Accurate and Generalizable Quantitative Scoring of Liver Steatosis from Ultrasound Images via Scalable Deep Learning

Background & Aims: Hepatic steatosis is a major cause of chronic liver disease. 2D ultrasound is the most widely used non-invasive tool for screening and monitoring, but associated diagnoses are highly subjective. We developed a scalable deep learning (DL) algorithm for quantitative scoring of liver steatosis from 2D ultrasound images. Approach & Results: Using retrospectively collected multi-view ultrasound data from 3,310 patients, 19,513 studies, and 228,075 images, we trained a DL algorithm to diagnose steatosis stages (healthy, mild, moderate, or severe) from ultrasound diagnoses. Performance was validated on two multi-scanner unblinded and blinded (initially to DL developer) histology-proven cohorts (147 and 112 patients) with histopathology fatty cell percentage diagnoses, and a subset with FibroScan diagnoses. We also quantified reliability across scanners and viewpoints. Results were evaluated using Bland-Altman and receiver operating characteristic (ROC) analysis. The DL algorithm demonstrates repeatable measurements with a moderate number of images (3 for each viewpoint) and high agreement across 3 premium ultrasound scanners. High diagnostic performance was observed across all viewpoints: area under the curves of the ROC to classify >=mild, >=moderate, =severe steatosis grades were 0.85, 0.90, and 0.93, respectively. The DL algorithm outperformed or performed at least comparably to FibroScan with statistically significant improvements for all levels on the unblinded histology-proven cohort, and for =severe steatosis on the blinded histology-proven cohort. Conclusions: The DL algorithm provides a reliable quantitative steatosis assessment across view and scanners on two multi-scanner cohorts. Diagnostic performance was high with comparable or better performance than FibroScan.