An organ transport system driven via static hypothermic preservation of a donor’s heart during transport to a recipient for heart transplantation has been reported to have successfully cleared its first clinical use.
The update was reported at the International Society for Heart and Lung Transplantation (ISHLT) during a presentation where the researchers have confirmed the success of the first six clinical usages of the device at Massachusetts General Hospital (mean age of recipients, 60 years; five men).
The Paragonix SherpaPak™ Cardiac Transport System (CTS) has been cleared by the US Food and Drug Administration (FDA) and it is the first and only FDA and CE marked system for donor organ heart transport and storage. Two clinical presentations were given by Noritsugu Naito, MD, PhD from Massachusetts General Hospital (Boston, MA) on the hospital’s use of the Paragonix SherpaPak™ CTS which included “The First Clinical Use of a Novel Cold Storage System of Donor Hearts” and “A Case of Heart Transplantation Using a Distantly Procured Brain Dead Donor Heart That Was Preserved in a Novel Cold Storage System”
During a conversation with the media Bill Edelman, chairman, and CEO of Paragonix Technologies told that “For many years, there has been a satisfactory preservation fluid designed to sustain the myocardial tissue during the time that it is removed from the donor and transported to a recipient”.
“The issue is that the methodology that has been employed for achieving this preservation is incredibly crude. The heart is packed in a series of plastic bags filled with the preservation fluid and then it is sandwiched between beds of crushed ice and slush. The result has been that the temperatures in the myocardial tissue begin to approach freezing. When that happens, possibilities include freezing of the myocardial wall and the opportunity for ice crystals to form in the preservation fluid and the tissue. That methodology has limited the distance that organs can travel from donation to implantation to around 4 hours of ischemic time. The upshot is that there are about 50,000 patients with end-stage heart failure, but only about 3,500 implants occur from about 8,000 available hearts.” he adds.
According to Mr. Edelman, this storage system is designed to maintain a temperate which is acquiescent with the optimal conditions of the preservation media, between 4°C and 8°C. The company has developed a suspension system that holds the heart in the interior of the device by cannulating the aortic root, which is the residual tissue left from the explanation. It comes with a canister that holds the heart, which is immersed completely in the preservation media, and then the canisters are wrapped in special packaging which holds temperatures between 4°C and 8°C. The entire assembly is loaded into a transport capsule, which thermally isolates it from the environment and enables us to measure and display the storage temperature immediately adjacent to the heart every 30 seconds on an app on the phones of the recovery team.