Pipeline Flex血流导向装置治疗颅内复杂动脉瘤的安全性及短期疗效

Safety and efficacy analysis of Pipeline Flex embolization device for treatment of complex intracranial aneurysms

目的评价第2代Pipeline血流导向装置(PED Flex)治疗颅内复杂动脉瘤的安全性及短期疗效。方法回顾性分析郑州大学人民医院2018年1月至2019年8月应用PED Flex治疗颅内复杂动脉瘤患者的临床及影像学资料,分析围手术期神经系统并发症情况,采用改良Rankin量表(mRS)评分评价患者临床预后;影像学随访采用O'Kelly-Marotta(OKM)分级评估动脉瘤闭塞情况。结果131例患者共应用144枚PED Flex治疗159个动脉瘤,手术成功率为100%。其中107个动脉瘤采用单纯支架置入,52个动脉瘤结合弹簧圈填塞。术后神经系统并发症发生率为3.1%(4/131),其中缺血性并发症发生率为2.3%(3/131),出血性并发症发生率为0.8%(1/131),无死亡病例,出院mRS 0分101例,1分25例,2分4例,4分1例,致残率为0.8%(1/131)。61例患者共80个动脉瘤获影像学随访,末次中位随访时间6.0(3~9)个月,动脉瘤完全闭塞(OKM分级D级)57个,完全闭塞率为71.3%(57/80);支架内狭窄4(6.6%,4/61)例,均无神经系统症状。87例患者获临床随访,中位随访时间为9.0(2~21)个月,mRS 0分78例,1分5例,2分3例,4分1例。结论PED Flex治疗颅内复杂动脉瘤手术成功率高,安全性较好;术后6个月随访完全闭塞率高,疗效良好。

Objective To evaluate the safety and short-term efficacy of Pipeline Flex embolization device(PED Flex)for treatment of complex intracranial aneurysms.Methods The clinical data of 131 patients with complex intracranial aneurysms who were treated with PED Flex in Zhengzhou university People's Hospital from June 2018 to August 2019 were retrospectively analyzed.Periprocedural complications were analyzed.Modified Rankin Scale(mRS)was used to evaluate clinical outcomes and the O’Kelly-Marotta(OKM)grading scale was used to evaluate imaging outcomes.Results A total of 131 patients with 159 complex aneurysms were treated with 144 PED Flex,and the procedure success rate was 100%.Adjunctive coiling was used in 52 aneurysms and 107 cases used the stent only.Postprocedural neurological complication rate was 3.1%(4/131).Among them,the thromboembolic and hemorrhagic complication was 2.3%(3/131)and 0.8%(1/131),respectively.There were no deaths occurred.The mRS were 0 in 101 patients,1 in 25,2 in 4,4 in 1 and the disability rate was 0.8%(1/131)at discharge.A total of 61 patients with 80 aneurysms obtained the imaging follow-up with a median of 6.0(3-9)months.Fifty-seven aneurysms were completely occluded(grade D of OKM grading scale)with a complete occlusion rate of 71.3%(57/80).The in-stent stenosis was observed in 4(6.6%,4/61)patients,but no patients were symptomatic.Eighty-seven patients obtained the clinical follow-up with a median of 9.0(2-21)months,and the mRS were 0 in 78 patients,1 in 5,2 in 3 and 4 in 1.Conclusions The treatment of complex intracranial aneurysms with PED Flex is safe with a high procedure success rate,and it is efficient with a high complete occlusion rate during the 6-months follow-up.