Clinical Data Shows Reduced Costs, Improved Outcomes in Heart Transplantation

Paragonix Technologies Inc. is sharing results of an organ transplant study that used real-world clinical data to compare two preservation methods: the Paragonix SherpaPak Cardiac Transport System (PGNX), and the traditional method of organ transport—ice cold storage (ICE). The study illustrates the favorable post-operative impact that advanced preservation technology may have on hospital costs and patient outcomes after heart transplant procedures. 
 
The study’s full dataset was collected from August 2015 to November 2021 as part of the GUARDIAN-Heart Clinical Registry, analyzing 174 propensity-matched patients (87 PGNX and 87 ICE) from 12 U.S. transplant hospitals. Study results show that patients whose hearts were transported in ice cold storage spent a significantly higher portion of their ICU days on mechanical circulatory support (MCS) compared to patients whose donor hearts were preserved with the Paragonix SherpaPak System (40.3% [ICE] vs. 10.8% [PGNX], p=<0.0001). Upon further comparison of the preservation methods, the transplants that used the Paragonix SherpaPak System displayed a statistically significant reduction of $26,700 in average hospital costs, due to the favorable clinical impacts affecting cost variables such as MCS usage, ICU stay, and overall hospital stay.

“Advanced organ preservation devices have become the new standard of care for patients,” Paragonix President/CEO Dr. Lisa Anderson said. “Our technology continues to operate in top hospitals and transplant centers across the country. The data shows that advanced preservation technology is a cost-effective and lower-risk solution than traditional transportation methods.”
 
The Paragonix SherpaPak Cardiac Transport System is a U.S. Food and Drug Administration-cleared and CE-marked device intended specifically to transport, preserve, and monitor donor hearts traveling from donor to recipient. When the advanced preservation device was used, recipients experienced a statistically significant reduction in the rate of severe Primary Graft Dysfunction (PGD) (16.1% [ICE] vs. 5.7% [PGNX], p=0.03), the study data indicated. The trial also found a reduced need for ECMO and usage of temporary VAD when comparing the patient cohort that utilized the Paragonix SherpaPak to the cohort reliant on cold ice storage.
 
The study concluded that using the Paragonix SherpaPak System within the United States can improve clinical outcomes and lower hospital costs when compared directly to traditional ice cooler methods of transport. 

Paragonix Technologies is a provider of advanced organ preservation (AOP) devices that safeguard donor organs during the journey between donor and recipient patients. Every Paragonix AOP device natively integrates with a digital app, delivering real-time organ tracking data and monitoring logistics for transplant teams seeking a secure and centralized solution. 
 
GUARDIAN is a registered clinical study (NCT04141605) funded and administered by Paragonix Technologies. At the time of this analysis, GUARDIAN contained data from 12 sites on 490 patients. In this analysis, U.S. adult cohorts were matched using statistical propensity matching to create cohorts of equal baseline characteristics (87 ice transports and 87 Paragonix SherpaPak CTS transports) with a matching propensity score allowable difference of 0.025.