Abstract 011: Early multi‐center experience with the NEVA VS in the treatment of subarachnoid hemorrhage‐related cerebral vasospasm

Introduction Cerebral vasospasm represents a formidable challenge in the aftermath of subarachnoid hemorrhage (SAH), significantly contributing to morbidity and mortality. This life‐threatening and potentially reversible complication is conventionally addressed through percutaneous transluminal balloon angioplasty (PTA) or intra‐arterial (IA) infusion of vasodilators, particularly when standard medical therapies prove ineffective. However, these endovascular interventions often fall short in efficacy or are marred by elevated complication rates, including vessel rupture and thromboembolic events. The persistent issue of frequent recurrence underscores a pressing unmet need in vasospasm management. In this context, the NeVa VS (Vesalio)—a patented, retrievable nitinol stent—emerges as a novel solution engineered explicitly for cerebral vasospasm post‐aneurysmal rupture. Notably, it is the sole device approved for this application in the United States. This study delineates our initial clinical experiences utilizing the NeVa VS device. Methods Our study encompassed 23 patients across seven US centers, all treated with the NeVa VS device. Of 24 cases analyzed to date, all were confronting refractory symptomatic cerebral vasospasm after aSAH. The deployment of NeVa VS involved a 0.021” or 0.027” ID micro‐catheter, positioning the stent across the affected vasospasm segment. Following a recommended 5‐10 minute interval, allowing the self‐expanding nitinol structure to dilate the constricted vessel segment mechanically, the device was resheathed into the microcatheter and removed. We aimed to evaluate intraoperative efficacy, user experience, safety parameters, and preliminary outcomes in this patient cohort. Parameters such as vessel caliber pre‐ and post‐intervention, procedural metrics, and outcomes—including symptom relief, patient status changes, and adverse events—were meticulously analyzed. Outcomes Comprehensive outcomes were ascertained for 23 patients. The median age was 42 years (±13, SD); 74% were female, and 70% were of Hispanic/Latino ethnicity. The device was deployed, on average 12 days (±8) after the index hemorrhage, in total 24 times (1.0 per case) in the MCA (57%) or basilar artery (43%) for an average of 6.4 minutes (±2.7). MAC/sedation was utilized in 17% of cases. With one exception, all treatments were deemed successful (96%) with significant improvement in the degree of spasm from 78% pre‐ and 22% post‐intervention, and no safety events occurred, in particular, no ischemic strokes or intraprocedural ruptures. Four patients (17%) required additional treatment, on average 11.0 days after the first treatment. Conclusion In this preliminary multi‐center study, the NeVa VS device demonstrates a 96% success rate in performing a safe and efficacious single‐stage intervention to address severe stenosis secondary to vasospasm post‐aSAH. The device's ability to control vessel expansion and preserve distal flow offers a significant advantage over traditional balloon angioplasty. It also exhibits a lower risk profile concerning vessel rupture and the option to utilize MAC/sedation instead of solely general anesthesia in selected cases (17%), marking a significant advancement in neurointerventional therapy for symptomatic vasospasm.