Artificial Liver Assist Devices for the Treatment of Liver Conditions
DESCRIPTION
Artificial liver assist devices, for the treatment of liver conditions, are intended as support therapy or treatment option, for individuals with liver failure caused by illness, alcohol, poisons or drugs. The device is intended to remove toxins from the blood stream.
The devices and therapies under investigation vary. The biological liver support therapies utilize hepatocytes or whole organs derived from animal or human sources. The non-biological approaches are based on dialysis, filtration, and adsorption techniques. The procedure can be referred to as liver dialysis.
POLICY
Artificial liver assist devices for the treatment of liver conditions is considered investigational.
ADDITIONAL INFORMATION
The lack of randomized controlled studies and the poor quality of published studies provide little evidence of the efficacy of these devices or the effect on health outcomes.
SOURCES
American Association for the Study of Liver Diseases (AASLD). (2005, May). AASLD position paper: The management of acute liver failure. Retrieved June 1, 2009 from http://www.aasld.org/practiceguidelines/Documents/Bookmarked%20Practice%20Guidelines/acute%20liver%20failure.pdf.
Bachli, E. B., Schuepbach, R. A., Maggiorini, M., Stocker, R., Mullhaupt, B., & Renner, E. L. (2007). Artificial liver support with the molecular adsorbent recirculating system: Activation of coagulation and bleeding complications. Liver International, 27 (4), 475-484. Abstract retrieved July 9, 2007 from PubMed.
Bansal, B., & Dhawan, A. (2006). Acute liver failure. Indian Journal of Pediatrics, 73 (10), 931-934.
Koffron, A., & Stein, J. A. (2008). (2008). Liver transplantation: Indications, pretransplant evaluation, surgery, and posttransplant complications. Medical Clinics of North America, 92 (4) 861-888.
Munoz, S. J. (2008). The hepatorenal syndrome. Medical Clinics of North America, 92 (4) 813-837.
Munoz, S. J. (2008). Hepatic encephalopathy. Medical Clinics of North America, 92 (4) 795-812.
Park, J. K. & Lee, D. H. (2005). Bioartificial liver systems: Current status and future perspective. Journal of Bioscience and Bioengineering, 99 (4), 311-319.
Stadibauer, V., & Jalan, R. (2007). Acute liver failure: Liver support therapies. Current Opinion in Critical Care, 13 (2), 215-221. Abstract retrieved July 9, 2007 from PubMed database.
U. S. Food and Drug Administration. (1999, September). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K992196. Retrieved May 29, 2009 from http://www.fda.gov/cdrh/pdf/k992196.pdf.
Van de Kerhove, M. P., Hoekstra, R., Chamuleau, R. A., & van Gulik, T. M. (2004). Clinical application of bioartificial liver support systems. Annals of Surgery, 240 (2), 216-230.
ORIGINAL EFFECTIVE DATE: 9/1/2002
MOST RECENT REVIEW DATE: 7/9/2009
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.