Breakthrough Cardiac Study Reveals Long-Term Impact on Post-Transplant Survival: A 2-Year Clinical Investigation Advancing Heart Preservation

By: Paragonix Technologies, Inc. via Business Wire

April 12, 2024 at 09:00 AM EDT

Investigators present statistically significant 24-month outcomes of transplant recipients with donor hearts preserved by the Paragonix SherpaPak Cardiac Transport System – a record-first advancement in long-term care empowered by controlled hypothermic preservation technology.

Paragonix Technologies, Inc., a pioneer in organ transplant technologies and services, announces the annual release of the latest GUARDIAN-Heart Clinical Registry report, shared earlier today at the 44th ISHLT Annual Meeting and Scientific Sessions – one of the largest international conferences focused on advanced treatment for end-stage heart and lung disease. Notably, the unprecedented study represents the first time any medical device technology has ever demonstrated statistically significant improvements in 2-year survival following heart transplantation.

The analysis consisted of a total of 1,261 US adult patients, which were matched using statistical propensity matching to create two cohorts of equal baseline characteristics to compare the use of the SherpaPak^® System against traditional ice storage. The matched cohorts consisted of 362 patients each. Investigators reported statistically significant improvements associated with utilizing the Paragonix SherpaPak System including:

5% increase in 2-year survival, which represents a 43% reduction in 2-year mortality – a technological milestone in heart transplantation.
50% reduction in Severe Primary Graft Dysfunction, defined as the use of Mechanical Circulatory Support (MCS), excluding balloon pumps, within 24 hours post-transplant.
32% reduction in all post-transplant MCS, including MCS continued from pre-transplant throughout the post-transplant period.
39% reduction in New Extracorporeal Membrane Oxygenation (ECMO)/Ventricular Assist Devices (VAD) post-transplant, including MCS use from transplant through discharge (both primary [<24 hours] and secondary [> 24 hours] graft dysfunction).
44% reduction in Severe Right Ventricular Dysfunction (RVD).

“This breakthrough is game-changing," said Dr. Scott Silvestry, a lead investigator and renowned cardiac surgeon with decades of clinical experience. "Previously when we started using SherpaPak, we were impressed how the donor hearts felt pliable and performed better immediately. Now, with evidence of superior survival 2 years after surgery, the average number of transplants required for a transplant center to see an impact on the survival of their patients is only 22 procedures. We are now talking about saving lives and any given program can save 1-5 lives per year in the survival difference alone.”

The study concluded that these advantages are increasingly important in an era of longer procurement distances with longer ischemic times occurring in contemporary heart transplantation.

“For as long as heart transplant has been a discipline, we have been racing against the clock,” said Dr. David D’Alessandro, a lead investigator and Surgical Director of Heart Transplantation and Ventricular Assist Devices at Massachusetts General Hospital. “This study indicates that the SherpaPak System can attenuate the risks of ischemic time through controlled hypothermic and isobaric preservation. Our findings showed that hearts performed better in a SherpaPak than on ice across all examined ischemic timeframes – whether it’s simply one hour or very long-distance procurements.”

Paragonix is committed to working closely with transplant centers, organ procurement organizations, and healthcare professionals to ensure broad accessibility of its Advanced Organ Preservation technology, including the Paragonix SherpaPakSystem, which is utilized across over 130 programs globally to preserve and protect donor hearts.

SherpaPak^® Cardiac Transport System 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.

About Paragonix Technologies

Paragonix Technologies is a leading developer, manufacturer, and service provider in the organ transplant industry, establishing a novel approach to preservation that represents a significant improvement over the traditional standard of care.

Paragonix Advanced Organ Preservation devices combine clinically-proven, stable temperature techniques with digital tracking and monitoring technologies to provide clinicians complete control and oversight throughout the donor organ journey. The clinical impact of Paragonix preservation technology is reinforced by the GUARDIAN clinical registries, the largest database of organ preservation data in the world that analyzes post-transplant outcomes in transplant recipients. For more information, visit www.paragonix.com.

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Adam Lafreniere, Sr. Director, Marketing

marketing@paragonixtechnologies.com

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Breakthrough Cardiac Study Reveals Long-Term Impact on Post-Transplant Survival: A 2-Year Clinical Investigation Advancing Heart Preservation

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