Department for International and Diagnostic Neuroradiology, University of Saarland, Homburg, Germany.
Eur J Neurol. 2009 Nov;16(11):1210-6. doi: 10.1111/j.1468-1331.2009.02750.x. Epub 2009 Jul 29.
This is the first single center experience illustrating the effectiveness of the penumbra system (PS) in the treatment of large vessel occlusive disease in the arena of acute ischaemic stroke. The PS is an innovative mechanical thrombectomy device, employed in the revascularization of large cerebral vessel occlusions in patients via the utilization of an aspiration platform.
This is a prospective, non-randomized controlled trial evaluating the clinical and functional outcome in 29 patients with acute intra-cranial occlusions consequent to mechanical thrombectomy by the PS either as mono-therapy or as an adjunct to current standard of care. Patients were evaluated by a neurologist and treated by our in house interventional neuro-radiologists. Primary end-points were revascularization of the occluded target vessel to TIMI grade 2 or 3 and neurological outcome as measured by an improvement in the NIH Stroke Scale (NIHSS) score after the procedure.
Complete revascularization (TIMI 3) was achieved in 21/29 (72.4%) of patients. Partial revascularization (TIMI 2) was established in 4/29 (13.8%) of patients. Revascularization failed in four (13.8%) patients. Nineteen (19) patients (65.5%) had at least a four-point improvement in NIHSS scores. Modified Rankin scale scores of < or =2 were seen in 37.9% of patients. There were no device-related adverse events. Symptomatic intra-cranial hemorrhage occurred in 7% of patients.
The PS has the potential of exercising a significant impact in the interventional treatment of ischaemic stroke in the future.
这是首例单中心经验，阐述了在急性缺血性脑卒中领域，Penumbra 系统（PS）治疗大血管闭塞性疾病的有效性。PS 是一种创新的机械血栓切除术装置，通过利用抽吸平台，对大血管闭塞患者进行血管再通治疗。
这是一项前瞻性、非随机对照试验，评估了 29 例急性颅内闭塞患者接受 PS 机械血栓切除术治疗的临床和功能结局，PS 作为单一疗法或作为当前标准治疗的辅助治疗。由神经科医生进行评估，由我们内部的介入神经放射科医生进行治疗。主要终点是闭塞目标血管的再通达到 TIMI 2 或 3 级，以及通过治疗后 NIH 卒中量表（NIHSS）评分的改善来衡量的神经功能结局。
29 例患者中，21 例（72.4%）完全再通（TIMI 3），4 例（13.8%）部分再通（TIMI 2），4 例（13.8%）再通失败。19 例（65.5%）患者 NIHSS 评分至少改善了 4 分。改良 Rankin 量表评分<或=2 的患者占 37.9%。无器械相关不良事件。7%的患者发生症状性颅内出血。
PS 有可能在未来对缺血性脑卒中的介入治疗产生重大影响。
