Favorable first-pass recanalization rates with NeVa™ thrombectomy device in acute stroke patients: Initial clinical experience
Favorable first-pass recanalization rates with NeVa™ thrombectomy device in acute stroke patients: Initial clinical experience
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DOI：
10.1177/1591019920938223
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发表时间：
2020-07-02
影响因子：
1.7
通讯作者：
Giray, Semih
中科院分区：
文献类型：
--
作者：
Akpinar, Cetin K.;Ozdemir, Atilla O.;Giray, Semih
背景：NeVa （TM）取栓装置（Vesalio LLC, Nashville， USA）已经在动物、体外和临床研究中成功地用于大血管闭塞取栓。该装置采用Drop Zone技术设计，末端闭合，径向膨胀力强，在临床前研究中，该装置在抵抗性“白色”血栓中表现出特别的效率。我们的目标是确定这种新型支架回收器在一次通过率和整体再通方面的安全性和性能。方法：介入神经病学数据库是一个前瞻性维护的前、后循环卒中取栓病例数据库。我们回顾性分析了采用NeVa （TM）取栓装置作为一线治疗策略的病例。数据收集时间为2019年1月至2020年1月。报告了首次再通、最终再通、90天功能结局、并发症和出血率。结果：118例患者使用了NeVa （TM）取栓装置。患者的平均年龄为69±14岁，美国国立卫生研究院卒中量表的中位基线为14岁，阿尔伯塔卒中计划早期计算机断层扫描评分的中位初始值为8岁。从腹股沟穿刺到成功再通的中位时间为29 min（四分位间距（IQR）： 20-40）。首次通通率分别为56.8%（改良脑梗死（mTICI） 2b/3）和44.9% （mTICI 2c/3）。最终再通成功率为95.8%（脑梗死溶栓2b/3）。良好的功能预后（改良Rankin量表0-2）在“首次通过”亚组中为53%，在总患者群体中为42.4%。达到最终再通分数的中位数为1 （IQR 1-2）。新区域栓塞率为1.7%。有症状性出血4例（3.3%）。结论：根据我们的经验，NeVa （TM）装置具有较高的首通率和整体再通率以及良好的安全性。
Background: The NeVa (TM) thrombectomy device (Vesalio LLC, Nashville, USA) has been reported to succeed in large vessel occlusion thrombectomy in animal, in-vitro, and clinical studies. Designed with Drop Zone technology, a closed distal tip, and strong expansive radial force, the device demonstrated particular efficiency in resistant "white" thrombi in preclinical research. Our goal is to determine the safety and performance of this novel stent retriever on first-pass rates and overall recanalization.Methods: The Interventional Neurology Database is a prospectively maintained database of anterior and posterior circulation stroke thrombectomy cases. We retrospectively analyzed cases where the NeVa (TM) thrombectomy device was used as the first-line treatment strategy. Data collection occurred between January 2019 and January 2020. First-pass recanalization, final recanalization, 90-day functional outcome, complication, and bleeding rates are reported.Results: One hundred eighteen patients were treated with the NeVa (TM) thrombectomy device. The mean patient age was 69 +/- 14 years, the median baseline National Institutes of Health Stroke Scale was 14, and the median initial Alberta Stroke Program Early Computed Tomography score was 8. The median time from groin puncture to successful recanalization was 29 min (interquartile range (IQR): 20-40). First-pass recanalization rates were 56.8% (modified treatment in cerebral infarction (mTICI) 2b/3) and 44.9% (mTICI 2c/3). Final successful recanalization rate was 95.8% (thrombolysis in cerebral infarction 2b/3). Favorable functional outcome (modified Rankin Scale 0-2) was 53% in the "first-pass" subgroup and 42.4% in the total patient population. The median number of passes to achieve the final recanalization score was 1 (IQR 1-2). The rate of embolization into new territory was 1.7%. Four patients (3.3%) had symptomatic hemorrhage.Conclusions: In our experience, the NeVa (TM) device demonstrated high first-pass and overall recanalization rates along with a good safety profile.