Multicenter Experience with the Pipeline Flex and Vantage with Shield Technology for Intracranial Aneurysm Treatment.

Abstract

The Pipeline Embolization Device is a safe and effective treatment option for intracranial aneurysms. The newer Pipeline generations have received structural refinements and a surface modification to improve deliverability, procedural safety, and angiographic outcomes. This multicenter study evaluated the clinical safety and efficacy of the 2 surface-modified Pipeline iterations, Pipeline Vantage and Pipeline Flex with Shield Technology (PFS). Consecutive patients treated between 2017 and 2023 were retrospectively reviewed for aneurysm characteristics, procedural details, complications, and angiographic outcomes. The safety end point was the rate of procedural and postprocedural major neurologic events occurring during the hospital stay. The efficacy end point was the rate of complete occlusion at last follow-up. One hundred forty-one patients underwent 112 Pipeline Vantage procedures and 32 PFS procedures for 147 aneurysms with a mean size of 8.0 (SD, 5.9) mm (11% ruptured, 16% posterior circulation, 18% nonsaccular morphology). All procedures were technically successful with a mean of 1.2 devices implanted. Balloon angioplasty was required in 20/144 (13.9%) procedures. Major neurologic adverse events occurred in 6/144 (4.2%) procedures (all ischemic stroke), resulting in death in 2 (1.4%) patients. There were no hemorrhagic complications. At a mean of 11 months, complete occlusion was achieved in 85/112 (75.9%) aneurysms, 15/112 (13.4%) had an entry remnant, and 12/112 (10.7%) had an aneurysm remnant. The results demonstrate high feasibility, procedural safety, and efficacy of the surface-modified Pipeline flow diverters.