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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\u003EThe Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High-Risk and Very High-Risk Subjects Who Need Aortic Valve Replacement [CoreValve; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01240902\u0026amp;atom=%2Fspmdc%2F14%2F30%2F13.atom\u0022\u003ENCT01240902\u003C\/a\u003E] evaluated transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery.\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\u003EInterventional Techniques \u0026amp; Devices\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EValvular Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Clinical Trials\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\u003EInterventional Techniques \u0026amp; Devices\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EValvular Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EThe Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High-Risk and Very High-Risk Subjects Who Need Aortic Valve Replacement [CoreValve; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01240902\u0026amp;atom=%2Fspmdc%2F14%2F30%2F13.atom\u0022\u003ENCT01240902\u003C\/a\u003E] evaluated transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. Extreme-risk patients were randomized to CoreValve implantation by iliofemoral (n = 489) or noniliofemoral (n = 150) access [Popma JJ et al. \u003Cem\u003EJ Am Coll Cardiol\u003C\/em\u003E. 2014]. At 1 year, the primary end point of all-cause mortality or major stroke rate was 26.0% (95% CI, 22.1% to 29.9%) compared with the objective performance goal (OPG) of 43.0% (\u003Cem\u003EP\u003C\/em\u003E \u0026lt; .0001).\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003ESteven J. Yakubov, MD, Riverside Methodist Hospital Columbus, Ohio, USA, presented the 2-year results of the CoreValve trial. At 2 years, 305 patients who received an implant by iliofemoral access remained in the study. The primary analysis cohort consisted of the \u201cattempted implant\u201d by iliofemoral access population (n = 489). The attempted implant population was defined as patients brought into the procedure room with anesthesia administration, transesophageal echocardiography, vascular line placement, or any other monitoring line placement. The OPG comparator for all-cause mortality was the calculated rate for 117 events in 179 patients (65.4%, lower confidence bound of 57.9% by Exact method).\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThe rate of all-cause mortality or major stroke (at risk n = 489) at 2 years was 38.0% (95% CI, 33.6% to 42.3%) vs the OPG of 57.9%.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EAll-cause mortality and cardiovascular mortality at 1 year were 24.3% and 18.3%, respectively, and at 2 years were 36.5% and 26.5%, respectively. All-cause mortality and cardiovascular mortality from 1 to 2 years were 16.1% and 10.0%. The 1-year, 2-year, and 1- to 2-year major stroke rates were 4.3%, 5.1%, and 0.9%, respectively.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThe secondary end point rates are shown in \u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E. At 2 years, 92% of patients improved at least 1 NYHA class and 58% improved at least 2 NYHA classes. The effective orifice area increased from 0.73 cm\u003Csup\u003E2\u003C\/sup\u003E at baseline to 1.85 cm\u003Csup\u003E2\u003C\/sup\u003E at 2 years. The mean gradient decreased from 47.31 mm Hg at baseline to 8.66 mm Hg at 2 years. At 2 years, paravalvular regurgitation was absent or trivial in 64.8%, mild in 30.8%, moderate in 4.4%, and severe in 0.0% of patients.\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\/11878\/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\/11878\/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\/11878\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\u003ESecondary End Points at 1 and 2 Years\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\u003EAmong patients with all-cause mortality, paravalvular leak (PVL) was absent or trivial in 30.3%, mild in 38.2%, moderate in 35.9%, and severe in 85.7%. Only severe PVL affected mortality (\u003Cem\u003EP\u003C\/em\u003E \u0026lt; .001). Among patients with all-cause mortality, 38.7% had received a new pacemaker and 35% had not received a new pacemaker. Pacemaker implantation did not affect mortality (\u003Cem\u003EP\u003C\/em\u003E = .534). A subgroup analysis showed that a Society of Thoracic Surgeons (STS) risk score \u0026gt; 15% (\u003Cem\u003EP\u003C\/em\u003E = .0120), coronary artery disease (CAD; \u003Cem\u003EP\u003C\/em\u003E = .0019), and assisted living (\u003Cem\u003EP\u003C\/em\u003E \u0026lt; .0001) were associated with 2-year all-cause mortality or major stroke.\u003C\/p\u003E\u003Cp id=\u0022p-11\u0022\u003EThe CoreValve 2-year results demonstrated low rates of all-cause mortality, major stroke, and moderate or severe aortic insufficiency. Patients experienced improvement in NYHA classification and durable improvement in hemodynamic valve performance. There was no association between mild or moderate paravalvular regurgitation and mortality. The 2-year results confirm the improved survival benefit in patients with severe aortic stenosis at extreme risk for surgery.\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\/13.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?nzot7e\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?nzot7e\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}