Zoltan Czigany1, Johann Pratschke, Jiří Froněk, Markus Guba, Wenzel Schöning, Dimitri Aristotle Raptis, Joachim Andrassy, Matthijs Kramer, Pavel Strnad, Rene Hany Tolba, Wenjia Liu, Theresa Keller, Hannah Miller, Sandra Pavicevic, Deniz Uluk, Matej Kocik, Isabella Lurje, Christian Trautwein, Arianeb Mehrabi, Irinel Popescu, Florian Wolfgang Rudolf Vondran, Cynthia Ju, Frank Tacke, Ulf Peter Neumann, Georg Lurje. 1. Department of Surgery and Transplantation, University Hospital RWTH Aachen, Aachen, Germany Department of Surgery, Campus Charité Mitte | Campus Virchow-Klinikum, Charité-Universitätsmedizin Berlin, Germany Department of Transplantation Surgery, Institute for Clinical and Experimental Medicine, Prague, Czech Republic Department of General, Visceral, and Transplant Surgery, Ludwig-Maximilians-University Munich, Munich, Germany Department of HPB Surgery and Liver Transplantation, Royal Free Hospital, London, UK University College London, London, UK Department of Hepatology, Maastricht University Medical Center (MUMC), Maastricht, The Netherlands Department of Internal Medicine III, University Hospital RWTH Aachen, Aachen, Germany Institute for Laboratory Animal Science and Experimental Surgery, University Hospital RWTH Aachen, Aachen, Germany Institute for Biometry and Clinical Epidemiology, Charité-Universitätsmedizin Berlin, Campus Charité Mitte, Berlin, Germany Department of Hepatology and Gastroenterology, Campus Charité Mitte | Campus Virchow-Klinikum, Charité-Universitätsmedizin Berlin, Germany Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Germany Department of General Surgery and Liver transplantation, Fundeni Clinical Institute, Bucharest, Romania Department for General, Visceral and Transplant Surgery, Hannover Medical School, Hannover, Germany Department of Anesthesiology, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX, USA.
Abstract
OBJECTIVE: To evaluate peak serum alanine aminotransferase (ALT) and postoperative clinical outcomes after hypothermic oxygenated machine perfusion (HOPE) versus static cold storage (SCS) in extended criteria donation (ECD) liver transplantation (LT) from donation after brain death (DBD). BACKGROUND:HOPE might improve outcomes in LT, particularly in high-risk settings such as ECD organs after DBD, but this hypothesis has not yet been tested in a randomized controlled clinical trial (RCT). METHODS:Between 09/2017-09/2020 46 patients undergoing ECD-DBD LT from four centers were randomly assigned to HOPE (n=23) or SCS (n=23). Peak-ALT levels within seven days following LT constituted the primary endpoint. Secondary endpoints included incidence of postoperative complications (Clavien-Dindo classification (CD), Comprehensive Complication Index (CCI)), length of intensive care- (ICU) and hospital-stay, and incidence of early allograft dysfunction (EAD). RESULTS: Demographics were equally distributed between both groups (donor age: 72 [IQR:59-78] years, recipient age: 62 [IQR:55-65] years, labMELD: 15 [IQR:9-25], 38 male and 8 female recipients). HOPE resulted in a 47% decrease in serum peak ALT (418 [IQR: 221-828] vs. 796 [IQR:477-1195] IU/L, p=0.030), a significant reduction in 90-day complications (44% vs. 74% CD grade ≥3, p=0.036; 32 [IQR:12-56] vs. 52 [IQR:35-98] CCI, p=0.021), and shorter ICU- and hospital-stays (5 [IQR:4-8] vs. 8 [IQR:5-18] days, p=0.045; 20 [IQR:16-27] vs. 36 [IQR:23-62] days, p=0.002) compared to SCS. A trend towards reduced EAD was observed for HOPE (17% vs. 35%; p=0.314). CONCLUSION: This multicenter RCT demonstrates that HOPE, in comparison to SCS, significantly reduces early allograft injury and improves post-transplant outcomes in ECD-DBD liver transplantation.
RCT Entities:
OBJECTIVE: To evaluate peak serum alanine aminotransferase (ALT) and postoperative clinical outcomes after hypothermic oxygenated machine perfusion (HOPE) versus static cold storage (SCS) in extended criteria donation (ECD) liver transplantation (LT) from donation after brain death (DBD). BACKGROUND: HOPE might improve outcomes in LT, particularly in high-risk settings such as ECD organs after DBD, but this hypothesis has not yet been tested in a randomized controlled clinical trial (RCT). METHODS: Between 09/2017-09/2020 46 patients undergoing ECD-DBD LT from four centers were randomly assigned to HOPE (n=23) or SCS (n=23). Peak-ALT levels within seven days following LT constituted the primary endpoint. Secondary endpoints included incidence of postoperative complications (Clavien-Dindo classification (CD), Comprehensive Complication Index (CCI)), length of intensive care- (ICU) and hospital-stay, and incidence of early allograft dysfunction (EAD). RESULTS: Demographics were equally distributed between both groups (donor age: 72 [IQR:59-78] years, recipient age: 62 [IQR:55-65] years, labMELD: 15 [IQR:9-25], 38 male and 8 female recipients). HOPE resulted in a 47% decrease in serum peak ALT (418 [IQR: 221-828] vs. 796 [IQR:477-1195] IU/L, p=0.030), a significant reduction in 90-day complications (44% vs. 74% CD grade ≥3, p=0.036; 32 [IQR:12-56] vs. 52 [IQR:35-98] CCI, p=0.021), and shorter ICU- and hospital-stays (5 [IQR:4-8] vs. 8 [IQR:5-18] days, p=0.045; 20 [IQR:16-27] vs. 36 [IQR:23-62] days, p=0.002) compared to SCS. A trend towards reduced EAD was observed for HOPE (17% vs. 35%; p=0.314). CONCLUSION: This multicenter RCT demonstrates that HOPE, in comparison to SCS, significantly reduces early allograft injury and improves post-transplant outcomes in ECD-DBD liver transplantation.
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