EndoCAS Center, Department of Translational Research on New Technologies in Medicine and Surgery, University of Pisa, Italy.
EndoCAS Center, Department of Translational Research on New Technologies in Medicine and Surgery, University of Pisa, Italy.
Eur J Vasc Endovasc Surg. 2014 Jan;47(1):53-60. doi: 10.1016/j.ejvs.2013.10.001. Epub 2013 Oct 7.
The purpose of this in vitro study was to clinically assess the feasibility of a three-dimensional (3D) electromagnetic (EM) navigator, including sensorized catheters and guidewires, to determine any reduction in radiation dose and contrast medium injection.
The study was performed using a navigator prototype developed at the EndoCAS center. The system includes catheters and guidewires simultaneously tracked with an EM localizer (Aurora, Northern Digital, Waterloo, Canada). Tests were performed on a commercial abdominal aortic aneurysm model. Fifteen operators were asked to cannulate renal arteries using the conventional fluoroscopic guidance and the EM navigator without fluoroscopic support. Each trial was video-recorded and analyzed for timing and success of completing the cannulation task by two blinded and independent observers. Performances were also qualitatively evaluated using the Imperial College Endovascular Cannulation Scoring Tool (IC3ST). Moreover, a questionnaire was administered to participants to evaluate the navigator potentialities.
Quantitative analysis results show no significant difference between the fluoroscopic and EM guidance regarding the total procedure time (median 2.36 minutes [interquartile range {IQR} = 1.26-4.7) vs. 2.95 min [IQR = 1.35-5.38], respectively; p = .93); number of total hits with catheter/guidewire tip to vessels wall (median 5.50 [IQR = 2.00-10.00] vs. 3.50 [IQR = 2.50-7.00], respectively; p = .65); and number of attempts at cannulation (median 4.0 [IQR = 2.00-5.00] vs. 4.0 [IQR = 2.00-5.00], respectively; p = .72]. Moreover, there was no significant difference between the IC3ST score obtained using the EM navigator and the traditional method (average 22.37 [STD = 7.95] vs. 21.58 [STD = 6.86]; p = .92). Finally, questionnaire results indicate a general agreement concerning the navigator usefulness, which clearly shows the positions of instruments inside the 3D model of the patient's anatomy. Participants also agreed that the navigator can reduce the amount of contrast media delivered to the patient, as well as fluoroscopy time.
This work provides proof of concept that simultaneous EM navigation of guidewires and catheters is feasible without the use of live fluoroscopic images.
本体外研究旨在临床评估三维（3D）电磁（EM）导航仪的可行性，包括传感器导管和导丝，以确定减少辐射剂量和造影剂注射量的可能性。
本研究使用在 EndoCAS 中心开发的导航仪原型进行。该系统包括同时使用 EM 定位器（加拿大滑铁卢 Northern Digital 的 Aurora）跟踪的导管和导丝。在商用腹主动脉瘤模型上进行了测试。十五名操作人员被要求使用传统的荧光透视引导和无荧光透视支持的 EM 导航仪进行肾动脉插管。每个试验都进行了录像，并由两名盲法和独立的观察者分析完成插管任务的时间和成功率。使用帝国学院血管内插管评分工具（IC3ST）还对性能进行了定性评估。此外，还向参与者发放了一份调查问卷，以评估导航仪的潜力。
定量分析结果显示，在总手术时间方面，荧光透视和 EM 引导之间没有显著差异（中位数分别为 2.36 分钟[四分位距 {IQR} = 1.26-4.7]和 2.95 分钟[IQR = 1.35-5.38]；p =.93）；导管/导丝尖端与血管壁的总命中次数（中位数分别为 5.50 [IQR = 2.00-10.00]和 3.50 [IQR = 2.50-7.00]；p =.65）；以及插管尝试次数（中位数分别为 4.0 [IQR = 2.00-5.00]和 4.0 [IQR = 2.00-5.00]；p =.72）。此外，使用 EM 导航仪获得的 IC3ST 评分与传统方法之间没有显著差异（平均 22.37 [STD = 7.95]与 21.58 [STD = 6.86]；p =.92）。最后，问卷调查结果表明，参与者普遍认为导航仪具有实用性，这清楚地显示了仪器在患者解剖 3D 模型内部的位置。参与者还同意导航仪可以减少向患者输送的造影剂数量以及荧光透视时间。
这项工作提供了概念验证，证明在不使用实时荧光透视图像的情况下，同时进行导丝和导管的 EM 导航是可行的。
