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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.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\u003EResults from an FDA-approved, prospective pilot trial suggest that the use of a self-expanding, intracranial stent for acute stroke may achieve high levels of revascularization. This follows on the heels of the Mechanical Embolus Removal in Cerebral Ischemia [MERCI; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00318071\u0026amp;atom=%2Fspmdc%2F9%2F1%2F14.atom\u0022\u003ENCT00318071\u003C\/a\u003E] trials that reported recanalization rates that ranged from approximately 60% to 70% percent with low associated morbidity.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ECerebrovascular Disease Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EResults from an FDA-approved, prospective pilot trial that were presented by J. Duffy Mocco, MD, University of Buffalo Neurosurgery, Buffalo, NY, suggest that the use of a self-expanding, intracranial stent for acute stroke may achieve high levels of revascularization. This follows on the heels of the Mechanical Embolus Removal in Cerebral Ischemia (MERCI; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00318071\u0026amp;atom=%2Fspmdc%2F9%2F1%2F14.atom\u0022\u003ENCT00318071\u003C\/a\u003E) trials that reported recanalization rates that ranged from approximately 60% to 70% percent with low associated morbidity.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EStroke is a leading cause of long-term disability and the third-leading cause of death. It is estimated that 795,000 strokes occur each year in the United States. This number is projected to increase 40% by the year 2025 (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). The MERCI 1 [Gobin YP et al. \u003Cem\u003EStroke\u003C\/em\u003E 2004] and Multi MERCI [Flint AC et al. \u003Cem\u003EStroke\u003C\/em\u003E 2007] trials, which used the MERCI Retrieval System, compared outcomes in patients who received mechanical embolectomy (recanalization) with outcomes in patients who were not recanalized. Significantly improved clinical outcomes and reduced mortality were reported for the recanalized patient group.\u003C\/p\u003E\u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/9\/1\/14\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Projected Number of Strokes in the US: 2002\u0026#x2013;2025.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1201876402\u0022 data-figure-caption=\u0022Projected Number of Strokes in the US: 2002\u0026#x2013;2025.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/9\/1\/14\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/9\/1\/14\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/9\/1\/14\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/11395\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\u003Cdiv class=\u0022fig-caption\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-4\u0022 class=\u0022first-child\u0022\u003EProjected Number of Strokes in the US: 2002\u20132025.\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-5\u0022\u003EAlthough mechanical recanalization appears to work, there are patients for whom the MERCI device fails. Based on the results of this pilot study, Dr. Mocco said he believes that the use of intracranial stenting for acute ischemic stroke after failed thrombolysis with other means is now possible.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EBased on preliminary results [Levy EI et al. \u003Cem\u003ENeurosurgery\u003C\/em\u003E 2006; Zaideat OO et al. \u003Cem\u003EStroke\u003C\/em\u003E 2008] that have demonstrated enhanced outcomes that are produced by self-expanding stents for recanalization of acute cerebrovascular occlusions compared with other means of thrombolysis, the FDA approved the SAIS (Stent-Assisted recanalization in acute Ischemic Stroke) study.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EEligibility included age \u226518 years and presentation within 8 hours of stroke onset. Subjects were required to have an NIHSS \u22658, angiographic demonstration of focal intracerebral artery occlusion not \u0026gt;14 mm, and either contraindication to IV tPA or failure to improve 1 hour after tPA administration. Patients who had CT perfusion imaging that demonstrated \u0026gt;1\/3 at-risk territory with nonsalvageable brain or with an intracerebral hemorrhage were excluded. More than 50% of the patients were female, mean age was 63\u00b118 years, mean NIHSS score=14\u00b13.8, and 85% had thrombolysis in myocardial infarction (TIMI)\u003Ca id=\u0022xref-fn-1-1\u0022 class=\u0022xref-fn\u0022 href=\u0022#fn-1\u0022\u003E*\u003C\/a\u003E scores=0.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EAll 20 patients achieved recanalization; 60% achieved a TIMI score=3 (full flow restored) and 40% had a TIMI score=2 (p\u0026lt;0.0001 compared with presenting TIMI scores). Improvement in NIHSS was documented in 85% of patients, wherein 65% improved by \u22654 NIHSS points. Median NIHSS improvement from intervention to discharge was 9 (range \u22126 to 14; p\u0026lt;0.001). There were 5 (25%) deaths at 1 month, which compares well with other similar studies. Dr Mocco completed his presentation with a case study of a 65-year-old male with stroke onset 6 hours before presentation and an NIHSS score of 14. Recanalization was achieved in 24 minutes. Four hours after the procedure, the patient\u0027s NIHSS score was 0. Based on these data, the FDA has approved an additional 20-patient extension to continue this prospective study, with the movement toward a definitive trial on the horizon.\u003C\/p\u003E\u003Cdiv class=\u0022section fn-group-alt\u0022 id=\u0022fn-group-2\u0022\u003E\u003Ch2\u003ENotes\u003C\/h2\u003E\u003Cul\u003E\u003Cli class=\u0022fn-other\u0022 id=\u0022fn-1\u0022\u003E\n            \n            \u003Cp id=\u0022p-9\u0022\u003E\u003Ca class=\u0022rev-xref\u0022 href=\u0022#xref-fn-1-1\u0022\u003E\u21b5\u003C\/a\u003E\u003Cspan class=\u0022fn-label\u0022\u003E*\u003C\/span\u003E In this case, TIMI represents the degree of occlusion.\u003C\/p\u003E\n         \u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2009 MD Conference Express\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\/9\/1\/14.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_figures.js?nzml42\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_openurl.js?nzml42\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}