{"id":27204,"date":"2012-03-14T17:15:48","date_gmt":"2012-03-14T21:15:48","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=interventional&p=27204"},"modified":"2012-03-14T11:12:16","modified_gmt":"2012-03-14T15:12:16","slug":"the-800-million-gamble-jumping-aboard-or-jumping-the-gun","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/03\/14\/the-800-million-gamble-jumping-aboard-or-jumping-the-gun\/","title":{"rendered":"The $800 Million Gamble: Jumping Aboard or Jumping the Gun?"},"content":{"rendered":"

In the CLOSURE I trial <\/a>(Evaluation of the STARFlex Septal Closure System in Patients with a Stroke and\/or Transient Ischemic Attack Due to a Presumed Paradoxical Embolism through a Patent Foramen Ovale), 909 patients with a PFO who had a stroke or a transient ischemic attack (TIA) of unclear etiology were randomly assigned to device closure of the PFO or to optimal medical therapy. The\u00a0risks for stroke, TIA,\u00a0and death (individually or combined) did not differ between the two groups.<\/p>\n\n\n\n\n\n\n\n
\n

2-year outcome<\/strong><\/p>\n<\/td>\n

\n

Device Closure<\/strong><\/p>\n<\/td>\n

\n

Medical Therapy<\/strong><\/p>\n<\/td>\n

\n

P value<\/strong><\/p>\n<\/td>\n<\/tr>\n

Stroke or TIA<\/td>\n\n

5.5%<\/p>\n<\/td>\n

\n

6.8%<\/p>\n<\/td>\n

\n

0.37<\/p>\n<\/td>\n<\/tr>\n

Stroke<\/td>\n\n

2.9%<\/p>\n<\/td>\n

\n

3.1%<\/p>\n<\/td>\n

\n

0.79<\/p>\n<\/td>\n<\/tr>\n

TIA<\/td>\n\n

3.1%<\/p>\n<\/td>\n

\n

4.1%<\/p>\n<\/td>\n

\n

0.44<\/p>\n<\/td>\n<\/tr>\n

Death from neurologic cause<\/td>\n\n

0%<\/p>\n<\/td>\n

\n

0%<\/p>\n<\/td>\n

\u00a0<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n

Furthermore, PFO closure increased the risks\u00a0for a major vascular event (3.2% absolute increase, P<\/em><0.001) and for atrial fibrillation (5% absolute increase, P<\/em><0.001).<\/p>\n

But here\u2019s the really interesting thing.\u00a0 <\/em><\/strong><\/p>\n

Patient enrollment was slow because of frequent off-label use of closure devices.\u00a0Each study site recruited an average of only\u00a0two patients per year, primarily\u00a0because of decisions to close many PFOs outside the trial.\u00a0During the 9-year study period, approximately 80,000 patients had a PFO closure with the use of a device.\u00a0At an average cost of $10,000 per procedure, we spent \u2248$800 million on a procedure that had no demonstrable benefit (and, as noted, increased risks)<\/em><\/strong>.<\/p>\n

In short, many cardiologists were convinced of the benefit of PFO closure devices before the study was performed.<\/p>\n

In the future, should\u00a0third-party payers\u00a0withhold reimbursement for unproven device therapy unless such treatment is part of a randomized trial?<\/strong><\/p>\n

\u00a0<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

In the CLOSURE I trial (Evaluation of the STARFlex Septal Closure System in Patients with a Stroke and\/or Transient Ischemic Attack Due to a Presumed Paradoxical Embolism through a Patent Foramen Ovale), 909 patients with a PFO who had a stroke or a transient ischemic attack (TIA) of unclear etiology were randomly assigned to device […]<\/p>\n","protected":false},"author":214,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9],"tags":[563,561,489],"class_list":["post-27204","post","type-post","status-publish","format-standard","hentry","category-interventional-cardiology","tag-closure-i","tag-pfo-closure","tag-stroke-prevention"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/27204","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\/214"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=27204"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/27204\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=27204"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=27204"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=27204"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}