School of Natural Sciences, University of California, Merced, Calif.
School of Gerontology, University of Southern California, Los Angeles, Calif.
J Vasc Surg Venous Lymphat Disord. 2020 Sep;8(5):831-839.e2. doi: 10.1016/j.jvsv.2019.11.020. Epub 2020 Mar 14.
Diagnostic-quality portable color Doppler ultrasound (PCD) offers convenient point-of-care venous reflux disease (VRD) diagnosis. Philips Lumify (Philips N.V., Best, The Netherlands), a high-fidelity broadband linear array transducer (4-12 MHz frequency), connects through a web-enabled smartphone or tablet to cloud software and offers B-mode and color Doppler imaging without pulsed wave Doppler capability. The aims of the study were to compare hand-held acoustic Doppler (HHD) vs PCD diagnostic performance using conventional duplex ultrasound (DUP) as the "gold standard" for VRD assessment, to assess effects of body mass index (BMI) and disease severity on diagnostic performance of HHD and PCD, and to determine whether PCD offers any diagnostic improvement over HHD in VRD assessment.
There were 241 patients (65 male, 176 female; mean age, 55.5 ± 15.5 years; mean BMI, 32.2 ± 7.9 kg/m). DUP (447 legs), PCD (262 legs), and HHD (217 legs) studied the great saphenous vein at above-knee (AK) and below-knee (BK) levels. A phlebologist performed HHD, whereas PCD and DUP were performed sequentially (PCD first) by an experienced technologist and interpreted independently. PCD was done blinded to DUP results. DUP findings were analyzed blinded to HHD and PCD results. Venous reflux was dichotomously assessed as <2 seconds and >2 seconds.
HHD improves from moderate to good sensitivity from AK level (68%) to BK level (94%) but suffers poor specificity that declines significantly from AK level (50%) to BK level (12%; P < .05). HHD positive predictive value exceeds its negative predictive value (NPV) and remains unchanged from AK level (71%) to BK level (72%). HHD NPV remains consistently poor at AK (48%) and BK (42%) levels. PCD has similar sensitivity from AK level (69%) to BK level (74%), better AK level (79%) vs BK level (58%) specificity (P < .05), similar positive predictive value for AK (76%) and BK levels (78%), and better NPV for AK level (72%) vs BK level (53%; P < .05). BMI range (<30 kg/m vs ≥ 30 kg/m) did not influence diagnostic performance of HHD and PCD significantly. HHD and PCD specificity was higher for Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) class <4 compared with CEAP class ≥4 (P < .05).
The relative diagnostic performance of HHD and PCD is highly dependent on insonation level. PCD advantages compared with HHD are marginally greater specificity at AK and BK levels and better NPV at AK level. Compared with HHD, PCD's disadvantage is lower sensitivity at BK level. Both HHD and PCD have higher specificity at AK level than at BK level. Overall, PCD offers only moderate sensitivity and specificity, making it inadequate for exclusion of significant venous reflux. Neither obesity nor CEAP class significantly influenced the general diagnostic performance of PCD or HHD.
便携式彩色多普勒超声（PCD）具有诊断质量，可为静脉反流疾病（VRD）提供便捷的即时护理诊断。飞利浦 Lumify（荷兰皇家飞利浦电子公司）是一种具有高保真度的宽带线阵换能器（4-12 MHz 频率），通过支持网络的智能手机或平板电脑连接到云软件，并提供 B 模式和彩色多普勒成像，而不具备脉冲波多普勒功能。本研究的目的是比较手持声学多普勒（HHD）与 PCD 的诊断性能，将传统的双功能超声（DUP）作为 VRD 评估的“金标准”，评估体重指数（BMI）和疾病严重程度对 HHD 和 PCD 诊断性能的影响，并确定 PCD 在 VRD 评估中是否比 HHD 具有任何诊断优势。
共有 241 名患者（65 名男性，176 名女性；平均年龄 55.5 ± 15.5 岁；平均 BMI 32.2 ± 7.9 kg/m²）。DUP（447 条腿）、PCD（262 条腿）和 HHD（217 条腿）检查大隐静脉在膝上（AK）和膝下（BK）水平的反流情况。由一名静脉疾病专家进行 HHD 检查，由一名经验丰富的技术员依次进行 PCD 和 DUP（先进行 PCD）检查，并由独立的技术人员进行解释。PCD 检查在不了解 DUP 结果的情况下进行。在不了解 HHD 和 PCD 结果的情况下对 DUP 检查结果进行分析。静脉反流被分为<2 秒和>2 秒两种情况进行二分类评估。
HHD 从 AK 水平（68%）到 BK 水平（94%）的敏感性从中度提高到良好，但特异性显著下降，从 AK 水平（50%）到 BK 水平（12%；P <.05）。HHD 的阳性预测值大于阴性预测值，且从 AK 水平（71%）到 BK 水平（72%）保持不变。HHD 的阴性预测值在 AK（48%）和 BK（42%）水平仍然较差。PCD 从 AK 水平（69%）到 BK 水平（74%）的敏感性相似，AK 水平（79%）的特异性优于 BK 水平（58%）（P <.05），AK 水平（76%）和 BK 水平（78%）的阳性预测值相似，AK 水平（72%）的阴性预测值优于 BK 水平（53%；P <.05）。BMI 范围（<30 kg/m 与≥30 kg/m）对 HHD 和 PCD 的诊断性能没有显著影响。与 CEAP 分级≥4 相比，CEAP 分级<4 的 HHD 和 PCD 特异性更高（P <.05）。
HHD 和 PCD 的相对诊断性能高度依赖于声束照射水平。与 HHD 相比，PCD 的优势在于 AK 和 BK 水平的特异性更高，AK 水平的阴性预测值更好。与 HHD 相比，PCD 的劣势在于 BK 水平的敏感性较低。与 HHD 相比，PCD 在 AK 水平的特异性较高，而在 BK 水平的特异性较低。总的来说，PCD 的敏感性和特异性均适中，不足以排除明显的静脉反流。肥胖或 CEAP 分级均未显著影响 PCD 或 HHD 的总体诊断性能。
