CLINICAL-EXPERIENCE WITH A PORCINE HEPATOCYTE-BASED LIVER SUPPORT SYSTEM

The only clinically proven effective treatment of fulminant hepatic fa ilure (FHF) is orthotopic liver transplant (OLT). However, many patien ts die before an organ becomes available. Thus, there is a need for de velopment of an extracorporeal liver support system to ''bridge'' thes e patients either to OLT or spontaneous recovery. We developed a bioar tificial liver (BAL) based on plasma perfusion through a circuit of a hollow-fiber cartridge seeded with matrix-anchored porcine hepatocytes to treat patients with severe acute liver failure. Two groups of pati ents were studied Group I (n = 12): patients with FHF. All patients we re successfully ''bridged'' to OLT. ''Bridge'' time to OLT was 21-96 h r (mean: 39.3 hr). All patients were discharged neurologically intact. Reversal of decerebration was noted in all 11 deep stage 4 coma patie nts. There was reduction in intracranial pressure (ICP mmHg, 18.2 +/- 2.2 to 8.5 +/- 1.2; p<0.004) and increase in cerebral perfusion pressu re (CPP mmHg, 71.1 +/- 4.0 to 84.7 +/- 2.6; p<0.006). Laboratory value s pre- and post-BAL treatment: glucose (mg/dl) 122 +/- 11 to 183 +/- 2 1, p<0.002; ammonia (mu mol/l) 155.6 +/- 13.2 to 121.6 +/- 9.5, p<0.02 ; total bilirubin (mg/dl) 21.6 +/- 2.8 to 18.2 +/- 2.2, p<0.001; PT (s ec) 23.2 +/- 1.7 to 21.9 +/- 1.0, p<0.3. Group II (n = 8): patients wi th chronic liver failure experiencing acute exacerbation. Two patients survived and later underwent OLT: Six patients (not OLT candidates) d ied 1-14 days after last BAL treatment Laboratory values pre- and post -treatment. ammonia (mu mol/l) 201 +/- 47 to 143 +/- 25, p<0.06; total bilirubin (mg/dl) 22.8 +/- 5.2 to 19.5 +/- 4.4, p<0.01; PT (sec) 22.5 +/- 2.0 to 21.8 +/- 1.1, p<0.6. Conclusion: our clinical experience w ith the BAL suggests that it may serve as ''bridge'' to OLT in patient s with FHF primarily by reversing intracranial hypertension, but it is not a substitute for OLT in patients with end-stage liver disease who are non-transplant candidates.