Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Barcelona, Spain.
Stroke Unit, Department of Neurology, Vall d'Hebron University Hospital, Barcelona, Spain.
J Neuroradiol. 2020 Jun;47(4):301-305. doi: 10.1016/j.neurad.2019.03.007. Epub 2019 Apr 2.
The NeVa™ (Vesalio, Nashville, Tennessee) thrombectomy device is a CE-approved novel hybrid-cell stent retriever with offset enlarged openings coupled with functional zones and a closed distal end. The device was designed to incorporate and trap resistant emboli. The purpose was to determine the safety and efficacy of the NeVa™ stent.
Prospective data was collected on the first thirty consecutive patients treated at four stroke centers with NeVa™ as first line treatment between December 2017 and May 2018. Clinical outcome measures included re-perfusion scores after each pass, complications (per-procedural complications, device related adverse events, all intracerebral hemorrhage (ICH) and symptomatic ICH (sICH) on follow up imaging), 24 hour NIHSS, mRS at discharge and 90 days. Baseline data as well as treatment parameters were documented.
Mean presenting NIHSS was 16. Sites of primary occlusion were 10 ICA, 16 M1-MCA, 3 M2-MCA and one basilar. There were five tandem occlusions. Reperfusion outcomes after each NeVa pass; TICI ≥ 2b after first pass 63%, after 1 or 2 passes 83%, after 1 to 3 passes 90%. TICI 2c-3 after first pass 47%, after 1-2 passes 57%, after 1-3 passes 60%. TICI ≥ 2b after final pass 93%; TICI 2c-3, 63%. There were no device related serious averse events and no sICH. Clot material was partially or completely incorporated into the device after 70% passes. The mean 24 hour NIHSS was 7 and the 90 day mRS was 0-2 in 53%.
The NeVa™ device demonstrated a high rate of first pass complete reperfusion effect, a good safety profile and favorable 90 day clinical outcomes in this initial clinical experience.
NeVa™（Vesalio，田纳西州纳什维尔）血栓切除术装置是一种获得 CE 批准的新型杂交细胞支架取栓器，具有偏移的扩大开口，结合功能区和封闭的远端。该设备旨在纳入和捕获耐药性栓塞物。目的是确定 NeVa™支架的安全性和有效性。
2017 年 12 月至 2018 年 5 月，在四家卒中中心，连续对前 30 例接受 NeVa™作为一线治疗的患者进行前瞻性数据收集。临床转归指标包括每次通过后的再灌注评分、并发症（术中并发症、器械相关不良事件、所有颅内出血（ICH）和随访影像学上的症状性 ICH（sICH））、24 小时 NIHSS、出院时 mRS 和 90 天。记录基线数据和治疗参数。
平均入院 NIHSS 为 16。原发闭塞部位为 10 例颈内动脉（ICA）、16 例 MCA-M1、3 例 MCA-M2 和 1 例基底动脉。有 5 例串联闭塞。每次 NeVa 通过后的再灌注结果：第一次通过后 TICI≥2b 为 63%，1-2 次通过后为 83%，1-3 次通过后为 90%。第一次通过后 TICI 2c-3 为 47%，1-2 次通过后为 57%，1-3 次通过后为 60%。最后一次通过后 TICI≥2b 为 93%；TICI 2c-3，63%。无器械相关严重不良事件和症状性 ICH。70%的情况下，血栓材料部分或完全被纳入装置中。平均 24 小时 NIHSS 为 7，90 天 mRS 为 0-2 的占 53%。
在这项初步临床经验中，NeVa™装置在第一次通过时显示出很高的完全再灌注效果、良好的安全性和良好的 90 天临床转归。
