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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\u003ETranscatheter aortic valve replacement (TAVR) is less invasive than surgical aortic valve replacement for patients with degenerative aortic stenosis who have a high risk of surgical complications. The purpose of the 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 Extreme Risk; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01240902\u0026amp;atom=%2Fspmdc%2F13%2F19%2F16.atom\u0022\u003ENCT01240902\u003C\/a\u003E] was to evaluate the safety and efficacy of the CoreValve transcatheter heart valve for the treatment of symptomatic severe aortic stenosis in patients with a =50% risk of operative mortality or serious, irreversible morbidity at 30 days.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EValvular Disease\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\u003ECardiology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology \u0026amp; Cardiovascular Medicine\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EValvular Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003ETranscatheter aortic valve replacement (TAVR) is less invasive than surgical aortic valve replacement for patients with degenerative aortic stenosis who have a high risk of surgical complications. The purpose of the 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 Extreme Risk; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01240902\u0026amp;atom=%2Fspmdc%2F13%2F19%2F16.atom\u0022\u003ENCT01240902\u003C\/a\u003E], presented by Jeffrey J. Popma, MD, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA, was to evaluate the safety and efficacy of the CoreValve transcatheter heart valve for the treatment of symptomatic severe aortic stenosis in patients with a \u226550% risk of operative mortality or serious, irreversible morbidity at 30 days.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EPatients at high risk of surgical complications in whom an 18 French vascular access sheath could be placed into the iliofemoral vessel were randomized to treatment with a CoreValve by iliofemoral (n=487) or noniliofemoral (n=147) access. Patients included in the trial had severe aortic stenosis, defined as aortic valve area (AVA) \u22640.8 cm\u003Csup\u003E2\u003C\/sup\u003E or AVA index \u22640.5 cm\u003Csup\u003E2\u003C\/sup\u003E\/m\u003Csup\u003E2\u003C\/sup\u003E; a mean gradient \u0026gt;40 mm Hg or peak velocity \u0026gt;4 m\/second at rest or with dobutamine stress (if left ventricular ejection fraction was \u0026lt;50%); and NYHA Functional Class II or higher. The primary endpoint was all-cause mortality or major stroke at 12 months. Clinical and echocardiographic assessments were performed at baseline (n=471), 1 month (n=435), and 1 year (n=355). There was no control arm in the trial.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThe primary analysis was performed in the as-treated population (n=471). The patients were elderly (aged 83.1\u00b18.6 years), 49% were men, and 91.9% had severe symptoms (NYHA Class III or IV). The composite rate of all-cause mortality and major stroke was 9.3% (95% CI, 6.7 to 12.0) at 1 month and 25.5% (95% CI, 21.6 to 29.4; p\u0026lt;0.0001) at 1 year. Variables predictive for the primary endpoint were Society of Thoracic Surgeons (STS) score \u0026gt;15 (p=0.02), coronary artery disease (p=0.003), and assisted living (p\u0026lt;0.001). The primary endpoints of all-cause and cardiovascular mortality rates at 1 year were 24.0% and 17.9%, respectively. The major stroke rate was 4.1% at 1 year.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EThe incidence of major secondary endpoint rates were assessed at 1 year (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). Of the patients alive at 1 year, 90% of patients had improvement of \u22651 NYHA class and 60% of patients improved by \u22652 NYHA classes. Echocardiography showed that effective orifice area increased from 0.73 cm\u003Csup\u003E2\u003C\/sup\u003E at baseline to 1.82 cm\u003Csup\u003E2\u003C\/sup\u003E at discharge and to 1.89 cm\u003Csup\u003E2\u003C\/sup\u003E at 1 year. The mean gradient decreased from 47.4 mm Hg at baseline to 9.4 mm Hg at discharge and to 8.8 mm Hg at 1 year.\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\/13\/19\/16\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Major Secondary Endpoints\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-359180646\u0022 data-figure-caption=\u0022Major Secondary Endpoints\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\/13\/19\/16\/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\/13\/19\/16\/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\/13\/19\/16\/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\/13779\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 attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-6\u0022 class=\u0022first-child\u0022\u003EMajor Secondary Endpoints\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EMI=myocardial infarction; VARC=Valve Academic Research Consortium.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-7\u0022\u003EAt 1 month, moderate paravalvular leak was present in 41.6% of patients and severe paravalvular leak was present in 11.0%. At 1 year, 28.8% of patients had moderate paravalvular leak and 4.1% had severe paravalvular leak. The severity of paravalvular leak declined in the majority of patients with moderate paravalvular leak at 1 month who survived to 1 year (80%). Patients with severe paravalvular leak had higher mortality rates when compared with patients without paravalvular leak (17.9% vs 85.7%; p\u0026lt;0.001).\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EThe CoreValve Extreme Risk study evaluated iliofemoral implantation of the CoreValve prosthesis in patients at extreme risk for mortality and morbidity from surgery. At 1 year after implantation, 25% of patients had either died or had a stroke. The rates of moderate and severe aortic regurgitation were low and improved over time. Patients with severe paravalvular leak had higher mortality compared with patients with no paravalvular leak. These results provide evidence for the safety and efficacy of TAVR with the CoreValve in patients at high risk of surgical complications.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2013 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\/13\/19\/16.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?nznk41\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?nznk41\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}