Objectives The purpose was to analyze the agreement and binary accuracy of the degree of internal carotid artery stenosis (ICAS) as determined by 4-dimensionally (4D) real-time gray-scale guided 3-dimensional (3D) color-Doppler ultrasonography (3DC-US) (4D/3DC-US) compared with catheter angiography (CA) and duplex ultrasonography (DUS). This study hypothesized that 4D/3DC-US is noninferior to CA and DUS in grading ICAS in selected patients.

Background Clinical stratification in patients with ICAS largely depends on a patient’s symptomatic status and the degree of stenosis.

Methods Screening with 4D/3DC-US was prospectively performed in 93 study patients (with 122 ICASs), thus yielding 80 patients for analysis (with 103 ICASs) after excluding patients with insufficient image quality, previous revascularization, and contraindications to CA. The ultrasound examination (10 MHz) consisted of consensus conform DUS examination and independent real-time 4D-guided gray-scale views for orientation followed by static 3DC-US NASCET (North American Symptomatic Carotid Endarterectomy Trial) percent stenosis quantification using off-line multiplanar rendering. Multiplanar selective CA of the same ICASs was quantified with dedicated software in a blinded fashion.

Results Quantitative CA of 103 stenoses with a mean degree of 65 ± 17% was compared with 4D/3DC-US, with a resulting concordance correlation coefficient of 0.89 and a standard deviation of differences (SDD) of 8.1% at a bias of +1.7%. Binary 50% and 70% stenosis detection with 4D/3DC-US revealed a sensitivity of 97% and 87%, respectively, and a specificity of 92% and 84%, respectively. Interobserver SDD for CA of 52 stenoses (7.2%) did not differ from SDD for 4D/3DC-US and CA (p = 0.274). Accuracy of 50% stenosis detection by 4D/3DC-US was tendentially higher compared with DUS (96% vs. 91%).

Conclusions The 4D/3DC-US method provides reliable and accurate stenosis quantification and binary classification with good diagnostic accuracy compared with CA and DUS.

目的目的是分析由4维（4D）实时灰度引导的3维（3D）彩色多普勒超声检查（3DC）确定的颈内动脉狭窄（ICAS）程度的一致性和二进制准确性-US）（4D / 3DC-US）与导管血管造影（CA）和双工超声检查（DUS）进行比较。这项研究假设4D / 3DC-US在选定患者的ICAS分级方面不逊于CA和DUS。

背景技术ICAS患者的临床分层在很大程度上取决于患者的症状状态和狭窄程度。

方法前瞻性对93例研究对象（122例ICAS）进行了4D / 3DC-US筛查，排除了图像质量欠佳，既往血运重建和CA禁忌症的患者后，对80例患者进行了分析（103例ICAS）。超声检查（10 MHz）包括共识性DUS检查和独立的实时4D引导的灰度灰度图，然后进行静态3DC-US NASCET（北美有症状颈动脉内膜切除术试验）百分比狭窄的定量分析，使用离线多平面渲染。使用专用软件以盲法对同一ICAS的多平面选择性CA进行了量化。

结果将103个狭窄平均水平为65±17％的CA与4D / 3DC-US进行比较，结果一致性相关系数为0.89，偏差的标准差（SDD）为8.1％，偏差为+1.7 ％。使用4D / 3DC-US进行二重性50％和70％狭窄检测时，灵敏度分别为97％和87％，特异性分别为92％和84％。CA观察者间52个狭窄的SDD（7.2％）与4D / 3DC-US和CA的SDD无差异（p = 0.274）。与DUS相比，通过4D / 3DC-US检测50％狭窄的准确性趋于更高（96％对91％）。

结论与CA和DUS相比，4D / 3DC-US方法可提供可靠，准确的狭窄量化和二值分类，并且具有良好的诊断准确性。