Department of Surgery, Division of Vascular and Endovascular Surgery, Universidade Federal de São Paulo, São Paulo, Brazil.
Evidence Based Medicine, Cochrane Brazil, Universidade Federal de São Paulo, São Paulo, Brazil.
Cochrane Database Syst Rev. 2022 Jul 11;7(7):CD013172. doi: 10.1002/14651858.CD013172.pub2.
Carotid artery stenosis is an important cause of stroke and transient ischemic attack. Correctly and rapidly identifying patients with symptomatic carotid artery stenosis is essential for adequate treatment with early cerebral revascularization. Doubts about the diagnostic value regarding the accuracy of duplex ultrasound (DUS) and the possibility of using DUS as the single diagnostic test before carotid revascularization are still debated.
To estimate the accuracy of DUS in individuals with symptomatic carotid stenosis verified by either digital subtraction angiography (DSA), computed tomography angiography (CTA), or magnetic resonance angiography (MRA).
We searched CRDTAS, CENTRAL, MEDLINE (Ovid), Embase (Ovid), ISI Web of Science, HTA, DARE, and LILACS up to 15 February 2021. We handsearched the reference lists of all included studies and other relevant publications and contacted experts in the field to identify additional studies or unpublished data.
We included studies assessing DUS accuracy against an acceptable reference standard (DSA, MRA, or CTA) in symptomatic patients. We considered the classification of carotid stenosis with DUS defined with validated duplex velocity criteria, and the NASCET criteria for carotid stenosis measures on DSA, MRA, and CTA. We excluded studies that included < 70% of symptomatic patients; the time between the index test and the reference standard was longer than four weeks or not described, or that presented no objective criteria to estimate carotid stenosis.
The review authors independently screened articles, extracted data, and assessed the risk of bias and applicability concerns using the QUADAS-2 domain list. We extracted data with an effort to complete a 2 × 2 table (true positives, true negatives, false positives, and false negatives) for each of the different categories of carotid stenosis and reference standards. We produced forest plots and summary receiver operating characteristic (ROC) plots to summarize the data. Where meta-analysis was possible, we used a bivariate meta-analysis model.
We identified 25,087 unique studies, of which 22 were deemed eligible for inclusion (4957 carotid arteries). The risk of bias varied considerably across the studies, and studies were generally of moderate to low quality. We narratively described the results without meta-analysis in seven studies in which the criteria used to determine stenosis were too different from the duplex velocity criteria proposed in our protocol or studies that provided insufficient data to complete a 2 × 2 table for at least in one category of stenosis. Nine studies (2770 carotid arteries) presented DUS versus DSA results for 70% to 99% carotid artery stenosis, and two (685 carotid arteries) presented results from DUS versus CTA in this category. Seven studies presented results for occlusion with DSA as the reference standard and three with CTA as the reference standard. Five studies compared DUS versus DSA for 50% to 99% carotid artery stenosis. Only one study presented results from 50% to 69% carotid artery stenosis. For DUS versus DSA, for < 50% carotid artery stenosis, the summary sensitivity was 0.63 (95% confidence interval [CI] 0.48 to 0.76) and the summary specificity was 0.99 (95% CI 0.96 to 0.99); for the 50% to 69% range, only one study was included and meta-analysis not performed; for the 50% to 99% range, the summary sensitivity was 0.97 (95% CI 0.95 to 0.98) and the summary specificity was 0.70 (95% CI 0.67 to 0.73); for the 70% to 99% range, the summary sensitivity was 0.85 (95% CI 0.77 to 0.91) and the summary specificity was 0.98 (95% CI 0.74 to 0.90); for occlusion, the summary sensitivity was 0.91 (95% CI 0.81 to 0.97) and the summary specificity was 0.95 (95% CI 0.76 to 0.99). For sensitivity analyses, excluding studies in which participants were selected based on the presence of occlusion on DUS had an impact on specificity: 0.98 (95% CI 0.97 to 0.99). For DUS versus CTA, we found two studies in the range of 70% to 99%; the sensitivity varied from 0.57 to 0.94 and the specificity varied from 0.87 to 0.98. For occlusion, the summary sensitivity was 0.95 (95% CI 0.80 to 0.99) and the summary specificity was 0.91 (95% CI 0.09 to 0.99). For DUS versus MRA, there was one study with results for 50% to 99% carotid artery stenosis, with a sensitivity of 0.88 (95% CI 0.70 to 0.98) and specificity of 0.60 (95% CI 0.15 to 0.95); in the 70% to 99% range, two studies were included, with sensitivity that varied from 0.54 to 0.99 and specificity that varied from 0.78 to 0.89. We could perform only a few of the proposed sensitivity analyses because of the small number of studies included.
AUTHORS' CONCLUSIONS: This review provides evidence that the diagnostic accuracy of DUS is high, especially at discriminating between the presence or absence of significant carotid artery stenosis (< 50% or 50% to 99%). This evidence, plus its less invasive nature, supports the early use of DUS for the detection of carotid artery stenosis. The accuracy for 70% to 99% carotid artery stenosis and occlusion is high. Clinicians should exercise caution when using DUS as the single preoperative diagnostic method, and the limitations should be considered. There was little evidence of the accuracy of DUS when compared with CTA or MRA. The results of this review should be interpreted with caution because they are based on studies of low methodological quality, mainly due to the patient selection method. Methodological problems in participant inclusion criteria from the studies discussed above apparently influenced an overestimated estimate of prevalence values. Most of the studies included failed to precisely describe inclusion criteria and previous testing. Future diagnostic accuracy studies should include direct comparisons of the various modalities of diagnostic tests (mainly DUS, CTA, and MRA) for carotid artery stenosis since DSA is no longer considered to be the best method for diagnosing carotid stenosis and less invasive tests are now used as reference standards in clinical practice. Also, for future studies, the participant inclusion criteria require careful attention.
颈动脉狭窄是中风和短暂性脑缺血发作的一个重要原因。正确和快速识别有症状的颈动脉狭窄患者对于早期进行大脑再通治疗至关重要。对于使用颈动脉再通术之前使用双功能超声(DUS)作为单一诊断测试的诊断价值的准确性,以及是否可以使用 DUS 作为单一诊断测试的准确性,仍存在争议。
评估 DUS 在经数字减影血管造影(DSA)、计算机断层血管造影(CTA)或磁共振血管造影(MRA)证实的有症状颈动脉狭窄患者中的准确性。
我们在 CRDTAS、CENTRAL、MEDLINE(Ovid)、Embase(Ovid)、ISI Web of Science、HTA、DARE 和 LILACS 中检索了截至 2021 年 2 月 15 日的研究。我们对所有纳入的研究和其他相关出版物进行了参考文献检索,并联系了该领域的专家以确定其他研究或未发表的数据。
我们纳入了评估 DUS 对有症状患者的可接受参考标准(DSA、MRA 或 CTA)的准确性的研究。我们认为使用经验证的双功能速度标准定义的颈动脉狭窄分类,以及 DSA、MRA 和 CTA 上的 NASCET 标准用于颈动脉狭窄测量。我们排除了<70%的有症状患者、索引测试和参考标准之间的时间超过四周或未描述,或没有客观标准来估计颈动脉狭窄的研究。
综述作者独立筛选文章、提取数据,并使用 QUADAS-2 域列表评估偏倚风险和适用性问题。我们努力完成每个不同颈动脉狭窄和参考标准类别中的真阳性、真阴性、假阳性和假阴性的 2×2 表。我们制作了森林图和汇总受试者工作特征(ROC)图来总结数据。如果可能,我们使用二变量荟萃分析模型进行荟萃分析。
我们共确定了 25087 项独特的研究,其中 22 项被认为符合纳入标准(4957 条颈动脉)。研究的偏倚风险差异很大,研究的质量通常为中等或低等。在七个研究中,我们没有进行荟萃分析,因为这些研究中使用的确定狭窄的标准与我们方案中提出的双功能速度标准差异太大,或者提供的资料不足以完成至少一个狭窄类别的 2×2 表。九个研究(2770 条颈动脉)提供了 DUS 与 DSA 用于 70%至 99%颈动脉狭窄的结果,两个研究(685 条颈动脉)提供了 DUS 与 CTA 在该范围内的结果。七个研究报道了 DSA 作为参考标准的闭塞情况,三个研究报道了 CTA 作为参考标准的闭塞情况。五项研究比较了 DUS 与 DSA 用于 50%至 99%的颈动脉狭窄。只有一项研究报道了 50%至 69%的颈动脉狭窄情况。对于 DUS 与 DSA,<50%的颈动脉狭窄,汇总敏感性为 0.63(95%置信区间 [CI] 0.48 至 0.76),汇总特异性为 0.99(95%CI 0.96 至 0.99);50%至 69%范围内,仅纳入了一项研究,未进行荟萃分析;50%至 99%范围内,汇总敏感性为 0.97(95%CI 0.95 至 0.98),汇总特异性为 0.70(95%CI 0.67 至 0.73);70%至 99%范围内,汇总敏感性为 0.85(95%CI 0.77 至 0.91),汇总特异性为 0.98(95%CI 0.74 至 0.90);对于闭塞,汇总敏感性为 0.91(95%CI 0.81 至 0.97),汇总特异性为 0.95(95%CI 0.76 至 0.99)。在敏感性分析中,排除基于 DUS 检测到闭塞的参与者选择方法的研究,对特异性有影响:0.98(95%CI 0.97 至 0.99)。对于 DUS 与 CTA,我们发现了两个 70%至 99%范围内的研究;敏感性从 0.57 到 0.94,特异性从 0.87 到 0.98。对于闭塞,汇总敏感性为 0.95(95%CI 0.80 至 0.99),汇总特异性为 0.91(95%CI 0.09 至 0.99)。对于 DUS 与 MRA,只有一项研究报道了 50%至 99%的颈动脉狭窄,敏感性为 0.88(95%CI 0.70 至 0.98),特异性为 0.60(95%CI 0.15 至 0.95);在 70%至 99%范围内,有两项研究,敏感性从 0.54 到 0.99,特异性从 0.78 到 0.89。由于纳入的研究数量较少,我们只能进行一些提议的敏感性分析。
本综述提供的证据表明,DUS 的诊断准确性很高,特别是在区分是否存在有意义的颈动脉狭窄(<50%或 50%至 99%)方面。这一证据,加上其非侵入性的性质,支持早期使用 DUS 检测颈动脉狭窄。70%至 99%颈动脉狭窄和闭塞的准确性较高。临床医生在使用 DUS 作为术前唯一诊断方法时应谨慎,应考虑到其局限性。几乎没有关于 DUS 与 CTA 或 MRA 比较的准确性的证据。由于患者选择方法的原因,本综述中的研究主要由于方法学质量较低,其结果应谨慎解释。在上述研究中,纳入标准的方法学问题显然影响了对患病率值的高估估计。大多数纳入的研究未能精确描述纳入标准和先前的测试。未来的诊断准确性研究应包括对颈动脉狭窄各种诊断测试(主要是 DUS、CTA 和 MRA)的直接比较,因为 DSA 不再被认为是诊断颈动脉狭窄的最佳方法,现在更具侵入性的测试被用作临床实践中的参考标准。此外,对于未来的研究,参与者的纳入标准需要仔细关注。