Evaluating a New Device for Reducing Second Warm Ischemia During Organ Transplantation in a Porcine Model of Kidney, Heart, and Pancreas Transplantation

Abstract

Second warm ischemia (SWI) injury between the completion of vascular anastomosis and graft reperfusion has been a longstanding issue in organ transplantation. This type of SWI injury is more severe in transplanted organs more sensitive to temperature changes. This study aimed to present the newly developed OrganPocket, an organ protector made from a proprietary elastomer material, and to demonstrate its efficacy in mitigating SWI injury in clinical kidney transplantation. We used an ex vivo porcine organ model to evaluate OrganPocket. After removal, donor organs were immersed and cryopreserved in an organ preservation solution at 4°C before being placed in an OrganPocket. The organ graft and OrganPocket were held for 30 minutes in a 37°C environment mimicking intra-abdominal conditions while temperatures were recorded. Control organs were evaluated under the same conditions without an OrganPocket. In addition, we tested OrganPocket in an intra-abdominal porcine allograft transplant model. The control organ group temperature reached ≥16°C after 30 minutes, while the mean core temperature in the OrganPocket organ group remained at no more than 10°C. Despite an SWI time of approximately 30 minutes, the surface organ temperature upon removal of OrganPocket was 20°C. Cardiac grafts also exhibited a normal heartbeat after reperfusion. OrganPocket is the world's first device designed to prevent SWI and should also prove useful for heart transplantation.