Non-invasive evaluation of liver disease severity and prognosis
These new EASL guidelines are a big step forward towards non-invasive management of patients with liver diseases and provide an unprecedented level of recommendation to Echosens solutions.
These new EASL Guidelines are very prescriptive for FibroScan® parameters.
• LSM by TE benefiting from unprecedented support from 13 “strong recommendations” and 4 other recommendations or supportive statements.
• CAP™ now mentioned in the guidelines, with clear cut-off for steatosis
• SSM now recommended as an additional NIT to further improve risk stratification and refine the risk of high-risk varices.
These new EASL Guidelines position FibroScan® as the cornerstone NIT for the future of liver diseases management, all along the liver care continuum and across all population groups.
…all along the liver care continuum, with a pivotal role in the 2 pathways presented in the guideline:
for early patient identification, in 1st line after Fib-4, either in primary care, diabetology clinic or liver clinic
for advanced liver disease patients management, portal hypertension and HCC risk stratification mentioned in 26 recommendations or statements
…across all population groups, mentioned in 26 recommendations or statements:
In NAFLD/NASH, ALD, HCV, PBS/PSC/AIH and even General Population (after Fib-4).
These new EASL Guidelines place FibroScan® as the NIT of reference, combining standardization, clinical performance and accessibility.
All recommended cut-off values are clearly specified for LSM by TE.
Upon referral of a patient with FIB-4 over 1.3, the use of TE and/or patented serum tests should be used to rule out/in advanced fibrosis (see Fig. 1) (LoE 2, strong recommendation).
Rule-out advanced fibrosis
LSM by TE <8 kPa preferred when available [LoE 3; strong recommendation]
For referral of at-risk patients (rule-in advanced fibrosis)
LSM by TE >=12-15 kPa (after considering causes of false positives) [LoE2; strong recommendation]
In patients with elevated liver stiffness and biochemical evidence of hepatic inflammation, LSM by TE should be repeated after at least 1 week of alcohol abstinence or reduced drinking [LoE 3; strong recommendation].
For patient with cACLD previous to antiviral therapy, LSM post-SVR could be helpful to refine the stratification of residual risk of liver-related complications; yearly repetition of LSM can be carried out while waiting confirmatory data [LoE3].
Although there has not been a general consensus for cut-off values, CAP values above 275 dB/m might be used to diagnose steatosis, since they have showed over 90% sensitivity to detect steatosis
Rule-out advanced fibrosis
LSM by TE <8 kPa [LoE 1; strong recommendation]
LSM by TE (and serum scores) should be used to stratify the risk of liver-related outcomes in NAFLD [LoE 3; strong recommendation].
Rule-in severe fibrosis/cACLD
LSM by TE >10 kPa [LoE 3; strong recommendation].
Discrimination of early and advanced stage disease at baseline
LSM by TE < or > 10 kPa and biochemical parameters [LoE 3; strong recommendation].
During treatment, risk stratification should be based on assessment of response by using continuous and/or qualitative criteria of response and LSM by TE [LoE 3; strong recommendation].
Rule-in advanced fibrosis in compensated patients with normal bilirubin and normal bilirubin without high-grade stenosis
LSM by TE > 9.5 kPa [LoE 3; weak recommendation].
LSM by TE correlate with outcomes and should be used for risk stratification both at baseline and during follow-up [LoE 3; strong recommendation].
In AIH patients, LSM by TE can be used in patients who are being treated to monitor the disease course together with transaminases and IgG,
and to stage live fibrosis after at least 6 months of immunosuppressive therapy [LoE 3; weak recommendation].
LSM by TE < 8-10 kPa [LoE 3; strong recommendation].
LSM by TE > 12-15 kPa [LoE 3; strong recommendation].
Diagnose CSPH in patients with cACLD
LSM by TE > 20-25 kPa [LoE 1; strong recommendation].
Rule-out high-risk varices and avoid endoscopic screening in patients with cACLD due to untreated viral hepatitis, HIV-HCV coinfection, alcohol, NAFLD, PBC, and PSC
LSM by TE < 20 kPa and platelet count > 150 G/L (BAVENO VI criteria) [LoE 1a; strong recommendation] (cf. Fig.2)
“Spleen stiffness” is added as “additional NITs to further improve risk stratification for CSPH” as well as “additional tool to redefine the risk of high-risk varices in cACLD”
“Liver stiffness can be used in addition to clinical variables and accepted risk scores to stratify the risk of HCC in patients with cACLD due to HBV”
“Inter-system variability should be taken into account when interpreting the results of different elastography techniques, since values, ranges and cut-offs [from different US-based elastography devices] are not comparable” (LoE 3, strong recommendation).
Recommendations included in 2015 Clinical Practice Guidelines not revised in the 2021 update remain applicable.
LoE: Level of Evidence
Level of evidence (LoE) – 1; 2; 3; 4; 5
Strength of recommendation – strong; weak
Based on PICO questions
Divided into 6 population groups, with 17 PICO questions