Accuracy of Velacur in Assessing MASLD and MASH Patients Using Biopsy as the Gold Standard.

IF 3 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL Diagnostics Pub Date : 2025-03-04 DOI:10.3390/diagnostics15050615
Muhammad Y Sheikh, Nameer Hasan, Marwan Almozuaghi, Nadeem M Akhtar, Yugjeet Grewal, Caitlin Schneider
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引用次数: 0

Abstract

Background/Objectives: VelacurTM is a novel, point-of-care ultrasound device developed to accurately diagnose patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and Metabolic Dysfunction-Associated Steatohepatitis (MASH). The Velacur system non-invasively assesses liver stiffness, attenuation, and the Velacurdetermined fat fraction (VDFF). In this study, the performance of Velacur was measured against biopsy results in a cohort of MASLD and MASH patients. Methods: This prospective study enrolled adult patients who were scheduled to undergo biopsy within 6 months of enrollment. The primary objective was to validate Velacur's findings against that of histological findings. The secondary objective was to compare Velacur results with those of FibroScan. Results: A total of 78 participants were enrolled, and 70 were included in the analysis. Patients had a mean age of 53.3 ± 13.1 years, with a mean BMI of 35.0 ± 6.24 kg/m2. A total of 11, 19, 13, 25, and 2 were characterized as F0 to F4, respectively. The mean Velacur stiffness was 6.48 ± 1.4 kPa, and the mean VDFF was 14.4 ± 5.1%. In patients with significant fibrosis the Velacur AUC [95% CI] was 0.86 [0.76, 0.93] and 0.79 [0.66, 0.88] for patients with advanced fibrosis. For measurements of steatosis, 2, 24, 20, and 24 patients were found to have S0 to S3, respectively. To determine moderate steatosis (≥S2), the VDFF had an AUC of 0.846 [0.716, 0.920]. In the comparison population (n = 59), VDFF (0.85 [0.72, 0.94]) was significantly different than FibroScan CAP (0.50 [0.35, 0.66]) for the detection of moderate steatosis. Conclusions: This study validates the use of Velacur as a non-invasive tool for assessment of steatosis and fibrosis, hallmarks of MASLD and MASH, when compared to histological evidence provided via hepatic biopsy. Further, Velacur outperformed FibroScan in the assessment of steatosis.

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来源期刊
Diagnostics
Diagnostics Biochemistry, Genetics and Molecular Biology-Clinical Biochemistry
CiteScore
4.70
自引率
8.30%
发文量
2699
审稿时长
19.64 days
期刊介绍: Diagnostics (ISSN 2075-4418) is an international scholarly open access journal on medical diagnostics. It publishes original research articles, reviews, communications and short notes on the research and development of medical diagnostics. There is no restriction on the length of the papers. Our aim is to encourage scientists to publish their experimental and theoretical research in as much detail as possible. Full experimental and/or methodological details must be provided for research articles.
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