两维剪切波弹性成像技术（SWE）由于伪阴性结果引起的伪影问题，限制了其在乳腺病变诊断中的应用。本研究旨在评估一种更新的经美国食品药品监督管理局批准的乳腺2D-SWE算法，并与标准算法（SA）进行比较。这是一项单中心前瞻性研究，经过我们当地机构评审委员会批准并符合《健康保险可穿戴性责任法》法规。自2019年4月25日至2022年5月2日，从西门子Sequoia US超声机筛查或诊断乳腺超声病人中保存了原始剪切波数据。删除重复图像和没有活检诊断或稳定超过2年的图像后，有298名病人和394个病灶，其中包括经活检证实的病理或>2年随访。使用SA和新算法（NA）处理原始数据。在SA上，在病变内最高硬度或相邻的3毫米放置5毫米兴趣区域，并记录来自这两种算法的硬度值（剪切波速度，最大值）。计算用于比较两种算法的统计数据。平均患者年龄为56.3 ± 16.1岁（范围为21-93岁）。良性病变平均大小为10.7 ± 8.0毫米（范围为2-46毫米），而恶性病变平均大小为14.9 ± 7.8毫米（范围为4-36毫米）。有201个良性病变（>2年随访）和193个活检病灶（65个良性；128个恶性）。良性病变的平均最大硬度为2.37 m/s（SD 1.26 m/s）（SA）和3.51 m/s（SD 2.05 m/s）（NA）。对于恶性病变，SA的平均最大硬度为4.73 m/s（SD 1.71 m/s），NA的平均最大硬度为8.45 m/s（SD 1.42 m/s）。使用最佳截断值时，接收者操作特征曲线下面积分别为0.87（SA）和0.95（NA）。使用NA的阈值值为5.0 m/s，并与SA进行比较时，灵敏度从0.45提高到1.00，特异度从0.94降低到0.81；阳性预测值为0.72，阴性预测值为1.00，阴性可能性比为0.00。使用新的乳腺SWE算法显着提高了技术的灵敏度，减少了特异度，几乎消除了“软”癌伪影。新的2D-SWE算法显着提高了诊断乳腺病变为良性或恶性的灵敏度和阴性预测值，并允许降级所有BI-RADS 4病灶。版权所有©2023作者。由 Wolters Kluwer Health, Inc. 发布。

Two-dimensional shear wave elastography (SWE) has been limited in breast lesion characterization due to false-negative results from artifacts. The aim of this study was to evaluate an updated Food and Drug Administration-approved breast 2D-SWE algorithm and compare with the standard algorithm (SA).This prospective, single-center study was approved by our local institutional review board and Health Insurance Portability and Accountability Act compliant. From April 25, 2019 to May 2, 2022, raw shear wave data were saved on patients having screening or diagnostic breast ultrasound on a Siemens Sequoia US. After removing duplicate images and those without biopsy diagnosis or stability over 2 years, there were 298 patients with 394 lesions with biopsy-proven pathology or >2-year follow-up. Raw data were processed using the SA and a new algorithm (NA). Five-millimeter regions of interest were placed in the highest stiffness in the lesion or adjacent 3 mm on the SA. Stiffness values (shear wave speed, max) in this location from both algorithms were recorded. Statistics were calculated for comparing the 2 algorithms.The mean patient age was 56.3 ± 16.1 years (range, 21-93 years). The mean benign lesion size was 10.7 ± 8.0 mm (range, 2-46 mm), whereas the mean malignant lesion size was 14.9 ± 7.8 mm (range, 4-36 mm). There were 201 benign (>2-year follow-up) and 193 biopsied lesions (65 benign; 128 malignant). The mean maximum stiffness for benign lesions was 2.37 m/s (SD 1.26 m/s) for SA and 3.51 m/s (SD 2.05 m/s) for NA. For malignant lesions, the mean maximum stiffness was 4.73 m/s (SD, 1.71 m/s) for SA and 8.45 m/s (SD, 1.42 m/s) for NA. The area under the receiver operating characteristic curve was 0.87 SA and 0.95 NA when using the optimal cutoff value. Using a threshold value of 5.0 m/s for NA and comparing to SA, the sensitivity increased from 0.45 to 1.00 and the specificity decreased from 0.94 to 0.81; the positive predictive value was 0.72, the negative predictive value was 1.00, and the negative likelihood ratio was 0.00.Using a new breast SWE algorithm significantly improves the sensitivity of the technique with a small decrease in specificity, virtually eliminating the "soft" cancer artifact. The new 2D-SWE algorithm significantly increases the sensitivity and negative predictive value in characterizing breast lesions as benign or malignant and allows for downgrading all BI-RADS 4 lesions.Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.