Primary results of the Vesalio NeVa VS for the Treatment of Symptomatic Cerebral Vasospasm following Aneurysm Subarachnoid Hemorrhage (VITAL) Study

Abstract

BackgroundCerebral 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.MethodsThis 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.ResultsThirty 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.ConclusionsThe 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.

2023 Guideline for the Management of Patients With Aneurysmal Subarachnoid Hemorrhage: A Guideline From the American Heart Association/American Stroke Association

“…Crystalloid infusions to maintain euvolemia have been supported in the literature. 362 With euvolemia as part of goal-directed therapy, DCI was observed in 13% of the patients in the goal-directed therapy group and in 32% of the patients in the control group (odds ratio, 0.324 [95% CI, 0.11–0.86]; P =0.021) in 1 study. 245 Duangthongphon and colleagues 320 found that initiation of the euvolemic protocol reduced DCI from 44.2% to 7.7% (odds ratio, 0.10 [95% CI, 0.04–0.23]; P <0.001).…”

Neuroradiological diagnosis and therapy of cerebral vasospasm after subarachnoid hemorrhage

“…Instead, a mechanical radial force is gradually exerted on the spastic vascular wall by means of self-expansion after release of the stent retriever without the need for temporary occlusion. In addition, different novel non-occlusive stents are currently used for treating spasms [71][72][73]. In our institution we have had positive experiences with the Comaneci instrument with an adjustable and easy-to-control radial force for the endovascular treatment of CVS.…”

COManeci MechANical Dilation for vasospasm (COMMAND): multicenter experience

“…The most utilized endovascular treatment options are balloon angioplasty and intra-arterial vasodilator (IAV) therapies 4. The recently published VITAL study demonstrated the complementary utility of the NeVa VS device (stent retriever) in mechanical dilatation treatment of severely narrowed vasospastic vessels following aSAH with mean improvement of 36.1% of vessel caliber compared with pre-treatment in 74 vessels in 30 patients 5. Other single-center reports have described the utility of other commercially available stent retrievers for mechanical endovascular dilation of symptomatic vasospasm with encouraging results 6–8.…”