Two-dimensional shear wave elastography (ElastQ) accurately rules out liver fibrosis and rules in advanced chronic liver disease across liver disease etiologies: a prospective multicenter study

Abstract

Purpose: This study evaluated ElastQ, a two-dimensional shear wave elastography (2D-SWE) technique, for the non-invasive assessment of liver fibrosis risk using liver stiffness measurement (LSM). The aim was to determine its diagnostic accuracy and establish LSM cutoffs for clinical risk stratification.

Methods: A prospective multicenter study was conducted, employing vibration-controlled transient elastography (VCTE) as a reference standard. The statistical analysis utilized Pearson correlations and Lin concordance correlation coefficients, diagnostic areas under the curve (AUCs), and 90%-specific rule-in and 90%-sensitive rule-out ElastQ cutoffs.

Results: The study included 875 patients at risk for liver disease, of whom 816 (376 women, 46.1%; median age, 57.0 years [interquartile range, 19.0]) had successful and reliable VCTE- and ElastQ-LSMs. The median LSM was 13.0 kPa (range, 2.0 to 75.0 kPa) for VCTE and 6.6 kPa (range, 2.9 to 26.5 kPa) for ElastQ. The correlation between VCTE-LSM and ElastQ-LSM was adequate for VCTE-LSM <15 kPa (Pearson r=0.63) but lower for VCTE-LSM ≥15.0 kPa (Pearson r=0.27). VCTE-LSM indicated no fibrosis risk (<5.0 kPa) in 178 cases (21.8%), gray zone (5.0-9.9 kPa) in 347 cases (42.5%), and advanced chronic liver disease (ACLD; ≥10.0 kPa) in 291 cases (35.7%). The diagnostic AUC for ElastQ-LSM was 0.82 for fibrosis risk and 0.90 for ACLD. The clinically relevant ElastQ cutoffs for ruling out fibrosis risk and ruling in compensated ACLD (cACLD) were <5.0 kPa and ≥9.0 kPa, respectively.

Conclusion: ElastQ 2D-SWE enables accurate, non-invasive assessments of liver fibrosis and cACLD risk. In clinical practice, ElastQ-LSM <5.0 kPa rules out fibrosis, while ElastQ-LSM ≥9.0 kPa rules in cACLD.

Keywords: Compensated advanced chronic liver disease; Non-invasive, chronic liver disease; Two-dimensional shear wave elastography; Ultrasound.

Fig. 1.. Study population flow chart.

A. Flow chart of the study population is shown. B. After the use of shear wave elastography the FIB-4 score was applied in a two-step approach to further refine fibrosis risk assessment. FIB-4, Fibrosis-4 score; VCTE, vibration-controlled transient elastography; LSM, liver stiffness measurement; EQ, ElastQ; ACLD, advanced chronic liver diseases; cACLD, compensated ACLD.

Fig. 2.. The correlation of ElastQ-LSM with VCTE-LSM overall and below and above 15 kPa.

Scatterplot shows (A) reliable LSM obtained through ElastQ and VCTE, including the correlation line and Pearson correlation results of VCTEand ElastQ-LSM (lower right corner), and (B) reliable LSM obtained through ElastQ and VCTE, featuring Pearson correlation results and correlation lines for values equal to and below 15 kPa (red) as well as above 15 kPa for VCTE-LSM (blue). LSM, liver stiffness measurement; VCTE, vibration-controlled transient elastography.

Fig. 3.. Bland-Altman-Leh plot comparing the differences between reliable VCTE and ElastQ-LSM to the median of VCTE and ElastQ-LSM, with median and 95% confidence intervals displayed (dotted lines).

LSM, liver stiffness measurement; VCTE, vibration-controlled transient elastography.