国产Tubridge血流导向装置治疗中小型颅内动脉瘤的短期疗效及安全性分析

Domestic Tubridge flow diverter for the treatment of small and medium-sized intracranial aneurysms:analysis of its short-term efficacy and safety

目的 评估国产Tubridge治疗中小型颅内动脉瘤的短期疗效和安全性。方法 回顾性分析2020年8月至2021年12月在复旦大学附属华山医院静安分院介入科接受Tubridge治疗的23例颅内未破裂中小型(≤10mm)动脉瘤患者的临床资料,共计31个动脉瘤;术后采用改良Rankin量表(mRS)评分评估患者临床预后(0~2分为预后良好,3~5分为预后不良),术后采用Raymond分级评估动脉瘤栓塞情况。结果 支架置入成功率100%。末次平均随访时间6.6个月,17例患者行数字减影血管造影(digital subtraction angiography,DSA)造影随访,其中RaymondⅠ级19个,RaymondⅡ级1个,RaymondⅢ级5个,末次造影随访动脉瘤完全栓塞率76%;术后发生1例出血并发症(4.4%),2例缺血并发症(8.7%),4例无症状性支架内膜增生伴轻度狭窄,症状性并发症发生率8.7%。全部患者获得临床随访结果,mRS≤2分22例,mRS>2分1例。结论 国产Tubridge治疗颅内中小型动脉瘤具有良好的效果,但是术后出血或缺血性并发症不容忽视。

Objective To evaluate the short-term efficacy and clinical safety of domestic Tubridge flow diverter(FD)in the treatment of small and medium-sized intracranial aneurysms.Methods The clinical data of 23 patients with small or medium-sized(≤10 mm)unruptured intracranial aneurysm(31 aneurysms in total),who received Tubridge FD at the Jing'an Branch of the Affiliated Huashan Hospital of Fudan University of China between August 2020 and December 2021,were retrospectively analyzed.After the treatment,modified Rankin Scale(mRS)score was used to evaluate patient's clinical outcomes(O-2 pints indicating a good prognosis,and 3-5 points indicating a poor prognosis),and Raymond grade was used to assess aneurysm embolization degree.Results Successful stent implantation was achieved in all patients,with a success rate of 100%.The average follow-up time was 6.6 months.Seventeen patients were followed up by digital subtraction angiography(DSA),which showed that Raymond grade Ⅰ was obtained in 19 aneurysms,Raymond grade Ⅱ in one aneurysm,and Raymond grade Ⅲ in 5 aneurysms.The last follow-up angiography showed that the complete embolization rate of the aneurysms was 76%.After the treatment,one patient had bleeding complication(4.4%),two patients developed ischemic complications(8.7%),and four patients had asymptomatic stent intimal hyperplasia with mild stenosis;the incidence of symptomatic complications was 8.7%.Clinical follow-up results were obtained in all patients,which showed that mRS≤2 points was seen in 22 patients and and mRS>2 points was seen in one patient.Conclusion For the treatment of intracranial small and medium-sized aneurysms,domestic Tubridge FD has good results.However,postoperative bleeding and ischemic complications should not be ignored.