Boseong Kwon, Jong-Tae Yoon, Yun Hyeok Choi, Soo Jeong, Byung Jun Kim, Joon Ho Choi, Sun Moon Hwang, Deok Hee Lee, Yunsun Song
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Primary outcomes were procedure time and serious adverse events. Secondary outcomes included catheterization success, adverse events, fluoroscopy time, fluoroscopy dose, and image quality.</p><p><strong>Results: </strong>A total of 200 participants (mean age 59 ± 10 years, 71% women) were randomized into the guided (n = 100) and the conventional (n = 100) groups. The guided group demonstrated shorter procedure times compared to the conventional group (18.3 ±9.2 min vs. 21.3 ± 8.1 min, <i>P</i> < .001). There were no serious adverse events in either group, and adverse event rates were similar. Catheterization success rates were similar between the guided and conventional groups (93.9% vs. 96.8%, <i>P</i> = .226). However, the guided angiography system backed up more catheterization failures from the conventional angiography system, but not vice versa (57.1% vs. 11.1%, <i>P</i> = .003). Among catheterization successes, the guided group achieved shorter fluoroscopy time (7.0 min vs. 7.7 min, <i>P</i> = .033) and lower fluoroscopy dose (466.8 μGy·m<sup>2</sup> vs. 566.5 μGy·m<sup>2</sup>, <i>P</i> = .015). Regarding imaging quality, clinical acceptability was comparable between the guided and conventional groups (95.3% vs. 95.5%, <i>P</i> = .781).</p><p><strong>Conclusions: </strong>The guided angiography system offers a simple and effective alternative for diagnostic cerebral catheter angiography, with reduced radiation exposure and a favorable safety profile.</p><p><strong>Abbreviations: </strong>AE = adverse events; Fr = French.</p>","PeriodicalId":93863,"journal":{"name":"AJNR. 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While its feasibility was demonstrated in a retrospective study, this randomized controlled trial aims to evaluate its safety and effectiveness.</p><p><strong>Materials and methods: </strong>This single-center, single-blind, randomized controlled trial was conducted from September 2021 to June 2022. Patients with unruptured intracranial aneurysms were enrolled and randomly assigned to either the guided or the conventional group. Primary outcomes were procedure time and serious adverse events. Secondary outcomes included catheterization success, adverse events, fluoroscopy time, fluoroscopy dose, and image quality.</p><p><strong>Results: </strong>A total of 200 participants (mean age 59 ± 10 years, 71% women) were randomized into the guided (n = 100) and the conventional (n = 100) groups. The guided group demonstrated shorter procedure times compared to the conventional group (18.3 ±9.2 min vs. 21.3 ± 8.1 min, <i>P</i> < .001). There were no serious adverse events in either group, and adverse event rates were similar. Catheterization success rates were similar between the guided and conventional groups (93.9% vs. 96.8%, <i>P</i> = .226). However, the guided angiography system backed up more catheterization failures from the conventional angiography system, but not vice versa (57.1% vs. 11.1%, <i>P</i> = .003). Among catheterization successes, the guided group achieved shorter fluoroscopy time (7.0 min vs. 7.7 min, <i>P</i> = .033) and lower fluoroscopy dose (466.8 μGy·m<sup>2</sup> vs. 566.5 μGy·m<sup>2</sup>, <i>P</i> = .015). 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引用次数: 0
摘要
背景和目的：引导血管造影系统是一种综合血管造影系统，可在诊断过程中实现连续引导和冲洗。造影剂注入扭曲血管时，导丝留在导管内提供引导。虽然在回顾性研究中证明了其可行性，但本随机对照试验旨在评估其安全性和有效性。材料与方法：该单中心、单盲、随机对照试验于2021年9月至2022年6月进行。未破裂的颅内动脉瘤患者被招募并随机分配到引导组和常规组。主要结局是手术时间和严重不良事件。次要结果包括置管成功、不良事件、透视时间、透视剂量和图像质量。结果：200名参与者（平均年龄59±10岁，71%为女性）随机分为引导组（n = 100）和常规组（n = 100）。与常规组相比，引导组的手术时间更短（18.3±9.2 min vs. 21.3±8.1 min, P < 0.001）。两组均无严重不良事件发生，不良事件发生率相似。引导组与常规组置管成功率相似（93.9% vs 96.8%, P = 0.226）。然而，与传统血管造影系统相比，引导血管造影系统的插管失败率更高，反之亦然（57.1% vs. 11.1%, P = 0.003）。在插管成功率中，引导组透视时间较短（7.0 min vs. 7.7 min, P = 0.033），透视剂量较低（466.8 μGy·m2 vs. 566.5 μGy·m2, P = 0.015）。在成像质量方面，引导组和常规组的临床可接受性相当（95.3% vs. 95.5%, P = .781）。结论：引导血管造影系统为诊断脑导管血管造影提供了一种简单有效的替代方法，具有减少辐射暴露和良好的安全性。缩写：AE =不良事件；Fr =法语。
Safety and Effectiveness of a Novel Integrated Angiography System for Continuous Guidance and Flushing in Diagnostic Cerebral Catheter Angiography: A Randomized Controlled Trial.
Background and purpose: The guided angiography system, an integrated angiography system, enables continuous guidance and flushing during diagnostic procedures. A guidewire provides guidance by remaining inside the catheter during contrast injection into tortuous vessels. While its feasibility was demonstrated in a retrospective study, this randomized controlled trial aims to evaluate its safety and effectiveness.
Materials and methods: This single-center, single-blind, randomized controlled trial was conducted from September 2021 to June 2022. Patients with unruptured intracranial aneurysms were enrolled and randomly assigned to either the guided or the conventional group. Primary outcomes were procedure time and serious adverse events. Secondary outcomes included catheterization success, adverse events, fluoroscopy time, fluoroscopy dose, and image quality.
Results: A total of 200 participants (mean age 59 ± 10 years, 71% women) were randomized into the guided (n = 100) and the conventional (n = 100) groups. The guided group demonstrated shorter procedure times compared to the conventional group (18.3 ±9.2 min vs. 21.3 ± 8.1 min, P < .001). There were no serious adverse events in either group, and adverse event rates were similar. Catheterization success rates were similar between the guided and conventional groups (93.9% vs. 96.8%, P = .226). However, the guided angiography system backed up more catheterization failures from the conventional angiography system, but not vice versa (57.1% vs. 11.1%, P = .003). Among catheterization successes, the guided group achieved shorter fluoroscopy time (7.0 min vs. 7.7 min, P = .033) and lower fluoroscopy dose (466.8 μGy·m2 vs. 566.5 μGy·m2, P = .015). Regarding imaging quality, clinical acceptability was comparable between the guided and conventional groups (95.3% vs. 95.5%, P = .781).
Conclusions: The guided angiography system offers a simple and effective alternative for diagnostic cerebral catheter angiography, with reduced radiation exposure and a favorable safety profile.
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