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Noninvasive Techniques for the Evaluation and Monitoring of Patients with Chronic Liver Disease

Section: Laboratory
Effective Date: March 01, 2020
Revised Date: February 28, 2020
Last Reviewed: January 22, 2020

Description

The diagnosis of non-neoplastic liver disease is often made from needle biopsy samples. Noninvasive monitoring alternatives to liver biopsy in patients with chronic liver disease are; specialized radiologic methods, including magnetic resonance elastography, transient elastography, acoustic radiation force impulse imaging, and real-time transient elastography.

Noninvasive Imaging Technologies

Noninvasive imaging technologies to detect liver fibrosis or cirrhosis among patients with chronic liver disease are being evaluated as alternatives to liver biopsy. The noninvasive imaging technologies include transient elastography (e.g FibroScan), magnetic resonance elastography, acoustic radiation force impulse (ARFI) imaging (e.g, Acuson S2000), and real-time tissue elastography (e.g., HI VISION Preirus). 

Transient Elastography

Transient elastography (FibroScan) uses a mechanical vibrator to produce mild amplitude and low-frequency (50 Hz) waves, inducing an elastic shear wave that propagates throughout the liver. Ultrasound tracks the wave, measuring its speed in kilopascals, which correlates with liver stiffness. Increases in liver fibrosis also increase liver stiffness and resistance of liver blood flow. Transient elastography does not perform as well in patients with ascites, higher body mass index, or narrow intercostal margins. Although FibroScan may be used to measure fibrosis (unlike liver biopsy), it does not provide information on necroinflammatory activity and steatosis, nor is it accurate during acute hepatitis or hepatitis exacerbations.

ARFI Imaging

ARFI imaging uses an ultrasound probe to produce an acoustic “push” pulse, which generates shear waves that propagate in tissue to assess liver stiffness. ARFI elastography evaluates the wave propagation speed (measured in meters per second) to assess liver stiffness. The faster the shear wave speed, the harder the object. ARFI technologies include Virtual Touch Quantification and Siemens Acuson S2000 system. ARFI elastography can be performed at the same time as a liver sonographic evaluation, even in patients with a significant amount of ascites.

Magnetic Resonance Elastography

Magnetic resonance elastography uses a driver to generate 60-Hz mechanical waves on the patient’s chest wall. The magnetic resonance equipment creates elastograms by processing the acquired images of propagating shear waves in the liver using an inversion algorithm. These elastograms represent the shear stiffness as a pixel value in kilopascals. Magnetic resonance elastography has several advantages over ultrasound elastography, including: (1) the ability to analyze larger liver volumes; (2) the ability to analyze liver volumes of obese patients or patients with ascites; and (3) the ability to precisely analyze viscoelasticity using a 3-dimensional displacement vector.

Real-Time Tissue Elastography

Real-time tissue elastography is a type of strain elastography that uses a combined autocorrelation method to measure tissue strain caused by manual compression or a person’s heartbeat. The relative tissue strain is displayed on conventional color B mode ultrasound images in real-time. Hitachi manufactures real-time tissue elastography devices, including the HI VISION Preirus. The challenge is to identify a region of interest while avoiding areas likely to introduce artifacts, such as large blood vessels, the area near the ribs, and the surface of the liver. Areas of low strain increase as fibrosis progresses and strain distribution becomes more complex. Various subjective and quantitative methods have been developed to evaluate the results. Real-time tissue elastography can be performed in patients with ascites or inflammation. This technology does not perform as well in severely obese individuals.

Criteria

Transient elastography (FibroScan) imaging may be considered medically necessary for the evaluation of patients with chronic liver disease

Transient elastography (FibroScan) imaging is considered investigational for monitoring of patients with chronic liver disease.

The use of other noninvasive imaging, including but not limited to magnetic resonance elastography, acoustic radiation force impulse imaging (e.g., Acuson S2000), or real-time tissue elastography, is considered investigational for the evaluation or monitoring of patients with chronic liver disease.

Procedure Codes

 

76391

76981

76982

 76983

91200

Diagnosis Codes

NA

Professional Statements and Societal Positions Guidelines

Practice Guidelines and Position Statements

Nonalcoholic Fatty Liver Disease

American Gastroenterological Association et al

The practice guidelines on the diagnosis and management of NAFLD, developed by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, and the American College of Gastroenterology (2018) stated that “NFS [NAFLD fibrosis score] or FIB-4 [Fibrosis-4] index are clinically useful tools for identifying NAFLD patients with higher likelihood of having bridging fibrosis (stage 3) or cirrhosis (stage 4).” It also cited VCTE [vibration-controlled transient elastography] and MRE [magnetic resonance elastography] as “clinically useful tools for identifying advanced fibrosis in patients with NAFLD.”

National Institute for Health and Care Excellence

The NICE (2016) published guidance on the assessment and management of NAFLD. The guidance did not reference elastography. The guidance recommended the enhanced liver fibrosis test to test for advanced liver fibrosis, utilizing a cut-off enhanced liver fibrosis score of 10.51.

American Gastroenterological Association Institute

The American Gastroenterological Association Institute (2017) published guidelines on the role of elastography in chronic liver disease. The guidelines indicated that, in adults with NAFLD, VCTE has superior diagnostic sensitivity and specificity for diagnosing cirrhosis than the APRI or FIB-4 tests (very low quality of evidence). Moreover, the guidelines stated that, in adults with NAFLD, magnetic resonance-guided elastography has little or no increased diagnostic accuracy for identifying cirrhosis compared with VCTE in patients who have cirrhosis, and has higher diagnostic accuracy than VCTE in patients who do not have cirrhosis (very low quality of evidence).

Hepatitis B and C Viruses

National Institute for Health and Care Excellence

The NICE (2013) published guidance on the management and treatment of patients with hepatitis B. The guidance recommended offering transient elastography as the initial test in adults diagnosed with chronic hepatitis B, to inform the antiviral treatment decision.

 Antiviral Treatment Recommendations by Transient Elasticity Score

Transient Elasticity Score

Antiviral Treatment

>11 kPa

Offer antiviral treatment

6-10 kPa

Offer liver biopsy to confirm fibrosis level prior to offering antiviral treatment

<6 kPa plus abnormal (ALT)

Offer liver biopsy to confirm fibrosis level prior to offering antiviral treatment

<6 plus normal ALT

Do not offer antiviral treatment

ALT: alanine aminotransferase; kPa: kilopascal.

As of September 2016, the NICE had placed a pause on the development of the guidance on hepatitis C, citing instability and costs in the availability of treatments for the condition.

American Association for the Study of Liver Diseases and Infectious Diseases Society of America

The American Association for the Study of Liver Diseases and Infectious Diseases Society of America (2018) guidelines for testing, managing, and treating hepatitis C virus (HCV) recommended that, for counseling and pretreatment assessment purposes, the following should be completed:

“Evaluation for advanced fibrosis using liver biopsy, imaging, and/or noninvasive markers is recommended in all persons with HCV infection to facilitate an appropriate decision regarding HCV treatment strategy and determine the need for initiating additional measures for the management of cirrhosis (e.g., hepatocellular carcinoma screening).
Rating: Class I, Level A [evidence and/or general agreement; data derived from multiple randomized trials, or meta-analyses]”

The guidelines noted that there are several noninvasive tests to stage the degree of fibrosis in patients with HCV. Tests included indirect serum biomarkers, direct serum biomarkers, and VCTE. The guidelines asserted that no single method is recognized to have high accuracy alone and careful interpretation of these tests is required.

American Gastroenterological Association Institute

Guidelines published by the American College of Gastroenterology Institute (2017) on the role of elastography in chronic liver disease indicated that, in adults with chronic hepatitis B virus and chronic HCV, VCTE has superior diagnostic performance for diagnosing cirrhosis than the APRI and FIB-4 tests (moderate quality of evidence for HCV, low quality of evidence for hepatitis B virus). In addition, the guidelines stated that, in adults with HCV, magnetic resonance-guided elastography has little or no increased diagnostic accuracy for identifying cirrhosis compared with VCTE in patients who have cirrhosis, and has lower diagnostic accuracy than VCTE in patients who do not have cirrhosis (very low quality of evidence).

Chronic Liver Disease

American College of Radiology

The American College of Radiology (2017) appropriateness criteria rated 1-dimensional transient elastography as a 7 (usually appropriate) for the diagnosis of liver fibrosis in patients with chronic liver disease. The criteria noted, “This procedure is less reliable in diagnosing liver fibrosis and cirrhosis in patients with obesity or ascites.”

European Association for the Study of Liver Disease et al

The European Association for the Study of Liver Disease and the Asociacion Latinoamericana para el Estudio del Higado (2015) convened a panel of experts to develop clinical practice guidelines on the use of noninvasive tests to evaluate liver disease severity and prognosis. The publication summarized the advantages and disadvantages of noninvasive techniques (serum biomarkers, imaging techniques). Table 9 summarized the joint recommendations for serum biomarkers and transient elastography.

Table 9. Recommendations for Serum Biomarkers and Transient Elastography

Biomarkers

QOE

SOR

“Serum biomarkers can be used in clinical practice due to high applicability (>95%) and good reproducibility.”

High

Strong

“TE can be considered the non-invasive standard for the measure of LS”

High

Strong

“Serum biomarkers are well-validated for chronic viral hepatitis…. They are less well-validated for NAFLD not validated in other chronic kidney diseases.”

High

Strong

"For the diagnosis of significant fibrosis a combination of tests with concordance may provide the highest diagnostic accuracy”

High

Weak

“All HCV patients should be screened to exclude cirrhosis by TE [or]… serum biomarkers.…”

High

Strong

“Non-invasive assessment including serum biomarkers or TE can be used as first-line procedure for the identification of patients at low risk of severe fibrosis/cirrhosis”

High

Strong

“Follow-up assessment by either serum biomarkers or TE for progression of liver fibrosis should be used for NAFLD patients at a 3-year interval”

Moderate

Strong

HCV: hepatitis C virus; LS: liver stiffness; NAFLD: nonalcoholic fatty liver disease; QOE: quality of evidence; SOR: strength of recommendation; TE: transient elastography.

Disclaimer

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