Background: Brain edema is the main cause of death in acute liver failure patients awaiting transplantation. We assessed the HepatAssist 2000, a liver-assist system containing porcine hepatocytes, as a bridge to transplantation in patients with acute liver failure.
Methods: Thirteen patients suffering from acute liver failure with criteria for transplantation entered an open baseline-controlled study, with liver-assist treatment sessions at 24-hr intervals until transplantation. Neurological status was regularly evaluated using the Glasgow Coma Scale.
Results: Three patients were not treated: one had an immediate transplantation and two improved spontaneously. Ten patients received one to three courses of HepatAssist. A significant neurological improvement (mean Glasgow Coma Scale before and after treatment: 6.5+/-3.7 and 9.6+/-4.4, respectively, P<0.02) was observed, which was related to the volume of plasma processed per square meter of body surface. A significant decrease was observed in mean levels of bilirubin (P=0.0005) and transaminases but not in the other indicators of liver function. Six patients had transient episodes of hemodynamic instability, and five had bleeding complications. Two patients died after transplantation. Eight patients survived with a mean follow-up of 24.3 (18-32) months.
Conclusion: The HepatAssist 2000 is well tolerated, improves cerebral function, and may be used as a bridge to transplantation for patients with liver failure.