Shin Seung Min, Lee Ji Young, Nam Hun Heo, Choo Se Woong, Jeon Yong Pyo, Chung Jaewoo, Ko Jung Ho, Koo Hae-Won, Shin Dong Seoung, Lee Man Ryul, Oh Jae Sang
Department of Neurosurgery, Soonchunhyang University Cheonan Hospital, College of Medicine, Soonchunhyang University, Cheonan, Republic of Korea.
Clinical Trial Center, Soonchunhyang University Cheonan Hospital, Cheonan, Republic of Korea.
Heliyon. 2024 Jul 26;10(15):e35205. doi: 10.1016/j.heliyon.2024.e35205. eCollection 2024 Aug 15.
We aimed to examine the effectiveness and safety of a novel torque-controlled catheter for cerebral angiography.
A total of 417 patients who underwent routine transfemoral cerebral angiography were enrolled in a randomized controlled study to compare the new torque-controlled and control group catheters. Device success was assessed on parameters such as the assessment of the common carotid artery, device rotation force, and success rate with the crossover group after the failed procedure. Four neurointerventionalists investigated the degree of satisfaction of using the new device. Superiority and non-inferiority tests of satisfaction scores were estimated for the new torque-controlled and the control group catheters.
The new torque-controlled catheter showed improved performance in terms of technical device success (92.79 vs. 98.09 %, = 0.010), crossover after technical device failure (0 vs. 86.67 %, = 0.004), and common carotid artery access (92.79 vs. 98.56 %, = 0.004). The flexibility and rotational force of the new torque-controlled catheter were higher than those of the control group catheters (75.48 vs. 100 %, < 0.001). No marked adverse cerebrovascular accidents or vessel damage occurred in either group during the procedure. The differences between the two groups in terms of the device rotational force and operator satisfaction were 1.836 (1.765-1.907) and 2.092 (2.000-2.183), respectively. The new torque-controlled catheter showed superior device rotational force satisfaction, operator satisfaction, and manufacturer satisfaction, with statistical significance.
The new torque-controlled catheter was effective, safe, and convenient compared to the control group catheters for diagnostic cerebrovascular angiography.
我们旨在研究一种新型扭矩控制导管用于脑血管造影的有效性和安全性。
总共417例行常规经股动脉脑血管造影的患者纳入一项随机对照研究，以比较新型扭矩控制导管和对照组导管。根据诸如颈总动脉评估、器械旋转力以及手术失败后交叉组的成功率等参数评估器械成功率。四名神经介入专家调查了使用新器械的满意度。对新型扭矩控制导管和对照组导管的满意度评分进行优效性和非劣效性检验。
新型扭矩控制导管在器械技术成功率（92.79%对98.09%，P = 0.010）、器械技术失败后的交叉率（0对86.67%，P = 0.004）以及颈总动脉穿刺成功率（92.79%对98.56%，P = 0.004）方面表现更优。新型扭矩控制导管的柔韧性和旋转力高于对照组导管（75.48%对100%，P < 0.001）。手术过程中两组均未发生明显的不良脑血管事件或血管损伤。两组在器械旋转力和术者满意度方面的差异分别为1.836（1.765 - 1.907）和；2.092（2.000 - 2.183）。新型扭矩控制导管在器械旋转力满意度、术者满意度和厂家满意度方面表现更优，具有统计学意义。
与对照组导管相比，新型扭矩控制导管用于诊断性脑血管造影有效、安全且便捷。
