A BIOARTIFICIAL LIVER TO TREAT SEVERE ACUTE LIVER-FAILURE

Objective To test the safety and efficacy of a bioartificial liver sup port system in patients with severe acute liver failure. Summary Backg round Data The authors developed a bioartificial liver using porcine h epatocytes. The system was tested in vitro and shown to have different iated liver functions (cytochrome P450 activity, synthesis of liver-sp ecific proteins, bilirubin synthesis, and conjugation). When tested in vivo in experimental animals with liver failure, it gave substantial metabolic and hemodynamic support. Methods Seven patients with severe acute liver failure received a double lumen catheter in the saphenous vein; blood was removed, plasma was separated and perfused through a c artridge containing 4 to 6 X 10(9) porcine hepatocytes, and plasma and blood cells were reconstituted and reinfused. Each treatment lasted 6 to 7 hours. Results All patients tolerated the procedure(s) well, wit h neurologic improvement, decreased intracranial pressure (23.0 +/- 2. 3 to 7.8 +/- 1.7 mm Hg; p < 0.005) associated with an increase in cere bral perfusion pressure, decreased plasma ammonia(163.3 +/- 21.3 to 11 2.2 +/- 9.8 mu Moles/L; p < 0.01), and increased encephalopathy index (0.60 +/- 0.17 to 1.24 +/-: 0.22; p < 0.03). All patients survived, ha d a liver transplant, and were discharged from the hospital. Conclusio ns This bioartificial liver is safe and serves as an effective ''bridg e'' to liver transplant in some patients.