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

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%(2/47),其中1例为左侧后交通穿支动脉梗死,1例为术中血栓,经对症治疗后均好转。术后6个月影像学随访率为43.8%(42/96),试验组与对照组动脉瘤复发占比的差异无统计学意义(P=1.000)。独立操作年限≤5年医师共行弹簧圈栓塞术30例,其中试验组微导管5 min到位占比、一次到位占比、输送优良占比均高于对照组(17/18比6/12,χ^(2)=5.660;17/18比8/12,χ^(2)=10.060;17/18比8/12,χ^(2)=10.060),输送到位时间短于对照组[34(11,58)s比294(71,726)s,Z=-3.409],输送次数少于对照组[1(1,1)次比1(1,2)次,Z=-2.023],组间差异均有统计学意义(均P<0.05)。结论术前智能化微导管塑形技术辅助有助于神经介入医师提升微导管塑形弹簧圈栓塞术的有效性,并且对于手术操作年限相对较短医师的栓塞操作有一定的辅助作用。

Objective 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),aneurysm location,regular aneurysm,and years of independent operation physicians≤5 years(all P>0.05).The 5-minute catheterization rate,one-time catheterization rate,and excellent catheterization rate of the experimental group were all higher than those of the control group(98.0%[48/49]vs.66.0%[31/47],χ^(2)=14.735;98.0%[48/49]vs.68.1%[32/47],χ^(2)=13.992;98.0%[48/49]vs.68.1%[32/47],χ^(2)=13.992),and the catheterization time and catheterization frequency were both less than those of the control group(34[17,51]s vs.200[123,478]s,Z=271.000;1[1,1]times vs.1[1,2]times,Z=804.000),with statistically significant differences between the groups(all P<0.01).There were no perioperative bleeding events in the experimental group and control group;there was no perioperative ischemic event in the experimental group,while the incidence of perioperative ischemic events in the control group was 4.3%(2/47),including 1 case of left posterior communicating artery perforator infarction and 1 case of intraoperative thrombus,which improved after treatment.The imaging follow-up rate at 6 months after surgery was 43.8%(42/96),and there was no statistically significant difference in the proportion of aneurysm recurrence between the experimental group and the control group(P=1.000).A total of 30 cases of coil embolization were performed by physicians with independent operation period≤5 years.The results showed that the experimental group had a higher 5-minute catheterization rate,one-time catheterization rate and excellent catheterization rate(17/18 vs.6/12,χ^(2)=5.660;17/18 vs.8/12,χ^(2)=10.060;17/18 vs.8/12,χ^(2)=10.060).The delivery time of experimental group was shorter than that of the control group(34[11,58]s vs.294[71,726]s,Z=-3.409),and the catheterization frequency was less than that of the control group(1[1,1]times vs.1[1,2]times,Z=-2.023),and the differences between groups were statistically significant(all P<0.05).Conclusion Preoperative intelligent microcatheter shaping technology can assist physicians in improving the effectiveness of shaping microcatheter in coil embolization,and it is also helpful for younger physicians in embolization operations.