• Franklin C Olumba, Fangyu Zhou, Yikyung Park, William C Chapman, and RESTORE Investigators Group.
• From the Department of Abdominal Organ Transplantation Surgery, Washington University School of Medicine, St Louis, MO (Olumba, Zhou, Chapman).
• J. Am. Coll. Surg. 2023 Apr 1; 236 (4): 614625614-625.

BackgroundOrgan waste is a major cause of the donor liver shortage. Roughly 67% of recovered organ donors have liver utilization annually. A new technology called normothermic machine perfusion (NMP) offers a way to recover marginal and declined livers for transplant. We report interim results of the RESTORE trial (FDA investigational drug exemption trial NCT04483102) that aims to transplant NMP-treated livers that would otherwise be discarded.Study DesignDeclined livers were screened for NMP eligibility (eg donation after circulatory death [DCD] grafts with warm ischemic time <40 minutes, donation after brain death [DBD] grafts with cold ischemic time <8 hours). Livers meeting pre-NMP eligibility criteria received NMP using the OrganOx metra device for a minimum of 4 hours. All NMP-treated livers meeting the viability criteria were transplanted to consented recipients.ResultsOver 22 months, 60 declined livers from three organ procurement organizations (OPOs; 40 DCD and 20 DBD donor livers) were offered, and 22 livers (10 DCD and 12 DBD livers) met the pre-NMP eligibility. After NMP, 16 of 22 livers passed viability testing and were transplanted into needy recipients (median Model for End-Stage Liver Disease [MELD] score of 8, range 6 to 24), resulting in a 72.7% rescue rate (50% DCD, 91.7% DBD). The rate of early allograft dysfunction was 31.3%, but there were no graft-related deaths, primary nonfunction, or instances of nonanastomotic biliary strictures.ConclusionsInterim results of the RESTORE trial suggest that a sizable number of declined livers can be reclaimed. They are safe for transplantation and can enable lower MELD patients at high risk of morbidity and mortality to receive lifesaving grafts while offering OPOs a way to allocate more livers and reduce organ waste.Copyright © 2023 by the American College of Surgeons. Published by Wolters Kluwer Health, Inc. All rights reserved.

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