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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\u003EImplantation of a leadless cardiac pacemaker (LCP) offers the potential to eliminate the need for the pocket, generator, and connections in most pacemaker systems\u2014the transvenous lead subcutaneous pocket, subcutaneous pulse generator, and intra-system connections. This article discusses a prospective, nonrandomized Evaluation of a New Cardiac Pacemaker study [LEADLESS; Reddy VY et al. \u003Cem\u003ECirculation\u003C\/em\u003E 2014], which found that permanent leadless cardiac pacing is safe and feasible at 1 year after implantation in patients with an indication for single-chamber (ventricular) pacing.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EArrhythmias\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\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology \u0026amp; Cardiovascular Medicine\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EArrhythmias\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\u003Cp id=\u0022p-2\u0022\u003EImplantation of a leadless cardiac pacemaker (LCP) offers the potential to eliminate the need for the pocket, generator, and connections in most pacemaker systems\u2014the transvenous lead subcutaneous pocket, subcutaneous pulse generator, and intra-system connections. Vivek Y. Reddy, MD, Mount Sinai School of Medicine, New York, New York, USA, reported that permanent leadless cardiac pacing is safe and feasible at 1 year after implantation in patients with an indication for single-chamber (ventricular) pacing. The leadless cardiac pacemaker contains a pulse generator and sensing or pacing electrodes within a single, miniaturized unit.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EIn this prospective, nonrandomized Evaluation of a New Cardiac Pacemaker study [LEADLESS; Reddy VY et al. \u003Cem\u003ECirculation\u003C\/em\u003E 2014], 33 patients received the Nanostim LCP. The device was delivered to the right ventricle using a deflectable delivery catheter and affixed to the myocardium using a distal single-turn (screwin) steroid-eluting helix. The mean age of the patients was 77\u00b18 years, and 67% were male (n=22). Permanent atrial fibrillation with atrioventricular block was the most common reason for cardiac pacing (n=22; 67%). The mean procedure duration was 28\u00b117 minutes, and the average time to hospital discharge was 31\u00b120 hours. The overall complication-free rate was 94% (n=31). Five patients (15%) required the use of more than 1 leadless cardiac pacemaker during the procedure. One male patient sustained right ventricular perforation and cardiac tamponade during implantation; although this was successfully surgically repaired, he ultimately died approximately 1 week later from an AF-related stroke. The implant success rate was 97% (32\/33).\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EAfter 1 year, the measures of pacing performance (sensing, impedance, and pacing threshold) either improved or were stable within the accepted range. Pacing threshold was 0.43\u00b10.30 V (p\u0026lt;0.0001), R-wave amplitude was 10.32\u00b12.23 mV (p=0.001), impedance was 627\u00b1209 ohms (p=0.001), and battery voltage was 3.29\u00b10.02 V (p\u0026lt;0.0001). The p values were derived from a comparison between that measured at 12 months and at time of implantation (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E).\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\/9\/19\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Pacing and Sensing Parameters\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1107458172\u0022 data-figure-caption=\u0022Pacing and Sensing Parameters\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\/9\/19\/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\/9\/19\/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\/9\/19\/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\/15892\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-5\u0022 class=\u0022first-child\u0022\u003EPacing and Sensing Parameters\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EReproduced with permission from VY Reddy, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-6\u0022\u003EThere were no device migration or dislodgements, no infections, no mechanical failure or early battery depletion, and no pro-arrhythmias detected after 1 year.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EA completely self-contained, single-chamber, leadless cardiac pacemaker is stable and highly reliable over a 1-year time frame, with few safety issues. This small study suggests the leadless pacemaker could represent a paradigm shift in cardiac pacing. Future studies include a USA multicenter, prospective, single-arm FDA study of \u223c667 patients indicated for ventricular pacing and rate-adaptive therapy, as well as a European observational study (both studies are in progress). Also in development is an atrial LCP that will perform dual- or multi-chamber pacing.\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\/9\/19.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?nzp6mp\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?nzp6mp\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}