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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EStroke is a major complication following transcatheter aortic valve replacement (TAVR) that increases mortality by \u0026gt;3.5 fold [Eggebrecht H et al. \u003Cem\u003EEuroIntervention\u003C\/em\u003E. 2012]. The Claret Montage dual-filter Cerebral Protection System was developed to protect the brain from injury caused by embolic debris. The Claret Embolic Protection and Transcatheter Aortic Valve Implantation Trial [CLEAN-TAVI; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01833052\u0026amp;atom=%2Fspmdc%2F14%2F30%2F11.atom\u0022\u003ENCT01833052\u003C\/a\u003E] evaluated the impact of the use of this filter on the number of cerebral lesions in high-risk, aortic stenosis patients undergoing TAVR using the Medtronic CoreValve.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ECerebrovascular Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EValvular Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ECerebrovascular Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EValvular Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EStroke is a major complication following transcatheter aortic valve replacement (TAVR) that increases mortality by \u0026gt; 3.5 fold [Eggebrecht H et al. \u003Cem\u003EEuroIntervention\u003C\/em\u003E. 2012]. About two-thirds of patients undergoing TAVR have evidence of ischemic events following the procedure [Daneault B et al. \u003Cem\u003EJ Am Coll Cardiol\u003C\/em\u003E. 2011]. The presence of silent brain infarcts increases the risk of major stroke by \u0026gt; 3 fold [Vermeer SE et al. \u003Cem\u003EStroke\u003C\/em\u003E. 2003]. They are also associated with several adverse neurological and cognitive consequences. Axel Linke, MD, University of Leipzig, Heart Center, Leipzig, Germany, reported that using an embolic filter with TAVR significantly reduces the number and volume of cerebral infarcts.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe Claret Montage dual-filter Cerebral Protection System was developed to protect the brain from injury caused by embolic debris. The Claret Embolic Protection and Transcatheter Aortic Valve Implantation Trial [CLEAN-TAVI; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01833052\u0026amp;atom=%2Fspmdc%2F14%2F30%2F11.atom\u0022\u003ENCT01833052\u003C\/a\u003E] evaluated the impact of the use of this filter on the number of cerebral lesions in high-risk, aortic stenosis (AS) patients undergoing TAVR using the Medtronic CoreValve (MCV). The study hypothesis was that use of the Claret Montage filter would reduce the number of cerebral emboli by 50% at 2 days post procedure.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EPatients (50 in each group) were randomized (1:1) in a blinded fashion to TAVR with and without the filter. The primary end point was the numerical reduction in positive postprocedure diffusion-weighted MRI (DW-MRI) perfused brain lesions relative to baseline at 2 days in various territories of the brain. Patients with symptomatic and relevant AS with an indication for TAVR using the Medtronic CoreValve were included. Patients with a pacemaker, patients having a stroke within the past 12 months, and patients with \u0026gt; 70% stenosis of the carotid artery were excluded.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EBaseline characteristics were similar between the groups with 51% having coronary artery disease, 92% in congestive heart failure, and 34% having prior atrial fibrillation\/flutter.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EDevice success was 96% (48\/50) with 2 unsuccessful filter deployments (1 each left coronary cusp tortuosity and stratum corneum tortuosity). Procedural success was 94% with accidental dislocation of a correctly deployed filter in one patient. \u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E shows the procedural outcomes.\u003C\/p\u003E\u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/11875\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/11875\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/11875\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-7\u0022 class=\u0022first-child\u0022\u003EProcedural Outcomes\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-10\u0022\u003EThere were significantly fewer lesions at 2 and 7 days in regions of the brain when TAVR was performed with the Claret Montage filter compared with the control group in which TAVR was performed without the filter. In the protected regions, there were 60% fewer lesions using the filter at 2 days (\u003Cem\u003EP\u003C\/em\u003E = .009) and 57% fewer lesions at 7 days (\u003Cem\u003EP\u003C\/em\u003E = .0023). In all regions, there were 50% less lesions with the filter compared with controls at day 2 (\u003Cem\u003EP\u003C\/em\u003E = .0023) and 50% less lesions at day 7 (\u003Cem\u003EP\u003C\/em\u003E = .0123).\u003C\/p\u003E\u003Cp id=\u0022p-11\u0022\u003ESimilar outcomes were noted for the total volume of lesions. Neurological outcomes were similar at 2, 7, and 30 days between the 2 groups in the intention-to-treat analysis. At 2 days, a neurological deficit was observed in 28% of the control patients when evaluated by a NIHSS-trained specialist. There were significantly (\u003Cem\u003EP\u003C\/em\u003E \u0026lt; .05) fewer incidences of ataxia in the filter group (9%) at 2 days compared with the control group (24%) in the per-protocol analysis.\u003C\/p\u003E\u003Cp id=\u0022p-12\u0022\u003EUse of Claret Montage filter during transfemoral TAVR using the MCV in surgically at risk patients with severe AS significantly reduces the number and volume of cerebral lesions as determined by DW-MRI subtraction at 2 and 7 days after procedure. Larger studies are needed to validate the observed beneficial effects of routine cerebral protection during TAVR in improving acute neurological outcome and reducing stroke rate.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2014 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/14\/30\/11.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzosz1\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_tables.js?nzosz1\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}