Drug & Device Development

Bioartificial liver improves survival in patients with severe hepatic failure

Last Updated: 2004-04-22 15:21:50 -0400 (Reuters Health)

NEW YORK (Reuters Health) - Extracorporeal support with a bioartificial liver can significantly improve survival in patients with fulminant/subfulminant hepatic failure (FHF/SHF), according to a report in the May issue of the Annals of Surgery.

Developed by researchers at the Cedars-Sinai Medical Center in Los Angeles, the HepatAssist support system is an extracorporeal bioartificial liver (BAL) that uses porcine hepatocytes.

"This is the first prospective, randomized, controlled, multicenter trial demonstrating a survival advantage for an extracorporeal liver assist system in FHF/SHF patients," lead author Dr. Achilles A. Demetriou, from Cedars-Sinai, and colleagues note.

The study involved 171 patients, with FHF/SHF or a nonfunctioning liver after transplantation, who were treated with the BAL system or received standard supportive care.

In the entire patient population, 30-day survival in the BAL group of 71% was not significantly different from the rate in the control group at 62%. However, when the analysis was limited to the 147 patients with FHF/SHF, a survival advantage for BAL emerged. Specifically, BAL-treated patients were 44% less likely to die those receiving standard care (p = 0.048).

The strongest predictor of survival was transplantation, the investigators point out.

With the exception of thrombocytopenia, noted in about 35% of patients in both groups, adverse effects were relatively uncommon, the authors report. Moreover, the groups did not differ significantly in the occurrence of any adverse event.

The results suggest that BAL can improve survival in FHF/SHF patients, the researchers state. "The outcome of the study becomes more important when one takes into account the heterogeneity of the patient population, the large number of centers involved with varying local standards of care, and the high degree of severity of illness of the study population."

Ann Surg 2004;239:000-000.