Safety and Efficacy of the Sofia (6F) PLUS Distal Access Reperfusion Catheter in the Endovascular Treatment of Acute Ischemic Stroke

Safety and Efficacy of the Sofia (6F) PLUS Distal Access Reperfusion Catheter in the Endovascular Treatment of Acute Ischemic Stroke
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DOI:
10.1093/neuros/nyx169
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发表时间:
2018-03-01
期刊:
影响因子:
4.8
通讯作者:
Levy, Elad I.
Levy, Elad I.
中科院分区:
医学1区
文献类型:
--
作者:
Shallwani, Hussain;Shakir, Hakeem J.;Levy, Elad I.

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背景:神经血管内介入治疗已成为急性缺血性脑卒中的关键治疗选择。 Sofia (6F) PLUS 导管设计用于诊断或治疗干预的神经血管通路。 目的:报告第一个系列描述使用 Sofia PLUS 中间/远端通路再灌注导管治疗急性缺血性卒中。 方法:在这项回顾性研究中,确定了 41 例使用该导管进行溶栓/血栓切除术的卒中病例。术前美国国立卫生研究院卒中量表平均评分为 16.5 +/- 5.2(范围 4-29)。闭塞血管包括 M1 段、M2 段、颈内动脉总站、颈部颈内动脉和基底动脉。 结果:在 41 例尝试使用动脉内组织纤溶酶原激活剂、直接抽吸首过技术和/或支架取出术尝试血栓切除或溶栓的病例中,有 38 例 (92.7%) 成功将 Sofia PLUS 导管定位在闭塞部位附近。 41 例患者中有 37 例术后脑梗塞溶栓 (TICI) 评分达到 2b/3。在使用 Sofia PLUS 进行直接抽吸首过技术的 15 例病例中,11 例 (73.3%) 达到了 TICI 2b/3。在一个案例中,动脉内组织纤溶酶原激活剂被用作唯一的治疗方式,达到了 TICI 2a。没有观察到与装置相关或导管相关的并发症。 39 名幸存者术后 7 天的美国国立卫生研究院卒中量表平均评分为 8.5 +/- 7.3(范围 0-23)。 结论:使用 Sofia (6F) PLUS 进行急性缺血性卒中血管内治疗的初步结果令人鼓舞。需要更大系列的经验来进一步评估该装置的安全性和有效性,并将其与其他再灌注导管进行比较。
BACKGROUND: Neuroendovascular intervention has become a key treatment option for acute ischemic stroke. The Sofia (6F) PLUS catheter was designed for neurovascular access for diagnostic or therapeutic interventions.OBJECTIVE: To report the first series describing use of the Sofia PLUS intermediate/distal access reperfusion catheter in the treatment of acute ischemic stroke.METHODS: In this retrospective study, 41 stroke caseswere identified inwhich the catheter was utilized for thrombolysis/thrombectomy. Mean preprocedure National Institutes of Health Stroke Scale score was 16.5 +/- 5.2 (range 4-29). Occluded vessels included the M1 segment, M2 segment, internal carotid artery terminus, cervical internal carotid artery, and basilar artery.RESULTS: Successful positioning of the Sofia PLUS catheter near the occlusion site was achieved in 38 (92.7%) of 41 cases in which thrombectomy or thrombolysis was attempted using intraarterial tissue plasminogen activator, a direct aspiration first-pass technique, and/or stent retrieval. A postprocedure thrombolysis in cerebral infarction (TICI) score of 2b/3 was achieved in 37 of 41 cases. Of 15 cases where the Sofia PLUS was used for a direct aspiration first-pass technique, TICI 2b/3 was achieved in 11 (73.3%). In one casewhere intraarterial tissue plasminogen activator was used as the only treatment modality, TICI 2a was achieved. No device-related or catheter-related complications were observed. The mean 7-d-postprocedure National Institutes of Health Stroke Scale score among the 39 survivors was 8.5 +/- 7.3 (range 0-23).CONCLUSION: Initial results with use of the Sofia (6F) PLUS for endovascular treatment of acute ischemic stroke have been encouraging. Experience with a larger series is warranted to further evaluate the safety and efficacy of this device and compare it with other reperfusion catheters.