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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 first human transcatheter aortic valve implantation (TAVI) was performed in 2002. Since then, TAVI has been evaluated as an alternative to surgical aortic valve replacement and medical treatment in several clinical trials. This article reviews the evidence from these trials. Also discussed are current tools for risk stratification and the risks of TAVI in low- and high-risk patients, and latest guidelines on the management of valvular heart disease.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EValvular Disease\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003ELessons from Clinical Trials\u003C\/h2\u003E\n         \u003Cp id=\u0022p-2\u0022\u003EThe first human transcatheter aortic valve implantation (TAVI) was performed in 2002. Since then, TAVI has been evaluated as an alternative to surgical aortic valve replacement (SAVR) and medical treatment (MT) in several clinical trials. Steven Windecker, MD, Bern University Hospital, Bern, Switzerland, reviewed the evidence from these trials.\u003C\/p\u003E\n         \u003Cp id=\u0022p-3\u0022\u003EThe Placement of Aortic Transcatheter Valve [PARTNER] B trial, assessed TAVI versus MT in inoperable patients with symptomatic aortic stenosis (AS) [Leon MB et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2010; Makkar RR et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2012]. TAVI versus standard treatment (including balloon aortic valvuloplasty) resulted in lower rates of all-cause death (43.3% vs 68.0%; HR, 0.56; 95% CI, 0.43% to 0.73%; p\u0026lt;0.001) and cardiac death (31.0% vs 62.4%; HR, 0.44; 95% CI, 0.32% to 0.60%; p\u0026lt;0.001) at 2 years. Cerebrovascular event rates were 13.8% with TAVI versus 5.5% with MT (HR, 2.79; 95% CI, 1.25% to 6.22%; p=0.01). The rate and severity of paravalvular aortic regurgitation (AR) with TAVI decreased from 30 days to 2 years after implantation (p=0.001), while transvalvular AR rates did not change significantly (p=0.75). Mortality rates were higher in patients with AR (p\u0026lt;0.01).\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003EIn the PARTNER A trial of TAVI versus SAVR in high-risk patients with symptomatic AS, all-cause death rates were similar after at least 2 years follow-up (HR, 0.90; 95% CI, 0.71% to 1.15%; p=0.41) [Smith CR et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2011; Kodali SK et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2012]. Stroke rates were 7.7% with TAVI versus 4.9% with SAVR (HR, 1.22; 95% CI, 0.67% to 2.23%; p=0.52), as was paravalvular regurgitation (p\u0026lt;0.001). After 2 years, aortic valve area and mean aortic gradient were similar in the TAVI and SAVR groups (p=0.16 for both).\u003C\/p\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EDuring the past decade, clinical trials have shown that TAVI is superior to standard treatment and non-inferior compared with SAVR. However, stroke is an issue early after TAVI. Valve durability appears to be maintained beyond 2 years of follow-up, but the impact of AR on outcomes needs to be improved. TAVI effectively alleviates symptoms and improves health-related quality of life (QoL) compared with standard medical therapy.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-2\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003ELow- and High-Risk Patients: What Are the Limits?\u003C\/h2\u003E\n         \u003Cp id=\u0022p-6\u0022\u003EBernard Prendergast, DM, John Radcliffe Hospital, Oxford, United Kingdom, discussed patient selection for TAVI. He reviewed current tools for risk stratification and the risks of TAVI in low- and high-risk patients.\u003C\/p\u003E\n         \u003Cp id=\u0022p-7\u0022\u003EThe PARTNER trial had strict entry criteria, requiring 2 cardiac surgeons and an interventionist to attest that candidates were not suitable for SAVR (high surgical risk due to coexisting conditions associated with mortality risk of at least 15% by 30 days after surgery [Society of Thoracic Surgeons (STS) score \u226510%]) [Leon MB et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2010]. In a registry of 3195 high-risk TAVI patients, 835 (26%) had a European System for Cardiac Operative Risk Evaluation (EuroSCORE) \u0026lt;20% and an STS score \u0026lt;10% but had contraindications to surgery [Gilard M et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2012]. Lange et al. [\u003Cem\u003EJ Am Coll Cardiol\u003C\/em\u003E 2012] reported that clinical outcomes were significantly better in lower-versus higher-risk patients undergoing TAVI in a single center from 2007 to 2010.\u003C\/p\u003E\n         \u003Cp id=\u0022p-8\u0022\u003EIn another observational study, patients allocated to SAVR were younger and had lower predicted perioperative risk than patients allocated to MT or TAVI [Wenaweser P et al. \u003Cem\u003EJ Am Coll Cardiol\u003C\/em\u003E 2011]. At 30 months, mortality was lower with SAVR (22.4%) and TAVI (22.6%) compared with MT (61.5%; p\u0026lt;0.001).\u003C\/p\u003E\n         \u003Cp id=\u0022p-9\u0022\u003EAccording to Kovac et al. [\u003Cem\u003EHeart\u003C\/em\u003E 2010], the EuroSCORE and STS scores have not been well validated in estimating risk for valve-only surgery; some TAVI-specific measures are not considered, and social and QoL issues are not included. Van Brabandt et al. [\u003Cem\u003EBMJ\u003C\/em\u003E 2012] claimed that TAVI is risky and costly, with rapid expansion in Europe beyond the evidence base and with insufficient device regulation. Concerns presented by Van Brabandt and colleagues included the cost and the learning curve associated with these new procedures. In addition they criticized the PARTNER trial because cost-effectiveness data had not been published, benefits in the subgroup undergoing TAVI by a transapical approach were less clear, and there were limitations in matching the treatment groups in Cohort B.\u003C\/p\u003E\n         \u003Cp id=\u0022p-10\u0022\u003EOverall, Prof. Prendergast recommended that TAVI be considered in patients with indications for AVR who are high-risk for surgery as described by clinical trials and guidelines. In addition, he noted that it is important to consider which patients are less likely to benefit from TAVI, including those with a EuroSCORE \u0026gt;40, severe left or right ventricle impairment, severe respiratory disease, severe immobility, or life expectancy \u0026lt;1 year. Patients with EuroSCORE \u0026lt;10 are too low-risk to be considered for TAVI, especially if TAVI selection is driven by patient choice. Assessment by a comprehensive heart team, as was performed in the clinical trials, is strongly recommended to determine patient suitability for TAVI.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-3\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EGuidelines for Management of Severe AS\u003C\/h2\u003E\n         \u003Cp id=\u0022p-11\u0022\u003EBernard Iung, MD, H\u00f4pital Bichat, Paris, France, reviewed the latest guidelines on the management of valvular heart disease. The European Society of Cardiology (ESC)\/European Association for Cardio-Thoracic Surgery (EACTS) Guidelines recommend evaluating severity of disease, presence of symptoms, life expectancy, QoL, intervention benefits versus risks, patient wishes, and available resources. Severe AS is defined as aortic valve area (AVA) \u0026lt;1.0 cm\u003Csup\u003E2\u003C\/sup\u003E, indexed AVA \u0026lt;0.6 cm\u003Csup\u003E2\u003C\/sup\u003E, mean gradient \u0026gt;40 mm Hg, maximum jet velocity \u0026gt;4.0 m\/s, and velocity ratio \u0026lt;0.25 [Vahanian A et al. \u003Cem\u003EEur Heart J\u003C\/em\u003E 2012]. While the guidelines do provide the listed criteria, these parameters have been shown to perform inconsistently in patients with normal LV function in whom use of AVA criteria results in a greater proportion of patients being classified as having severe AS [Minners J et al. \u003Cem\u003EEur Heart J\u003C\/em\u003E 2008]. These inconsistencies should be considered when evaluating patients with AS.\u003C\/p\u003E\n         \u003Cp id=\u0022p-12\u0022\u003EThe guidelines recommend TAVI for eligible patients with contraindications to surgical AVR [Vahanian A et al. \u003Cem\u003EEur Heart J\u003C\/em\u003E 2012] (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). In the PARTNER trials, EuroSCOREs and STS scores were 26.4% and 11.2%, respectively, in patients with contraindications for surgery [Leon MB et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2010] and 29.3% and 11.8% in high-risk operable patients [Smith CR et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2011]. Risk scores have good discrimination (low- vs high-risk) but poor calibration (predicted vs observed risk). EuroSCORE II has improved calibration, but there are no specific data in high-risk patients. The ESC Working Group reported that risk scores have limitations in high-risk patients and that patients with comorbidities require an individualized approach. In the absence of a more precise quantitative score, risk assessment should mostly rely on the clinical judgment of a comprehensive heart team as was used in the PARTNER trials [Leon MB et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2010; Makkar RR et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2012].\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\/12\/13\/9\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Management of Severe AS.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-182432125\u0022 data-figure-caption=\u0022Management of Severe AS.\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\/12\/13\/9\/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\/12\/13\/9\/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\/12\/13\/9\/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\/14239\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-13\u0022 class=\u0022first-child\u0022\u003EManagement of Severe AS.\u003C\/p\u003E\n            \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EAS=aortic stenosis; AVR=aortic valve replacement; LVEF=left ventricular ejection fraction; TAVI=transcatheter aortic valve implantation.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-2\u0022\u003EReproduced with permission from the European Society of Cardiology. All rights reserved. Copyright \u00a9 2012.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-14\u0022\u003ETAVI should be considered for patients with severe symptomatic AS who are deemed to be high-risk for traditional SAVR. Risk assessment is a key issue, and a better definition of contraindications to SAVR is needed. Risk scores in patients with AS have limitations, and there is a need for better identification of patients who should not have any intervention. Clinical judgment through a multidisciplinary approach is essential for optimal patient selection.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-4\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003ETAVI in the \u201cReal World\u201d\u003C\/h2\u003E\n         \u003Cp id=\u0022p-15\u0022\u003EBased on a review of data from TAVI registries, Martyn R. Thomas, MD, St. Thomas\u0027 Hospital, London, United Kingdom, concluded that TAVI is rapidly being adopted in the real world but penetration varies widely from country to country. Outcome results for the Sapien and CoreValve devices are the same except for higher permanent pacemaker rates with the CoreValve. Mortality is 4% to 8% at 30 days and 15% to 25% at 1 year after TAVI, and stroke rates are 3% to 4% [Toggweiler S et al. \u003Cem\u003EJ Am Coll Cardiol\u003C\/em\u003E 2012; Wendler O. TCT 2012; Meridith IT. TCT 2010]. Moderate to severe paravalvular leak is associated with worse outcomes, as was shown in the PARTNER trials. The registries contain only limited QoL data. Comparison between transfemoral and alternative access outcomes is difficult because the patient populations are different, as shown in the SOURCE XT registry (\u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E).\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\/14241\/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\/14241\/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\/14241\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 \n               \u003Cp id=\u0022p-16\u0022 class=\u0022first-child\u0022\u003ETF Versus Non-TF: SOURCE XT.\u003C\/p\u003E\n            \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-19\u0022\u003EOverall, novel interventional options for patients with AS who need AVR continue to evolve. These therapies provide an opportunity to improve patient outcomes. Importantly, adoption of these new therapies should be based primarily on clinical outcome data rather than enthusiasm, finances, and healthcare systems. Optimal outcomes can only be achieved through sensible use governed by current data and caution should be used with regard to performing TAVI in lower-risk patients.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2012 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\/12\/13\/9.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?nznay2\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?nznay2\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?nznay2\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}