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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\n            \u003Cp id=\u0022p-1\u0022\u003EImportantly, up to 35% of patients that undergo arrhythmic device implantation also require chronic anticoagulant treatment. Current clinical practice guidelines recommend discontinuing warfarin treatment prior to surgery and treating patients with low-molecular-weight heparin [Douketis JD et al. \u003Cem\u003EChest\u003C\/em\u003E 2012]. This article presents data from the Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial [BRUISE CONTROL; Birnie D et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2013], which tested the hypothesis that continued treatment with warfarin would reduce the number of device-pocket hematomas without increasing the risk of major perioperative bleeding events.\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\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 \u0026amp; Cardiovascular Medicine\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EDavid Birnie, MD, University of Ottawa Heart Institute, Ottawa, Ontario, Canada, presented data from the Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial [BRUISE CONTROL; Birnie D et al. \u003Cem\u003EN Engl J Med 2013\u003C\/em\u003E].\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EImportantly, up to 35% of patients that undergo arrhythmic device implantation also require chronic anticoagulant treatment. Current clinical practice guidelines recommend discontinuing warfarin treatment prior to surgery and treating patients with low-molecular-weight heparin (LMWH) [Douketis JD et al. \u003Cem\u003EChest\u003C\/em\u003E 2012]. The BRUISE CONTROL trial tested the hypothesis that continued treatment with warfarin would reduce the number of device-pocket hematomas without increasing the risk of major perioperative bleeding events, as compared with bridging with LMWH [Birnie D et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2013].\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EIn the international Phase 4, multicenter, single-blind, randomized controlled BRUISE CONTROL trial, 681 patients were randomized to continue warfarin or discontinue warfarin and receive LMWH or intravenous heparin [Birnie D et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2013]. Patients were eligible if they had a \u22655% annual risk of thromboembolism or were treated with warfarin, and required device implantation. In patients continuing warfarin, the target international normalized ratio (INR) was \u22643.0, or \u22643.5 in patients with mechanical valves. In patients receiving LMWH or heparin, warfarin was discontinued 5 days prior to surgery and LMWH or heparin was administered 3 days prior to surgery; LMWH or heparin was readministered 24 hours after surgery until therapeutic INR was reached.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EAt the second interim analysis, the data and safety monitoring board recommended halting the BRUISE CONTROL trial early [Birnie D et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2013]. Therefore, data from 681 patients were analyzed for the primary outcome of the presence of a clinically significant hematoma within the device pocket that resulted in repeated surgery, prolonged hospitalization, and\/or interruption of all anticoagulation for longer than 24 hours. Embolic events and patients\u0027 satisfaction were key secondary endpoints.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EIn the continued warfarin arm, 3.5% of patients experienced a clinically significant hematoma, as compared with 16% of the heparin-bridging arm (p\u0026lt;0.001), resulting in a relative risk ratio of 0.19 (95% CI, 0.10 to 0.36) [Birnie D et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2013]. Embolic events were reported in two patients in the continued warfarin arm, as compared with no patients in the heparin-bridging arm. In addition, patients that continued warfarin reported greater satisfaction with their anticoagulation management than patients receiving LMWH or heparin (p\u0026lt;0.001).\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EIn patients that continued warfarin during surgery, 0.6% developed device system infections, as compared with 1.8% of patients receiving LMWH or heparin (p=0.17) [Birnie D et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2013]. In all cases, complete system extraction was required. In addition, one patient in the heparin-bridging arm experienced cardiac tamponade that required pericardiocentesis.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EIn Dr. Birnie\u0027s opinion, based on the data from the BRUISE CONTROL trial, continuing patients with warfarin therapy is preferable over bridging with heparin for device implantation. In addition, he also noted that other factors such as pressure dressings and sandbags did not appear to contribute to a reduction in device-pocket hematoma.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003E\u201cTo many, the substantial reduction in pocket hematoma that we observed with continued warfarin may be counterintuitive,\u201d said Dr. Birnie. \u201cOne explanation that has been proposed is the concept of an \u2018anticoagulant stress test.\u2019 That is, if patients undergo surgery while fully anticoagulated, any excessive bleeding will be detectable and appropriately managed while the wound is still open. In contrast, when surgery is performed with heparin bridging, such bleeding may remain latent, and appear only when full anticoagulation is resumed postoperatively,\u201d he concluded.\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\/10.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?nznynd\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}