Artificial Liver Assist Devices for the Treatment of Liver Conditions
Liver assist devices are intended to support an individual in acute liver failure until the native liver has time to recover, or to bridge the individual to liver transplantation. This procedure may also be referred to as liver dialysis. Liver assist therapies may include cell-free artificial or bioartificial systems.
Cell-free artificial support therapies make use of the processes of adsorption and filtration, assuming that removal of toxins from the individual’s plasma will result in clinical improvement. Bioartificial systems were developed to assume some of the functions of the liver in addition to providing detoxification. Liver cells (hepatocytes) derived from human or animal sources have been investigated for this purpose.
A variety of liver assist systems have been tested in nonrandomized trials including: HepatAssist™, extracorporeal liver support device (ELAD™), modular extracorporeal liver support system (MELS™), bioartificial liver support system (BLSS™), and the Amsterdam Medical Center bioartificial liver (AMC-BAL™). To date, these systems have not proven to provide a substantial survival benefit.
Artificial liver assist devices for the treatment of liver conditions are considered investigational.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
The American Association for the Study of Liver Diseases (AASLD) maintains that despite great early interest in liver support systems, the field has had little forward movement. Both artificial (i.e., sorbent-based) and bioartificial (i.e., cell-based) systems have been tested. They find no good evidence that any liver support system reliably reduces mortality in acute liver failure.
American Association for the Study of Liver Diseases (AASLD). (2011, December). AASLD position paper: The management of acute liver failure: update 2011. Retrieved March 26, 2014 from https://www.aasld.org.
Bañares, R., Catalina, M. V., & Vaquero, J. (2014). Molecular adsorbent recirculating system and bioartificial devices for liver failure. Clinical Liver Disease, 18 (4), 945-956. Abstract retrieved August 2, 2016 from PubMed database.
Bernal, W., & Wendon, J. (2013). Acute liver failure. The New England Journal of Medicine, 369, 2525-2534. (Level 5 evidence)
Karvellas, C. J., & Subramanian, R. M. (2016). Current evidence for extracorporeal liver support systems in acute liver failure and acute-on-chronic liver failure. Critical Care Clinic, 32 (3), 439-451. Abstract retrieved August 2, 2016 from PubMed database.
Lexmond, W., Van Dael, C., Scheenstra, R., Goohuis, J., Sieders, E., Verkade, H., et al. (2015). Experience with molecular adsorbent recirculating system treatment in 20 children listed for high-urgency liver transplantation. Liver Transplantation, 21 (3), 369-380. Abstract retrieved May 25, 2017 from PubMed database.
National Institute for Health and Clinical Excellence. (2009, September). Extracorporeal albumin dialysis for acute liver failure. Retrieved October 4, 2012 from http://www.nice.org.
Pares, A. & Mas, A. (2014, July). Extracorporeal liver support in severe alcoholic hepatitis. World Journal of Gastroenterology, 20 (25), 8011-8017. (Level 5 evidence)
Tsipotis, E., Shuja, A., & Jaber, B. (2015). Albumin dialysis for liver failure: a systematic review. Advances in Chronic Kidney Disease, 22 (5), 382-390. Abstract retrieved May 25, 2017 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.
U. S. Food and Drug Administration. (2005, May). Center for Devices and Radiological Health. 510(k)Premarket Notification Database. K033262. Retrieved October 4, 2012 from http://www.accessdata.fda.gov.
Willars, C. (2014). Update in intensive care medicine: acute liver failure. Initial management, supportive treatment and who to transplant. Current Opinion in Critical Care, 20 (2), 202-209. Abstract retrieved August 2, 2016 from PubMed database.
ORIGINAL EFFECTIVE DATE: 9/1/2002
MOST RECENT REVIEW DATE: 5/9/2019
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.
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