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      Clinical and Anatomical Follow-up in Patients With Aneurysms Treated With the WEB Device : 1-Year Follow-up Report in the Cumulated Population of 2 Prospective, Multicenter Series (WEBCAST and French Observatory)

      research-article
      WEBCAST and French Observatory Investigators
      Neurosurgery
      Oxford University Press
      Aneurysms, Endovascular treatment, Flow disruption, WEB device

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          Abstract

          BACKGROUND:

          Flow disruption with WEB is an innovative endovascular approach for wide-neck bifurcation aneurysms. Initial series have shown a low complication rate with good efficacy.

          OBJECTIVE:

          To report clinical and anatomical results of the WEB treatment in the cumulated population of WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm) and French Observatory series.

          METHODS:

          WEBCAST and French Observatory are single-arm, prospective, multicenter, Good Clinical Practice studies dedicated to the evaluation of WEB treatment. Ruptured and unruptured bifurcation aneurysms located in the basilar artery, middle cerebral artery, anterior communicating artery, and internal carotid artery terminus were included in both studies. Clinical data were independently evaluated. Postoperative, 6-month (in WEBCAST), and 1-year aneurysm occlusion was independently evaluated with a 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant.

          RESULTS:

          The cumulated population was 113 patients (74 female, 65.5%) 33 to 74 years of age with 114 aneurysms with a mean neck size of 5.6 mm. There was no mortality at 1 month, and morbidity was 2.7%. A statistically significant difference in the rate of occurrence of thromboembolic events was observed between the use of any antiplatelet agent and the use of no antiplatelet agent ( P < .001). At 1 year, complete aneurysm occlusion was observed in 56.0%, neck remnant in 26.0%, and aneurysm remnant in 18.0%. Worsening of aneurysm occlusion between the procedure and 12 months was observed in 2.0% and between 6 months and 1 year in 7.1%.

          CONCLUSION:

          The analysis in this large cumulated population of studies confirms favorable safety and efficacy of WEB treatment.

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          Most cited references25

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          • Article: not found

          Endovascular treatment of intracranial aneurysms: current status.

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            Immediate clinical outcome of patients harboring unruptured intracranial aneurysms treated by endovascular approach: results of the ATENA study.

            The management of unruptured intracranial aneurysms remains controversial and the results of endovascular treatment are not precisely known because no prospective data exist. The first prospective multicenter study (ATENA) was conducted in Canada and France to determine clinical outcome and risks of this treatment. Six hundred forty-nine patients harboring a total of 1100 aneurysms from 27 Canadian and French neurointerventional centers were prospectively and consecutively treated by endovascular coil embolization. Of these, 739 unruptured intracranial aneurysms were treated during 700 procedures. Aneurysms were selectively treated in the great majority of cases (98.4%) with coils alone (54.5%), the balloon remodeling technique (37.3%), or stenting (7.8%). Endovascular treatment failed in 32 aneurysms (4.3%). Technical adverse events with or without clinical modification were encountered in 15.4% of patients and included thromboembolic complications (7.1% per procedure), intraoperative rupture (2.6% per procedure), and device-related problems (2.9% per procedure). Adverse events associated with transient or permanent neurological deficit or death were encountered in 5.4% of cases. The 1-month morbidity and mortality rates were 1.7% and 1.4%, respectively. Endovascular treatment of unruptured intracranial aneurysms is feasible in a high percentage of cases with low morbidity and mortality rates.
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              • Article: not found

              Hydrogel-coated coils versus bare platinum coils for the endovascular treatment of intracranial aneurysms (HELPS): a randomised controlled trial.

              Coated coils for endovascular treatment of cerebral aneurysm were developed to reduce recurrence and retreatment rates, and have been in clinical use for 8-9 years without robust evidence to determine their efficacy. We assessed the efficacy and safety of hydrogel-coated coils. This randomised trial was undertaken in 24 centres in seven countries. Patients aged 18-75 years with a previously untreated ruptured or unruptured cerebral aneurysm of 2-25 mm in maximum diameter were randomly allocated (1:1) to aneurysm coiling with either hydrogel-coated coils or standard bare platinum coils (control). Randomisation was done with a computer-generated sequence, stratified by aneurysm size, shape, and dome-to-neck ratio; intention to use assist device; and by region. Participants and those assessing outcomes were masked to allocation. Analysis was by modified intention to treat (excluding missing data). Primary outcome was a composite of angiographic and clinical outcomes at 18-month follow-up. We also did prespecified subgroup analyses of characteristics likely to be relevant to angiographic outcome. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN30531382. 249 patients were allocated to the hydrogel coil group and 250 to the control group. In 44 of 467 patients for whom an 18-month composite primary outcome was unavailable, 6-month angiographic results were used. 70 (28%) patients in the hydrogel group and 90 (36%) control patients had an adverse composite primary outcome, giving an absolute reduction in the proportion of adverse composite primary outcomes with hydrogel of 7·0% (95% CI -1·6 to 15·5), odds ratio (OR) 0·73 (0·49-1·1, p=0·13). In a prespecified subgroup analysis in recently ruptured aneurysms, there were more adverse composite primary outcomes in the control group than in the hydrogel group-OR 2·08 (1·24-3·46, p=0·014). There were 8·6% fewer major angiographic recurrences in patients allocated to hydrogel coils-OR 0·7 (0·4-1·0, p=0·049). There were five cases of unexplained hydrocephalus in not-recently-ruptured aneurysms in the hydrogel coil group and one case in the control group. Whether use of hydrogel coils reduces late aneurysm rupture or improves long-term clinical outcome is not clear, but our results indicate that their use lowers major recurrence. MicroVention Inc. Copyright © 2011 Elsevier Ltd. All rights reserved.
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                Author and article information

                Journal
                Neurosurgery
                Neurosurgery
                neurosurgery
                Neurosurgery
                Oxford University Press
                0148-396X
                1524-4040
                January 2016
                06 November 2015
                06 November 2015
                : 78
                : 1
                : 133-141
                Affiliations
                [* ]Department of Neuroradiology, Maison Blanche Hospital, University of Reims-Champagne-Ardenne, France
                []Department of Interventional Neuroradiology, CHU Kremlin-Bicêtre, Kremlin Bicêtre, France
                [§ ]Oxford Neurovascular & Neuroradiology Research Unit, Oxford Radcliffe Hospital, Oxford, United Kingdom
                Author notes
                []Correspondence: Laurent Pierot, MD, PhD, Department of Neuroradiology, Maison Blanche Hospital, 45 Rue Cognacq Jay, Reims 51092, France. E-mail: lpierot@ 123456gmail.com
                Article
                10.1227/NEU.0000000000001106
                6975162
                26552042
                285249d6-3bbd-4b1d-8f17-11ee408d9ffb
                Copyright © 2015 by the Congress of Neurological Surgeons

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by/3.0/), which permits non-commercial reuse, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

                History
                : 27 July 2015
                : 12 October 2015
                Page count
                Pages: 9
                Categories
                Research—Human—Clinical Studies

                aneurysms,endovascular treatment,flow disruption,web device

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