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      Periprocedural to 1-year safety and efficacy outcomes with the Pipeline Embolization Device with Shield technology for intracranial aneurysms: a prospective, post-market, multi-center study

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          Abstract

          Background

          The first and second generations of the Pipeline Embolization Device (PED) have been widely adopted for the treatment of intracranial aneurysms (IAs) due to their high associated occlusion rates and low morbidity and mortality. The objective of this study was to evaluate the safety and effectiveness of the third- generation Pipeline Shield device (PED-Shield) for the treatment of IAs.

          Methods

          The SHIELD study was a prospective, single-arm, multicenter, post-market, observational study evaluating the PED-Shield device for the treatment of IAs. The primary efficacy endpoint was complete aneurysm occlusion without significant parent artery stenosis or retreatment at 1-year post-procedure and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurological death.

          Results

          Of 205 subjects who consented across 21 sites, 204 subjects with 204 target aneurysms were ultimately treated (mean age 54.8±12.81 years, 81.4% [166/204] female). Technical success (ie, deployment of the PED-Shield) was achieved in 98.0% (200/204) of subjects with a mean number of 1.1±0.34 devices per subject and a single device used in 86.8% (177/204) of subjects. The primary effectiveness endpoint was met in 71.7% (143/200) of subjects while the primary safety endpoint occurred in six (2.9%) subjects, two (1.0%) of which led to neurological death.

          Conclusions

          The findings of the SHIELD study support the safety and effectiveness of the PED-Shield for IA treatment, evidenced by high occlusion rates and low rates of neurological complications in the study population.

          Clinical trial registration-URL

          http://www.clinicaltrials.gov. Unique identifier: NCT02719522.

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          Most cited references30

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          Changes in case fatality of aneurysmal subarachnoid haemorrhage over time, according to age, sex, and region: a meta-analysis.

          In a systematic review, published in 1997, we found that the case fatality of aneurysmal subarachnoid haemorrhage (SAH) decreased during the period 1960-95. Because diagnostic and treatment strategies have improved and new studies from previously non-studied regions have been published since 1995, we did an updated meta-analysis to assess changes in case fatality and morbidity and differences according to age, sex, and region. A new search of PubMed with predefined inclusion criteria for case finding and diagnosis identified reports on prospective population-based studies published between January, 1995, and July, 2007. The studies included in the previous systematic review were reassessed with the new inclusion criteria. Changes in case fatality over time and the effect of age and sex were quantified with weighted linear regression. Regional differences were analysed with linear regression analysis, and the regions of interest were subsequently defined as reference regions and compared with the other regions. 33 studies (23 of which were published in 1995 or later) were included that described 39 study periods. These studies reported on 8739 patients, of whom 7659 [88%] were reported on after 1995. 11 of the studies that were included in the previous review did not meet the current, more stringent, inclusion criteria. The mean age of patients had increased in the period 1973 to 2002 from 52 to 62 years. Case fatality varied from 8.3% to 66.7% between studies and decreased 0.8% per year (95% CI 0.2 to 1.3). The decrease was unchanged after adjustment for sex, but the decrease per year was 0.4% (-0.5 to 1.2) after adjustment for age. Case fatality was 11.8% (3.8 to 19.9) lower in Japan than it was in Europe, the USA, Australia, and New Zealand. The unadjusted decrease in case fatality excluding the data for Japan was 0.6% per year (0.0 to 1.1), a 17% decrease over the three decades. Six studies reported data on case morbidity, but these were insufficient to assess changes over time. Despite an increase in the mean age of patients with SAH, case-fatality rates have decreased by 17% between 1973 and 2002 and show potentially important regional differences. This decrease coincides with the introduction of improved management strategies. Netherlands Organisation for Scientific Research; ZonMw.
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            Prevalence of unruptured intracranial aneurysms, with emphasis on sex, age, comorbidity, country, and time period: a systematic review and meta-analysis.

            Unruptured intracranial aneurysms (UIAs) are increasingly detected and are an important health-care burden. We aimed to assess the prevalence of UIAs according to family history, comorbidity, sex, age, country, and time period. Through searches of PubMed, Embase, and Web of Science we updated our 1998 systematic review up to March, 2011. We calculated prevalences and prevalence ratios (PRs) with random-effects binomial meta-analysis. We assessed time trends with year of study as a continuous variable. We included 68 studies, which reported on 83 study populations and 1450 UIAs in 94 912 patients from 21 countries. The overall prevalence was estimated as 3·2% (95% CI 1·9-5·2) in a population without comorbidity, with a mean age of 50 years, and consisting of 50% men. Compared with populations without the comorbidity, PRs were 6·9 (95% CI 3·5-14) for autosomal dominant polycystic kidney disease (ADPKD), 3·4 (1·9-5·9) for a positive family history of intracranial aneurysm of subarachnoid haemorrhage, 3·6 (0·4-30) for brain tumour, 2·0 (0·9-4·6) for pituitary adenoma, and 1·7 (0·9-3·0) for atherosclerosis. The PR for women compared with men was 1·61 (1·02-2·54), with a ratio of 2·2 (1·3-3·6) in study populations with a mean age of more than 50 years. Compared with patients older than 80 years, we found no differences by age, except for patients younger than 30 years (0·01, 0·00-0·12). Compared with the USA, PRs were similar for other countries, including Japan (0·8, 0·4-1·7) and Finland (1·0, 0·4-2·4). There was no statistically significant time trend. The prevalence of UIAs is higher in patients with ADPKD or a positive family history of intracranial aneurysm of subarachnoid haemorrhage than in people without comorbidity. In Finland and Japan, the higher incidence of subarachnoid haemorrhage is not explained by a higher prevalence of UIAs, implicating higher risks of rupture. Julius Centre for Health Sciences and Primary Care and Department of Neurology and Neurosurgery, University Medical Centre, Utrecht. Copyright © 2011 Elsevier Ltd. All rights reserved.
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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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                Author and article information

                Journal
                J Neurointerv Surg
                J Neurointerv Surg
                neurintsurg
                jnis
                Journal of Neurointerventional Surgery
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                1759-8478
                1759-8486
                November 2020
                1 June 2020
                : 12
                : 11
                : 1107-1112
                Affiliations
                [1 ] departmentInterventional Neuroradiology , Gold Coast University Hospital , Southport, Queensland, Australia
                [2 ] departmentEndovascular Neurosurgery/Interventional Neuroradiology , Hospital Clínico Universitario de Valladolid , Valladolid, Castilla y León, Spain
                [3 ] departmentNeuroradiology , Rigshospitalet , Copenhagen, Denmark
                [4 ] departmentInterventional Neuroradiology , Hôpital Bicêtre , Le Kremlin-Bicetre, Île-de-France, France
                [5 ] departmentInterventional Neuroradiology , 251 Air Force General Hospital , Athens, Attica, Greece
                [6 ] departmentNeuroradiology , Maurizio Bufalini Hospital , Cesena, Emilia-Romagna, Italy
                [7 ] departmentRadiology , Hospital Universitario Central de Asturias , Oviedo, Asturias, Spain
                [8 ] departmentNeuroradiology , Lancashire Teaching Hospitals NHS Foundation Trust , Preston, UK
                [9 ] departmentDepartment of Intracranial Endovascular Therapy , Alfried Krupp Krankenhaus Ruttenscheid , Essen, Nordrhein-Westfalen, Germany
                [10 ] departmentInterventional Neuroradiology. Radiology , Queen Elizabeth Hospital , Birmingham, Birmingham, UK
                Author notes
                [Correspondence to ] Dr Hal Rice, Interventional Neuroradiology, Gold Coast University Hospital, Southport, QLD 4215, Australia; Hal.Rice@ 123456qscan.com.au
                Author information
                http://orcid.org/0000-0002-3612-4289
                Article
                neurintsurg-2020-015943
                10.1136/neurintsurg-2020-015943
                7569365
                32482834
                2343bd8d-30cc-43fa-af08-59f2dc19e21a
                © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 22 February 2020
                : 14 April 2020
                : 15 April 2020
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100004374, Medtronic;
                Categories
                Hemorrhagic Stroke
                1506
                1543
                Original research
                Custom metadata
                unlocked

                Surgery
                aneurysm,flow diverter
                Surgery
                aneurysm, flow diverter

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