术前智能化微导管塑形模拟技术辅助颅内未破裂动脉瘤栓塞术的安全性和有效性研究  

Study on the safety and effectiveness of preoperative intelligent microcatheter shaping simulation technology assisted unruptured intracranial aneurysm embolization

作　　者：耿介文 胡鹏[1] 何川[1] 张鸿祺[1] Geng Jiewen;Hu Peng;He Chuan;Zhang Hongqi(Department of Neurosurgery,Xuanwu Hospital,Capital Medical University,Beijing 100053,China)

机构地区：[1]首都医科大学宣武医院神经外科,北京100053

出　　处：《中国脑血管病杂志》2023年第7期441-448,共8页Chinese Journal of Cerebrovascular Diseases

基　　金：国家重点研发计划重大慢性非传染性疾病防控研究重点专项(2016YFC1300800);北京市科学技术委员会首都临床诊疗技术研究及转化应用(Z201100005520021);北京市卫生健康科技成果和适宜技术推广项目(BHTPP202018);北京市博士后资助项目(2023-ZZ-009);首都医科大学医学创新能力提升建设专项(12300122)。

摘　　要：目的分析颅内未破裂动脉瘤栓塞术前智能化微导管塑形软件技术辅助的安全性和有效性,以及对低年资医师治疗效果的影响。方法前瞻性连续纳入首都医科大学宣武医院神经外科2020年12月至2021年9月行弹簧圈栓塞术的颅内未破裂动脉瘤患者,通过中央随机系统将符合纳入与排除标准的患者随机分配到试验组和对照组,试验组采用颅内动脉瘤手术计划软件[强联智创(北京)科技有限公司]辅助下进行微导管塑形,对照组由神经外科医师根据自身诊疗经验进行微导管塑形。分析试验组和对照组患者有效性终点(微导管一次到位率、5 min微导管到位率、微导管输送到位时间、微导管输送次数、优良率)和安全性终点(围手术期出血和缺血事件、术后6个月动脉瘤复发)。为分析颅内动脉瘤手术计划软件辅助不同操作经验神经介入医师的有效性,进一步对独立操作年限≤5年的医师操作弹簧圈栓塞手术的有效性终点进行分析。结果共100例颅内未破裂动脉瘤患者,4例被排除(2例入组时发生破裂,2例为外院复发动脉瘤),最终纳入96例患者,其中试验组纳入49例患者49个动脉瘤,对照组纳入47例患者47个动脉瘤。试验组和对照组患者性别、年龄、基础病史(高血压病、高脂血症、糖尿病)、动脉瘤部位、规则动脉瘤、术者年限≤5年独立操作的差异均无统计学意义(均P>0.05)。试验组微导管5 min到位率、一次到位率、输送优良率均高于对照组[98.0%(48/49)比66.0%(31/47),χ^(2)=14.735;98.0%(48/49)比68.1%(32/47),χ^(2)=13.992;98.0%(48/49)比68.1%(32/47),χ^(2)=13.992],而输送到位时间和输送次数均少于对照组[34(17,51)s比200(123,478)s,Z=271.000;1(1,1)次比1(1,2)次,Z=804.000],组间差异均有统计学意义(均P<0.01)。试验组和对照组均未发生围手术期出血事件;试验组未发生围手术期缺血事件,对照组围手术期缺血事件发生率为4.3%(2/4Objective To analyze the safety and efficiency of preoperative intelligent microcatheter shaping in assisting physicians to perform unruptured intracranial aneurysm embolization,as well as the improvement on the treatment effectiveness of younger physicians.Methods The patients with unruptured intracranial aneurysms who underwent coil embolization in Department of Neurosurgery,Xuanwu Hospital,Capital Medical University from December 2020 to September 2021 were prospectively included in the study.The patients who met the inclusion and exclusion criteria were randomly assigned to the experimental group and the control group through the central randomization system.The experimental group used the intracranial aneurysm surgery planning software(UnionStrong[Beijing]Technology Co.Ltd.)to conduct microcatheter shaping,while in the control group,neurosurgeons shaped microcatheters according to their own diagnosis and treatment experience.The efficacy endpoints(one-time catheterization rate,5-minute catheterization rate,catheterization delivery time,catheterization frequency,and excellent catheterization rate)and safety endpoints(perioperative bleeding and ischemic events,aneurysm recurrence at 6 months after surgery)of patients in the experimental and control groups were analyzed.According to the number of years of independent operation by physicians,physicians with an independent operation period of≤5 years were subjected to subgroup analysis to compare the efficacy endpoints.Results There were a total of 100 patients with unruptured intracranial aneurysms,of which 4 were excluded(2 had ruptures during enrollment,and 2 had recurrent aneurysms outside the hospital),and 96 patients were ultimately included.Among them,49 patients with 49 aneurysms were included in the experimental group,and 47 patients with 47 aneurysms were included in the control group.There was no significant difference between the experimental group and the control group in terms of gender,age,medical history(hypertension,hyperlipidemia,diabetes),ane

关 键 词：颅内动脉瘤 微导管塑形 不同操作经验 人工智能 栓塞 

分 类 号：R651.12[医药卫生—外科学]