{"id":7899,"date":"2011-04-19T16:00:47","date_gmt":"2011-04-19T20:00:47","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?p=7899"},"modified":"2011-07-19T17:44:27","modified_gmt":"2011-07-19T21:44:27","slug":"non-evidence-based-icd-implants-the-debate-continues","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2011\/04\/19\/non-evidence-based-icd-implants-the-debate-continues\/","title":{"rendered":"Non-Evidence-Based ICD Implants: The Debate Continues"},"content":{"rendered":"<p><a href=\"http:\/\/jama.ama-assn.org\/content\/305\/1\/43.short\">A  controversial study published earlier this year in <em>JAMA<\/em><\/a> that found that nearly a quarter of all ICD implantations did not meet  evidence-based criteria is the subject of further debate this week in  the letters section of <em>JAMA<\/em>.<\/p>\n<p>In the <a href=\"http:\/\/jama.ama-assn.org\/content\/305\/15\/1537.extract\">first letter<\/a>, Jeanne  Poole and George Crossley take issue with the designation by the authors  of ICD implantations within 3 months of a new HF diagnosis as being  non-evidence based. They point out that current guidelines &#8220;do not  specify a 3-month wait from HF diagnosis before ICD implantation for any  etiology of HF.&#8221; <a href=\"http:\/\/jama.ama-assn.org\/content\/305\/15\/1539.2.full\">In response<\/a>, Sana Al-Khatib and colleagues argue that  &#8220;recommendations for primary prevention ICDs apply only to patients  whose left ventricular ejection fraction remains low despite optimal  medical therapy&#8221; and that &#8220;achieving optimal medical therapy in patients  with newly diagnosed HF is an iterative process&#8221; that has required more  than 3 months to demonstrate full benefits in clinical trials.<\/p>\n<p>In  the <a href=\"http:\/\/jama.ama-assn.org\/content\/305\/15\/1538.1.extract\">second letter<\/a>, Kathleen Blake and Charles Swerdlow write that the  NCDR data &#8220;is not designed to determine the medical necessity of ICD  implants that do not meet evidence-based guidelines.&#8221; They describe  several scenarios in which non-evidence-based implants may be medically  justified. Al-Khatib et al agree that some non-evidence-based implants  can be &#8220;clinically appropriate&#8221; but, they write, &#8220;the important question  is how many.&#8221; They point out that non-evidence-based implantations in  hospitals in their study ranged from 0% to 60%, and write that &#8220;the  proportion of such cases should generally not be high, and if it is,  additional investigations are needed to identify reasons.&#8221;<\/p>\n<p>In the  <a href=\"http:\/\/jama.ama-assn.org\/content\/305\/15\/1538.2.extract\">third letter<\/a>, Steven Zweibel, Christopher Clyne, and Eric Crespo  question the accuracy of the NCDR registry, since &#8220;the registry relies  on busy clinicians&#8230; who may not be completely familiar with the  subtleties of clinical care and decision making for patients with  cardiovascular disease.&#8221; They cite numerous deficiencies in the data  collection for the registry at their own institution. In their response,  Al-Khatib et al say that the NCDR has numerous mechanisms to ensure the  quality of its data, and that a professional audit found a 90%  agreement between hospital records and registry data. CMS reimbursement  for ICDs requires participation in the registry, &#8220;and penalties may be  levied if inaccurate data are knowingly submitted.&#8221;<\/p>\n<p>\ufeff<\/p>\n","protected":false},"excerpt":{"rendered":"<p>A controversial study published earlier this year in JAMA that found that nearly a quarter of all ICD implantations did not meet evidence-based criteria is the subject of further debate this week in the letters section of JAMA. In the first letter, Jeanne Poole and George Crossley take issue with the designation by the authors [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13,14],"tags":[448,638],"class_list":["post-7899","post","type-post","status-publish","format-standard","hentry","category-electrophysiology","category-heart-failure","tag-icds","tag-ncdr"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/7899","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=7899"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/7899\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=7899"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=7899"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=7899"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}