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      Single-Center Experience With the Bare p48MW Low-Profile Flow Diverter and Its Hydrophilically Covered Version for Treatment of Bifurcation Aneurysms in Distal Segments of the Anterior and Posterior Circulation

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          Abstract

          Background and Purpose: Flow diversion has profoundly changed the way aneurysms are treated. However, it conventionally requires dual antiplatelet medication and has yet been considered off-label use in the posterior circulation or within peripheral vessels of the anterior circulation. Here, we report our experience with the p48MW/p48MW hydrophilic coating (HPC) in the anterior and posterior circulation. This novel low-profile flow diverter is specifically designed for treatment of small peripheral vessels, and the p48MW HPC has an anti-thrombotic polymer coating, which allows application of a single antiplatelet function medication in conditions that expectably require further surgery.

          Materials and Methods: Thirty-two patients were prospectively included. Twenty-six treatments were performed with one flow diverter, four required two overlapping flow diverters, one case demanded three overlapping flow diverters, and in one case, extensive dissecting aneurysm telescoping with eight flow diverters was necessary. Twenty-two complex bifurcation aneurysms were treated. Three months' follow-up was available for 14 patients.

          Results: Deployment was uneventful in all cases. In four cases, undersizing was unavoidable and resulted in significant shortening of the flow diverter, which demanded implantation of further flow diverters to sufficiently treat the target aneurysm. Three flow diverters required balloon angioplasty for optimal wall approximation. All parent vessels remained patent. Available 3-month follow-up studies showed decreased influx or delayed washout in all aneurysms; none was occluded completely. There were no device-related clinical complications.

          Conclusions: Implantation of the p48MW/p48MW HPC is safe and effective for treatment of distally located cerebral aneurysms. Considering the reported rates of ischemic complications associated with flow diversion of complex bifurcation aneurysms, the p48MW/p48MW HPC potentially provides increased safety for complex bifurcation aneurysms in the anterior and posterior circulation.

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          Most cited references29

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          A novel grading scale for the angiographic assessment of intracranial aneurysms treated using flow diverting stents.

          Flow diverting stents are emerging as a treatment option for difficult intracranial aneurysms. Current grading scales for assessment of angiographic outcomes following aneurysm treatment do not apply to aneurysms treated by flow diversion. We propose a novel grading scale based on the degree of angiographic filling and contrast stasis. This scale will facilitate communication and standardize reporting of outcomes following flow diversion treatments.
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            Long-Term Clinical and Angiographic Outcomes Following Pipeline Embolization Device Treatment of Complex Internal Carotid Artery Aneurysms: Five-Year Results of the Pipeline for Uncoilable or Failed Aneurysms Trial.

            Early and mid-term safety and efficacy of aneurysm treatment with the Pipeline Embolization Device (PED) has been well demonstrated in prior studies.
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              Safety and efficacy of the Pipeline embolization device for treatment of intracranial aneurysms: a pooled analysis of 3 large studies.

              OBJECTIVE The authors performed a pooled analysis of 3 studies-IntrePED (International Retrospective Study of the Pipeline Embolization Device), PUFS (Pipeline for Uncoilable or Failed Aneurysms Study), and ASPIRe (Aneurysm Study of Pipeline in an Observational Registry)-in order to assess angiographic outcomes and clinical safety of the Pipeline embolization device (PED). METHODS IntrePED was a retrospective study, while PUFS and ASPIRe were prospective studies. For each patient included in these studies, the authors collected baseline demographic data, aneurysm characteristics, and procedural details. The primary outcomes for this combined analysis were clinical outcomes, including neurological morbidity and mortality and major ipsilateral intracranial hemorrhage and ischemic stroke. The secondary outcomes were angiographic occlusion rates, which were available for ASPIRe and PUFS only. RESULTS A total of 1092 patients with 1221 aneurysms were included across the 3 studies. The mean aneurysm size was 12.0 ± 7.8 mm and the mean neck size was 6.6 ± 4.8 mm. The major ipsilateral ischemic stroke rate was 3.7% (40/1091). The major ipsilateral intracranial hemorrhage rate was 2.0% (22/1091). The major neurological morbidity rate was 5.7% (62/1091). The neurological mortality rate was 3.3% (36/1091). The combined major morbidity and neurological mortality rate was 7.1% (78/1091). The complete occlusion rates were 75.0% at 180 days (111/148) and 85.5% at 1 year (94/110). The overall aneurysm retreatment rate was 3.0% (33/1091) at a mean follow-up time of 10.2 ± 10.8 months. CONCLUSIONS Endovascular treatment of intracranial aneurysms with the PED is safe and effective. Angiographic occlusion rates progressed with follow-up. Rates of stroke, hemorrhage, morbidity and mortality, and retreatment were low, especially given the fact that the aneurysms treated were generally large and wide necked.
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                Author and article information

                Contributors
                Journal
                Front Neurol
                Front Neurol
                Front. Neurol.
                Frontiers in Neurology
                Frontiers Media S.A.
                1664-2295
                23 September 2020
                2020
                : 11
                : 1050
                Affiliations
                Abteilung für Neuroradiologie, Universitätsklinikum Leipzig , Leipzig, Germany
                Author notes

                Edited by: Santiago Ortega-Gutierrez, The University of Iowa, United States

                Reviewed by: Edgar A. Samaniego, The University of Iowa, United States; Pervinder Bhogal, The Royal London Hospital, United Kingdom

                *Correspondence: Stefan Schob stefan.schob@ 123456medizin.uni-leipzig.de

                This article was submitted to Endovascular and Interventional Neurology, a section of the journal Frontiers in Neurology

                Article
                10.3389/fneur.2020.01050
                7538783
                5766c4d1-23cf-4ae9-9155-015d209130e5
                Copyright © 2020 Schob, Kläver, Richter, Scherlach, Maybaum, Mucha, Schüngel, Hoffmann and Quaeschling.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 23 January 2020
                : 11 August 2020
                Page count
                Figures: 3, Tables: 1, Equations: 0, References: 29, Pages: 10, Words: 6534
                Categories
                Neurology
                Original Research

                Neurology
                flow diversion,p48mw,small cerebral vessels,cerebral aneurysm,reduced platelet function inhibition

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