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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 Placement of Aortic Transcatheter Valves 2 trial [PARTNER 2; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01314313\u0026amp;atom=%2Fspmdc%2F13%2F2%2F24.atom\u0022\u003ENCT01314313\u003C\/a\u003E] indicated that the new SAPIEN XT transcatheter heart valve system is noninferior to the old SAPIEN system when used in an inoperable cohort of patients. The new slimmer version was associated with improved procedural outcomes and reduced vascular complications, including major vascular bleeding.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices Cardiology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology \u0026amp; Cardiovascular Medicine\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EResults from the Placement of Aortic Transcatheter Valves 2 trial [PARTNER 2; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01314313\u0026amp;atom=%2Fspmdc%2F13%2F2%2F24.atom\u0022\u003ENCT01314313\u003C\/a\u003E] indicated that the new SAPIEN XT transcatheter heart valve (THV) system is noninferior to the old SAPIEN system when used in an inoperable cohort of patients. The new slimmer version was associated with improved procedural outcomes and reduced vascular complications, including major vascular bleeding. Martin B. Leon, MD, Columbia University Medical Center and New York-Presbyterian Hospital, New York, New York, USA, presented the results of PARTNER 2.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe objective of PARTNER 2 was to compare the safety and effectiveness of the new balloon-expandable SAPIEN XT with the old SAPIEN system in a randomized controlled trial of patients with symptomatic severe aortic stenosis who could not have surgery. The longer-profile SAPIEN XT incorporates important enhancements to the valve support frame, the valve leaflet geometry, the delivery system, and a significant reduction in sheath size designed to improve clinical outcomes.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThis noninferiority trial included patients with severe aortic stenosis, NYHA Class \u2265II and \u226550% risk of death or of serious irreversible morbidity as assessed by a cardiologist and 2 surgeons. After being assessed for inoperability and transfemoral access, patients (n=560) were randomly assigned 1:1 to THV replacement with either the SAPIEN XT or SAPIEN system. The primary study endpoint was a composite of all-cause mortality, disabling stroke, and rehospitalization for symptoms of aortic stenosis and\/or complications of the valve procedure at 1 year.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003ERandomized patients (n=560) were 50% female, a mean age of 84 years, and had a mean Society of Thoracic Surgeons (STS) score of 10.3. More than half (59%) were deemed inoperable due to frailty.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EAt 12 months, SAPIEN XT was noninferior for the primary endpoint compared with SAPIEN (33.9% vs 34.7%; HR, 0.97; 95% CI, 0.73 to 1.30; p for noninferiority= 0.0034; p for superiority=0.863; \u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). There was no significant difference in all-cause mortality at 12 months between the SAPIEN XT and SAPIEN groups (22.5% vs 23.7%; HR, 0.93; 95% CI, 0.66 to 1.33; p=0.706; \u003Ca id=\u0022xref-fig-2-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F2\u0022\u003EFigure 2\u003C\/a\u003E). There were also no significant differences between the 2 groups in the number of disabling strokes or rehospitalization events.\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\/2\/24\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022All-Cause Mortality, Disabling Stroke, and Rehospitalization\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-586055545\u0022 data-figure-caption=\u0022All-Cause Mortality, Disabling Stroke, and Rehospitalization\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\/2\/24\/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\/2\/24\/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\/2\/24\/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\/13140\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\u003EAll-Cause Mortality, Disabling Stroke, and Rehospitalization\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EReproduced with permission from MB Leon, 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\u003EThere were no significant differences between the SAPIEN XT and SAPIEN groups at 30 days for the primary endpoint (17.0% vs 15.3%; p=0.60), all-cause mortality (3.5% vs 5.1%; p=0.36), or disabling stroke (3.2% vs 3.0%; p=0.85).\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EThere were lower rates of major vascular complications with SAPIEN XT (9.6% vs 15.5%; p=0.04). Disabling bleeding was also numerically lower but not statistically significantly lower with SAPIEN XT (7.8% vs 12.6%; p=0.06).\u003C\/p\u003E\u003Cdiv id=\u0022F2\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\/2\/24\/F2.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022All-Cause Mortality\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-586055545\u0022 data-figure-caption=\u0022All-Cause Mortality\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 2.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/13\/2\/24\/F2.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\/2\/24\/F2.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 2.\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\/2\/24\/F2.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\/13141\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 2.\u003C\/span\u003E \n            \u003Cp id=\u0022p-10\u0022 class=\u0022first-child\u0022\u003EAll-Cause Mortality\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-2\u0022\u003EReproduced with permission from MB Leon, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-11\u0022\u003ESAPIEN XT was associated with numeric reductions in anesthesia time (197.6 vs 212.0 minutes; p=0.02), need for multiple (\u22652) valve implants (3 vs 10; p=0.05), aborted procedures (2 vs 8; p=0.06), and need for intra-aortic balloon pump support during the procedure (1 vs 6; p=0.06) compared with SAPIEN.\u003C\/p\u003E\u003Cp id=\u0022p-12\u0022\u003EBy 1 year, \u0026gt;80% of patients were categorized as NYHA Class I or II heart failure after either intervention. Increases in echocardiographic value area, and reductions in mean and peak gradients based on as-treated analyses were similar for both devices at 30 days and persisted to 1 year. Values for total aortic regurgitation were also similar.\u003C\/p\u003E\u003Cp id=\u0022p-13\u0022\u003EDr. Leon said that the SAPIEN XT system represents a worthwhile advance with incremental clinical value and is now considered the preferred balloon-expandable THV system.\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\/2\/24.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?nzo1np\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?nzo1np\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}