First clinical multicenter experience with the new Pipeline Vantage flow diverter.

ABSTRACT

BACKGROUND: Flow diversion is an innovative and increasingly used technique for the treatment of intracranial aneurysms. New flow diverters (FDs) are being introduced to improve the safety and efficacy of this treatment. The aim of this study was to assess the safety, feasibility, and efficacy of the new Pipeline Vantage (PV) FD. METHODS: Patients with intracranial aneurysms treated with the PV at 10 international neurovascular centers were retrospectively analyzed. Patient and aneurysm characteristics, procedural parameters, complications, and the grade of occlusion were assessed. RESULTS: 60 patients with 70 aneurysms (5.0% with acute hemorrhage, 90.0% located in the anterior circulation) were included. 82 PVs were implanted in 61 treatment sessions. The PV could be successfully implanted in all treatments. Additional coiling was performed in 18.6%, and in-stent balloon angioplasty (to enhance the vessel wall apposition) in 24.6%. Periprocedural technical complications occurred in 24.6% of the treatments, were predominantly FD deployment problems, and were all asymptomatic. The overall symptomatic complication rate was 8.2% and the neurological symptomatic complication rate was 3.3%. Only one symptomatic complication was device-related (perforator artery infarctions leading to stroke). After a mean follow-up of 7.1 months, the rate of complete aneurysm occlusion was 77.9%. One patient (1.7%) died due to aneurysmal subarachnoid hemorrhage which occurred before treatment, unrelated to the procedure. CONCLUSIONS: The new PV FD is safe and feasible for the treatment of intracranial aneurysms. The short-term occlusion rates are promising but need further assessment in prospective long-term follow-up studies.