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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\u003Cp id=\u0022p-1\u0022\u003ERenal denervation is a promising strategy to treat true treatment-resistant hypertension. However, careful patient selection is required, by a cardiac team using well-defined criteria. Renal denervation should only be performed in an experienced catheterization laboratory performing at least 14 ablations a year. Promising results have been obtained with new ablation devices.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Erenal denervation\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Esymplicity HTN\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Esymplicity HTN-3\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ecatheter design\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EALSTER BP\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eglobal SYMPLICITY registry\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Erenal disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ecardiology \u0026amp; cardiovascular medicine clinical trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Einterventional techniques \u0026amp; devices\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\u003Cp id=\u0022p-2\u0022\u003ERenal denervation (RDN) with percutaneous, catheter-based radiofrequency ablation was shown to reduce blood pressure (BP) in patients with true treatment-resistant hypertension in the initial registry of RDN [Schlaich MP et al. \u003Cem\u003EHypertension.\u003C\/em\u003E 2009] and in the Symplicity HTN trials [Symplicity HTN-1 Investigators. \u003Cem\u003EHypertension.\u003C\/em\u003E 2011; Symplicity HTN-2 Investigators. \u003Cem\u003ELancet.\u003C\/em\u003E 2010].\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EHowever, the promising results found in these trials of reductions in systolic blood pressure (SBP), such as \u221233 mm Hg at 3 years in the nonrandomized Symplicity HTN-1 trial (\u003Cem\u003EP\u003C\/em\u003E \u0026lt; .01 vs baseline) and \u221232 mm Hg at 6 months in seated office SBP versus sham (\u003Cem\u003EP\u003C\/em\u003E \u0026lt; .0001) in the randomized Symplicity HTN-2 trial, were not supported by the results of the Symplicity HTN-3 trial [Bhatt DL et al. \u003Cem\u003EN Engl J Med.\u003C\/em\u003E 2014]. No significant difference was found for the primary efficacy end point of change in office SBP at 6 months between the denervation and sham groups (\u22122.39 mm Hg; 95% CI, \u22126.89 to 2.12; \u003Cem\u003EP\u003C\/em\u003E = .26).\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EA number of potential explanations have emerged for the negative results in Symplicity HTN-3 and were reviewed by Oscar A. Mendiz, MD, Favaloro University, Buenos Aires, Argentina. These include technical issues such as catheter design and level of operator experience, trial conduct, Hawthorne effect, placebo effect, patient demographics, and medication changes or adherence.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EIn regard to catheter design, with the monopolar single-point catheter, there is energy loss into tissue and blood and nonhomogeneous injury distribution. Animal data have shown that the number of ablations is correlated with the concentration of norepinephrine and that approximately 6 to 10 ablations are required to achieve sufficient RDN [Mazor M. \u003Cem\u003EJ Am Coll Cardiol.\u003C\/em\u003E 2012]. Subanalyses of the Symplicity HTN-3 data revealed a significant reduction in SBP at 6 months in nonblack patients, which raises the question of whether this is because of racial differences or adherence to medication, said Prof Mendiz. RDN was also effective in patients taking an aldosterone antagonist at study entry.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EWhether adequate maximal sympathetic blockade was achieved before RDN in Symplicity HTN-3 is questioned, because approximately 40% of the patients in the RDN and sham groups had changes in their medication between baseline and 6 months. Patients were taking about 5 drugs each, \u0026gt; 50% had \u2265 1 drug change, 69% of all medication changes were \u201cescape\u201d changes, and about 50% were taking central-acting sympatholytics.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EA subanalysis of Symplicity HTN-3 showed that the use of aldosterone antagonists at baseline, the total number of ablation attempts, and baseline office SBP \u2265 180 mm Hg were predictors of a change in SBP at 6 months in the RDN group [Kandzari D et al. EuroPCR. 2014]. A matched cohort analysis by these authors also showed an association between the number of ablations and change in office and ambulatory SBP, with \u2265 10 ablations associated with a significant reduction.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EThe ALSTER BP real-world registry of the Symplicity RDN system showed that there are 3 types of responders: early, late, and non [Kaiser L et al. \u003Cem\u003EEuroIntervention.\u003C\/em\u003E 2014]. In 5 of 8 nonresponders who had a second RDN procedure, SBP was reduced at 6 months. The company-sponsored Global SYMPLICITY Registry [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01534299\u0026amp;atom=%2Fspmdc%2F14%2F16%2F16.atom\u0022\u003ENCT01534299\u003C\/a\u003E] showed that there were reductions in the mean 24-hour ambulatory SBP and in office SBP (by 11.9 to 20.2 mm Hg) in its first 1581 patients.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EProf Mendiz stated that patients with true treatment-resistant hypertension would be considered candidates for RDN after careful patient selection using a team approach with well-defined criteria in a well-trained catheterization laboratory, which should perform \u2265 14 ablations per patient. New RDN devices are showing promising preliminary outcomes, and new applications for different clinical settings (eg, for kidney failure, heart failure, obesity, diabetes, and sleep apnea) are being investigated.\u003C\/p\u003E\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\/14\/16\/16.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?nzlkb2\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}