 16.5% to 31% of heart transplant recipients and, when severe, represents a major cause of early post-transplant mortality. Severe PGD is the deadliest complication of heart transplantation and is associated with a 7.8-fold increase in probability of 1-year mortality.
The analysis studied the post-transplant outcomes of 1,061 US adult heart transplants (452 ice transports and 559 Paragonix SherpaPak CTS transports) performed between October 2015 and December 2022 by 19 total centers. The resulting data showed that the Paragonix SherpaPak reduced the incidence of Severe PGD by 36% in a study of the entire population. Further analysis revealed that the rate of reduction increased to over 50% in over 550 patients who were propensity-matched based on donor characteristics.
Key Findings
Full US Adult Cohort
Full US Adult Cohort - Propensity Matching
Study results indicate that the use of the Paragonix SherpaPak represents one of the very few modifiable factors available to transplant physicians to decrease the probability of severe PGD. The researchers discovered that in many cases, utilizing the Paragonix SherpaPak System to provide advanced organ preservation, as opposed to ice storage, is the sole controllable variable for preventing severe PGD.
The Impact of Severe PGD
The researchers conducted a logistic regression analysis to forecast the likelihood of experiencing severe PGD based on ischemic time within each preservation-method group. It was found that as ischemic time lengthened, the probability of severe PGD escalated in both groups. However, they found the escalation was less pronounced in the SherpaPak preservation cohort. Additionally, there wasn't any duration of ischemic time where ice preservation demonstrated an advantage over controlled hypothermic preservation. Notably, the influence of ischemic time on the likelihood of severe PGD was mitigated within the controlled hypothermic preservation cohort (p=0.009).
“Use of controlled hypothermic preservation was associated with a 50% relative reduction in the incidence of severe PGD compared to traditional ice, and the adverse effects of increased ischemic time were attenuated, with a corresponding extension to the upper limit of safe ischemic times for transport. Thus, controlled hypothermic preservation represents one of the first tools available for physicians to alter the early risk trajectory of heart transplant recipients,” investigators concluded.
This analysis comes on the heels of a recently published study in JHLT on advanced preservation in Extended Criteria Donors in which investigators concluded that the Paragonix SherpaPak Cardiac Transport System provides a simple, cost-effective solution to safely increase donor heart utilization while minimizing adverse post-transplant events.
The clinical investigators representing the GUARDIAN Clinical Registries plan to announce the latest donor heart preservation analysis at the 44th ISHLT Annual Meeting and Scientific Sessions, located at the Prague Congress Center in Prague, Czech Republic from April 10-13, 2024. On April 12, Dr. Scott Silvestry will present key 2-year findings in an oral session entitled "Improved 2-Year Heart Transplant Survival with Moderate Hypothermic Donor Heart Preservation in the Guardian Heart Registry."
About Paragonix Technologies
Paragonix Technologies is a leading developer, manufacturer, and service provider in the organ transplant industry, establishing a novel approach to organ preservation.
Paragonix Technologies provides Advanced Organ Preservation (“AOP”) devices that safeguard donor organs during the journey between donor and recipient patients. Our FDA-cleared and CE-marked devices incorporate clinically proven and medically trusted cold preservation techniques that allow unprecedented physical and thermal protection to the organ during transit. All Paragonix AOP devices are natively integrated with our novel digital app, delivering real-time organ tracking data and monitoring logistics for transplant teams seeking a secure and centralized solution.
For more information, visit www.paragonix.com.
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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. The data from the registry is descriptive, not statistically powered, and not pre-specified. The information should be interpreted accordingly.
Paragonix SherpaPak® Indications for Use
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 4 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.
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