Determination of reliability criteria for liver stiffness evaluation in a cohort of 1165 patients
Background and aims: The manufacturer of Fibroscan has defined reliability criteria for liver stiffness evaluation (LSE): ≥10 valid shots with ≥60% success rate and IQR/median ratio (IQR/M) ≤30%. In the present study, we aimed at providing a first-ever assessment of the validity of these LSE reliability criteria. Methods: 1165 patients with chronic hepatitis, liver biopsy, and LSE by Fibroscan were included. Fibrosis classification (F0/1, F2/3, F4) was defined from LSE results according to diagnostic cut-offs published by Friedrich-Rust (Gastroenterology 2008). Results: Causes of chronic hepatitis were: viral hepatitis (76.3%), alcohol (12.6%), NAFLD (2.8%), and other (8.3%). 75.3% of LSEs were reliable according to the manufacturer’s criteria. AUROCs of significant fibrosis (F≥2), severe fibrosis (F≥3), and cirrhosis (F4) were not significantly different between reliable and unreliable LSEs, respectively: 0.836±0.014 vs 0.789±0.027 (p=0.122), 0.882±0.011 vs 0.857±0.023 (p=0.327), and 0.915±0.012 vs 0.906±0.021 (p=0.710). Significant fibrosis was independently associated with LSE result (1st step, p <10-3), age (2nd step, p <10-3), and IQR/M (3rd step, p=0.028). Severe fibrosis was independently associated with LSE result (1st step, p<10-3), IQR/M (2nd step, p=0.007), and age (3rd step, p=0.007). Cirrhosis was independently associated with LSE result (1st step, p <10-3), biopsy length (2nd step, p=10-3), and IQR/M (3rd step, p=0.011). AUROCs for significant fibrosis, severe fibrosis, and cirrhosis were significantly higher when IQR/M was ≤0.10. In LSE 0.30. In LSE >13.0kPa, the diagnostic accuracy significantly decreased when IQR/M was >0.10. 17.3% of patients had an IQR/M ≤0.10, 68.1% had 0.100.30. Conclusion: The Reliability criteria for LSE defined by the Fibroscan manufacturer are not relevant: the only parameter influencing LSE accuracy is IQR/M; number of valid shots and success rate had no influence. IQR/M defines 3 groups of LSE: “very reliable” when IQR/M is ≤0.10, especially in LSE >13 kPa; “reliable” when IQR/M is between 0.10 and 0.30; and “unreliable” when IQR/M is >0.30 in LSE ≥7.6kPa.
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