A novel, institutionally developed hypothermic oxygenated machine PErfusion system allows low-cost, universal implementation for liver transplantation: A safety and feasibility pilot study.

Despite significant benefit, the substantial economic cost has prevented the widespread adoption of Hypothermic Oxygenated machine PErfusion (HOPE) globally. Currently, HOPE is primarily utilised by liver transplantation (LT) units within high-income countries, leading to disparities in access for units operating within lower-resource settings. To address this, the Centre for Organ Assessment, Repair and Optimisation (COARO) has developed a low-cost HOPE system for clinical use. The aim of this paper was to assess the feasibility of translating the COARO system into routine clinical practice for all LT procedures at an Australian LT unit. The COARO system comprises readily available components and is built upon institutionally developed electrical and software architecture. Pre-clinical testing was conducted by sequentially perfusing human livers using HOPE followed by long-term normothermic machine perfusion. Following clinical introduction, all LT recipients at Royal Prince Alfred Hospital in Sydney, Australia were eligible to receive a graft perfused using the COARO system. Primary endpoints were measured perfusion dynamics and secondary endpoints were system costs and early graft and patient outcomes. Forty-five LT have been performed using the COARO system. No instances of device failure or unsafe perfusion have occurred. Seven patients developed early allograft dysfunction (15.6%) and the 3-month graft failure risk was 2.7% (1.8-3.9) based on the Liver Graft Assessment Following Transplantation (L-GrAFT7) score. Thirteen patients (28.9%) developed a Clavien-Dindo ≥IIIb complication. One patient developed primary non-function considered unrelated to HOPE. The total cost of the COARO system is US$1,494.87 per LT, 80% cheaper than a commercial equivalent. The COARO system is safe and presents significant economic advantage over commercial systems, allowing universal implementation of HOPE for all LT procedures in under resourced units.