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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\u003Cp id=\u0022p-1\u0022\u003EAccording to early performance results from a single-arm trial, the Micra Transcatheter Pacing System was safe and effective in patients who required ventricular pacing for a variety of conditions. The serious adverse event rate was 5.7%, but there were no device-related deaths, infections, dislodgements, or reoperation.\u003C\/p\u003E\u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Epacing\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Eventricular pacing\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003Epacemaker\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EMicra Transcatheter Pacing System\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EMicra\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENCT02004873\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ETPS\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\u003EThe Micra Transcatheter Pacing System (TPS)\u2014which is about 10-fold smaller than the conventional pacemaker and is implanted from the femoral vein and fixed in the right ventricle\u2014was safe and effective in a range of patients who required ventricular pacing. Philippe Ritter, MD, Hospital Haut-L\u00e9v\u00e8que, Pessac, France, presented data from the Micra Transcatheter Pacing Study [Ritter P et al. \u003Cem\u003EEur Heart J\u003C\/em\u003E. 2015].\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003ECurrently, the only treatment for symptomatic bradycardia is permanent cardiac pacing. However, transvenous pacing systems may result in serious adverse events (AEs) in up to 12.4% of patients [Udo EO et al. \u003Cem\u003EHeart Rhythm\u003C\/em\u003E. 2012]. The purpose of this study was to determine if the Micra TPS was effective and resulted in fewer serious AEs.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EIn this international phase 3 trial, patients with a class I or II indication for ventricular pacing [Epstein AE et al. \u003Cem\u003EHeart Rhythm\u003C\/em\u003E. 2008] received the Micra TPS system. The Micra TPS system is about 10 times smaller than the conventional pacemaker and consists of an intracardiac accelerometer with flexible tines. At baseline, the median age was 78 years; 61% were men; and the median body mass index was 26 kg\/m\u003Csup\u003E2\u003C\/sup\u003E. In addition, 65% were diagnosed with bradycardia with permanent or persistent atrial tachyarrhythmia or atrial fibrillation; 16% had sinus node dysfunction; 14% had atrioventricular block; and 6% had another indication.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EThe primary safety end point was freedom from major Micra TPS\u2013associated complications or procedures in the 6 months following implantation. The primary efficacy end point was a low and stable pacemaker threshold at 6 months. This analysis of 6-month outcomes included data from 140 patients, and analyses using longer term outcomes are planned.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThe mean implantation time was 37 minutes, and the success rate was 100%. The Micra TPS implant was placed within the apex in 77% of patients, in the septum in 16%, in the midseptum in 6%, and in the right ventricular outflow tract in 1%. The median deployment per patient was 1, with successful first deployment in 59%, success achieved within 2 deployments in 81%, and success achieved within 4 deployments in 96%.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EThe serious AE rate was 5.7%, and 1.4% of patients required prolonged hospitalization; however, there were no device telemetry issues, dislodgements, infections, reoperations, or device-related deaths. Serious AEs included transient atrioventricular block, right bundle branch block, ventricular tachycardia, and ventricular fibrillation (\u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E).\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\/16753\/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\/16753\/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\/16753\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 in Patients With the Micra Transcatheter 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-12\u0022\u003EThe R-wave sensing amplitude was a mean of 11 mV at time of implant and 16 mV at 3 months. The pacing capture threshold remained steady\u20140.64 V at the time of implant and 0.51 V at 3 months. Pacing impedance was 731 \u03a9 at the time of implant and 651 \u03a9 at 3 months.\u003C\/p\u003E\u003Cp id=\u0022p-13\u0022\u003EIn conclusion, Prof Ritter stated that according to the early performance measurements, the Micra TPS system was safe and effective in a large range of patients. However, long-term safety and efficacy will be studied in an ongoing 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\/22\/8.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?nzl3eq\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?nzl3eq\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}