编织品及其他:从PREMIER数据中对管道设备编织品稳定性的综合研究
Fernanda Rodriguez-Erazú1,2, Gustavo M Cortez1,3, Demetrius K Lopes4
1Lyerly Neurosurgery, Baptist Medical Center Downtown, Jacksonville, Florida, USA.
Journal of neurointerventional surgery
|October 2, 2024
概括
管道栓塞装置 (PED) 在早期几代人中表现出极好的编织稳定性,罕见的变形不会影响脑动脉瘤治疗的安全性或有效性. 长期随访证实了设备的完整性.
科学领域:
- 内血管神经外科手术 血管内血管神经外科
- 医疗器械技术 医疗器械技术
- 脑血管疾病管理的管理
背景情况:
- 人们对新一代的管道栓塞装置 (PED) 使用绘制填充管道技术的编织稳定性存在担忧.
- 对于治疗内动脉瘤,PED越来越多地被采用.
研究的目的:
- 在PREMIER临床试验中,评估早期一代PED设备 (Classic和Flex) 的编织稳定性.
- 评估PED在动脉瘤治疗中的长期安全性和有效性.
主要方法:
- 在PREMIER试验中,用PED (Classic和Flex) 治疗的内动脉瘤的回顾性分析.
- 评估编织稳定性 (鱼口,缩短,编织撞击,崩) 使用立即后过程和1年和2年的随访成像 (形光束CT和血管造影).
- 评估安全性 (修改的兰金尺度,血管狭窄) 和有效性 (雷蒙德-罗伊尺度,再处理率).
主要成果:
- 有133/141个动脉瘤的完整数据集;6% (8/133) 呈现出形变形.
- 形变形与静脉支架狭窄症>50% (P=0.029) 有关,但没有影响整体安全性或有效性.
- 具体的变形包括鱼口 (0.75%),前缩 (4.5%),凸 (0.75%),其中一种鱼口导致>50%的狭窄.
- 在2年的随访期间,没有观察到新的编织稳定性问题;由于新极度增生症的无症状狭窄发生在3.0%的无编织变化中.
结论:
- 管道栓塞装置 (Classic和Flex) 在PREMIER试验队列中表现出极好的编织稳定性.
- 观察到的变化很少发生,并且不会影响动脉瘤治疗装置的安全性或疗效.
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