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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\u003EResults of a first-in-man study of a novel intracardiac leadless catheter pacemaker (LCP) show its feasibility, safety, and efficacy for right ventricular (RV) pacing, reported study investigators. The prospective, nonrandomized, single-arm LEADLESS study [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01700244\u0026amp;atom=%2Fspmdc%2F13%2F3%2F21.atom\u0022\u003ENCT01700244\u003C\/a\u003E], conducted at three sites, evaluated the \u003Cem\u003Ein vivo\u003C\/em\u003E implantation of the LCP for the first time in 33 patients who required a permanent rate modulated ventricular-based pacemaker.\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\u003ECardiology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EArrhythmias\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EArrhythmias\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EResults of a first-in-man study of a novel intracardiac leadless catheter pacemaker (LCP) show its feasibility, safety, and efficacy for right ventricular (RV) pacing, reported study investigators.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EAlthough conventional pacemakers are safe and effective, complications related to lead and generator pocket remain problematic. Each year, it is estimated that chronic lead-related problems affect 65,000 of the over 4.4 million people worldwide with pacemakers.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EIn an attempt to eliminate the complications related to the lead in conventional pacemakers, a novel percutaneously-delivered LCP was developed for implantation in the right ventricle with a battery life of at least 8 years.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EIn the prospective, nonrandomized, single-arm LEADLESS study [NCTO1700244] conducted at three sites, Vivek Reddy, MD, Mount Sinai School of Medicine, New York, New York, USA, and colleagues evaluated the \u003Cem\u003Ein vivo\u003C\/em\u003E implantation of the LCP for the first time in 33 patients who required a permanent rate modulated ventricular-based pacemaker. All patients included in the study had documented evidence of chronic atrial fibrillation (AF), normal sinus rhythm with second or third degree atrioventricular block and a low level of physical activity or short expected lifespan, or sinus bradycardia; were aged \u226518 years; had a life expectancy of at least 1 year; and were not pacemaker dependent.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EOverall, the mean age of the patients included in the study was 75 years (range, 53 to 91 years), 64% were male, and most had sinus rhythm with low activity or short lifespan (60%) followed by chronic AF and second- or third-degree block (28%) and infrequent pauses or unexplained syncope (24%).\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EImplantation of the LCP was done by affixing the LCP to the endocardium with a single-turn helix, with a docking feature for repositioning and retrieval capability at the proximal end of the LCP. Implantation was done in the right ventricle by femoral venous access using a deflectable delivery catheter under x-ray guidance. Prior to release, baseline pacing and sensing thresholds were determined and the device was repositioned if these thresholds were suboptimal.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EThe pacemaker works by increasing the pacing rate with increased metabolic demand by sensing the RV blood temperature.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EEvaluation of the primary endpoint (ie, safety) and secondary performance endpoints (ie, RV pacing function, battery longevity, rate response, implant success rate, and implant times) were done at 2 days, 2 weeks, 6 weeks, and 3 months after implantation.\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003EOverall, 32 of the 33 (97%) of the patients were implanted successfully with the LCP. The time from procedure to hospital discharge was a mean of 1 day (range, 1 to 4 days).\u003C\/p\u003E\u003Cp id=\u0022p-11\u0022\u003EThe study found no major safety complications related to femoral access, with only one minor groin hematoma that did not require treatment. One patient also had a cardiac perforation and tamponade that was surgically repaired, but the patient had a large right-sided stroke 5 days after surgery and died.\u003C\/p\u003E\u003Cp id=\u0022p-12\u0022\u003EThe performance of the device was demonstrated in data that showed pacing threshold changes over time (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E), R-Wave amplitude changes over time, and impedance changes over time, that were similar to those expected to be seen in conventional pacemakers. Overall, pacing was achieved in \u223c40% of patients.\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\/13\/3\/21\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Leadless Catheter Pacemaker Pacing Threshold Changes Over Time\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1926079901\u0022 data-figure-caption=\u0022Leadless Catheter Pacemaker Pacing Threshold Changes Over Time\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\/13\/3\/21\/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\/13\/3\/21\/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\/13\/3\/21\/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\/13168\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\u003ELeadless Catheter Pacemaker Pacing Threshold Changes Over Time\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-14\u0022\u003EBased on these results, the investigators concluded that leadless RV cardiac pacing is feasible and raises the possibility of eliminating lead from pacemakers. According to Dr. Reddy, commercial access of the LCP for clinical use is expected in Europe later this year, and a large multicenter study of the LCP in the United States is set to begin by sometime next year. In addition, an atrial LCP to allow for multichamber cardiac pacing is currently in development.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2013 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\/13\/3\/21.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?nznzcd\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?nznzcd\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}