Chen Fei, Bai Xuesong, Hu Wei, Guo Fuqiang, Chen Jian, Zhou Zhiming, Chen Yanfei, Gao Peng, Liu Yongchang, Yang Qingwu, Liu Xinfeng, Xu Yun, Chen Huisheng, Wang Yabing, Yang Bin, Dmytriw Adam A, Patel Aman B, Ma Qingfeng, Jiao Liqun
Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.
Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.
Front Neurol. 2022 Jun 9;13:864563. doi: 10.3389/fneur.2022.864563. eCollection 2022.
This study was conducted to determine the safety and efficacy of the Esperance Distal Access Catheter (0.071"), a novel large bore aspiration catheter in treating acute ischemic stroke (AIS) with large vessel occlusion (LVO).
A prospective multicenter clinical trial involving 15 stroke centers was performed. Baseline characteristics, procedural data, and angiographic and clinical outcomes of all acute stroke procedures (from May 2020 to March 2021) using the novel large bore aspiration catheter were analyzed.
During the study period, 160 consecutive patients were recruited. The mean age and median baseline NIHSS were 65.4 years and 16, respectively. Successful reperfusion was achieved in 147 (91.9%) cases [at least modified Thrombolysis in Cerebral Infarction (mTICI) 2b] with aspiration alone, with complete reperfusion (mTICI 3) in 94 (58.8%) cases. Successful/complete first pass reperfusion was achieved in 104 (64.60%) cases, including mTICI 2b in 34 (21.1%) cases and mTICI 3 in 70 (43.5%) cases. The time from groin puncture to successful reperfusion was 44 (33, 62) min. There were 16 (9.9%) cases requiring rescue therapy using stent-retriever. Procedure-related complications included 2 (1.3%) cases of arterial perforation, 2 (1.3%) cases of arterial dissection, 12 (7.5%) cases of distal embolization, and 1(0.6%) case of puncture site infection. The rate of symptomatic intracranial hemorrhage (sICH) was 3.8% and mortality rate was 13.8%. A total of 99 (62.3%) cases had a favorable outcome (mRS 0-2) at 90 days.
In current practice, the first-line aspiration approach with the Esperance Distal Access Catheter is safe and efficacious. This device may achieve high reperfusion rates with lower instances of rescue stent retriever therapy.
本研究旨在确定新型大口径抽吸导管埃斯佩兰斯远端通路导管（0.071英寸）治疗伴有大血管闭塞（LVO）的急性缺血性卒中（AIS）的安全性和有效性。
进行了一项涉及15个卒中中心的前瞻性多中心临床试验。分析了使用新型大口径抽吸导管的所有急性卒中手术（2020年5月至2021年3月）的基线特征、手术数据以及血管造影和临床结果。
在研究期间，连续招募了160例患者。平均年龄和基线NIHSS中位数分别为65.4岁和16。仅通过抽吸，147例（91.9%）实现了成功再灌注[至少改良脑梗死溶栓（mTICI）2b级]，94例（58.8%）实现了完全再灌注（mTICI 3级）。104例（64.60%）实现了成功/完全首次通过再灌注，包括34例（21.1%）mTICI 2b级和70例（43.5%）mTICI 3级。从腹股沟穿刺到成功再灌注的时间为44（33，62）分钟。有16例（9.9%）需要使用取栓支架进行补救治疗。与手术相关的并发症包括2例（1.3%）动脉穿孔、2例（1.3%）动脉夹层、12例（7.5%）远端栓塞和1例（0.6%）穿刺部位感染。症状性颅内出血（sICH）发生率为3.8%，死亡率为13.8%。99例（62.3%）在90天时获得了良好结局（mRS 0-2）。
在当前实践中，使用埃斯佩兰斯远端通路导管的一线抽吸方法安全有效。该装置可能以较低的补救性取栓支架治疗发生率实现高再灌注率。
