Safety and Efficacy of the Pipeline Embolization Device Use in the Outside Circle of Willis Located Intracranial Aneurysms: A Single-Center Experience.

Background: The use of Pipeline Embolization Device (PED) is approved by the US Food and Drug Administration (FDA) to treat aneurysms located between the petrous and superior hypophyseal segments of the internal carotid artery. The purpose of this study is to evaluate the feasibility and efficacy of treating aneurysms outside the FDA approved anatomical locations. Furthermore, we analyze the safety of our antiplatelet protocol.

Methods: Data on all patients treated with PED at our center from March 2015 to December 2017 were reviewed. Only patients with aneurysms treated with PED as off label use were included. Procedural complications and long-term functional outcome measured by modified Rankin Scale (mRS) were recorded. Tirofiban maintenance infusion was administered intravenously after PED deployment. None of the patients had platelet function testing.

Results: A total of 36 patients harboring 36 aneurysms were included in the study. Mean age was 58.2 years ±14.6. Nineteen were women (52.8%) and most aneurysms were unruptured (80.6%). There were no intraoperative complications. Five patients experienced postoperative complications - 4 ischemic strokes and one groin hematoma. None led to any significant disability at follow-up. Thirty-one patients (86.1%) achieved an mRS of 0-2 at follow-up. A Raymond-Roy classification of 1 was achieved in 78.9% of patients.

Conclusion: The use of PED to treat aneurysms located outside the circle of Willis is feasible and effective. Our novel antiplatelet protocol did not require platelet function assay testing and did not lead to a higher rate of thrombo-embolic events compared to what has been previously reported.