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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\u003EIn the LEADLESS II trial, a leadless cardiac pacemaker was demonstrated to be safe and effective. At 6 months, the serious device-related adverse events occurred in 5.7% of patients, and the primary efficacy end point of acceptable pacing capture threshold and therapeutically acceptable sensing amplitude was achieved in 90% of patients.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EICD\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Epacemaker\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Epacing\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eleadless pacemaker\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Earrhythmias\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\u003EA leadless cardiac pacemaker (LCP) system was demonstrated to be safe and effective in patients who required single-chamber ventricular pacing. Vivek Y. Reddy, MD, Mount Sinai Hospital, New York, New York, USA, presented data from the study of percutaneous implantation of an entirely intracardiac leadless pacemaker [LEADLESS II; Reddy VY et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E. 2015].\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003ECurrent implantable cardiac defibrillators (ICDs) are associated with potential problems such as lead failure, device pocket infection, hematomas, discomfort, and complication rates up to 15% [Udo EO et al. \u003Cem\u003EHeart Rhythm\u003C\/em\u003E. 2012]. The leadless pacemaker was developed as a strategy to avoid surgery and use of leads. The purpose of the LEADLESS II trial was to determine the safety and efficacy of the LCP system.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EIn the prospective, multicenter, nonrandomized LEADLESS II trial, patients indicated for VVI(R) pacemaker implantation received the LCP. The LCP is delivered percutaneously through the femoral vein and is self-contained within the ventricle. The primary efficacy end point was acceptable pacing capture threshold and therapeutically acceptable sensing amplitude up to 6 months. The primary safety end point was freedom from device-related serious adverse events (SAEs) at 6 months. The primary cohort analysis was of the first 300 patients; safety and efficacy were analyzed in the intention-to-treat (ITT) population.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EPatients were eligible for enrollment if they had chronic atrial fibrillation or normal sinus rhythm with secondary or tertiary atrioventricular or bifascicular bundle branch block, or sinus bradycardia with infrequent pauses or unexplained syncope. At baseline, the mean age in the primary cohort was 75.7, the mean body mass index was 29.2, 64.3% of patients were men, and 89.7% were white. In addition, coronary artery disease was present in 40.3%, hypertension in 84%, diabetes mellitus in 27.3%, and tricuspid valve disease with regurgitation or prolapse in 19.7%, and the mean left ventricular ejection fraction was 57.1%.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EIn the LEADLESS II trial, the total duration of the procedure in the primary cohort was 50 minutes, with the insertion to removal of the delivery catheter lasting 30.4 minutes. Device repositioning was required once in 18.3% of patients and twice in 8.3% of patients. The final location of the LCP was within the apex in 48.4% of patients; in the outflow, septum, or other area in 49.8%; and in the apical septum in 1.7%.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EThe primary safety end point was achieved in 93.3% of patients (95% CI, 89.9 to 95.9; \u003Cem\u003EP\u2005\u003C\/em\u003E\u0026lt;\u2005.001), and the efficacy end point was achieved in 90% (95% CI, 86 to 93.2; \u003Cem\u003EP\u003C\/em\u003E\u2005=\u2005.007). LCP implantation was successful in 93.4% of patients (95% CI, 89.9 to 96; \u003Cem\u003EP\u003C\/em\u003E\u2005=\u2005.001). Freedom from SAEs at 6 months was 97.5% in the primary cohort, with the most common device-related SAEs including cardiac perforation and vascular complications (\u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E). Dr Reddy pointed out that most SAEs occurred within the first several weeks after implantation.\u003C\/p\u003E\u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/17035\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/17035\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/17035\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\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \u003Cp id=\u0022p-8\u0022 class=\u0022first-child\u0022\u003EDevice-Related Serious Adverse Events in the LEADLESS II Trial\u003Csup\u003E*\u003C\/sup\u003E\u003C\/p\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-11\u0022\u003EDr Reddy concluded that the safety and efficacy data from the LEADLESS II trial suggest that the LCP system is a feasible alternative to the standard implantable pacemakers in patients who require single-chamber ventricular pacing.\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\/15\/28_suppl_2\/7.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?nzl7cd\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_tables.js?nzl7cd\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}