Background

The efficacy of flow diverters is dependent upon robust wall apposition in the parent artery. Usage in large caliber cerebral vessels has therefore been limited as few implants with diameters > 5 mm exist. We present our initial experience in treating cerebral aneurysms using the 5.5 mm and 6 mm diameter implants of the Derivo embolization device (DED).

Methods

Our prospectively maintained institutional database was reviewed to identify patients in whom a > 5 mm DED was implanted between November 2016 and February 2021. The primary efficacy outcome was complete or near-complete aneurysm occlusion at 6 months (O’Kelly-Marotta, OKM, C–D, adapted for magnetic resonance angiography). Safety outcomes included 30-day major morbidity defined as modified Rankin Score (mRS) 3–5, mortality, serious adverse events and procedural complications.

Results

A total of 21 large diameter DEDs were deployed in 18 patients (age 59.5 ± 14.1 years), harboring 19 unruptured aneurysms. Of the aneurysms 14 (73.7%) were saccular in morphology (sac diameter 10.9 ± 5.5 mm, neck diameter 6.8 ± 3.1 mm), 3 (15.8%) aneurysms were dissecting, 1 (5.3%) iatrogenic pseudoaneurysm and 1 (5.3%) fusiform. Aneurysm locations were: ICA (internal carotid artery) (n = 17); (7 cavernous, 4 paraophthalmic, 2 paraclinoid, 1 petrous, 2 communicating, 1 cervical); vertebrobasilar (n = 2). Adjunct stenting to optimize proximal wall apposition was undertaken in 5 (27.8%) patients. At 6 months 75% of patients followed-up met the primary efficacy endpoint (OKM C–D). There were no serious adverse events, 30-day major morbidity (mRS 3–5) or mortality.

Conclusion

Implantation of large diameter (5.5 mm and 6 mm) DEDs into capacious cerebral vessels to treat a range of complex aneurysms is safe and technically feasible but may require adjunct stenting to optimize proximal wall apposition. Short-term efficacy of this device subset is comparable to previous DED and other flow diverter studies. Long-term follow-up and comparative studies are required for further assessment.

中文翻译：

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植入大直径（5.5-6 mm）衍生栓塞装置治疗脑动脉瘤

背景

分流器的功效取决于载瘤动脉中坚固的壁并置。因此，在大口径脑血管中的使用受到限制，因为直径 > 5 mm 的植入物很少。我们介绍了使用 Derivo 栓塞装置 (DED) 的 5.5 毫米和 6 毫米直径植入物治疗脑动脉瘤的初步经验。

方法

我们对前瞻性维护的机构数据库进行了审查，以确定 2016 年 11 月至 2021 年 2 月期间植入 > 5 mm DED 的患者。主要疗效结果是 6 个月时动脉瘤完全或接近完全闭塞（O'Kelly-Marotta，OKM， C-D，适用于磁共振血管造影）。安全性结果包括定义为改良 Rankin 评分 (mRS) 3-5 的 30 天主要发病率、死亡率、严重不良事件和手术并发症。

结果

18 名患者（年龄 59.5 ± 14.1 岁）共部署了 21 个大直径 DED，其中有 19 个未破裂的动脉瘤。在动脉瘤中，14 个（73.7%）在形态上呈囊状（囊直径 10.9 ± 5.5 mm，颈直径 6.8 ± 3.1 mm），3 个（15.8%）动脉瘤被夹层，1 个（5.3%）医源性假性动脉瘤和 1 个（5.3%）梭形。动脉瘤位置为：ICA（颈内动脉）（n  = 17）；（7 个海绵体，4 个眼旁，2 个床突，1 个岩部，2 个交通，1 个颈椎）；椎基底动脉（n  = 2）。5 名 (27.8%) 患者进行了辅助支架以优化近端壁并置。在 6 个月时，75% 的随访患者达到了主要疗效终点 (OKM C-D)。没有严重的不良事件、30 天主要发病率 (mRS 3-5) 或死亡率。

结论

将大直径（5.5 毫米和 6 毫米）DED 植入宽敞的脑血管以治疗一系列复杂的动脉瘤是安全且技术上可行的，但可能需要辅助支架以优化近端壁并置。该设备子集的短期功效与之前的 DED 和其他分流器研究相当。进一步评估需要长期随访和比较研究。