3.1 To inform the committee, NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 11 sources, which was discussed by the committee. The evidence included 1 randomised controlled trial, 7 matched case-control studies, 2 non-randomised control studies, and 1 case series, and is presented in table 2 of the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The specialist advisers and the committee considered the key efficacy outcomes to be: graft function, patient survival and use of marginal grafts.
3.3 The specialist advisers and the committee considered the key safety outcomes to be: graft damage (including vascular damage), biliary tract complications and infection.
3.4 No patient commentary was sought because the procedure is done ex situ, not directly to the patient.
3.5 The literature described different methods used for this procedure including: variation in the temperature used for machine perfusion (hypo- or normothermic); the point at which machine perfusion was started after donor liver explantation; and the duration of machine perfusion.
3.6 This procedure might allow for better assessment and more frequent use of marginal livers, so increasing the number of livers available for transplantation.