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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\u003EThe PARTNER II trial investigated the use of the SAPIEN 3 transcatheter aortic valve replacement in patients who were high-risk\/inoperable or intermediate-risk for surgical complications. Clinical outcomes were excellent, with low rates of adverse events and paravalvular leak.\u003C\/p\u003E\n\u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Eaortic stenosis\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Etranscatheter heart valve\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ESAPIEN 3\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Etranscatheter aortic valve replacement\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Estroke\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Emortality\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eparavalvular leak\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ecardiology \u0026amp; cardiovascular medicine clinical trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENCT01314313\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n\n\u003Cp id=\u0022p-2\u0022\u003EThe PARTNER II trial [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01314313\u0026amp;atom=%2Fspmdc%2F15%2F5%2F13.2.atom\u0022\u003ENCT01314313\u003C\/a\u003E] enrolled high-risk operable, inoperable, and intermediate-risk operable patients with symptomatic severe aortic stenosis (AS) to receive the most recently available transcatheter heart valve (THV). Both patient groups experienced lower-than-expected mortality and stroke outcomes, with low rates of adverse events (AEs) and paravalvular leak.\u003C\/p\u003E\n\u003Cp id=\u0022p-3\u0022\u003ESince their introduction in 2003, balloon-expandable THVs have continued to evolve. The current SAPIEN 3 (S3) valve, available since 2013, is size 14 French and has several modified features in the valve and its delivery system. To investigate this new iteration of transcatheter aortic valve replacement, the PARTNER II trial was designed to evaluate safety and efficacy outcomes for the S3 THV system for use in inoperable, high-risk, and intermediate-risk patients.\u003C\/p\u003E\n\u003Cp id=\u0022p-4\u0022\u003ESusheel Kodali, MD, Columbia University Medical Center, New York, New York, USA, presented an as-treated analysis of 30-day data from the PARTNER II trial, which consisted of 2 single-arm, nonrandomized, historical-controlled studies, and enrolled a combined 1659 patients with symptomatic severe AS: 1076 intermediate-risk operable (S3i), and 583 high-risk operable or inoperable (S3HR). All patients received the S3 THV. Exclusion criteria were stroke or transient ischemic attack within 6 months, myocardial infarction within 1 month, untreated significant coronary artery disease, upper gastrointestinal bleed within 3 months, renal failure, prior prosthetic valve, left ventricular ejection fraction \u0026lt;\u200520%, and estimated life expectancy \u0026lt;\u200524 months. S3HR patients were enrolled at 29 sites across the United States, and S3i patients were enrolled at 51 US sites.\u003C\/p\u003E\n\u003Cp id=\u0022p-5\u0022\u003EIn both patient groups, 99.5% of patients completed follow-up visits 30 days after receiving the S3 THV. Baseline characteristics reflect the high-risk nature of both groups; the average ages were \u0026gt;\u200580 years, with average Society of Thoracic Surgeons (STS) surgery risk scores at 5.3% for S3i patients and 8.6% for S3HR patients. Between-group differences in baseline characteristics and comorbidities also reflected the risk status of each group.\u003C\/p\u003E\n\u003Cp id=\u0022p-6\u0022\u003EThirty-day results for the as-treated S3i and S3HR patients are summarized in \u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E. The STS risk scores were 5.3% for the S3i group and 8.6% for the S3HR group.\u003C\/p\u003E\n\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\/16193\/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\/16193\/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\/16193\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 \u003Cp id=\u0022p-7\u0022 class=\u0022first-child\u0022\u003EMortality and Stroke Outcomes at 30 Days\u003C\/p\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n\u003Cp id=\u0022p-9\u0022\u003EAEs were low for these populations, and the procedure was considered well tolerated.\u003C\/p\u003E\n\u003Cp id=\u0022p-10\u0022\u003ECompared to previous studies, at 30-day follow-up, the S3 THV resulted in the lowest rates of all-cause mortality, stroke, and paravalvular leak of all available balloon-expandable THVs. Dr Kodali went over the excellent clinical outcomes seen in both the intermediate-risk and high-risk\/inoperable groups, and cited these results as evidence that the S3 THV is an attractive alternative to surgery for all patients with AS.\u003C\/p\u003E\n\u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2015 SAGE Publications\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\/15\/5\/13.2.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_openurl.js?nzloxp\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?nzloxp\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}