{"id":11672,"date":"2011-09-12T16:46:31","date_gmt":"2011-09-12T20:46:31","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=11672"},"modified":"2011-09-12T16:48:08","modified_gmt":"2011-09-12T20:48:08","slug":"global-monitor-early-signs-of-possible-problems-with-icd-leads-dabigatran","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2011\/09\/12\/global-monitor-early-signs-of-possible-problems-with-icd-leads-dabigatran\/","title":{"rendered":"Global Monitor: Early Signs of Possible Problems with ICD Leads, Dabigatran"},"content":{"rendered":"<p>Reports from Ireland and New Zealand may herald new concerns about <strong>Riata defibrillator leads<\/strong>\u00a0(St. Jude Medical) and\u00a0<strong>dabigatran<\/strong>\u00a0(Pradaxa).<\/p>\n<p>A poster presented at the European Society of Cardiology meeting last month\u00a0by researchers at the\u00a0Royal Victoria Hospital in Belfast found that 15% of 212 patients who received Riata leads had an insulation breach on screening. The researchers reported that 20% of the patients had \u201cclinically significant events.\u201d<\/p>\n<p>Quoted in<a href=\"http:\/\/www.startribune.com\/business\/129556878.html\">\u00a0an article in the\u00a0<em>Minneapolis Star Tribune<\/em><\/a>, the chief of the Arrhythmia Service at Brigham and Women\u2019s Hospital in Boston, Laurence Epstein, acknowledges the small size of the single-center study but states that \u201cit could ultimately be a big issue\u2026 we\u2019re just starting to scratch the tip of the iceberg of what the scope of the problem is.\u201d Although the Riata leads were discontinued last year, more than 227,000 were sold worldwide.<\/p>\n<p>In New Zealand, meanwhile, health authorities are struggling with a surge in bleeding complications following the government\u2019s decision to fund dabigatran (Pradaxa). According to\u00a0<a href=\"http:\/\/www.stuff.co.nz\/national\/health\/5602413\/Pharmac-attacked-for-rushing-drug\">an article in the<em>\u00a0Star Times<\/em><\/a>, the country\u2019s drug monitoring agency \u201chas received around 50 reports of people experiencing bleeding since the drug was introduced two months ago as a replacement\u201d for warfarin.<\/p>\n<p>The\u00a0<em>Star Times<\/em>\u00a0reports that about 56,000 people in New Zealand take warfarin and that thousands have been switched to dabigatran.\u00a0The reports quotes an official of the country\u2019s Haematology Society: &#8220;We do have concerns about the way it was rolled out. &#8230; It was rolled out very rapidly without a lot of forethought and planning. In particular the fact that general practitioners could have widespread access to this drug from day one was a concern to us, when some of them did not know how to use it.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Reports from Ireland and New Zealand may herald new concerns about Riata defibrillator leads\u00a0(St. Jude Medical) and\u00a0dabigatran\u00a0(Pradaxa). A poster presented at the European Society of Cardiology meeting last month\u00a0by researchers at the\u00a0Royal Victoria Hospital in Belfast found that 15% of 212 patients who received Riata leads had an insulation breach on screening. The researchers reported [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[495,13,1],"tags":[339,681,975],"class_list":["post-11672","post","type-post","status-publish","format-standard","hentry","category-anticoagulation-2","category-electrophysiology","category-general","tag-dabigatran","tag-icd-leads","tag-riata"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/11672","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/196"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=11672"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/11672\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=11672"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=11672"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=11672"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}