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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.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\u003EHypertension (HTN) affects more than 25% of adults in developed societies [Wolf-Maier K et al. \u003Cem\u003EHypertension\u003C\/em\u003E 2004] and is a leading attributable cause of mortality worldwide, causing 7.5 million deaths annually [Symplicity HTN-1 Investigators. \u003Cem\u003EHypertension\u003C\/em\u003E 2011]. Refractory or resistant hypertension, which is defined as elevated blood pressure despite full doses of 3 antihypertensive agents, including a diuretic, is being increasingly recognized as a clinically important problem that might affect 13% of the hypertensive population [Geisler BP et al. \u003Cem\u003EJ Am Coll Cardiol\u003C\/em\u003E 2012]. Recently, catheter-based renal denervation treatment has proven to be a viable therapeutic approach for resistant HTN [Geisler BP et al. \u003Cem\u003EJ Am Coll Cardiol\u003C\/em\u003E 2012]. This article discusses emerging technologies and new renal denervation devices in development.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EHypertensive Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EHypertension (HTN) affects more than 25% of adults in developed societies [Wolf-Maier K et al. \u003Cem\u003EHypertension\u003C\/em\u003E 2004] and is a leading attributable cause of mortality worldwide, causing 7.5 million deaths annually [Symplicity HTN-1 Investigators. \u003Cem\u003EHypertension\u003C\/em\u003E 2011]. Every 20\/10 mm Hg increase in blood pressure (BP) is associated with a doubling of cardiovascular mortality [Lewington S et al. \u003Cem\u003ELancet\u003C\/em\u003E 2002; Chobanian AV et al. \u003Cem\u003EHypertension\u003C\/em\u003E 2003]. Refractory or resistant hypertension, which is defined as elevated BP despite full doses of 3 antihypertensive agents, including a diuretic, is being increasingly recognized as a clinically important problem that might affect 13% of the hypertensive population [Geisler BP et al. \u003Cem\u003EJ Am Coll Cardiol\u003C\/em\u003E 2012].\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003ERecently, catheter-based renal denervation treatment has proven to be a viable therapeutic approach for resistant HTN [Geisler BP et al. \u003Cem\u003EJ Am Coll Cardiol\u003C\/em\u003E 2012]. Horst Sievert, MD, PhD, Johann Wolfgang Goethe University Frankfurt, Frankfurt, Germany, discussed emerging technologies and new renal denervation devices in development.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EA revolutionary treatment principle, renal denervation uses ablation of the renal sympathetic nerves with a radiofrequency (RF)-emitting catheter inserted percutaneously via the femoral artery into the lumen of both renal arteries [Laurent S et al. \u003Cem\u003ELancet\u003C\/em\u003E 2012]. The randomized controlled Symplicity HTN-2 trial confirmed a systolic BP (SBP) reduction of 32\u00b123 mm Hg compared with a change of +1\u00b121 mm Hg observed for standard of care (p\u0026lt;0.0001) from a baseline SBP of 178\u00b117 mm Hg [Esler MD et al. \u003Cem\u003ELancet\u003C\/em\u003E 2010].\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EA multielectrode and RF-ablation\u2013based system, EnligHTN, lowered patients\u0027 BP even faster. Thirty-day results in 47 resistant hypertension patients showed mean office BP changes at 1 month of \u221228 mm Hg systolic and \u221210 mm Hg diastolic (p\u0026lt;0.0001 from baseline), with 78% of patients having systolic BP drops of \u226510 mm Hg and 41% having SBP \u0026lt;140 mm Hg (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E) [Worthley S et al. EuroPCR 2012]. In the ARSENAL study [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01438229\u0026amp;atom=%2Fspmdc%2F12%2F8%2F22.atom\u0022\u003ENCT01438229\u003C\/a\u003E] of the EnligHTN system, no serious complications were seen in the renal artery or at the access site; minor procedure-related events included 4 hematomas, 3 vasovagal responses to sheath removal, and 2 postprocedure transient bradycardias.\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\/12\/8\/22\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u002230-Day Results from St. Jude\u0027s Medical First-in-Man Study on the Multielectrode and RF-Ablation-Based EnligHTN System.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-417585856\u0022 data-figure-caption=\u002230-Day Results from St. Jude\u0027s Medical First-in-Man Study on the Multielectrode and RF-Ablation-Based EnligHTN 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\/12\/8\/22\/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\/8\/22\/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\/8\/22\/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\/12770\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\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-6\u0022 class=\u0022first-child\u0022\u003E30-Day Results from St. Jude\u0027s Medical First-in-Man Study on the Multielectrode and RF-Ablation-Based EnligHTN System.\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-7\u0022\u003EThe renal denervation system OneShot received European CE mark clearance in February 2012 [Valigra L. \u003Cem\u003EMass High Tech\u003C\/em\u003E 2012]. Patients in its first-in-man [FIM] study (n=9) had baseline office SBP of 186\u00b118 mm Hg and diastolic BP (DBP) of 91\u00b114 mm Hg. The decrease in office SBP (155\u00b119 mm Hg) and DBP (86\u00b114 mm Hg) at 30 days was statistically significant (p\u0026lt;0.001; \u003Ca id=\u0022xref-fig-2-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F2\u0022\u003EFigure 2\u003C\/a\u003E) [Ormiston J et al. EuroPCR 2012]. The balloon was inflated to 1 atm for 2 minutes ablation of each side; irrigation cooling protected the nontreated region of the artery. Technical success was achieved in 8 of 9 patients. The only failure required minor reprogramming of the RF generator. The median total procedure time was 34 minutes; median fluoroscopy time was 8 minutes; median contrast volume 126 mL. No adverse events were reported.\u003C\/p\u003E\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\/12\/8\/22\/F2.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u002230-Day Outcomes from Covidien\u0027s OneShot Renal Denervation System.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-417585856\u0022 data-figure-caption=\u002230-Day Outcomes from Covidien\u0027s OneShot Renal Denervation System.\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\/12\/8\/22\/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\/12\/8\/22\/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\/12\/8\/22\/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\/12771\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-8\u0022 class=\u0022first-child\u0022\u003E30-Day Outcomes from Covidien\u0027s OneShot Renal Denervation System.\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EDBP=diastolic blood pressure; SBP=systolic blood pressure.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-9\u0022\u003EThe Vessix V2 renal denervation system also has received European CE Mark approval. This system uses a balloon catheter with bipolar RF electrodes, low pressure (\u0026lt;3 atm), and simultaneous energy delivery to all electrodes. Suitable for renal arteries of 3 to 7 mm, treatment time is 30 seconds using \u0026lt;1\/2 to 1 watt. In the Vessix FIM trial (n=7), 30-day results demonstrated declines in SBP of \u221228 mm Hg and in DBP of \u221211 mm Hg (95% CI) [REDUCE-HTN pilot clinical trial. EuroPCR 2012]. The response rate (defined as a change in SBP and DBP) was 100%. This compared to a 1 month \u221219 mm Hg drop in SBP and a \u22129 mm Hg decline in DBP seen in the Symplicity HTN-1 trial (n=138). A multicenter, international Vessix study is currently underway [REDUCE-HTN; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01541865\u0026amp;atom=%2Fspmdc%2F12%2F8%2F22.atom\u0022\u003ENCT01541865\u003C\/a\u003E]. It is the first clinical trial to treat patients with accessory renal arteries.\u003C\/p\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003ELooking to the Future\u003C\/h2\u003E\n         \u003Cp id=\u0022p-10\u0022\u003EAccording to Prof. Sievert, likely areas for future innovation include novel drugs, ultrasound, sound intervention, and radiation.\u003C\/p\u003E\n         \u003Cp id=\u0022p-11\u0022\u003ENano particles are being developed (approximately 100 nanometers) to treat refractory hypertension. Biodegradable catheters have a paramagnetic core with polymeric coating and Botox B. The particles are injected into the renal artery and pulled inside the artery wall by a magnetic field. Two possible mechanisms include heat generated by the magnetic field or Botox released by the particles.\u003C\/p\u003E\n         \u003Cp id=\u0022p-12\u0022\u003EA catheter tipped with a balloon-sheathed microneedle is another innovation. It is guided and inflated in a manner similar to an angioplasty catheter but with far lower expansion pressures (2 atm). The catheter deploys a microneedle into the adventitia, allowing drug delivery to the renal sympathetic nerve sheath. Catheters are available for \u0026gt;2 mm arteries.\u003C\/p\u003E\n         \u003Cp id=\u0022p-13\u0022\u003EA nonfocused ultrasound system for performing renal denervation in patients with resistant hypertension consists of an ultrasound transducer mounted inside a 6 F balloon catheter. The ultrasound creates heat within the surrounding structures and tissue, while cooled water in the balloon protects the endothelium against heat.\u003C\/p\u003E\n         \u003Cp id=\u0022p-14\u0022\u003EOther technologies under development include the Cardiosonic TIVUS System, with outcomes from a FIM trial expected in 2013, sound intervention, and radiation. Sound intervention does not require wall contact, and uses dosimetry-based \u201ctargeting\u201d of nerves with 360 degrees of unfocused ultrasound and blood flow to keep the artery cool. The Beta-Cath 3.5F System delivers \u03b2-radiation, which offers potential \u201csparing\u201d of endothelial injury, a localized effect, small sheath size, and a short procedure time of 5 to 8 minutes per artery [Waksman R. EuroPCR 2012].\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\/8\/22.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?nznakp\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?nznakp\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}