Authors:
Clemens M. Schirmer, Shahid Nimjee, Eric Savageau, Michael Chen, Ameer E. Hassan
Journal:
Journal of NeuroInterventional Surgery
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 more than 41 patients across six US centers, all treated with the NeVa VS device. Of 17 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 4–5 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.
Outcomes:
Comprehensive outcomes were ascertained for 17 out of the 41 patients.
- The median age was 45 years;
- 75% were female,
- 81% of Hispanic/Latino ethnicity.
The device was deployed:
- On average 14 days after the index hemorrhage,
- In total 18 times (1.1 per case)
- In the MCA (47%) or the basilar artery (53%)
- For an average of 6.6 minutes.
Treatment success:
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.
1.
Treatment was successful in 94% of patients (16/17)
Further treatment required in 12% of patients (2/17)
Average interval to 2nd treatment: 11.5 days
2.
Significant improvement was observed in the degree of spasm pre and post intervention
3.
Good safety profile was observed
Conclusion:
In this preliminary multi-center exploration, the NeVa VS device demonstrates a 94% 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 edge over traditional balloon angioplasty. It also exhibits a lower risk profile concerning vessel rupture, marking a significant advancement in neurointerventional therapy.
