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

Authors

• Guergana G Panayotova
• Keri E Lunsford
• R Cutler Quillin
• Abbas Rana
• Vatche G Agopian
• Grace S Lee-Riddle
• Daniela Markovic
• Flavio Paterno
• Adam D Griesemer
• Arpit Amin
• Diane Alonso
• Juan P Rocca
• Daniel Borja-Cacho
• Roberto Hernandez-Alejandro
• John J Fung
• Shawn J Pelletier
• Shimul A Shah
• James V Guarrera

Publication/Presentation Date

5-1-2024

Abstract

BACKGROUND AND AIMS: 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.

APPROACH AND RESULTS: 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).

CONCLUSIONS: 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.

Volume

79

Issue

5

First Page

1033

Last Page

1047

ISSN

1527-3350

Published In/Presented At

Panayotova, G. G., Lunsford, K. E., Quillin, R. C., 3rd, Rana, A., Agopian, V. G., Lee-Riddle, G. S., Markovic, D., Paterno, F., Griesemer, A. D., Amin, A., Alonso, D., Rocca, J. P., Borja-Cacho, D., Hernandez-Alejandro, R., Fung, J. J., Pelletier, S. J., Shah, S. A., & Guarrera, J. V. (2024). Portable hypothermic oxygenated machine perfusion for organ preservation in liver transplantation: A randomized, open-label, clinical trial. Hepatology (Baltimore, Md.), 79(5), 1033–1047. https://doi.org/10.1097/HEP.0000000000000715

Disciplines

Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods

PubMedID

38090880

Department(s)

Administration and Leadership

Document Type

Article