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      A Systematic Review and Meta-Analysis of Machine Perfusion vs. Static Cold Storage of Liver Allografts on Liver Transplantation Outcomes: The Future Direction of Graft Preservation

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          Abstract

          Background: Machine perfusion (MP) and static cold storage (CS) are two prevalent methods for liver allograft preservation. However, the preferred method remains controversial.

          Aim: To conduct a meta-analysis on the impact of MP preservation on liver transplant outcome.

          Methods: PubMed, EMBASE, and Cochrane Library databases were systematically searched to identify relevant trials comparing the efficacy of MP vs. CS. Odds ratios (OR) and fixed-effects models were calculated to compare the pooled data.

          Results: Ten prospective cohort studies and two randomized controlled trials (RCTs) were included (MP livers vs. CS livers = 315:489). Machine perfusion demonstrated superior outcomes in posttransplantation aspartate aminotransferase levels compared to CS ( P < 0.05). The overall incidence of early allograft dysfunction (EAD) was significantly reduced with MP preservation than CS [OR = 0.46; 95% confidence interval (CI) = 0.31–0.67; P < 0.0001]. The incidence of total biliary complications (OR = 0.53; 95% CI = 0.34–0.83; P = 0.006) and that of ischemic cholangiopathy (OR = 0.39; 95% CI = 0.18–0.85; P = 0.02) were significantly lower in recipients with MP preservation compared with CS preservation. Hypothermic machine perfusion (HMP) but not normothermic machine perfusion (NMP) was found to significantly protect grafts from total biliary complications and ischemic cholangiopathy ( P < 0.05). However, no significant differences could be detected utilizing either HMP or NMP in primary nonfunction, hepatic artery thrombosis, postreperfusion syndrome, 1-year patient survival, or 1-year graft survival ( P > 0.05).

          Conclusions: Machine perfusion is superior to CS on improving short-term outcomes for human liver transplantation, with a less clear effect in the longer term. Hypothermic machine perfusion but not NMP conducted significantly protective effects on EAD and biliary complications. Further RCTs are warranted to confirm MP's superiority and applications.

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          A randomized trial of normothermic preservation in liver transplantation

          John Karani, Hynek Mergental, M. Zeeshan Akhtar … (2018)
          Liver transplantation is a highly successful treatment, but is severely limited by the shortage in donor organs. However, many potential donor organs cannot be used; this is because sub-optimal livers do not tolerate conventional cold storage and there is no reliable way to assess organ viability preoperatively. Normothermic machine perfusion maintains the liver in a physiological state, avoids cooling and allows recovery and functional testing. Here we show that, in a randomized trial with 220 liver transplantations, compared to conventional static cold storage, normothermic preservation is associated with a 50% lower level of graft injury, measured by hepatocellular enzyme release, despite a 50% lower rate of organ discard and a 54% longer mean preservation time. There was no significant difference in bile duct complications, graft survival or survival of the patient. If translated to clinical practice, these results would have a major impact on liver transplant outcomes and waiting list mortality.
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            Validation of a current definition of early allograft dysfunction in liver transplant recipients and analysis of risk factors.

            Kim M Olthoff, Laura Kulik, Benjamin Samstein … (2010)
            Translational studies in liver transplantation often require an endpoint of graft function or dysfunction beyond graft loss. Prior definitions of early allograft dysfunction (EAD) vary, and none have been validated in a large multicenter population in the Model for End-Stage Liver Disease (MELD) era. We examined an updated definition of EAD to validate previously used criteria, and correlated this definition with graft and patient outcome. We performed a cohort study of 300 deceased donor liver transplants at 3 U.S. programs. EAD was defined as the presence of one or more of the following previously defined postoperative laboratory analyses reflective of liver injury and function: bilirubin >or=10mg/dL on day 7, international normalized ratio >or=1.6 on day 7, and alanine or aspartate aminotransferases >2000 IU/L within the first 7 days. To assess predictive validity, the EAD definition was tested for association with graft and patient survival. Risk factors for EAD were assessed using multivariable logistic regression. Overall incidence of EAD was 23.2%. Most grafts met the definition with increased bilirubin at day 7 or high levels of aminotransferases. Of recipients meeting the EAD definition, 18.8% died, as opposed to 1.8% of recipients without EAD (relative risk = 10.7 [95% confidence interval: 3.6, 31.9] P < 0.0001). More recipients with EAD lost their grafts (26.1%) than recipients with no EAD (3.5%) (relative risk = 7.4 [95% confidence interval: 3.4, 16.3] P < 0.0001). Donor age and MELD score were significant EAD risk factors in a multivariate model. In summary a simple definition of EAD using objective posttransplant criteria identified a 23% incidence, and was highly associated with graft loss and patient mortality, validating previously published criteria. This definition can be used as an endpoint in translational studies aiming to identify mechanistic pathways leading to a subgroup of liver grafts with clinical expression of suboptimal function. (c) 2010 AASLD.
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              Liver Transplantation After Ex Vivo Normothermic Machine Preservation: A Phase 1 (First-in-Man) Clinical Trial.

              R. Ravikumar, W Jassem, H Mergental … (2016)
              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.
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                Author and article information

                Contributors
                Journal
                Journal ID (nlm-ta): Front Med (Lausanne)
                Journal ID (iso-abbrev): Front Med (Lausanne)
                Journal ID (publisher-id): Front. Med.
                Title: Frontiers in Medicine
                Publisher: Frontiers Media S.A.
                ISSN (Electronic): 2296-858X
                Publication date (Electronic): 12 May 2020
                Publication date Collection: 2020
                Volume: 7
                Electronic Location Identifier: 135
                Affiliations
                [1] 1Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, First Affiliated Hospital, School of Medicine, Zhejiang University, College of Medicine , Hangzhou, China
                [2] 2Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Key Laboratory of Combined Multi-organ Transplantation, Ministry of Public Health , Hangzhou, China
                Author notes

                Edited by: Pedro M. Baptista, University of Zaragoza, Spain

                Reviewed by: René Adam, Assistance Publique Hopitaux De Paris, France; Zuzana Macek Jilkova, Centre Hospitalier Universitaire de Grenoble, France

                *Correspondence: Junjun Jia jiajunjun1987@ 123456163.com

                This article was submitted to Gastroenterology, a section of the journal Frontiers in Medicine

                †These authors have contributed equally to this work

                Article
                DOI: 10.3389/fmed.2020.00135
                PMC ID: 7247831
                PubMed ID: 32528963
                SO-VID: a2cdf3dd-d452-417b-b694-8a3ab5a4b4ad
                Copyright © Copyright © 2020 Jia, Nie, Li, Xie, Zhou, Yu and Zheng.
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                Date received : 05 February 2020
                Date accepted : 30 March 2020
                Page count
                Figures: 6, Tables: 2, Equations: 0, References: 37, Pages: 13, Words: 8218
                Funding
                Funded by: Natural Science Foundation of Zhejiang Province 10.13039/501100004731
                Categories
                Subject: Medicine
                Subject: Systematic Review

                Keywords: machine perfusion,static cold storage,graft preservation,liver transplantation,meta-analysis
                Data availability:
                Keywords: machine perfusion, static cold storage, graft preservation, liver transplantation, meta-analysis

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