Background and purpose

Flow diverters are considered as an essential tool in the stent-based treatment of complex intracranial aneurysms. We report here a subgroup analysis of the nationwide prospective DIVERSION study to investigate the safety and efficacy of the Silk flow diverter at 12 months follow-up.

Methods

We performed a subgroup analysis of patients included in the DIVERSION, a national prospective cohort study including all flow diverters placement between 2012 and 2014 in France, and treated with the Silk. The primary outcome was the morbi-mortality at 12 months, including death, morbidity event and aneurysm retreatment within 12 months post-treatment. All reported serious events were adjudicated by an independent Data Safety and Monitoring Board. Satisfactory occlusion was defined as 3 or 4 on Kamran's scale by an independent imaging core laboratory during follow-up.

Results

A total of 102 procedures involving 101 patients (mean age ± standard deviation, 54.3 ± 13.5 years) harbouring 118 aneurysms (113/118 located in the anterior circulation; mean size 8.2 ± 7.1 mm) were included. During the 12-month follow-up, 34 (33.3%) procedures experienced at least one morbi-mortality event: 3 deaths, 27 morbidity events and 4 retreatments. Overall, 1/3 deaths and 10/27 morbidity events were related to the device and/or the procedure, leading to a specific survival rate and a specific free-morbidity survival rate at 12 months of 98.98% [95% confidence interval, 92.98%–99.86%] and 89.73% [95%CI, 81.71%–94.36%], respectively. The rate of permanent-related neurological deficit was 5.9% within 12 months. One year follow-up imaging showed satisfactory occlusion in 82.2% of cases.

Conclusion

Flow diversion with the Silk device has a reasonable safety and effectiveness profile for the endovascular treatment of intracranial aneurysms.

中文翻译：

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Silk 分流器的安全性和有效性：来自 DIVERSION 前瞻性队列研究的见解

背景和目的

分流器被认为是基于支架治疗复杂颅内动脉瘤的重要工具。我们在此报告对全国范围内前瞻性 DIVERSION 研究的亚组分析，以调查 Silk 分流器在 12 个月随访时的安全性和有效性。

方法

我们对 DIVERSION 中的患者进行了亚组分析，这是一项国家前瞻性队列研究，包括 2012 年至 2014 年间在法国放置的所有分流器，并接受了 Silk 治疗。主要结果是 12 个月的死亡率，包括治疗后 12 个月内的死亡、发病事件和动脉瘤再治疗。所有报告的严重事件均由独立的数据安全和监测委员会裁定。在随访期间，由独立的成像核心实验室将满意的咬合定义为 Kamran 量表上的 3 或 4。

结果

共有 102 例手术，涉及 101 名患者（平均年龄 ± 标准差，54.3  ±  13.5 岁），有 118 个动脉瘤（113/118 位于前循环；平均大小 8.2  ±  7.1 mm) 包括在内。在 12 个月的随访期间，34 例 (33.3%) 手术经历了至少 1 例死亡事件：3 例死亡、27 例发病事件和 4 例再治疗。总体而言，1/3 的死亡和 10/27 的发病事件与设备和/或手术有关，导致 12 个月的特定生存率和特定无病生存率为 98.98% [95% 置信区间，92.98 %–99.86%] 和 89.73% [95%CI, 81.71%–94.36%]。12 个月内永久性相关神经功能缺损率为 5.9%。一年的随访影像显示，82.2% 的病例咬合良好。

结论

Silk 装置的分流对于颅内动脉瘤的血管内治疗具有合理的安全性和有效性。