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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\u003EThis article provides a broad overview of the methodology, major findings, and impact of the 3 major transcatheter aortic valve replacement (TAVR) trials (PARTNER, CoreValve, and CHOICE) along with some perspective.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Evalvular disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Einterventional techniques \u0026amp; devices\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ecardiology clinical trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \n         \u003Cp id=\u0022p-2\u0022\u003EMartin B. Leon, MD, Columbia University Medical Center, New York, New York, USA, provided a broad overview of the methodology, major findings, and impact of the 3 major transcatheter aortic valve replacement (TAVR) trials (PARTNER, CoreValve, and CHOICE) along with some perspective.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-2\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EPARTNER\u003C\/h2\u003E\n         \u003Cp id=\u0022p-3\u0022\u003EThe PARTNER I trials (1A, 1B, and continued access registry) [Kodali SK et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2012; Makkar RR et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2012; Smith CR et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2011; Leon MB et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2010] comprised a total of 3128 patients with symptomatic severe (high-risk and inoperable) aortic stenosis (AS) who were treated with either TAVR using the SAPIEN Transcatheter Heart Valve device or standard aortic valve replacement (AVR) surgery. In high-risk patients, comparisons were also made between transfemoral and transapical accesses. When comparing standard AVR and TAVR in inoperable patients, all-cause mortality was significantly higher for AVR patients (HR, 0.53; 95% CI, 0.41 to 0.68; p \u0026lt; .0001). The number needed to treat at 3 years was 3.7 patients. In high-risk patients, all-cause mortality at 3 years was similar between the 2 groups.\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003EPredictors of mortality included strokes, major vascular complications, and major bleeding. After 3 years, the 2 treatments were similar with respect to mortality, reduction in symptoms, and improved valve hemodynamics, but paravalvular regurgitation was more frequent after TAVR and was associated with increased late mortality.\u003C\/p\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EOther findings from the PARTNER trial include improved clinical outcomes in transfemoral versus transapical TAVR patients with marked improvement in all quality-of-life metrics. Earlier recovery in NYHA class compared with AVR was reported in the transfemoral cohort. Subanalyses have indicated that compared with surgery, clinical outcomes are better in women, patients with diabetes, those with significant mitral regurgitation, and cases of patient\u2013prosthesis mismatch.\u003C\/p\u003E\n         \u003Cp id=\u0022p-6\u0022\u003EThe ongoing 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%2F14%2F13%2F15.atom\u0022\u003ENCT01314313\u003C\/a\u003E] is similar in design to PARTNER I but larger (n = 3716). It includes patients with moderate disease and replaces the original SAPIEN device with the SAPIEN XT, a lower profile device that is currently being used in Europe.\u003C\/p\u003E\n         \u003Cp id=\u0022p-7\u0022\u003EThe PARTNER trials established TAVR as the standard of care for inoperable patients and as an acceptable\/preferred therapy in high-risk patients. Strokes and paravalvular regurgitation are of concern following TAVR.\u003C\/p\u003E\n         \u003Cdiv id=\u0022sec-3\u0022 class=\u0022subsection\u0022\u003E\n            \u003Ch3\u003ECoreValve\u003C\/h3\u003E\n            \u003Cp id=\u0022p-8\u0022\u003EThe CoreValve Platform is a multilevel self-expanding valve designed to maintain coronary access and mitigate paravalvular aortic regurgitation. In the United States, the safety and efficacy of the CoreValve have been evaluated in 2 pivotal trials: a registry in extreme-risk patients and a randomized controlled trial in patients with severe AS at high surgical risk.\u003C\/p\u003E\n            \u003Cp id=\u0022p-9\u0022\u003EIn the extreme-risk study (n = 489), the primary end point of all-cause mortality or major stroke at 12 months was 26.0% (95% CI, 21.6 to 29.9) versus the 43.0% prespecified objective performance goal (p \u0026lt; .0001; \u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E) [Popma JJ et al. \u003Cem\u003EJ Am Coll Cardiol\u003C\/em\u003E 2014]. Procedural events at 30 days included life-threatening or disabling bleeding (12.7%), major vascular complications (8.2%), and need for permanent pacemaker placement (21.6%). Paravalvular aortic regurgitation was lower with the CoreValve device at 12 months compared with discharge.\u003C\/p\u003E\n            \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\/14\/13\/15\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022CoreValve Improved All-Cause Mortality or Major Stroke Outcome\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1848133707\u0022 data-figure-caption=\u0022CoreValve Improved All-Cause Mortality or Major Stroke Outcome\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\/14\/13\/15\/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\/14\/13\/15\/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\/14\/13\/15\/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\/16398\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-10\u0022 class=\u0022first-child\u0022\u003ECoreValve Improved All-Cause Mortality or Major Stroke Outcome\u003C\/p\u003E\n               \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EReproduced from Popma JJ et al. Transcatheter Aortic Valve Replacement Using a Self-Expanding Bioprosthesis in Patients With Severe Aortic Stenosis at Extreme Risk for Surgery. \u003Cem\u003EJ Am Coll Cardiol\u003C\/em\u003E. 2014;63(19)1972\u20131981. With permission from Elsevier.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n            \u003Cp id=\u0022p-11\u0022\u003EIn the high-risk study, patients were randomly assigned to TAVR (n = 390) with the self-expanding transcatheter valve or to surgical AVR (n = 357) [Adams DH et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2014]. The primary end point was the rate of death from any cause at 1 year evaluated with the use of both noninferiority and superiority testing. After 1 year, the rate of death from any cause was significantly lower (p = .04 for superiority) in the TAVR group than in the surgical group (14.2% vs 19.1%). Major stroke rates were 7.0% for AVR and 5.8% for TAVR (not significant).\u003C\/p\u003E\n            \u003Cp id=\u0022p-12\u0022\u003ECoreValve performed well in both high- and extreme-risk patients with acceptable risk of stroke and vascular complications. This is the first TAVR study to demonstrate clear incremental benefits (all-cause mortality at 1 year and valve hemodynamics) compared with AVR.\u003C\/p\u003E\n         \u003C\/div\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-4\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003ECHOICE\u003C\/h2\u003E\n         \u003Cp id=\u0022p-13\u0022\u003EThe CHOICE randomized clinical trial compared transcatheter deployment of aortic valves using either a balloon-expandable (SAPIEN XT; n = 121) or self-expandable (CoreValve; n = 120) system [Abdel-Wahab M et al. \u003Cem\u003EJAMA\u003C\/em\u003E 2014]. The study was also performed in patients with severe AS at high surgical risk. The primary end point was device success (successful vascular access and deployment of the device and retrieval of the delivery system, correct position of the device, and intended performance of the heart valve without moderate or severe regurgitation).\u003C\/p\u003E\n         \u003Cp id=\u0022p-14\u0022\u003EDevice success occurred in 95.9% of patients in the balloon-expandable valve group and 77.5% patients in the self-expandable valve group (p \u0026lt; .001; \u003Ca id=\u0022xref-fig-2-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F2\u0022\u003EFigure 2\u003C\/a\u003E), which the investigators attributed to the need for more multiple-valve implantations and a higher frequency of paravalvular regurgitation in the self-expanding group.\u003C\/p\u003E\n         \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\/14\/13\/15\/F2.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Device Success With Balloon-Expandable TAVR Better Than With Self-Expandable TAVR\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1848133707\u0022 data-figure-caption=\u0022Device Success With Balloon-Expandable TAVR Better Than With Self-Expandable TAVR\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\/14\/13\/15\/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\/14\/13\/15\/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\/14\/13\/15\/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\/16400\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-15\u0022 class=\u0022first-child\u0022\u003EDevice Success With Balloon-Expandable TAVR Better Than With Self-Expandable TAVR\u003C\/p\u003E\n            \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-2\u0022\u003ERR=relative risk; TAVR=transcatheter aortic valve replacement.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-3\u0022\u003EReproduced from Popma JJ et al. Transcatheter Aortic Valve Replacement Using a Self-Expanding Bioprosthesis in Patients With Severe Aortic Stenosis at Extreme Risk for Surgery. \u003Cem\u003EJ Am Coll Cardiol\u003C\/em\u003E. 2014;63(19)1972\u20131981. With permission from Elsevier.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-16\u0022\u003EMajor clinical outcomes (death, stroke, and myocardial infarction vascular complications) at 30 days were similar between the 2 groups. There was improved valve hemodynamics but increased paravalvular aortic regurgitation with the self-expandable system. This was a small and somewhat controversial study with a questionable primary end point that may exaggerate the clinically meaningful difference between the 2 systems.\u003C\/p\u003E\n         \u003Cdiv id=\u0022sec-5\u0022 class=\u0022subsection conclusions\u0022\u003E\n            \u003Ch3\u003EConclusions\u003C\/h3\u003E\n            \u003Cp id=\u0022p-17\u0022\u003ETAVR has become the preferred therapy for high-risk AS patients, transcending the usual bounds of a new interventional therapy while transforming the pathways for managing patients with complex cardiovascular disease.\u003C\/p\u003E\n         \u003C\/div\u003E\n      \u003C\/div\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\/13\/15.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?nzoyzq\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?nzoyzq\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}