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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\u003EResults from the FRANCE (French Aortic National CoreValve and Edwards) Registry demonstrated high implantation success with excellent and sustained hemodynamic and clinical improvement in high-risk patients with severe aortic stenosis who were treated with transcatheter aortic valve replacement.\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\u003Cp id=\u0022p-2\u0022\u003EResults from the FRANCE (French Aortic National CoreValve and Edwards) Registry, presented by Helene Eltchaninoff, MD, University of Rouen, Rouen, France, demonstrated high implantation success with excellent and sustained hemodynamic and clinical improvement in high-risk patients with severe aortic stenosis who were treated with transcatheter aortic valve (TAVI) replacement.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003ETAVI is an emerging treatment for patients with aortic stenosis who are at too high a risk to undergo conventional surgical replacement of the aortic valve. The FRANCE Registry is a multicenter prospective clinical registry that was developed to evaluate the safety and efficacy of the two aortic valve replacement devices that are currently available in France. The two valves that were used in the registry were the Edwards Sapien balloon-expandable valve (68% of patients), using either a transfemoral (39%) or transapical (29%) approach, and the CoreValve self-expandable valve (32% of patients), using a transfemoral (27%) or subclavian approach (5%).\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EStudy patients were required to have severe aortic stenosis (effective orifice area [EOA] \u0026lt;1 cm\u003Csup\u003E2\u003C\/sup\u003E\/m\u003Csup\u003E2\u003C\/sup\u003E) and severe symptoms (New York Heart Association [NYHA] Class \u22652) and be at high surgical risk (Logistics EuroScore \u0026gt;20%, Society of Thoracic Surgeons [STS] mortality risk score \u0026gt;10%), or have a contraindication to surgery). The primary endpoint of the study was 30-day mortality. Secondary endpoints (up to 3 years) included mortality, major adverse cardiac events, hemodynamics, and quality of life.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EA total of 244 patients (mean age 82 years; 56% men) were recruited between February and September 2009. Diabetes was present in 27% patients; 23% had a previous myocardial infarction; 10% had a previous stroke; and \u223c42% had coronary artery disease. The only significant (p=0.02) difference between the four subgroups was the presence of peripheral artery disease and abdominal aortic aneurysm, which were more common in patients who were treated with a transapical or subclavian approach. The mean baseline EuroScore was 25.6%; mean STS score was 16%. The mean aortic annulus (21.9\u00b11.8 mm) was slightly smaller in patients who received the Edwards due to the availability of the 23-mm stent and larger in the CoreValve group due to the availability of a 29-mm stent. The mean EOA was 0.68\u00b10.16 cm\u003Csup\u003E2\u003C\/sup\u003E. Mean left ventricular ejection fraction was 51% (47% [p=0.02] in patients who received the Edwards valve via the transfemoral approach). Two-thirds of the procedures were done in the cardiac catherization lab.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThe devices were successfully implanted (defined as successful delivery and deployment of the valve without death on the table) in 97% of patients. Failure occurred in 7 patients; there were 4 procedural deaths. There was no difference between the groups in 30-day mortality (mean 12.7%; p=0.32; \u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). Hemodynamic results immediately after implantation were significant (mean increase in EOA from 0.68\u00b10.16 cm\u003Csup\u003E2\u003C\/sup\u003E to 1.74\u00b10.47 cm\u003Csup\u003E2\u003C\/sup\u003E; p\u0026lt;0.001). The rate of new pacemaker implantation (overall mean 11.8%) was significantly (p\u0026lt;0.001) higher in the CoreValve group (25% to 27%) compared with 4% to 5% in the Edwards valve group. The transfusion rate (mean 21.3%) was higher when a transapical (27.4%) or subclavian (83.3%) approach was used.\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\/5\/17.2\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u002230-Day Mortality.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-957954181\u0022 data-figure-caption=\u002230-Day Mortality.\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\/5\/17.2\/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\/5\/17.2\/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\/5\/17.2\/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\/11424\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-7\u0022 class=\u0022first-child\u0022\u003E30-Day Mortality.\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EReproduced with permission by H. Eltchaninoff, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-8\u0022\u003EVascular complications (mean 6.5% of patients) were comparable between the four groups. Postimplantation aortic regurgitation occurred in \u0026lt;10% of patients. Factors that were predictive of 30-day mortality (by univariate and multivariate analysis) were prior CABG and Euroscore \u226525%.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EA total of 111 patients have reached the 6-month follow-up. Survival at 6 months is 76.5%. Hemodynamic and clinical results are persistent.\u003C\/p\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\/5\/17.2.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?nzmi3q\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?nzmi3q\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}