Evaluation of Hepatic Dysfunction in Patients Receiving Intravenous Amiodarone at an Academic Veterans Affairs Medical Center

Abstract

Purpose: Amiodarone is a class III anti-arrhythmic used for the treatment of life-threatening ventricular arrhythmias. The adverse effects of oral amiodarone are well documented and involve most organ systems leading to the cessation of the medication in 10-15% of patients. In contrast, IV amiodarone has been documented in only a few case reports causing transaminitis. Several studies have indicated that hepatic dysfunction may be the diluent rather than the drug itself. Amiodarone is dissolved in polysorbate-80 and animal studies show that it causes hemolysis, cholestasis, and reversible fat accumulation in rat hepatocyte cell lines within three hours of exposure. Other medications with the polysorbate-80 diluent also support the hypothesis that it may be a causative factor of hepatic injury. The purpose of this study is to evaluate the degree of hepatic dysfunction and mortality in patients receiving intravenous amiodarone at the Michael E. DeBakey VA Medical Center between July 2005 and July 2011. The primary objective is to determine the incidence of transaminitis (ALT or AST > twice the normal value) in patients receiving IV amiodarone. Secondary objectives include determining the incidence of in-hospital and all-cause mortality. Methods: The study is a single-center, retrospective chart review of patients who have received IV amiodarone between July 2005 and July 2011. Patients less than 18 years of age or pregnant were excluded in addition to those who received only oral amiodarone, or received IV amiodarone one week prior to hospital admission. Descriptive statistics will be used to analyze baseline characteristics and study outcomes. Data will be presented in percentages, mean and median values. Results: A total of 1510 patients received intravenous amiodarone from July 2005 to July 2011. Seventy-eight patients, approximately 5.16% had elevated liver enzymes [median:range; AST 253:82-12005; ALT 189:37-10006] after the administration of IV amiodarone. Of the 78 patients with transaminitis, 10 developed fulminate hepatic failure (AST or ALT >1000) with 90% all-cause mortality. Most patients developed a transient transaminitis that lasted three days on average that resolved with cessation of the medication. Conclusion: Although transaminitis is common with oral amiodarone, only 5.16% developed transaminitis while receiving intravenous amiodarone. Since the transaminitis resolved after cessation of the medication, it is more of a transient hepatic injury. The incidence of fulminate hepatic failure was rare but with an all cause mortality of 90%.