Journal Article

Treatment of intracranial aneurysms using the pipeline flex embolization device with shield technology: angiographic and safety outcomes at 1-year follow-up

Kabbasch, Christoph, Chapot, Rene, Boccardi, Edoardo P, Stockx, Luc, Piano, Mariangela, Lamin, Saleh M, Liebig, Thomas, Lagios, Konstantinos G, Nordmeyer, Hannes, Boulanger, Thierry, Chavda, Swarupsinh, Martínez-Galdámez, Mario, Faragò, Giuseppe, Ciceri, Elisa F

2019

Overview

PurposeThe Pipeline Embolization Device (PED) is a routine first-line treatment option for intracranial aneurysms (IAs). The Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield) is an updated version of the PED which has been modified to include a surface phosphorylcholine biocompatible polymer. Its early technical success and safety have been reported previously. Here, we assessed the long-term safety and efficacy of the Pipeline Shield for the treatment of IAs.Materials and methodsThe Pipeline Flex Embolization Device with Shield Technology (PFLEX) study was a prospective, single-arm, multicenter study for the treatment of unruptured IAs using the Pipeline Shield. The primary endpoint was a major stroke in the territory supplied by the treated artery or neurologic death at 1-year post-procedure. Angiographic outcomes were also assessed by an independent radiology laboratory at 6 months and 1 year.ResultsFifty patients (mean age, 53 years; 82% female) with 50 unruptured IAs were treated. Mean aneurysm diameter was 8.82±6.15 mm. Of the target aneurysms, 38/50 (76%) were small (<10 mm), 11/50 (22%) were large (≥10 and<25 mm), and 1/50 (2%) was giant (≥25 mm). Forty-seven (94%) were located in the internal carotid artery and three (6%) in the vertebral artery. At 1-year post-procedure, no major strokes or neurologic deaths were reported, and complete occlusion was achieved in 27/33 (81.8%). There were no instances of aneurysm recurrence or retreatment.ConclusionsOur 1-year follow-up concerning angiographic and safety outcomes corroborate previous evidence that the Pipeline Shield is a safe and effective treatment for IAs.Trial registration number NCT02390037

• Publisher: BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Adult / Aged / Aneurysms / Aspirin / Blood platelets / Blood Vessel Prosthesis - adverse effects / Blood Vessel Prosthesis - trends / Carotid arteries / Cerebral Angiography - adverse effects / Cerebral Angiography - trends / Embolization / Embolization, Therapeutic - adverse effects / Embolization, Therapeutic - instrumentation / Embolization, Therapeutic - trends / Female / Follow-Up Studies / Humans / Intracranial Aneurysm - diagnostic imaging / Intracranial Aneurysm - therapy / Laboratories / Male / Medical imaging / Middle Aged / Neurosurgery / New Devices / Patients / Pipelines / Prospective Studies / Recurrence / Retreatment - trends / Stroke / Time Factors / Treatment Outcome / Veins & arteries