Interpretation of FibroScan

TE & CAP
 Transient Elastography (TE)
• TE is reliable for the diagnosis of cirrhosis in patients with chronic liver diseases.
• Most extensively studied and validated imaging technique, with high intra- and
inter-observer reproducibility.
• TE is better at “ruling out” than “ruling in” cirrhosis (NPV = 96% and PPV = 74%)
• Correctly classifies cirrhosis in 80 to 98% of patients (AUROC 0.8-0.99); less
accurate for lesser fibrosis.
• Cut-offs are different by diagnosis.
• TE is better validated in viral (HCV, HCV/HIV, HBV) than in NAFLD.
• If ALT higher than 5 x ULN, repeat test after hepatitis is controlled.
• In Alcoholic Liver Disease the values are not very reliable while actively drinking.
• If AST is > 100 U/mL, repeat the Test after 2 weeks or more of abstinence.
 • Interquartile Range IQR/ median value (<30%),
• Serum aminotransferases levels (<5 x ULN),
Parameters • Absence of extra-hepatic cholestasis,
Needed for • Absence of right heart failure, or other causes
of congestive liver
Correct • Absence of ongoing excessive alcohol intake,
Interpretation • BMI (use XL Probe above BMI of 30 kg/m2 or if
skin-to-capsule distance is >25 mm),
of TE & CAP • Presence of Diabetes Mellitus
• Presence of NAFLD or NASH
 UofL TE Interpretation Summary
Modified from: Bonder A, Afdhal N. Current Gastroenterology Reports 2014; 16:372, Lim JK et al. Gastroenterology 2017; 152:1536-1543,
Moreno C et al. J of Hepatology 2019(70): 273-283; Wu S et al. Hepatology International (2019) 13:91–101

F0-F1 (kPa) F2 (kPa) F3 (kPa) F4 (kPa)

HBV </= 6 6.1 to 9 9.1 to 10.9 >/= 11*
HCV </= 7 7.1 to 9.4 9.5 to 12.4 >/= 12.5*
HCV-HIV </= 7 7.1 to 10 10.1 to 13.9 >/= 14
Cholestatic Liver Disease </= 7 7.1 to 9.9 10 to 16.9 >/= 17
Autoimmune Hepatitis </= 6.2 6.3 to 8.4 8.5 to 12.3 >/= 12.4
NAFLD/NASH </= 7 7.1 to 9.9 10 to 13.9 >/= 14
Alcoholic Liver Disease </= 6 6.1 to 7.9 8 to 12.4 >/= 12.5*
(Abstinent > 2 weeks and without alcoholic [>/= 30 kPa if with AH]
hepatitis (AH))

High Probability of varices >/= 19.5*

Low probability of CSPH < 17*
HBV: -Liver Biopsy if it could change management Baveno VI Consensus recommended: *AGA 2017
-With NORMAL ALT, consider treating if > 9 or 11 kPa (vs Bx) TE >/= 20 kPa, or Platelets < 150,000. Guideline
HCV: after recent SVR, TE </= 9.5 kPa identifies In PBC cut-off is TE >/= 17 kPa.
patients that can be discharged (no HCC risk)
 FibroScan “Controlled Attenuation Parameter” (CAP)
Interpretation
Meta-analysis of 2735 patients comparing histology and CAP with BMI </= 35: Karlas T et al. J Hepatol. 2017 May;66(5):1022-1030**

CAP measures the increased attenuation of ultrasound waves when travelling

through steatotic hepatic tissue, compared to normal liver.
Interpretation is based in studies of CAP results paired with liver biopsy samples.

Steatosis Degree S0 S1 S2 S3
Affected < 10% 10-33% 34-66% > 66%
Hepatocytes (%)
CAP (dB/m) < 248 248-267 268-279 > 280

CORRECTIONS: **Patients with BMI > 35 were excluded

Deduct 10 dB/m for NAFLD/NASH
Deduct 10 dB/m for Diabetes
Deduct 4.4 dB/m for each BMI point below 25 (max 22 dB/m) CAP validity is lower if the IQR of CAP
Add 4.4 dB/m for each BMI point above 25 (max 22 dB/m) is ≥ 40 dB/m (AUROC 0.77 vs 0.9 if < 40)
 Sequential Algorithm for Fibrosis Evaluation (SAFE) in Hepatitis C
Modified from: Journal of Hepatology 2015 vol. 63; 237–264 and Gastroenterology 2017 Vol. 152, 1536–1543

Treatment Naive
Hepatitis C
HCV alone = APRI, FIB-4, FibroTest, or FibroMeter +/- HIV
HCV/HIV = FIB-4, FibroTest, or FibroMeter
Transient Elastography
+ Serum Marker
Discordant
Concordant: Liver Bx will confirm in:
84 % of cases for F ≥2 fibrosis,
Repeat Exams, 95 % for F ≥3 fibrosis, and
Search for Explanation 94 % for F = 4 fibrosis

No Severe Fibrosis Severe Fibrosis

Discordant

Liver Biopsy if Treat and Discharge Treat and place in Screening

HCV: after recent SVR, TE </= 9.5 kPa identifies
Result Influence after Cured Program for Varices and HCC
patients that can be discharged (no HCC risk)
Management
 FibroScan (TE) in Hepatitis C
• When the elastography and FibroTest (e.g.: Fibro Sure, Fibro Test-
ActiTest) results agreed, liver biopsy examination confirmed the stage
of fibrosis in:
• 84 percent of cases for F ≥2 fibrosis,
• 95 percent for F ≥3 fibrosis, and
• 94 percent for F = 4 fibrosis
 In patients with active HCV:

• TE >/= 12.5 kPa reliably identifies cirrhosis

(< 5% False Negative rate).

Transient In patients with HCV after SVR:

Elastography (TE)
in HCV • TE < /= 9.5 kPa, shortly after SVR, reliably
identifies patient who can be discharged (< F3,
with < 7% False Negative rate; no need for
surveillance).

MR elastography is NOT superior to TE

in patients with Hepatitis C.
 Sequential Algorithm for Fibrosis Evaluation (SAFE) in HBV
by ALT Elevation & TE
Modified from: Journal of Hepatology 2015 vol. 63; 237–264 and Gastroenterology 2017 Vol. 152, 1536–1543

Hepatitis B APRI > 2 suggests Cirrhosis (WHO)

Treatment Naive TE is preferred over APRI

Liver Stiffness by
Normal ALT Transient Elastography (TE) Elevated ALT but < 5 x ULN

TE 6 to < 11 kPa TE 6 to < 11 kPa TE >/= 11 kPa

TE < 6 kPa TE >/= 11 kPa TE < 6 kPa
(EASL 6 to 9 kPa) (EASL 6-12 kPa) (EASL > 12 kPa)
(EASL > 9 kPa)

No Significant Gray Severe Fibrosis No Significant Gray Severe Fibrosis

Fibrosis Area Cirrhosis Fibrosis Area Cirrhosis

Any HBV-DNA Level Any HBV-DNA Level

and any HBeAg Status and any HBeAg Status

Consider F/U TE Consider Liver Bx Consider Treatment, Consider F/U TE Consider Liver Bx Consider Treatment,
if HBV-DNA if Results affect Screening for varices, Treat by HBV-DNA If Results affect Screening for varices,
> 2,000 IU Management and for HCC & HBeAg Criteria Management and for HCC
 In patients with HBV:
• TE >/= 11 kPa in USA reliably identifies
cirrhosis (AGA 2017) (In Europe: > 9 kPa
Transient with normal ALT, or > 12 kPa with elevated
ALT < 5 x ULN).
Elastography (TE) • False negative rate < 5% (sens 81%; specif 83%);
in HBV • All patients with cirrhosis should be treated.
• If ALT is elevated but < 5 x ULN, either
HBeAg(+) or HBeAg(-), and independently
of HBV-DNA level:
• TE with kPa >/= 6 to < 11 in USA ( >/= 6 to 12 kPa
in Europe) should lead to liver biopsy, if likely to
change management.
 In patients with HBV:
• If ALT is normal but TE > 11 kPa in USA
(AGA 2017 guidelines) (> 9 kPa in
Europe by EASL 2015), strongly consider
Transient therapy + varices surveillance ( > 19.5
Elastography (TE) kPa)
• All patients with cirrhosis should be treated.
in HBV • In patients older than 35 with normal
ALT, and either HBeAg(+) or HBeAg(-):
• TE with >/= 6 to < 11 kPa in USA (likely >/= 6
kPa to 9 kPa in Europe) should lead to liver
biopsy to decide if treatment is needed (EASL
2015; AGA 2017).
 Sequential Algorithm for Fibrosis Evaluation (SAFE) in NAFLD
Modified from: J Hepatol 2016; 64:1388-1402; J Hepatol 2019; 71:389-396; Am J Gastroenterol 2017;112:740-751

NAFLD Fibrosis Score (NFS) or FIB4

NFS < -1.455 (< 0.12 if age > 65) NFS from -1.455 to 0.676 (0.12 to 6.76 if age > 65) NFS > 0.676
FIB4 < 1.30 (< 2 if age > 65) FIB4 from 1.3 to 3.25 (2 to 3.25 if age > 65) FIB4 > 3.25

Low Risk Intermediate Risk High Risk

F >/= 3 Excluded Grey Zone F >/= 3 Established

FibroSure NASH < 0.3 FibroSure NASH 0.3 to 0.7 FibroSure NASH > 0.7
TE < 7.9 kPa TE 7.9 to 9.6 kPa TE > 9.6 kPa

Monitor Every 2 years Liver Biopsy

TE = Transient Elastography
 SAFE for NAFLD with Transient Elastography + FibroMeter
Modified from: Journal of Hepatology 2019 vol. 71: 389–396

Transient Elastography

Less than 8 kPa 8 to 15.7 kPa More than 15.7 kPa

FibroMeter NAFLD

Less than 0.32 0.32 to 0.69 More than 0.69

with IQR/M >/= 0.3 with IQR/M < 0.3

No or Mild Fibrosis Gray Zone Advanced Fibrosis

F0 to F2 Liver Biopsy F3 to F4
Liver Biopsy
 In patients with NAFLD: TE nor
APRI nor FIB-4 are reliable
enough to diagnose cirrhosis
Transient • In populations with high prevalence
Elastography (TE) of cirrhosis (subspecialty clinic) MR
Elastography is superior to TE to
in NAFLD diagnose cirrhosis in NAFLD (less
“False Positives”).
• Liver Biopsy is needed for accurate
diagnosis/staging, and before drug-
therapy.
 In Alcoholic Liver disease (not actively drinking >/=
2 weeks & AST < 100) a cut-off of 12.5 kPa detects
cirrhosis with low “false negative” rates (< 1.5%)
but relatively high “false positive” rates (27.5% and
20.3%) in low vs high prevalence groups,
respectively, most of the false (+) being F3.

Transient
Elastography (TE) TE is NOT reliable to diagnose cirrhosis in
Acute Alcoholic Hepatitis.
in ALD

In Alcoholic Hepatitis, TE > 30 kPa

indicates cirrhosis.
 In patients with cirrhosis, a TE >/= 19.5 kPa
identifies patients at higher risk of esophageal
varices (AGA Guidelines, 2017).

In PBC, a TE >/= 17 identifies patients at higher

Transient risk of esophageal varices (AASLD PBC-Guidance,
2018)
Elastography (TE) • Baveno VI Consensus recommended TE > 20 kPa or
platelet count < 150,000 as triggers for screening
in Cirrhosis EGD
• A TE of >/= 50.7 kPa suggests high risk of variceal
bleed.
A TE < 17 kPa is indicative of absence of
“clinically significant portal hypertension” (no
varices) with misclassification rate < 6.8%.