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      First Experience of Three Neurovascular Centers With the p64MW-HPC, a Low-Profile Flow Diverter Designed for Proximal Cerebral Vessels With Antithrombotic Coating

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          Abstract

          Background: In the last decade, flow diversion (FD) has been established as hemodynamic treatment for cerebral aneurysms arising from proximal and distal cerebral arteries. However, two significant limitations remain—the need for 0.027” microcatheters required for delivery of most flow diverting stents (FDS), and long-term dual anti-platelet therapy (DAPT) in order to prevent FDS-associated thromboembolism, at the cost of increasing the risk for hemorrhage. This study reports the experience of three neurovascular centers with the p64MW-HPC, a FDS with anti-thrombotic coating that is implantable via a 0.021” microcatheter.

          Materials and methods: Three neurovascular centers contributed to this retrospective analysis of patients that had been treated with the p64MW-HPC between March 2020 and March 2021. Clinical data, aneurysm characteristics, and follow-up results, including procedural and post-procedural complications, were recorded. The hemodynamic effect was assessed using the O'Kelly–Marotta Scale (OKM).

          Results: Thirty-two patients (22 female, mean age 57.1 years) with 33 aneurysms (27 anterior circulation and six posterior circulation) were successfully treated with the p64MW-HPC. In 30/32 patients (93.75%), aneurysmal perfusion was significantly reduced immediately post implantation. Follow-up imaging was available for 23 aneurysms. Delayed aneurysm perfusion (OKM A3: 8.7%), reduction in aneurysm size (OKM B1-3: 26.1%), or sufficient separation from the parent vessel (OKM C1-3 and D1: 65.2%) was demonstrated at the last available follow-up after a mean of 5.9 months. In two cases, device thrombosis after early discontinuation of DAPT occurred. One delayed rupture caused a caroticocavernous fistula. The complications were treated sufficiently and all patients recovered without permanent significant morbidity.

          Conclusion: Treatment with the p64MW-HPC is safe and feasible and achieves good early aneurysm occlusion rates in the proximal intracranial circulation, which are comparable to those of well-established FDS. Sudden interruption of DAPT in the early post-interventional phase can cause in-stent thrombosis despite the HPC surface modification. Deliverability via the 0.021” microcatheter facilitates treatment in challenging vascular anatomies.

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          Most cited references55

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          Platelet activation and atherothrombosis.

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            Pipeline for uncoilable or failed aneurysms: results from a multicenter clinical trial.

            To evaluate the safety and effectiveness of the Pipeline Embolization Device (PED; ev3/Covidien, Irvine, Calif) in the treatment of complex intracranial aneurysms. The Pipeline for Uncoilable or Failed Aneurysms is a multicenter, prospective, interventional, single-arm trial of PED for the treatment of uncoilable or failed aneurysms of the internal carotid artery. Institutional review board approval of the HIPAA-compliant study protocol was obtained from each center. After providing informed consent, 108 patients with recently unruptured large and giant wide-necked aneurysms were enrolled in the study. The primary effectiveness endpoint was angiographic evaluation that demonstrated complete aneurysm occlusion and absence of major stenosis at 180 days. The primary safety endpoint was occurrence of major ipsilateral stroke or neurologic death at 180 days. PED placement was technically successful in 107 of 108 patients (99.1%). Mean aneurysm size was 18.2 mm; 22 aneurysms (20.4%) were giant (>25 mm). Of the 106 aneurysms, 78 met the study's primary effectiveness endpoint (73.6%; 95% posterior probability interval: 64.4%-81.0%). Six of the 107 patients in the safety cohort experienced a major ipsilateral stroke or neurologic death (5.6%; 95% posterior probability interval: 2.6%-11.7%). PED offers a reasonably safe and effective treatment of large or giant intracranial internal carotid artery aneurysms, demonstrated by high rates of complete aneurysm occlusion and low rates of adverse neurologic events; even in aneurysms failing previous alternative treatments.
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              Intra-aneurysmal thrombosis as a possible cause of delayed aneurysm rupture after flow-diversion treatment.

              FD technology enables reconstructive repair of otherwise difficult-to-treat intracranial aneurysms. These stentlike devices may induce progressive aneurysm thrombosis without additional implants and may initiate complete reverse vessel remodeling. The associated vascular biologic processes are as yet only partially understood. From 12 different centers, 13 cases of delayed postprocedural aneurysm rupture were recorded and analyzed. Symptom, aneurysm location and morphology, and the time elapsed from treatment until rupture were analyzed. There were 10 internal carotid and 3 basilar artery aneurysms. Mean aneurysm diameter was 22 ± 6 mm. Eleven patients were symptomatic before treatment. A single FD was used for all saccular aneurysms, while fusiform lesions were treated by using multiple devices. A supplementary loose coiling of the aneurysm was performed in 1 patient only. Ten patients developed early aneurysm rupture after FD treatment (mean, 16 days; range, 2-48 days); in 3 patients, rupture occurred 3-5 months after treatment. In all cases, most of the aneurysm cavity was thrombosed before rupture. The biologic mechanisms predisposing to rupture under these conditions are reviewed and discussed FDs alone may modify hemodynamics in ways that induce extensive aneurysm thrombosis. Under specific conditions, however, instead of reverse remodeling and cicatrization, aggressive thrombus-associated autolysis of the aneurysm wall may result in delayed rupture.
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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
                14 September 2021
                2021
                : 12
                : 724705
                Affiliations
                [1] 1Institut für Neuroradiologie, Universitätsklinikum Leipzig , Leipzig, Germany
                [2] 2Klinik und Poliklinik für Anästhesiologie und Intensivtherapie, Universitätsklinikum Leipzig , Leipzig, Germany
                [3] 3Institut für Radiologie und Neuroradiologie, Heinrich-Braun- Klinikum , Zwickau, Germany
                [4] 4Institut für Radiologie und Neuroradiologie, Klinikum Chemnitz gGmbH , Chemnitz, Germany
                [5] 5Paul-Flechsig-Institut für Hirnforschung, Universität Leipzig , Leipzig, Germany
                [6] 6Abteilung für Neuroradiologie, Klinik & Poliklinik für Radiologie, Universitätsklinikum Halle , Halle (Saale), Germany
                Author notes

                Edited by: Pervinder Bhogal, The Royal London Hospital, United Kingdom

                Reviewed by: Waldo Rigoberto Guerrero, University of South Florida, United States; Alberto Maud, Texas Tech University Health Sciences Center El Paso, United States

                *Correspondence: Stefan Schob stefan.schob@ 123456uk-halle.de

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

                †These authors have contributed equally to this work

                Article
                10.3389/fneur.2021.724705
                8476967
                34594297
                cfedf552-f5cd-495d-b2de-b58977faf95b
                Copyright © 2021 Winters, Schüngel, Scherlach, Mucha, Thalwitzer, Härtig, Donitza, Bailis, Maybaum, Hoffmann, Quäschling and Schob.

                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
                : 14 June 2021
                : 12 August 2021
                Page count
                Figures: 4, Tables: 2, Equations: 0, References: 55, Pages: 12, Words: 8738
                Categories
                Neurology
                Original Research

                Neurology
                flow diverter,p64mw-hpc,hydrophilic coating,hpc,navigability,anti-platelet therapy
                Neurology
                flow diverter, p64mw-hpc, hydrophilic coating, hpc, navigability, anti-platelet therapy

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