title: Liver Transplantation After Ex Vivo Normothermic Machine Preservation: A Phase 1 (First-in-Man) Clinical Trial.
abstract: The number of donor organs suitable for liver transplantation is restricted by cold preservation and ischemia-reperfusion injury. We present the first patients transplanted using a normothermic machine perfusion (NMP) device that transports and stores an organ in a fully functioning state at 37°C. In this Phase 1 trial, organs were retrieved using standard techniques, attached to the perfusion device at the donor hospital, and transported to the implanting center in a functioning state. NMP livers were matched 1:2 to cold-stored livers. Twenty patients underwent liver transplantation after NMP. Median NMP time was 9.3 (3.5-18.5) h versus median cold ischaemia time of 8.9 (4.2-11.4) h. Thirty-day graft survival was similar (100% NMP vs. 97.5% control, p = 1.00). Median peak aspartate aminotransferase in the first 7 days was significantly lower in the NMP group (417 IU [84-4681]) versus (902 IU [218-8786], p = 0.03). This first report of liver transplantation using NMP-preserved livers demonstrates the safety and feasibility of using this technology from retrieval to transplantation, including transportation. NMP may be valuable in increasing the number of donor livers and improving the function of transplantable organs.
authors.affiliation: Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.|Institute of Biomedical Engineering, University of Oxford, Oxford, UK.
authors.forename: R
authors.initials: R
authors.lastname: Ravikumar
authors.affiliation: Liver Unit, Kings College Hospital, London, UK.
authors.forename: W
authors.initials: W
authors.lastname: Jassem
authors.affiliation: Liver Unit, University Hospital Birmingham, Birmingham, UK.
authors.forename: H
authors.identifier: 0000-0001-5480-9380
authors.initials: H
authors.lastname: Mergental
authors.affiliation: Liver Unit, Kings College Hospital, London, UK.
authors.forename: N
authors.initials: N
authors.lastname: Heaton
authors.affiliation: Liver Unit, University Hospital Birmingham, Birmingham, UK.
authors.forename: D
authors.initials: D
authors.lastname: Mirza
authors.affiliation: Liver Unit, University Hospital Birmingham, Birmingham, UK.
authors.forename: M T P R
authors.identifier: 0000-0002-5417-3850
authors.initials: MT
authors.lastname: Perera
authors.affiliation: Liver Unit, Kings College Hospital, London, UK.
authors.forename: A
authors.initials: A
authors.lastname: Quaglia
authors.affiliation: Institute of Biomedical Engineering, University of Oxford, Oxford, UK.
authors.forename: D
authors.initials: D
authors.lastname: Holroyd
authors.affiliation: Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.
authors.forename: T
authors.initials: T
authors.lastname: Vogel
authors.affiliation: Institute of Biomedical Engineering, University of Oxford, Oxford, UK.
authors.forename: C C
authors.initials: CC
authors.lastname: Coussios
authors.affiliation: Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.
authors.forename: P J
authors.initials: PJ
authors.lastname: Friend
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016022:Case-Control Studies; D050377:Cold Ischemia; D005240:Feasibility Studies; D005260:Female; D006085:Graft Survival; D006801:Humans; D008107:Liver Diseases / Q000601:surgery*; D016031:Liver Transplantation / Q000295:instrumentation / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009926:Organ Preservation / Q000295:instrumentation / Q000379:methods*; D010477:Perfusion / Q000379:methods*; D014019:Tissue Donors; D020858:Tissue and Organ Harvesting / Q000295:instrumentation / Q000379:methods*; D052096:Warm Ischemia; D055815:Young Adult