颅内动脉瘤支架辅助弹簧圈栓塞术的 Neuroform Atlas 支架多中心上市后分析。
Multicenter Postmarket Analysis of the Neuroform Atlas Stent for Stent-Assisted Coil Embolization of Intracranial Aneurysms.
机构信息
From the Department of Neurosurgery (J.-K.B., V.S., A.S., O.T., J.J., S.C., P.K.), Baylor College of Medicine, Houston, Texas
From the Department of Neurosurgery (J.-K.B., V.S., A.S., O.T., J.J., S.C., P.K.), Baylor College of Medicine, Houston, Texas.
出版信息
AJNR Am J Neuroradiol. 2020 Jun;41(6):1037-1042. doi: 10.3174/ajnr.A6581. Epub 2020 May 28.
BACKGROUND AND PURPOSE
The Neuroform Atlas is a new microstent to assist coil embolization of intracranial aneurysms that recently gained FDA approval. We present a postmarket multicenter analysis of the Neuroform Atlas stent.
MATERIALS AND METHODS
On the basis of retrospective chart review from 11 academic centers, we analyzed patients treated with the Neuroform Atlas after FDA exemption from January 2018 to June 2019. Clinical and radiologic parameters included patient demographics, aneurysm characteristics, stent parameters, complications, and outcomes at discharge and last follow-up.
RESULTS
Overall, 128 aneurysms in 128 patients (median age, 62 years) were treated with 138 stents. Risk factors included smoking (59.4%), multiple aneurysms (27.3%), and family history of aneurysms (16.4%). Most patients were treated electively (93.7%), and 8 (6.3%) underwent treatment within 2 weeks of subarachnoid hemorrhage. Previous aneurysm treatment failure was present in 21% of cases. Wide-neck aneurysms (80.5%), small aneurysm size (<7 mm, 76.6%), and bifurcation aneurysm location (basilar apex, 28.9%; anterior communicating artery, 27.3%; and middle cerebral artery bifurcation, 12.5%) were common. A single stent was used in 92.2% of cases, and a single catheter for both stent placement and coiling was used in 59.4% of cases. Technical complications during stent deployment occurred in 4.7% of cases; symptomatic thromboembolic stroke, in 2.3%; and symptomatic hemorrhage, in 0.8%. Favorable Raymond grades (Raymond-Roy occlusion classification) I and II were achieved in 82.9% at discharge and 89.5% at last follow-up. mRS ≤2 was determined in 96.9% of patients at last follow-up. The immediate Raymond-Roy occlusion classification grade correlated with aneurysm location (< .0001) and rupture status during treatment (= .03).
CONCLUSIONS
This multicenter analysis provides a real-world safety and efficacy profile for the treatment of intracranial aneurysms with the Neuroform Atlas stent.
背景与目的
Neuroform Atlas 是一种新的微支架，用于辅助颅内动脉瘤的线圈栓塞，最近获得了 FDA 的批准。我们对 Neuroform Atlas 支架进行了上市后多中心分析。
材料与方法
根据 11 个学术中心的回顾性图表审查，我们分析了 2018 年 1 月至 2019 年 6 月期间接受 Neuroform Atlas 治疗的患者。临床和影像学参数包括患者人口统计学特征、动脉瘤特征、支架参数、并发症以及出院和最后随访时的结果。
结果
总体而言，128 名患者的 128 个动脉瘤（中位年龄 62 岁）接受了 138 个支架治疗。危险因素包括吸烟（59.4%）、多发动脉瘤（27.3%）和动脉瘤家族史（16.4%）。大多数患者为择期治疗（93.7%），8 例（6.3%）在蛛网膜下腔出血后 2 周内进行治疗。21%的病例存在先前的动脉瘤治疗失败。宽颈动脉瘤（80.5%）、小动脉瘤大小（<7mm，76.6%）和分叉部位的动脉瘤（基底动脉尖，28.9%；前交通动脉，27.3%；大脑中动脉分叉，12.5%）较为常见。92.2%的病例使用了单个支架，59.4%的病例使用了单个导管进行支架放置和线圈填塞。支架置入过程中出现技术并发症的比例为 4.7%，症状性血栓栓塞性卒中为 2.3%，症状性出血为 0.8%。出院时达到 Raymond-Roy 分级（Raymond-Roy 闭塞分类）I 和 II 级的比例为 82.9%，最后随访时达到 89.5%。最后随访时，96.9%的患者 mRS≤2。即刻 Raymond-Roy 闭塞分级与动脉瘤位置（<.0001）和治疗期间的破裂状态（=0.03）相关。
结论
这项多中心分析为使用 Neuroform Atlas 支架治疗颅内动脉瘤提供了真实世界的安全性和有效性概况。
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