剪切波弹性成像作为乳腺种植术后包膜挛缩的客观诊断工具：一项比较研究

摘要(中文译文)

背景：包膜挛缩（CC）是乳房植入物手术最常见的并发症，影响高达20%的隆乳患者和高达40%的乳房切除术后重建患者。诊断依赖于Baker分级，其观察者间信度较差（κ = 0.55）。本研究通过定量测量假体周围包膜硬度，评估剪切波弹性成像（SWE）作为CC客观诊断工具的价值。方法：一项在罗马尼亚开展的前瞻性单中心比较研究，纳入26例隆乳患者（50侧乳房）伴无症状Baker I/II级CC作为对照组，以及25侧经确诊为Baker III/IV级CC的乳房切除术后重建患者乳房作为研究组。使用SuperSonic MACH 30平台测量硬度（均值、中位数、最小值、最大值、标准差，单位kPa）。分析包括Mann-Whitney U检验、采用自举法95% CI的ROC曲线以及Youden J指数。混杂因素分析（Spearman相关性、多变量logistic回归、偏相关）评估了SWE结果相对于植入物深度、假体周围组织厚度、感兴趣区（ROI）直径和体重指数（BMI）的独立性。结果：所有四项主要硬度参数在两组间均存在显著差异（< 10，r > 0.97）。对照组中位硬度为32.6 kPa，研究组为138.0 kPa。所有四项参数均达到优异的判别性能（AUC 0.988-0.994）；SWE中位数获得最高AUC（0.994；95% CI 0.980-1.000）。82 kPa阈值提供100%敏感性、98%特异性和100% NPV。Baker III级（约92 kPa）与IV级（约147 kPa）之间也存在显著差异（= 0.0001）。在任一组内，没有任何协变量（植入物深度、假体周围组织厚度、ROI直径、BMI）显著影响SWE值（所有组内Spearman ρ > 0.05），并且在完全调整的多变量模型中，SWE中位硬度仍是唯一的显著预测因子（调整后OR = 1.18，95% CI 1.08-1.31，< 0.001）。结论：SWE能够以优异的准确性客观区分正常假体周围包膜与具有临床意义的CC。82 kPa中位硬度阈值提供了一种可重复、非侵入性的方法，可作为Baker分级的有益补充，并为基于弹性成像的CC分期奠定了基础。

Abstract

: Capsular contracture (CC) is the most frequent complication of breast implant surgery, affecting up to 20% of augmentation and up to 40% of post-mastectomy reconstruction patients. Diagnosis relies on the Baker classification with poor interobserver reliability (κ = 0.55). This study evaluated shear-wave elastography (SWE) as an objective diagnostic tool for CC via quantitative measurement of periprosthetic capsule stiffness. : A prospective single-center comparative study (Romania) enrolled 26 augmentation patients (50 breasts) with asymptomatic Baker I/II CC as controls, and 25 breasts with confirmed Baker III/IV CC in post-mastectomy reconstruction patients as the study group. Stiffness was measured using the SuperSonic MACH 30 platform (mean, median, min, max, SD in kPa). Analysis included Mann-Whitney U tests, ROC curves with bootstrapped 95% CIs, and Youden's J index. Confounder analyses (Spearman correlations, multivariable logistic regression, partial correlations) assessed the independence of SWE findings from implant depth, periprosthetic tissue thickness, region-of-interest (ROI) diameter, and body mass index (BMI). : All four primary stiffness parameters differed significantly between groups ( < 10, r > 0.97). Control median stiffness was 32.6 kPa versus 138.0 kPa in the study group. All four parameters achieved outstanding discriminative performance (AUC 0.988-0.994); SWE median yielded the highest AUC (0.994; 95% CI 0.980-1.000). A threshold of 82 kPa provided 100% sensitivity, 98% specificity, and 100% NPV. Baker Grades III (~92 kPa) and IV (~147 kPa) also differed significantly ( = 0.0001). No covariate (implant depth, periprosthetic tissue thickness, ROI diameter, BMI) significantly influenced SWE values within either group (all intra-group Spearman ρ > 0.05), and SWE median stiffness remained the sole significant predictor in the fully adjusted multivariable model (adjusted OR = 1.18, 95% CI 1.08-1.31, < 0.001). : SWE objectively differentiates normal periprosthetic capsules from clinically significant CC with outstanding accuracy. An 82 kPa median stiffness threshold offers a reproducible, non-invasive complement to the Baker classification and provides a foundation for elastography-based CC staging.

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