Portable hypothermic oxygenated machine perfusion for organ preservation in liver transplantation: A randomized, open-label, clinical trial

• Published in: Hepatology (Baltimore, Md.) Vol. 79; no. 5; pp. 1033 - 1047
• Main Authors: Panayotova, Guergana G, Lunsford, Keri E, Quillin, 3rd, R Cutler, Rana, Abbas, Agopian, Vatche G, Lee-Riddle, Grace S, Markovic, Daniela, Paterno, Flavio, Griesemer, Adam D, Amin, Arpit, Alonso, Diane, Rocca, Juan P, Borja-Cacho, Daniel, Hernandez-Alejandro, Roberto, Fung, John J, Pelletier, Shawn J, Shah, Shimul A, Guarrera, James V
• Format: Journal Article
• Language: English
• Published: United States Lippincott Williams & Wilkins 01.05.2024
• Subjects: Constriction, Pathologic; Humans; Liver; Liver Transplantation - methods; Organ Preservation - methods; Original : Liver Failure/Cirrhosis/Portal Hypertension; Perfusion - methods; Reperfusion Injury - etiology; Reperfusion Injury - prevention & control
• ISSN: 0270-9139; 1527-3350
• DOI: 10.1097/HEP.0000000000000715

In liver transplantation, cold preservation induces ischemia, resulting in significant reperfusion injury. Hypothermic oxygenated machine perfusion (HMP-O 2 ) has shown benefits compared to static cold storage (SCS) by limiting ischemia-reperfusion injury. This study reports outcomes using a novel portable HMP-O 2 device in the first US randomized control trial. The PILOT trial (NCT03484455) was a multicenter, randomized, open-label, noninferiority trial, with participants randomized to HMP-O 2 or SCS. HMP-O 2 livers were preserved using the Lifeport Liver Transporter and Vasosol perfusion solution. The primary outcome was early allograft dysfunction. Noninferiority margin was 7.5%. From April 3, 2019, to July 12, 2022, 179 patients were randomized to HMP-O 2 (n=90) or SCS (n=89). The per-protocol cohort included 63 HMP-O 2 and 73 SCS. Early allograft dysfunction occurred in 11.1% HMP-O 2 (N=7) and 16.4% SCS (N=12). The risk difference between HMP-O 2 and SCS was -5.33% (one-sided 95% upper confidence limit of 5.81%), establishing noninferiority. The risk of graft failure as predicted by Liver Graft Assessment Following Transplant score at seven days (L-GrAFT 7 ) was lower with HMP-O 2 [median (IQR) 3.4% (2.4-6.5) vs. 4.5% (2.9-9.4), p =0.024]. Primary nonfunction occurred in 2.2% of all SCS (n=3, p =0.10). Biliary strictures occurred in 16.4% SCS (n=12) and 6.3% (n=4) HMP-O 2 ( p =0.18). Nonanastomotic biliary strictures occurred only in SCS (n=4). HMP-O 2 demonstrates safety and noninferior efficacy for liver graft preservation in comparison to SCS. Early allograft failure by L-GrAFT 7 was lower in HMP-O 2 , suggesting improved early clinical function. Recipients of HMP-O 2 livers also demonstrated a lower incidence of primary nonfunction and biliary strictures, although this difference did not reach significance.