Michael Barbella, Managing Editor05.22.24
Paragonix Technologies Inc. has released the latest GUARDIAN-Heart Clinical Registry report, which shows the company's heart preservation technology can help improve post-transplant survival rates. The unprecedented study represents the first time any medical device technology has ever demonstrated statistically significant improvements in two-year survival after a heart transplant.
The analysis consisted of 1,261 U.S. adult patients who were matched using statistical propensity matching to create two cohorts of equal baseline characteristics to compare the use of Paragonix's SherpaPak System against traditional ice storage. The matched cohorts consisted of 362 patients each. Investigators reported statistically significant improvements associated with using the Paragonix SherpaPak System including:
The study concluded that these advantages are increasingly important in an era of longer procurement distances with longer ischemic times occurring in contemporary heart transplants.
“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.”
The Paragonix SherpaPak Cardiac Transport System is used for the static hypothermic preservation of hearts during transportation and eventual transplantation using cold storage solutions. The intended organ storage time for the Paragonix SherpaPak Cardiac Transport System is up to four hours.
Paragonix Technologies develops, manufactures, and provides organ transplant technology, having established 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.
The analysis consisted of 1,261 U.S. adult patients who were matched using statistical propensity matching to create two cohorts of equal baseline characteristics to compare the use of Paragonix's SherpaPak System against traditional ice storage. The matched cohorts consisted of 362 patients each. Investigators reported statistically significant improvements associated with using the Paragonix SherpaPak System including:
- A 5% increase in two-year survival, which represents a 43% reduction in two-year mortality—a technological milestone in heart transplantation.
- A 50% reduction in Severe Primary Graft Dysfunction, defined as the use of Mechanical Circulatory Support (MCS), excluding balloon pumps, within 24 hours post-transplant.
- A 32% reduction in all post-transplant MCS, including MCS continued from pre-transplant throughout the post-transplant period.
- A 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).
- A 44% reduction in Severe Right Ventricular Dysfunction (RVD).
The study concluded that these advantages are increasingly important in an era of longer procurement distances with longer ischemic times occurring in contemporary heart transplants.
“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.”
The Paragonix SherpaPak Cardiac Transport System is used for the static hypothermic preservation of hearts during transportation and eventual transplantation using cold storage solutions. The intended organ storage time for the Paragonix SherpaPak Cardiac Transport System is up to four hours.
Paragonix Technologies develops, manufactures, and provides organ transplant technology, having established 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.