{"id":225539,"date":"2026-02-26T12:49:02","date_gmt":"2026-02-26T09:49:02","guid":{"rendered":"https:\/\/new-inbit.dev-praxis.gr\/?post_type=hta_library&#038;p=225539"},"modified":"2026-02-26T12:49:02","modified_gmt":"2026-02-26T09:49:02","slug":"implantable-devices-for-closure-of-patent-foramen-ovale-pfo-in-adults","status":"publish","type":"hta_library","link":"https:\/\/www.inbit.gr\/el\/hta_library\/implantable-devices-for-closure-of-patent-foramen-ovale-pfo-in-adults\/","title":{"rendered":"Implantable devices for closure of patent foramen ovale (PFO) in adults"},"content":{"rendered":"\n<p>Percutaneous closure of patent foreman ovale (PFO) is one of the treatment options for\u00a0patients with PFO suffering from transient ischemic attacks (TIA), cryptogenic stroke or\u00a0persistent migraine. At time of writing, none of the several CE marked PFO closure devices have\u00a0been approved by the US Food and Drug Administration (FDA). Currently there are 12 different\u00a0PFO closure devices available on the Italian market and it has been estimated, that in 2012,\u00a02,541 PFO procedures were performed. The price for a single PFO closure device ranged from\u00a0\u20ac 5,535 to \u20ac 6,868 (excluding VAT), resulting in an estimated impact on the Servizio Sanitario\u00a0Nazionale (SSN) budget of \u20ac 15 millions in 2012. We performed a systematic review and a\u00a0meta-analysis of clinical studies in which patients with PFO suffering from TIAs, cryptogenic\u00a0stroke or persistent migraine underwent insertion of percutaneous devices for the closure of\u00a0PFO were compared to patients treated by usual care. We included 6 primary studies: 5\u00a0controlled clinical trials (CCT), and 1 randomised controlled trial (RCT). In the 5 CCTs we found\u00a0that percutaneous closure of PFO was better than medical treatment in reducing stroke, TIA or\u00a0the combination of both even if in the presence of significant heterogeneity. Poor\u00a0methodological study quality and heterogeneity undermines our confidence in the results of this\u00a0review. We attempted to stratify by device type the overall pooling of study data but it resulted\u00a0in loss of power and further fragmentation of the evidence base. The safety profile of the\u00a0technology appears to be of concern, in that 4.7% of device- or procedure-related serious\u00a0adverse events were observed in the only RCT included. We recommend that large multicentre,\u00a0sufficiently powered, and properly randomised trials be carried out in Europe with particular\u00a0attention to patient selection and risk\/benefit ratio.<\/p>\n","protected":false},"featured_media":0,"template":"","categories":[20],"tags":[66,93],"class_list":["post-225539","hta_library","type-hta_library","status-publish","hentry","category-rapid-assessment","tag-implantable","tag-patent-foramen-ovale"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.inbit.gr\/el\/wp-json\/wp\/v2\/hta_library\/225539","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.inbit.gr\/el\/wp-json\/wp\/v2\/hta_library"}],"about":[{"href":"https:\/\/www.inbit.gr\/el\/wp-json\/wp\/v2\/types\/hta_library"}],"wp:attachment":[{"href":"https:\/\/www.inbit.gr\/el\/wp-json\/wp\/v2\/media?parent=225539"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.inbit.gr\/el\/wp-json\/wp\/v2\/categories?post=225539"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.inbit.gr\/el\/wp-json\/wp\/v2\/tags?post=225539"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}