The paediatric registry collects real-world data and determines the impact of advanced preservation methods compared to standard methods
Paragonix Technologies has initiated GUARDIAN-HEART, a paediatric donor heart preservation registry and enrolled the first participant at the University of Florida Health (UF Health).
The GUARDIAN-HEART paediatric research is built on the company’s previous GUARDIAN-HEART registry for donor heart preservation in adults and the GUARDIAN-LUNG registry for donor lung preservation.
Paragonix said that the paediatric registry is designed to collect real-world data and determines the impact of advanced preservation methods compared to standard methods.
Data collected by the clinical investigators at different enrolling centres will be pooled and analysed for patient outcomes based on donor heart preservation methods.
The study will focus on short term post-transplant outcomes, within 48 hours; intermediate-term outcomes, within 30 days; and long-term one-year survival outcomes.
GUARDIAN-HEART paediatric registry principal investigator Jeffrey Jacobs said: “Many infants, children, and adults have had successful outcomes after undergoing heart transplantation at University of Florida with donor hearts preserved with the Paragonix system.
“The organ transplant community has spent decades studying and improving the techniques of preoperative care, surgery and postoperative care. The impact of improved donor heart preservation and transportation is a critical component of this ongoing research.
“A clinical registry dedicated to improving the preservation of the donor heart has the potential to save lives. We anticipate strong participation from centres across the globe.”
According to previous clinical studies, donor hearts preserved by the Paragonix SherpaPak system resulted in reduced ICU stays.
Paragonix SherpaPak system has effectively transported nearly 900 adult and paediatric donor hearts since its clinical launch in 2018, said the company.
UF Health’s Congenital Heart Centre shifted to Paragonix SherpaPak Cardiac Transport System in mid-2019, leaving behind the traditional storage methods involving ice coolers.
The advanced cardiac transport system leverages hypothermic preservation techniques and a novel suspension system to offer superior physical and thermal protection.
Paragonix SherpaPak CTS is said to be the only commercially available FDA approved and CE marked device for heart transportation and the only device for paediatric donor hearts.
Paragonix Technologies CEO Lisa Anderson said: “Paediatric care is a special practice held in the highest regard as these clinicians care for our most vulnerable patient population.
“Contributing to the quality-of-care children receive is of utmost importance to our team, and it is why this paediatric registry has been a top priority for our company.
“We are dedicated to supporting the transplant community – providers, patients and their families – by proving that more can be done to preserve the precious organs they have likely waited a very long time for.”