Session Time: 10:50am-11:50am
Presentation Time: 10:50am-11:00am
*Purpose: The OCS Liver PROTECT Trial was the first U.S. randomized controlled trial for liver perfusion and was designed to evaluate the impact of portable warm machine perfusion on clinical outcomes and donor liver utilization.
*Methods: PROTECT compared outcomes in recipients of livers preserved using the liver Organ Care System (OCS) or ischemic cold storage (ICS Control). Primary effectiveness endpoint was incidence of early allograft dysfunction (EAD). Other clinical endpoints included overall survival and incidence of ischemic biliary complications (IBC) at 6 and 12 months. Primary safety endpoint was average number of liver graft related SAEs (LGRSAEs).
*Results: 300 patients were enrolled (153 OCS and 147 Control). OCS use resulted in significant reduction of EAD (OCS 17.3% vs. Control 30.5% p=0.009), attenuation of reperfusion syndrome in the recipient, and reduction in the severity of reperfusion injury on allograft histology. Importantly, the presence of EAD conferred a significantly higher risk of graft failure (log-rank 0.0002). OCS was also associated with significant reduction of IBC at 6 and 12-months post-transplant (6 months- OCS 1.3% vs. Control 8.5% p=0.004; 12 months – OCS 2.6% vs Control 9.9 p=0.010). PROTECT’s safety endpoint was met with low mean LGRSAEs (OCS 0.046 to Control 0.075, non-inferiority p<0.0001). OCS preservation resulted in significantly higher utilization of DCD donor livers for transplantation (OCS 45.9% vs. Control 24.5% p= 0.020). Overall patient and graft survival were similar between the groups.
*Conclusions: To our knowledge, PROTECT results represent the first report of an intervention simultaneously reducing both EAD and IBC post liver transplantation. In addition, OCS resulted in significantly increased utilization of DCD donors. We conclude that OCS Liver preservation is associated with superior post-transplant outcomes and increased donor liver utilization for transplantation.
To cite this abstract in AMA style:Markmann J, Abouljoud M, Ghobrial M, Bhati C, Pelletier S, Magliocca J, Pruett T, Lu A, Rizzari M, Ottmann S, Klair T, Eymard C, Roll G, Reyes G, Black S, Florman S, Mirani S, Marsh C, Schnickel G, Kinkhabwala M, Demetris A, Yeh H, Vagefi P, MacConmara M. Superior Post-transplant Clinical Outcomes Using Portable Normothermic Perfusion and Assessment with the Organ Care System (ocs) Liver System: 1-year Outcomes of the Ocs Liver Protect Randomized Controlled Trial [abstract]. Am J Transplant. 2021; 21 (suppl 3). https://atcmeetingabstracts.com/abstract/superior-post-transplant-clinical-outcomes-using-portable-normothermic-perfusion-and-assessment-with-the-organ-care-system-ocs-liver-system-1-year-outcomes-of-the-ocs-liver-protect-randomized-contr/. Accessed September 25, 2021.
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