Introduction: Currently, the gold standard for donor organ preservation in clinical organ transplantation consists of 3 plastic bags and an ice box. The first plastic bag includes the organ itself immersed in preservation solution (e.g. Celsior). This bag is put in a second bag filled with saline, and then these two are put in a third bag filled with saline which is then put in the ice box. The disadvantage of this method is that the organ usually gets too cold. It has been shown that the theoretical perfect temperature for organ preservation is 4°C - 8°C. While higher temperatures lead to hypoxic injury of the organ because the metabolism is not decreased efficiently, lower temperatures than 4°C increase the risk of cold injury with protein denaturation. In the current study, we investigated a device that keeps the organ temperature consistently in the desired range of 4°C - 8°C and can potentially decrease cold injury to donor organs.
Methods: Three different ex vivo studies were performed with the Paragonix Sherpa Pak™ devices: 1) the temperature of the fluid-filled device was measured for up to 30 hours at an outside temperature set at 22°C, 2) the temperature of the fluid-filled device was measured for up to 30 hours at extreme outside temperatures set at -8°C and 31°C, 3) the temperature of a pig heart attached to the device was measured up to 12 hours.
Results: All studies showed that the Paragonix Sherpa Pak™ can keep the temperature of the heart consistently between 4° and 8°C.
Conclusions: The Paragonix Sherpa Pak™ device may decrease cold injury of donor organs by maintaining the temperature consistently between 4°C and 8°C and therefore may decrease primary graft failure after organ transplantation.
Keywords: heart transplantation; hypothermic cold storage; kidney transplantation; organ preservation.