Neuroform EZ支架对颅内富穿支动脉粥样硬化性狭窄的安全性及有效性分析

Safety and efficacy of Neuroform EZ stent in the treatment of intracranial atherosclerotic stenosis in the arteries of rich perforating branches

目的探讨Neuroform EZ支架用于富穿支动脉区域症状性颅内动脉粥样硬化性狭窄(ICAS)的安全性及有效性。方法回顾性连续纳入2017年6月至2019年9月解放军总医院第一医学中心神经内科接受Neuroform EZ支架经皮腔内血管成形及支架置入术(PTAS)的富穿支区域ICAS住院患者63例,颅内富穿支区域包括大脑中动脉M1段、基底动脉中下段。记录患者的年龄、性别、高血压病、糖尿病、吸烟史及术前改良Rankin量表(mRS)评分、狭窄段长度、狭窄率和狭窄血管形态等。主要结局为手术相关并发症,分为术中、早期(术后72 h内)和随访期(术后9个月的临床随访)并发症;次要结局为手术成功率、支架内再狭窄率。将支架的准确输送和部署,完全覆盖靶血管病变,PTAS后即刻DSA示支架部位残余狭窄率<50%定义为手术成功。分别于术后6、12个月对患者行DSA随访,支架内再狭窄定义为术后至少6个月以上支架管腔内狭窄率>50%。术后9个月对患者进行临床随访,mRS评分>2分为致残,其中mRS评分6分为死亡。结果(1)63例患者成功行Neuroform EZ支架PTAS,其中大脑中动脉M1段狭窄患者38例,基底动脉中下段狭窄患者25例。(2)大脑中动脉M1段、基底动脉中下段狭窄患者各有1例手术未成功,手术成功率为96.8%(61/63)。无术中并发症;早期并发症共4例(大脑中动脉M1段狭窄和基底动脉中下段狭窄各2例),包括穿支闭塞事件、支架内血栓形成各2例,并发症发生率为6.3%(4/63)。(3)31例患者完成影像学随访,影像学随访期平均(7.9±3.3)个月,再狭窄率为6.5%(2/31),均为基底动脉中下段狭窄。53例患者完成临床随访,临床随访期平均(16.7±5.3)个月,卒中发生率1.9%(1/53),为30 d内支架内血栓形成;致残率1.9%(1/53)。结论Neuroform EZ支架用于颅内富穿支动脉粥样硬化性狭窄的血管内治疗是可行的,确切的结论还需大样本和更严格的临床研究证实。

Objective To investigate the safety and efficacy of Neuroform EZ stent for symptomatic intracranial atherosclerotic stenosis(ICAS)in the arteries of rich perforating branches.Methods From June 2017 to September 2019,63 ICAS inpatients who were underwent percutaneous transluminal angioplasty and stenting(PTAS)with Neuroform EZ stent in the First Medical Center of the Chinese People′s Liberation Army General Hospital were recruited.ICAS located in arteries of rich perforators,including M1 segment of middle cerebral artery(MCA)and middle and lower segment of basilar artery(BA).The patients′age,gender,history of hypertension,history of diabetes,history of smoking,preoperative modified Rankin scale(mRS)score,stenosis length,stenosis rate and vascular morphology were recorded.The primary outcome was surgery-related complications,which were divided into intraoperative,early(within 72 hours after operation)and follow-up period(9 months after operation)complications;the secondary outcomes were surgical success rate and in-stent restenosis rate.The successful operation was defined as the stent accurately delivered,completely covered target arterial lesions,and residual stenosis rate was less 50%in immediate DSA after PTAS.The patients were followed up by DSA at 6 and 12 months after operation.The in-stent restenosis was defined as restenosis rate in stent more than 50%in follow-up period at least 6 months.The patients were followed up 9 months after operation.The mRS score>2 was defined as disability,and mRS score of 6 was death.Results(1)Neuroform EZ stent implantation was successfully performed in 63 patients,including 38 patients of MCA M1 segment and 25 patients of BA middle and lower segment.(2)There was one case of MCA and one case of BA stenosis,respectively.The success rate was 96.8%(61/63).There were no intraoperative complications.There were 4 cases of early complications(2 cases of MCA and 2 cases of BA stenosis),including 2 cases of perforator occlusion and 2 cases of in-stent thrombosis.The incidence of complications was 6.3%(4/63).(3)Thirty one patients were followed up by DSA and the mean follow-up period was(7.9±3.3)months.The restenosis rate was 6.5%(2/31),and both cases occurred in the BA middle and lower segment.53 patients completed clinical follow-up.The average clinical follow-up period was(16.7±5.3)months,and the incidence of stroke was 1.9%(1/53),which was stent thrombosis within 30 days.The disability rate was 1.9%(1/53).Conclusions Neuroform EZ may feasible for endovascular treatment of ICAS in the arteries of rich perforating branches.The exact conclusion needs to be confirmed by large sample and more rigorous clinical studies.