Liguori Antonio, Esposto Giorgio, Ainora Maria Elena, Mignini Irene, Borriello Raffaele, Galasso Linda, Paratore Mattia, Giustiniani Maria Cristina, Riccardi Laura, Garcovich Matteo, Gasbarrini Antonio, Miele Luca, Zocco Maria Assunta
Centro Malattie Apparato Digerente-CEMAD, Fondazione Policlinico Universitario A. Gemelli, IRCCS, 00168 Roma, Italy.
Unità di Medicina Interna e Trapianto di Fegato, Fondazione Policlinico Universitario A. Gemelli, IRCCS, 00168 Roma, Italy.
Biomedicines. 2025 Jan 9;13(1):138. doi: 10.3390/biomedicines13010138.
The aim of this study was to investigate the accuracy in fibrosis staging of a novel shear wave elastography (SWE) device (S-Shearwave Imaging by Samsung) and a previously validated 2D-SWE by Supersonic Imagine (SSI) in patients with biopsy proven metabolic dysfunction-associated steatotic liver disease (MASLD). This prospective study included 75 consecutive patients with MASLD who underwent liver biopsy for suspected MASH. All patients underwent S-Shearwave Imaging by Samsung and 2D-SWE with SSI on the same day of liver biopsy. Fibrosis was histologically assessed using the METAVIR classification system. Agreement between the equipment was assessed with the Pearson coefficient. A receiver operator characteristic curve (ROC) analysis with the Youden index was used to establish thresholds for fibrosis staging. A good correlation was found between S-Shearwave Imaging by Samsung and 2D-SWE with SSI (Pearson's R = 0.68; < 0.01). At multivariate regression analysis, S-Shearwave Imaging was associated with advanced fibrosis (≥F3) independently from age, diabetes and platelets (OR 2.94, CI 1.69-5.11, < 0.01). The fibrosis diagnostic accuracy of both S-Shearwave Imaging and 2D-SWE was good to optimal with AUROCs of 0.81 and 0.70 for significant fibrosis (≥F2), 0.94 and 0.91 for severe fibrosis (≥F3), respectively. The accuracy of S-Shearwave is not significantly different from Fibroscan and Agile3+ (DeLong test value 0.16 and 0.15, respectively) while is slightly better than 2D-SWE, FIB4 and NFS (DeLong test value < 0.05). For S-Shearwave Imaging by Samsung, the best cut-off values for diagnosing fibrosis ≥F2, ≥F3 were, respectively, 7.9 kPa (Sens 74.4%, Spec 87.5%) and 8.1 kPa (Sens 95.6%, Spec 78.8%). For 2D-SWE by SSI, the best cut-off values for diagnosing fibrosis ≥F2, ≥F3 were, respectively, 7.2 kPa (Sens 55.8%, Spec 84.4%) and 7.6 kPa (Sens 82.6%, Spec 84.6%). S-Shearwave Imaging is a useful and reliable non-invasive technique for staging liver fibrosis in patients with MASLD. Its diagnostic accuracy is non-inferior to other shear wave elastography techniques (TE and 2D-SWE by SSI).
本研究旨在调查一种新型剪切波弹性成像（SWE）设备（三星公司的S-Shearwave Imaging）以及先前经Supersonic Imagine（SSI）验证的二维SWE在经活检证实的代谢功能障碍相关脂肪性肝病（MASLD）患者中进行纤维化分期的准确性。这项前瞻性研究纳入了75例连续的疑似MASH并接受肝活检的MASLD患者。所有患者在肝活检当天接受了三星公司的S-Shearwave Imaging和SSI的二维SWE检查。使用METAVIR分类系统对纤维化进行组织学评估。通过Pearson系数评估设备之间的一致性。采用带有约登指数的受试者工作特征曲线（ROC）分析来确定纤维化分期的阈值。发现三星公司的S-Shearwave Imaging与SSI的二维SWE之间具有良好的相关性（Pearson相关系数R = 0.68；P < 0.01）。在多变量回归分析中，S-Shearwave Imaging与高级别纤维化（≥F3）独立相关，不受年龄、糖尿病和血小板的影响（比值比2.94，置信区间1.69 - 5.11，P < 0.01）。S-Shearwave Imaging和二维SWE的纤维化诊断准确性良好至最佳，显著纤维化（≥F2）的曲线下面积（AUROC）分别为0.81和0.70，严重纤维化（≥F3）的AUROC分别为0.94和0.91。S-Shearwave的准确性与Fibroscan和Agile3 +无显著差异（DeLong检验值分别为0.16和0.15），而略优于二维SWE、FIB4和NFS（DeLong检验值< 0.05）。对于三星公司的S-Shearwave Imaging，诊断纤维化≥F2、≥F3的最佳截断值分别为7.9 kPa（敏感度74.4%，特异度87.5%）和8.1 kPa（敏感度95.6%，特异度78.8%）。对于SSI的二维SWE，诊断纤维化≥F2、≥F3的最佳截断值分别为7.2 kPa（敏感度55.8%，特异度84.4%）和7.6 kPa（敏感度82.6%，特异度84.6%）。S-Shearwave Imaging是一种用于MASLD患者肝纤维化分期的有用且可靠的非侵入性技术。其诊断准确性不低于其他剪切波弹性成像技术（TE和SSI的二维SWE）。
