Behme Daniel, Kowoll Annika, Mpotsaris Anastasios, Hader Claudia, Hechelhammer Lukas, Weber Johannes, Weber Werner
Department of Neuroradiology, Georg-August-University Göttingen, University Medical Center, Göttingen, Germany.
Department of Radiology and Neuroradiology, Ruhr University Bochum, University Medical Center-Knappschaftskrankenhaus Langendreer, Bochum, Germany.
J Neurointerv Surg. 2016 Jan;8(1):8-12. doi: 10.1136/neurintsurg-2014-011446. Epub 2014 Nov 3.
The aim of this study was to assess reperfusion and clinical outcome of treatment with the self-expanding retrievable Separator 3D in revascularization of acute ischemic stroke. The three-dimensional (3D) device secures thrombus with direct aspiration and supports debulking of the clot.
At two centers, 129 consecutive stroke patients with National Institutes of Health Stroke Scale (NIHSS) scores ≥5 were treated with mechanical thrombectomy using the Separator 3D as a component of the Penumbra System within 8 h of symptom onset; modified Treatment in Cerebral Infarction (mTICI) revascularization scores, NIHSS score on admission and discharge, mortality rates, and modified Rankin Scale (mRS) outcomes at 90 days were evaluated.
A total of 129 vessels in 129 patients were treated. Occlusions were located in the middle cerebral artery (MCA, 48%), internal carotid artery (ICA, 33%), cervical ICA-MCA (3%), and vertebrobasilar arteries (16%). Intravenous thrombolytic therapy with recombinant tissue plasminogen activator was given to 78% of patients. Median NIHSS was 15 prior to treatment. Reperfusion to mTICI 2b or 3 was successful in 96/129 (74%) target arterial lesions, with more than half of cases (51%) achieving mTICI 3. The mean time from arterial puncture to revascularization was 65 min. At 90 days, the symptomatic intracranial hemorrhage rate was 4%, all cause mortality was 32%, and 43/99 patients (43%) achieved functional independence with an mRS score of ≤2.
The results suggest that the Separator 3D enables safe and effective revascularization of occluded large arteries in acute stroke intervention, leading to a high rate of functional independence at 90 days.
本研究旨在评估在急性缺血性卒中血管重建中使用自膨胀可回收分离器3D进行再灌注治疗的效果及临床结局。这种三维（3D）装置通过直接抽吸固定血栓，并辅助减少血栓体积。
在两个中心，129例连续的卒中患者，美国国立卫生研究院卒中量表（NIHSS）评分≥5，在症状发作8小时内使用分离器3D作为Penumbra系统的一个组件进行机械取栓治疗；评估改良脑梗死治疗（mTICI）再灌注评分、入院和出院时的NIHSS评分、死亡率以及90天时的改良Rankin量表（mRS）结局。
共治疗了129例患者的129条血管。闭塞部位位于大脑中动脉（MCA，48%）、颈内动脉（ICA，33%）、颈段ICA-MCA（3%）和椎基底动脉（16%）。78%的患者接受了重组组织型纤溶酶原激活剂静脉溶栓治疗。治疗前NIHSS中位数为15。96/129（74%）个目标动脉病变成功再灌注至mTICI 2b或3级，超过半数病例（51%）达到mTICI 3级。从动脉穿刺到再灌注的平均时间为65分钟。90天时，有症状颅内出血率为4%，全因死亡率为32%，43/99例患者（43%）达到功能独立，mRS评分为≤2。
结果表明，分离器3D在急性卒中干预中能够安全有效地实现闭塞大动脉的血管重建，90天时功能独立率较高。
