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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 EnligHTN renal denervation system reduced office blood pressure (BP) with no serious periprocedural adverse events over 24 months of follow-up. This article presents long-term data from the first-in-human Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients trial [EnligHTN I; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01438229\u0026amp;atom=%2Fspmdc%2F14%2F18%2F12.atom\u0022\u003ENCT01438229\u003C\/a\u003E].\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\u003EHypertension \u0026amp; Kidney Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHypertensive Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERenal Disease\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology \u0026amp; Cardiovascular Medicine\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHypertension \u0026amp; Kidney Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHypertensive Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERenal Disease\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EThe EnligHTN renal denervation system reduced office blood pressure (BP) with no serious periprocedural adverse events over 24 months of follow-up. Costas Tsioufis, MD, PhD, University of Athens, Athens, Greece, presented long-term data from \u003Cem\u003Ethe\u003C\/em\u003E first-in-human \u003Cem\u003ESafety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients trial\u003C\/em\u003E [EnligHTN I; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01438229\u0026amp;atom=%2Fspmdc%2F14%2F18%2F12.atom\u0022\u003ENCT01438229\u003C\/a\u003E].\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe EnligHTN renal denervation system uses a multielectrode device to produce acute lesions with a predictable pattern. During the procedure, after being positioned proximal to the bifurcation of the renal artery, the basket is expanded, and a diagnostic check is performed to ensure electrode contact. Ablation is performed for 90 seconds per electrode. The basket is collapsed, pulled back 1 cm, then rotated and expanded, wherein the diagnostic check is performed, followed by ablation. The purpose of this study was to determine the long-term safety and efficacy of renal denervation with the EnligHTN renal denervation system.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EIn the open-label interventional EnligHTN I trial, 46 patients with resistant hypertension received renal denervation and were followed for 24 months. No control group was enrolled. Resistant hypertension was defined as office systolic BP of \u2265160 mm Hg that did not respond to \u22653 concurrent antihypertensive medications at maximally tolerated doses for a minimum of 14 days before enrollment. Patients aged 18 to 80 years were excluded if they had a history of renal artery intervention, renal artery stenosis \u0026gt;30%, multiple main renal arteries, main renal arteries \u0026lt;4 mm in diameter or \u0026lt;20 mm in length, a glomerular filtration rate of \u0026lt;45 mL\/minute\/1.73m\u003Csup\u003E2\u003C\/sup\u003E, type 1 diabetes, identified cause of secondary hypertension, or significant valvular heart disease.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EThe primary objective was to evaluate all adverse events and office BP. At baseline, mean systolic and diastolic BP (SBP and DBP) were 176 and 96 mm Hg, respectively, with a mean number of antihypertensives of 4.7. In addition, 33% of patients had diabetes; 30% had sleep apnea; 59% had hyperlipidemia; 20% had coronary artery disease; and the mean body mass index was 32 kg\/m\u003Csup\u003E2\u003C\/sup\u003E. The mean number of left and right renal artery ablations performed were 7.4 and 7.7, respectively, with a mean of 15 total ablations performed per patient. The mean procedure time was 34 minutes.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EIn the EnligHTN I trial, renal denervation resulted in a significant decrease in office SBP and DBP at 1 month that was maintained to 24 months (p\u0026lt;0.0001; \u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). Similarly, ambulatory BP was significantly decreased from baseline following renal artery denervation (p\u0026lt;0.0001). At 24 months, 77% of patients were considered to have responded to renal denervation, with a reduction of office SBP by \u0026gt;10 mm Hg from baseline. In addition, at 24 months, 39% of patients experienced an office SBP of \u0026lt;140 mm Hg.\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\/14\/18\/12\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Office Blood Pressure Following Renal Denervation by the EnligHTN Renal Denervation System\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-2010363766\u0022 data-figure-caption=\u0022Office Blood Pressure Following Renal Denervation by the EnligHTN Renal Denervation System\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\/18\/12\/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\/18\/12\/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\/18\/12\/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\/14621\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\u003EOffice Blood Pressure Following Renal Denervation by the EnligHTN Renal Denervation System\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EBP=blood pressure.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-2\u0022\u003EReproduced with permission from C Tsioufis, 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\u003EThrough 24 months of follow-up, there were no serious periprocedural events in the EnligHTN I trial. Serious device- or procedure-related events included 1 case of worsening preexisting proteinuria, 1 case of symptomatic hypotension, and 2 events in 1 patient of worsening of preexisting renal artery stenosis with a new stenotic lesion.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EProf. Tsioufis concluded that data from the EnligHTN I trial indicate that renal denervation with the EnligHTN system is effective in lowering office BP with an acceptable safety profile.\u003C\/p\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\/18\/12.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?nzp12p\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?nzp12p\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}