Vanguard Study: Initial experience with the new fourth generation Pipeline Vantage Flow Diverter (PVFD): 6-month results, technical and clinical considerations.

Background: The Pipeline Embolization Device has proven to be a safe and effective device for the treatment of intracranial aneurysms. The Pipeline Vantage Flow Diverter (PVFD) with Shield Technology is the new fourth generation of this implant, with modifications made compared to previous iterations. We aimed to evaluate the mechanical properties and clinical safety and efficacy of this device.

Methods: Vanguard is a single arm, single center, prospective study. Between April 2021 and April 2023, all consecutive patients with an unruptured aneurysm treated with Pipeline Vantage flow-diverting stents were included. There were no aneurysm size or location exclusion criteria. Safety (neurological serious adverse events) and efficacy (device deployment and aneurysm occlusion) were independently reviewed. Imaging follow-up data, and immediate, early (<30 days), and delayed (>30 days) neurological serious adverse events were independently assessed.

Results: 101 consecutive patients with a total of 115 aneurysms were included. The aneurysms were situated in the anterior (90.4%) or posterior (9.6%) circulations. A total of 124 devices were implanted. The deployment success rate was 100%. In four (4.0%) cases post-deployment angioplasty was required to optimize device wall apposition. Occlusion rates at 1 month were 54.7%, at 3 months 72.1%, and at 6 months 81.7%. Morbidity and mortality were 4.9% and 0%, respectively, at 6 months. Eight cases (6.9%) demonstrated in-stent stenosis, four of which had 'fish mouth' deformity.

Conclusion: Initial results of the new generation PVFD for unruptured intracranial aneurysm treatment demonstrate overall satisfactory device performance, safety profile, and effectiveness.