Background The Pipeline Embolisation Device (PED) has proven to be a safe and effective device for the treatment of intracranial aneurysms.^{1 2} There have been three previous iterations of the PED: Classic, Flex and Shield devices.³ The Pipeline Vantage Embolisation Device with Shield technology (PVED) is the 4th generation of this device. We present the initial single center results of the first 75 patients treated with PVED.

Methods The Vantage One is a single arm, prospective study, of patients with unruptured aneurysms allocated for treatment with a flow diverting stent, when considered best clinical practice. There were no aneurysm size or location exclusion criteria. Efficacy (device deployment and aneurysm occlusion) and safety (Neurological Serious Adverse Event) were independently reviewed and analysed.Data of all consecutive patients with aneurysms electively treated with PVED, at a single institution, was prospectively collected and retrospectively analysed. Patient demographics, aneurysm characteristics, procedural parameters, device properties, imaging follow-up data assessed by core lab adjudication, immediate, early (<30 days) and delayed (>30 days) neurological serious adverse events were independently assessed.

Results 75 consecutive elective patients with 86 unruptured aneurysms located in the anterior (88%), posterior (11%), and extracranial (1%) circulations were included. A total of 90 devices were implanted. The deployment success rate was 100%. In 5% of cases angioplasty was required for sufficient proximal stent opening/adequate wall apposition. At 30 days following the procedure, the morbidity was 2% and mortality was 0%. Occlusion rates at one month were 45%, at three months 62% and at 6 months 73%.

Conclusion The new PVED reveals improved device visibility, ease of delivery and repositioning with precise distal opening in comparison to previous PED generations. Initial results demonstrate overall good device performance, safety profile and effectiveness. The implant requires a modified deployment technique for successful vessel wall apposition of the proximal stent as opposed to the previous generations of PED.

References

1. Lylyk I, Scrivano E, Lundquist J, Ferrario A, Bleise C, Perez N, Lylyk PN, Viso R, Nella-Castro R, Lylyk P. Pipeline embolization devices for the treatment of intracranial aneurysms, single-center registry: long-term angiographic and clinical outcomes from 1000 aneurysms. Neurosurgery. 2021 Aug 16;89(3):443-449. doi: 10.1093/neuros/nyab183. PMID: 34098575; PMCID: PMC8374967.

2. Chia GS, de Villiers L, Carraro do Nascimento V, et al. Safety and clinical effectiveness of pipeline shield device for intracranial aneurysms in an Australian Cohort (SCOPE-AUS). Stroke Vasc Interv Neurol. 2022;2(5):e000292.

3. Rice H, Martínez Galdámez M, Holtmannspötter M, et al. J NeuroIntervent Surg 2020;12:1107-1112.

Disclosures L. de Viliers: 1; C; Medtronic, Stryker, Microvention. 2; C; Medtronic, Stryker, Microvention. V. Carraro do Nascimento: 2; C; Medtronic, Stryker, Microvention. L. Domitrovic: None. H. Rice: 1; C; Medtronic, Stryker, Microvention. 2; C; Medtronic, Stryker, Microvention.