INTERPRETATION GUIDE Quantifying fibrosis with FibroScan FibroScan: medical device which measures liver stiffness (fibrosis)® Immediate results and CAP (steatosis)simultaneously on the same volume of tissue (3High reproducibility of exams results, irrespective of operator cm3) (Intra-class correlation coefficient: 0.84) [1] Non-invasive, painless, reliable, reproducible and quantitative More than 2,000 peer-reviewed publications* on liver stiffness measurements measurement (LSM) Chronic Hepatitis C (n=183) [2] Chronic Hepatitis B (n=4386) [3] HCV-HIV co-infection (n=100)[4] NAFLD (n=246) [5] Alcohol (n=834) [6] Primary Biliary Cholangitis (n=103) [7] Autoimmune hepatitis (n=94) [8] | | | | | | | | | | | | | | | | | | | | | | | | 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 75 LIVER STIFFNESS (KPA) F0-F1 F2 F3 F4 Factors affecting liver stiffness [9] Amyloidosis Fibrosis (portal,sinusoidal, content…) Cholestasis Acute inflammation, flares, elevated Congestion transaminases… (heart failure,…) Other histological parameters (inflammation, ballooning, steatosis…) Meal [1] Recio, E., et al. Interobserver concordance in controlled attenuation parameter measurement, a novel tool for the assessment of hepatic steatosis on the basis of transient elastography. European Journal of Gastroenterology & Hepatology 2013; 25 (8) : 905-11. [2] Castera, et al., Prospective comparison of transient elastography, Fibrotest, APRI, and liver biopsy for the assessment of fibrosis in chronic hepatitis C. Gastroenterology 2005 Feb;128(2):343-50. [3] Li, et al., Systematic review with meta-analysis: FibroScan for liver fibrosis in chronic hepatitis B. Aliment Pharmacol Ther 2016 Feb;43(4):458-69. doi: 10.1111/apt.13488. Epub 2015 Dec 15. [4] Sanchez-Conde, et al., Comparison of transient elastography and liver biopsy for the assessment of liver fibrosis in HIV/hepatitis C virus-coinfected patients and correlation with noninvasive serum markers. J Viral Hepat. 2010 Apr;17(4):280-6. doi: 10.1111/j.1365-2893.2009.01180.x. Epub 2009 Sep 2. [5] Wong, et al., Diagnosis of Fibrosis and Cirrhosis Using Liver Stiffness Measurement in Nonalcoholic Fatty Liver Disease. hepatology. 2010 [6] D’après Brunt score : Pavlov, C.S., et al., Transient Elastography for diagnosis of stages oh hepatic fibrosis and cirrhosis in people with alcoholic liver disease. The Cochrane database of systematic reviews, 2015. 1: p. CD010542. [7] Corpechot, et al., Noninvasive elastography-based assessment of liver fibrosis progression and prognosis in primary biliary cirrhosis. Hepatology. 2012 Jul;56(1):198-208. doi: 10.1002/hep.25599. Epub 2012 Jun 5. [8] Hartl, et al.,Transient elastography in autoimmune hepatitis: Timing determines the impact of inflammation and fibrosis. J hepatol. 2016 Oct;65(4):769-775. doi: 10.1016/j.jhep.2016.05.023. Epub 2016 May 26. [9] Mueller, S. et L. Sandrin, Liver stiffness: a novel parameter for the diagnosis of liver disease. Hepatic Medicine: Evidence and Research, 2010: p. 49-67.* Publications parues dans des revues à comité de lecture. Retrouvez toutes les publications relatives à l’élasticité et au CAP sur la Librairie Clinique Echosens : http://www.echosensclinicallibrary.com/ These guides are based on a selection of clinical studies from the existing literature reporting use of stiffness and CAP with FibroScan. These guides are not intended to be used as a conversion table from liver stiffness and CAP readings in kilopascals (kPa) and decibels per meter (dB/m) tofibrosis and steatosis grade. These guides can in no way replace the judgment of the physician who is ultimately responsible for the final diagnosis. Echosens accepts no responsibility for the incorrect and/or inappropriate interpretation of liver stiffness or CAP values. FibroScan® is a class IIa medical device according to Directive EC/93/42 and is manufactured by Echosens. CE mark is in progress. FibroScan® is indicated for the non invasive measurement of liver stiffness (E) and controlled attenuation parameter (CAP) in humans. It is expressly recommended to carefully read the guidance and instruction of the users’ guide and labeling of the device. Results obtained must be interpreted by a physician experienced in dealing with liver disease, taking into account the complete medical record of the patients. Our products are subject to regulatory requirements that vary from country to country and therefore may not be available for sale or distribution in all markets. ESAESID REVIL