THE HEPATIX EXTRACORPOREAL LIVER ASSIST DEVICE - INITIAL CLINICAL-EXPERIENCE

Eleven patients were treated with the Hepatix extracorporeal liver ass ist device (ELAD) between June 1991 and August 1993. The first 2 patie nts were treated according to Food and Drug Administration guidelines (''Emergency Use of Unapproved Medical Devices,'' October 22, 1985), a nd the remaining 9 were treated according to an Investigational Device Exemption (IDE). The goal of the study was to establish the short-ter m safety of ELAD therapy, with a focus on acute medical complications such as hemodynamic instability, complement activation, and deteriorat ion of vital organ function. As secondary goals, the metabolic capacit y of ELAD cartridges and their clinical impact were assessed. Treatmen t was considered successful if the patient recovered sufficient liver function to survive weaning from the ELAD or was stabilized until orth otopic liver transplantation was performed. No short-term safety probl ems were associated with ELAD use. In addition, metabolic support was documented in 10 of the 11 patients, and 6 patients reached a successf ul end-point. The Hepatix ELAD is safe, and it provides measurable met abolic support in patients with late-stage liver failure. This pilot s tudy provides the impetus to perform controlled trials of ELAD therapy in the treatment of various types of end-stage liver disease.