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Introduction
The Pipeline Embolization Device (PED) has become an important tool in the management of intracranial aneurysms. After receiving the European CE mark and FDA approval in June 2008 and 2011, respectively, clinical experience with the device has been widely described in the literature. 1-5 Recently, the PUFS trial demonstrated a high rate of complete occlusion of large and giant wide-necked aneurysms arising from the internal carotid artery with a reasonably low rate of major safety events. 6
The second generation of PED, the Pipeline Flex Embolization Device (PED Flex), received the CE mark in March 2014. We report our preliminary experience using this device, with an emphasis on the potential technical advantages compared with the previous device.
Methods and materials
A total of six patients with a diagnosis of intracranial aneurysm were treated with the PED Flex in three University Hospitals between May and June 2014. Clinical, procedural, and angiographic data, including aneurysm size and location, device or devices used were prospectively collected into each institution database and subsequently analyzed. Intraprocedural events were selected as the primary outcome. Differences between the premorbid and discharge modified Rankin Scale (mRS) score and neurological deficit were noted as a clinical outcome.
Aneurysm size was classified by the maximum diameter, with a mean of 11.5 mm (range 4-30 mm). All cases were unruptured. Of these, three cases were asymptomatic incidental aneurysms, two were symptomatic dissecting aneurysms and one was a recanalized previously coiled aneurysm.
The patients were premedicated with double antiplatelet therapy (100 mg aspirin and 75 mg clopidogrel) a mean of 5 days before the intervention. Platelet function test responses were within the therapeutic range in all six cases at the time of groin puncture. An initial 70-100 U/kg heparin bolus was administered and activated clotting time was maintained two times above the patient's baseline level intraoperatively. Heparin was discontinued but not reversed at the conclusion of the procedure. PED Flex devices were deployed through a Marksman microcatheter (ev3, Irvine, California, USA) using a triaxial guide catheter system in all cases. Any intraprocedural event including thromboembolic complications, dissection, aneurysm rupture, endoleak, twist or flattening of the device was immediately collected after each procedure. All procedures were performed by senior neurointerventionists with experience of more than 30...