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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\u003EThe first formal analysis of the ASA-Plavix (ASAP) Registry found that the Watchman left atrial appendage closure device can be used safely and effectively in patients with atrial fibrillation for whom anticoagulants are contraindicated.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EArrhythmias\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EThe first formal analysis of the ASA-Plavix (ASAP) Registry found that the Watchman left atrial appendage closure device can be used safely and effectively in patients with atrial fibrillation (AF) for whom anticoagulants are contraindicated. Vivek Y. Reddy, MD, Mount Sinai School of Medicine, New York, New York, USA, presented findings from the study.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe purpose of the prospective, nonrandomized, multicenter study was to determine if the Watchman device can be used safely without a warfarin transition in patients with AF and if the device decreases the subsequent risk for stroke. After receiving the device, all of the patients received 6 months of clopidogrel and indefinite aspirin.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThe study included 150 patients with paroxysmal, persistent, or permanent nonvalvular AF; a CHADS\u003Csub\u003E2\u003C\/sub\u003E score of \u22651; and a contraindication for warfarin. Follow-up visits took place at 3, 6, 12, 18, and 24 months and included transesophageal echocardiogram imaging, neurological assessment, Barthel Index\/Modified Rankin, and NIH stroke scale. Patients were monitored for a total of 14.4\u00b18.6 months, with a compliance rate of 99.4%.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EThe mean age of patients was 72.5\u00b17.4 years; 64% were male. Most patients had hypertension (94.7%); 67% had a history of overt bleeding; 61 (40.7%) had a prior stroke, transient ischemic attack, or systemic embolism. Participants were required to have a CHADS\u003Csub\u003E2\u003C\/sub\u003E score of at least 1, and the average was 2.8 (current guidelines recommend anticoagulation in those with a CHADS\u003Csub\u003E2\u003C\/sub\u003E score of 2 or above).\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EOverall implant success at the 4 study sites (3 in Germany and 1 in the Czech Republic) was 94.7%. The mean procedure time was 51.5\u00b127.7 minutes. Measured as events per patient-year, the rate of death from any cause was 5.0% and for all stroke, 2.3%. The rate of major bleeding events, mostly gastrointestinal, was 2.7%. Five patients (3.3%) had device thrombus without sequelae.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EAccording to Dr. Reddy, the expected rate of ischemic stroke, based on the distribution of CHADS\u003Csub\u003E2\u003C\/sub\u003E scores, was 7.3%; the observed rate in ASAP patients was 1.7%, a relative 77% lower than predicted. The expected rate, if clopidogrel was used throughout follow-up, was 5.1%; the observed rate was a relative 67% lower.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EDr. Reddy noted that a significant number of patients with AF who can not or will not take warfarin are at risk for stroke, and pharmacological alternatives are not suitable. He concluded that Watchman implantation without a warfarin transition is feasible, with a low but manageable rate of device thrombus.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2012 MD Conference Express\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\/12\/6\/9.1.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?nzndl1\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}