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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\u003EThe first-in-human trial of a miniaturized leadless transcatheter pacing system finds a rate of serious adverse events in line with traditional transvenous pacing systems and as-expected electrical performance, offering a promising solution to permanent pacing.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Etransvenous pacing\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Ebradycardia\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eminiaturized leadless pacing system\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Esinus node dysfunction\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eatrioventricular block\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EMitra Transcatheter Pacing study\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENCT02004873\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Efirst in human\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 self-contained, miniaturized, leadless transcatheter pacing system demonstrated excellent electrical performance and a rate of serious adverse events (AEs) in line with traditional transvenous pacing systems. Data from the Micra Transcatheter Pacing study [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT02004873\u0026amp;atom=%2Fspmdc%2F15%2F12%2F13.atom\u0022\u003ENCT02004873\u003C\/a\u003E]\u2014a first-in-human safety and efficacy study\u2014were reported by Philippe Ritter, MD, H\u00f4pital Haut-L\u00e9v\u00eaque, Pessac, France.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EAt 0.8 cc, the Micra pacing system is \u0026lt;\u200510% the size and mass of conventional transvenous pacing systems. The device is fixated directly in the right ventricle via the femoral vein through 4 protractible nitinol tines, and it delivers electrical impulses through an electrode.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EDr Ritter described the experience from the first 140 patients (mean age, 78 years) to undergo implantation during a single-arm 23-center global trial. All patients had class I or II indications for ventricular inhibited pacing, with the primary indication being bradycardia with permanent or persistent atrial tachyarrhythmia (65%). They were followed for an average of 1.9 months, with early performance analysis conducted in the first 60 patients who were followed to 3 months. Ninety-seven percent of patients had \u2265\u20051 comorbidity.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EOutcomes of interest were serious AEs related to the device (as adjudicated by an independent clinical events committee) and the electrical parameters and function of the device.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EImplant success was 100%. Mean implant time was 37 minutes, and the median number of deployments per procedure was 1. Site implant was the apex in 77%, septum in 16%, midseptum in 6%, and right ventricular outflow tract in 1%. At baseline, 44% of patients were on anticoagulation, and 29% were on antiplatelet agents. During the procedure, 40% of patients received a heparin intravenous bolus. One patient died from a noncardiovascular-related cause 139 days after implant. There were no procedure-related deaths.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EThe rate of serious AEs was 5.7%, a rate comparable to the 7.3% rate observed in a Medtronic reference data set, said Dr Ritter. There were no unforeseen events, device telemetry issues, dislodgements, infections, reoperations, or related deaths. Eight patients had a total of 9 serious AEs related to the device or procedure, resulting in 2 prolonged hospitalizations (\u0026gt;\u200548 hours; \u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E). One patient had a pericardial effusion without tamponade after persistent device repositioning, which was resolved with drainage. Another patient was hospitalized after an arterial pseudoaneurysm.\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\/16701\/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\/16701\/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\/16701\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\u003ESerious Adverse Events With Micra Miniaturized Leadless Pacing System\u003C\/p\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-13\u0022\u003EElectrical measurements, including R-wave sensing amplitude and pacing, were as expected. Specifically, the median pacing percentage was 49%; the median pacing capture threshold at 0.24 milliseconds was 0.38 V; and the median pacing impedance was 640 \u03a9. Based on the mean pacing percentage, the projected battery longevity is estimated at an average of 12.6 years.\u003C\/p\u003E\u003Cp id=\u0022p-14\u0022\u003EA miniaturized leadless pacing system is a promising solution to permanent cardiac pacing that may reduce the risks associated with traditional technology and improve patient satisfaction, said Dr Ritter. Long-term safety and benefit are being evaluated in an ongoing clinical trial.\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\/12\/13.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?nzlj5d\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?nzlj5d\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}