Neurosurgery, WellStar Health System, Marietta, Georgia, USA
Department of Radiology, Fort Sanders Regional Medical Center, Knoxville, Tennessee, USA.
J Neurointerv Surg. 2022 Aug;14(8):815-819. doi: 10.1136/neurintsurg-2021-017859. Epub 2021 Sep 7.
Cerebral vasospasm (CV) after aneurysmal subarachnoid hemorrhage (aSAH) is linked to worse neurological outcomes. The NeVa VS is a novel cerebral dilation device based on predicate stent retrievers. We report the results of the Vesalio NeVa VS for the Treatment of Symptomatic Cerebral Vasospasm following aSAH (VITAL) Study.
This was a single-arm prospective multicenter trial to assess the safety and probable benefit of the NeVa VS device to treat CV. Patients were screened and treated if they had CV >50% on non-invasive imaging confirmed by cerebral angiography. The vessel diameters were measured before and after treatment by an independent core laboratory. The primary endpoint was ≥50% vessel diameter immediately after treatment with the NeVa VS device.
Thirty patients with a mean age of 52±11 years and mean Hunt-Hess grade of 3.1±0.9 were enrolled. A total of 74 vessels were treated with an average of 1.3 deployments per vessel (95 deployments total). The mean pre-treatment narrowing of the target vessel (n=74) was 65.6% with reduction of the narrowing to 29.4% after treatment. The primary endpoint was achieved in 64 of 74 vessels (86.5%). In three of 95 total deployments (3.2%), thrombus at the site of deployment was observed during the procedure without apparent neurological sequelae.
The NeVa VS device appears to be a safe treatment to regain vessel diameter in severely narrowed intracranial arteries secondary to CV associated with aSAH. This treatment offers a new tool that allows for controlled vessel expansion to treat CV.
动脉瘤性蛛网膜下腔出血（aSAH）后发生的脑血管痉挛（CV）与更差的神经结局相关。NeVa VS 是一种基于预测性支架取栓器的新型脑扩张装置。我们报告了 Vesalio NeVa VS 用于治疗 aSAH 后症状性 CV（VITAL）研究的结果。
这是一项单臂前瞻性多中心试验，旨在评估 NeVa VS 装置治疗 CV 的安全性和可能的益处。如果通过脑血管造影证实非侵入性成像发现 CV >50%，则对患者进行筛选和治疗。独立核心实验室在治疗前后测量血管直径。主要终点是 NeVa VS 装置治疗后血管直径立即增加≥50%。
共纳入 30 例平均年龄为 52±11 岁、平均 Hunt-Hess 分级为 3.1±0.9 的患者。共对 74 条血管进行了治疗，每条血管的平均植入次数为 1.3 次（共 95 次植入）。目标血管（n=74）的平均术前狭窄程度为 65.6%，治疗后狭窄程度减少至 29.4%。74 条血管中的 64 条达到了主要终点（86.5%）。在 95 次总植入中，有 3 次（3.2%）在手术过程中观察到植入部位的血栓，但无明显神经后遗症。
NeVa VS 装置似乎是一种安全的治疗方法，可以恢复因 aSAH 相关 CV 导致的严重狭窄颅内动脉的血管直径。这种治疗方法提供了一种新的工具，可以控制血管扩张来治疗 CV。
