使用Pipeline栓塞装置治疗颅内动脉瘤后中小型动脉瘤的结局：PLUS注册研究的亚组分析
Small and Medium-Sized Aneurysm Outcomes Following Intracranial Aneurysm Treatment Using the Pipeline Embolization Device: A Subgroup Analysis of the PLUS Registry.
作者信息
Zhang Hongyun, Li Li, Zhang Hongqi, Liu Jianmin, Song Donglei, Zhao Yuanli, Guan Sheng, Maimaitili Aisha, Wang Yunyan, Feng Wenfeng, Wang Yang, Wan Jieqing, Mao Guohua, Shi Huaizhang, Luo Bin, Shao Qiuji, Chang Kaitao, Zhang Qianqian, He Yingkun, Zhang Peng, Yang Xinjian, Li Tian Xiao
机构信息
Cerebrovascular Department of Interventional Center, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Henan University People's Hospital, Zhengzhou, China.
Neurosurgery Department of Stroke Center, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Henan University People's Hospital, Zhengzhou, China.
出版信息
Front Neurol. 2022 May 31;13:881353. doi: 10.3389/fneur.2022.881353. eCollection 2022.
OBJECTIVE
The purpose of this work was to summarize the real-world safety and efficacy of Pipeline Embolization Device (PED) therapy for small and medium-sized intracranial aneurysms in China.
METHODS
Patients from the PED in China post-market multi-center registry study (PLUS) with aneurysms smaller than 12 mm were selected. Radiographic outcomes were assessed using digital subtraction angiography. Clinical outcomes included functional outcomes (modified Rankin Scale, MRS) in the early postoperative period ( ≤ 30 days) and early postoperative complications associated with PED therapy.
RESULTS
A total of 652 patients with a combined 754 aneurysms were included in this study (mean age of 53.9 ± 10.3 years, 68.7% women). Mean aneurysm diameter was 6.78 ± 2.67 mm. Of the 687 stents deployed, 99.7% (685/689) were successfully deployed. In this study, 64.7% (488/754) of aneurysms were treated with only the PED, whereas 35.3% (266/754) were subjected to PED-assisted therapy. Radiographic outcome at the last follow-up (median time: seven months) was available for 64.3% (485/754) of the aneurysms. 82.5% (400/485) of aneurysms demonstrated complete occlusion (Raymond Roy Grade I). 81.4% (395/485) of aneurysms were found to meet the study's primary effectiveness outcome. At the early postoperative period, the mRS score was determined to be 0-2 vs. 3-6 in 98.2% (640/652) vs. 1.8% (12/652) of the cases, respectively. The combined major morbidity and mortality rate was 3.2% (21/652).
CONCLUSION
In the largest study of PED therapy for small and medium-sized intracranial aneurysms to date, pipeline-assisted coil embolization was chosen more often than multiple stent implantation for aneurysm treatment, demonstrating good results, high surgical success rates, high occlusion rates, and low morbidity and mortality.
CLINICAL TRIAL REGISTRATION
www.ClinicalTrials.gov, identifier: NCT03831672.
目的
本研究旨在总结中国使用Pipeline栓塞装置（PED）治疗中小型颅内动脉瘤的真实世界安全性和有效性。
方法
选取中国PED上市后多中心注册研究（PLUS）中动脉瘤小于12mm的患者。采用数字减影血管造影评估影像学结果。临床结果包括术后早期（≤30天）的功能结果（改良Rankin量表，mRS）以及与PED治疗相关的术后早期并发症。
结果
本研究共纳入652例患者，共计754个动脉瘤（平均年龄53.9±10.3岁，女性占68.7%）。动脉瘤平均直径为6.78±2.67mm。在687枚支架的植入中，99.7%（685/689）成功植入。本研究中，64.7%（488/754）的动脉瘤仅接受PED治疗，而35.3%（266/754）接受PED辅助治疗。64.3%（485/754）的动脉瘤在末次随访（中位时间：7个月）时有影像学结果。82.5%（400/485）的动脉瘤显示完全闭塞（Raymond Roy I级）。81.4%（395/485）的动脉瘤达到研究的主要有效性结果。术后早期，mRS评分为0 - 2分和3 - 6分的病例分别占98.2%（640/652）和1.8%（12/652）。主要并发症和死亡率合计为3.2%（21/652）。
结论
在迄今为止关于PED治疗中小型颅内动脉瘤的最大规模研究中，与多次支架植入相比，更多地选择了Pipeline辅助弹簧圈栓塞治疗动脉瘤，结果显示效果良好、手术成功率高、闭塞率高且发病率和死亡率低。
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