Department of Neuroradiology, Medical Faculty and University Hospital, University of Cologne, Cologne, Germany; University Institute for Radiology, Neuroradiology and Nuclear Medicine, Johannes Wesling Klinikum Minden, Minden, Germany.
Department of Neuroradiology, Medical Faculty and University Hospital, University of Cologne, Cologne, Germany; Center for Neurosurgery, Medical Faculty and University Hospital, University of Cologne, Cologne, Germany.
World Neurosurg. 2021 Apr;148:e121-e129. doi: 10.1016/j.wneu.2020.12.075. Epub 2021 Jan 5.
The NeVa M1 thrombectomy device is a novel hybrid-cell stent retriever with multifunctional zones for optimized retrieval of resistant clots located in the M1 segment of the middle cerebral artery. The objective was to evaluate the safety and efficacy of the NeVa in a "real-life" setting.
Twenty-nine consecutive patients (median age: 77 years) treated with the NeVa M1 for acute ischemic stroke of the M1 segement were retrospectively reviewed. First-pass and final modified thrombolysis in cerebral infarction (mTICI) scores, device-related complications, symptomatic intracranial hemorrhage, and 90-day modified Rankin scale (mRS) scores are reported. Primary outcome parameters were first-pass mTICI 2b-3 reperfusion and mRS 0-2 at 90 days.
Median National Institutes of Health Stroke Scale scores decreased from 16 to 12 after treatment. mTICI 2b-3 reperfusion rates were 55% after the first pass, 79% after 1-2 passes, and 100% after the final pass. mTICI 2c-3 was obtained in 48% after the first pass, 62% after 1-2 passes, and 72% after the final pass. Rescue treatment was performed in 4 patients (14%). Device-related complications included 1 asymptomatic caroticocavernous fistula, 1 asymptomatic M2 dissection, and 1 symptomatic intracranial hemorrhage. The procedure-related vasospasm rate was 48%. A 90-day mRS of 0-2 was achieved by 31%.
The NeVa M1 provides a high first-pass complete reperfusion rate with an adequate safety profile. To retrieve resistant clots, the stent design exerts high mechanical traction forces, which may trigger vasospasm and vessel wall damage. Large, comparative studies are warranted to draw a definite conclusion on this device.
NeVa M1 血栓切除术装置是一种新型杂交细胞支架取栓器，具有多功能区域，可优化对大脑中动脉 M1 段内的耐药性血栓的提取。目的在于评估 NeVa 在“真实生活”环境中的安全性和疗效。
回顾性分析 29 例接受 NeVa M1 治疗的大脑中动脉 M1 段急性缺血性脑卒中患者。报告首次通过和最终改良脑梗死溶栓（mTICI）评分、与器械相关的并发症、症状性颅内出血和 90 天改良 Rankin 量表（mRS）评分。主要结果参数为首次通过 mTICI 2b-3 再灌注和 90 天 mRS 0-2。
治疗后，美国国立卫生研究院卒中量表评分中位数从 16 分降至 12 分。首次通过的 mTICI 2b-3 再灌注率为 55%，1-2 次通过的再灌注率为 79%，最终通过的再灌注率为 100%。首次通过获得 mTICI 2c-3 的比例为 48%，1-2 次通过的比例为 62%，最终通过的比例为 72%。4 例患者（14%）进行了挽救性治疗。与器械相关的并发症包括 1 例无症状颈动脉海绵窦瘘、1 例无症状 M2 夹层和 1 例症状性颅内出血。与操作相关的血管痉挛发生率为 48%。90 天 mRS 0-2 评分达到 31%。
NeVa M1 提供了高的首次通过完全再灌注率，具有良好的安全性。为了提取耐药性血栓，支架设计产生了高的机械牵引力，这可能引发血管痉挛和血管壁损伤。需要进行大型的、对比研究来对该设备得出明确的结论。
