Stroke prevention by percutaneous closure of patent foramen ovale: a systematic review and meta-analysis
Context The role of percutaneous closure of patent foramen oval (PFO) in patients with cryptogenic stroke has been very controversial for years due to a lack of clear evidence. Objective Systematic review and meta-analysis of the effect of percutaneous PFO closure for secondary prevention of cryptog...
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| Veröffentlicht in: | Heart (British Cardiac Society) 2014-03, Vol.100 (5), p.389-395 |
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| creator | Wolfrum, Mathias Froehlich, Georg M Knapp, Guido Casaubon, Leanne K DiNicolantonio, James J Lansky, Alexandra J Meier, Pascal |
| description | Context The role of percutaneous closure of patent foramen oval (PFO) in patients with cryptogenic stroke has been very controversial for years due to a lack of clear evidence. Objective Systematic review and meta-analysis of the effect of percutaneous PFO closure for secondary prevention of cryptogenic strokes as compared to best medical therapy (BMT). Data sources Trials were identified through a literature search until 28 May 2013. Study selection Controlled clinical trials (randomised and non-randomised) comparing percutaneous PFO closure with BMT. Data extraction and synthesis Main end point of interest was stroke. A random effects model was used to calculate the pooled relative risks (RR) with 95% CIs. Results A total of 14 studies (three randomised controlled trials (RCT) and 11 non-randomised observational studies (non-RCT)), and a total of 4335 patients were included for this analysis. There was no significant treatment effect of PFO closure regarding stroke among the RCT (RR 0.66, 95% CI 0.37 to 1.19, p=0.171). However, among non-RCT stroke was reduced (RR 0.37, 95% CI 0.20 to 0.67, p |
| doi_str_mv | 10.1136/heartjnl-2013-304394 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1499146435</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1499146435</sourcerecordid><originalsourceid>FETCH-LOGICAL-b441t-e758d1e88e82e5b3ae31ff74cdb8a3562dfc56362dcdb6ca7210a5ec9d55ab63</originalsourceid><addsrcrecordid>eNqNkU9P3DAQxS1UBHThGyBkqZde0rUzduL0hlD_SUgcyoFbNHEmIksSp7YD2m9frwIceuppRqPfPM28x9ilFF-khGL7SOjjbhqyXEjIQCio1BE7k6owh9HDh9SD1lkhoDxlH0PYCSFUZYoTdppDWQGUcMYef0fvnojPnp5pir2beLPnM3m7RJzILYHbwYXFE3cdnzEmiHfO40gTd8840FeOPOxDpBFjb3nS6emF49TykSJmOOGwD304Z8cdDoEuXuuG3X__dn_zM7u9-_Hr5vo2a5SSMaNSm1aSMWRy0g0ggey6Utm2MQi6yNvO6gJSTZPCYplLgZps1WqNTQEb9nmVnb37s1CI9dgHS8OwPlNLVVXJIgU6oZ_-QXdu8encRJVGlJArIxOlVsp6F4Knrp59P6Lf11LUhyDqtyDqQxD1GkRau3oVX5qR2velN-cTsF2BZtz9n-Rf0FGXiQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1780732481</pqid></control><display><type>article</type><title>Stroke prevention by percutaneous closure of patent foramen ovale: a systematic review and meta-analysis</title><source>MEDLINE</source><source>BMJ Journals - NESLi2</source><source>PubMed Central</source><creator>Wolfrum, Mathias ; Froehlich, Georg M ; Knapp, Guido ; Casaubon, Leanne K ; DiNicolantonio, James J ; Lansky, Alexandra J ; Meier, Pascal</creator><creatorcontrib>Wolfrum, Mathias ; Froehlich, Georg M ; Knapp, Guido ; Casaubon, Leanne K ; DiNicolantonio, James J ; Lansky, Alexandra J ; Meier, Pascal</creatorcontrib><description>Context The role of percutaneous closure of patent foramen oval (PFO) in patients with cryptogenic stroke has been very controversial for years due to a lack of clear evidence. Objective Systematic review and meta-analysis of the effect of percutaneous PFO closure for secondary prevention of cryptogenic strokes as compared to best medical therapy (BMT). Data sources Trials were identified through a literature search until 28 May 2013. Study selection Controlled clinical trials (randomised and non-randomised) comparing percutaneous PFO closure with BMT. Data extraction and synthesis Main end point of interest was stroke. A random effects model was used to calculate the pooled relative risks (RR) with 95% CIs. Results A total of 14 studies (three randomised controlled trials (RCT) and 11 non-randomised observational studies (non-RCT)), and a total of 4335 patients were included for this analysis. There was no significant treatment effect of PFO closure regarding stroke among the RCT (RR 0.66, 95% CI 0.37 to 1.19, p=0.171). However, among non-RCT stroke was reduced (RR 0.37, 95% CI 0.20 to 0.67, p<0.001) after PFO closure. A time-to-event (stroke) analysis, combining all three RCT and the two non-RCT which applied strict multivariate adjustments, showed a borderline significant risk reduction after PFO closure (HR 0.58, 95% CI 0.33 to 0.99, p=0.047). Neither risk of bleeding nor mortality differed significantly between the groups. However, there was a higher incidence of new onset atrial fibrillation in the closure group (RR 3.50, 95% CI 1.47 to 8.35, p=0.005). Conclusions Percutaneous closure of PFO in patients with cryptogenic stroke does not appear superior to medical therapy according to currently available randomised data. Furthermore, it is associated with an increased incidence of atrial fibrillation. However, there are signals pointing towards a potential benefit and more research should be strongly encouraged.</description><identifier>ISSN: 1355-6037</identifier><identifier>EISSN: 1468-201X</identifier><identifier>DOI: 10.1136/heartjnl-2013-304394</identifier><identifier>PMID: 23793373</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Bias ; Cardiac arrhythmia ; Cardiac Catheterization ; Confidence intervals ; Embolisms ; Foramen Ovale, Patent - complications ; Foramen Ovale, Patent - therapy ; Global Health ; Handbooks ; Humans ; Incidence ; Quality ; Risk Assessment - methods ; Secondary Prevention - methods ; Septal Occluder Device ; Stroke ; Stroke - epidemiology ; Stroke - etiology ; Stroke - prevention & control ; Studies ; Survival Rate - trends ; Thrombolytic Therapy - methods</subject><ispartof>Heart (British Cardiac Society), 2014-03, Vol.100 (5), p.389-395</ispartof><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</rights><rights>Copyright: 2014 Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b441t-e758d1e88e82e5b3ae31ff74cdb8a3562dfc56362dcdb6ca7210a5ec9d55ab63</citedby><cites>FETCH-LOGICAL-b441t-e758d1e88e82e5b3ae31ff74cdb8a3562dfc56362dcdb6ca7210a5ec9d55ab63</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttp://heart.bmj.com/content/100/5/389.full.pdf$$EPDF$$P50$$Gbmj$$H</linktopdf><linktohtml>$$Uhttp://heart.bmj.com/content/100/5/389.full$$EHTML$$P50$$Gbmj$$H</linktohtml><link.rule.ids>114,115,313,314,780,784,792,3194,23570,27921,27923,27924,77371,77402</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23793373$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Wolfrum, Mathias</creatorcontrib><creatorcontrib>Froehlich, Georg M</creatorcontrib><creatorcontrib>Knapp, Guido</creatorcontrib><creatorcontrib>Casaubon, Leanne K</creatorcontrib><creatorcontrib>DiNicolantonio, James J</creatorcontrib><creatorcontrib>Lansky, Alexandra J</creatorcontrib><creatorcontrib>Meier, Pascal</creatorcontrib><title>Stroke prevention by percutaneous closure of patent foramen ovale: a systematic review and meta-analysis</title><title>Heart (British Cardiac Society)</title><addtitle>Heart</addtitle><description>Context The role of percutaneous closure of patent foramen oval (PFO) in patients with cryptogenic stroke has been very controversial for years due to a lack of clear evidence. Objective Systematic review and meta-analysis of the effect of percutaneous PFO closure for secondary prevention of cryptogenic strokes as compared to best medical therapy (BMT). Data sources Trials were identified through a literature search until 28 May 2013. Study selection Controlled clinical trials (randomised and non-randomised) comparing percutaneous PFO closure with BMT. Data extraction and synthesis Main end point of interest was stroke. A random effects model was used to calculate the pooled relative risks (RR) with 95% CIs. Results A total of 14 studies (three randomised controlled trials (RCT) and 11 non-randomised observational studies (non-RCT)), and a total of 4335 patients were included for this analysis. There was no significant treatment effect of PFO closure regarding stroke among the RCT (RR 0.66, 95% CI 0.37 to 1.19, p=0.171). However, among non-RCT stroke was reduced (RR 0.37, 95% CI 0.20 to 0.67, p<0.001) after PFO closure. A time-to-event (stroke) analysis, combining all three RCT and the two non-RCT which applied strict multivariate adjustments, showed a borderline significant risk reduction after PFO closure (HR 0.58, 95% CI 0.33 to 0.99, p=0.047). Neither risk of bleeding nor mortality differed significantly between the groups. However, there was a higher incidence of new onset atrial fibrillation in the closure group (RR 3.50, 95% CI 1.47 to 8.35, p=0.005). Conclusions Percutaneous closure of PFO in patients with cryptogenic stroke does not appear superior to medical therapy according to currently available randomised data. Furthermore, it is associated with an increased incidence of atrial fibrillation. However, there are signals pointing towards a potential benefit and more research should be strongly encouraged.</description><subject>Bias</subject><subject>Cardiac arrhythmia</subject><subject>Cardiac Catheterization</subject><subject>Confidence intervals</subject><subject>Embolisms</subject><subject>Foramen Ovale, Patent - complications</subject><subject>Foramen Ovale, Patent - therapy</subject><subject>Global Health</subject><subject>Handbooks</subject><subject>Humans</subject><subject>Incidence</subject><subject>Quality</subject><subject>Risk Assessment - methods</subject><subject>Secondary Prevention - methods</subject><subject>Septal Occluder Device</subject><subject>Stroke</subject><subject>Stroke - epidemiology</subject><subject>Stroke - etiology</subject><subject>Stroke - prevention & control</subject><subject>Studies</subject><subject>Survival Rate - trends</subject><subject>Thrombolytic Therapy - methods</subject><issn>1355-6037</issn><issn>1468-201X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNqNkU9P3DAQxS1UBHThGyBkqZde0rUzduL0hlD_SUgcyoFbNHEmIksSp7YD2m9frwIceuppRqPfPM28x9ilFF-khGL7SOjjbhqyXEjIQCio1BE7k6owh9HDh9SD1lkhoDxlH0PYCSFUZYoTdppDWQGUcMYef0fvnojPnp5pir2beLPnM3m7RJzILYHbwYXFE3cdnzEmiHfO40gTd8840FeOPOxDpBFjb3nS6emF49TykSJmOOGwD304Z8cdDoEuXuuG3X__dn_zM7u9-_Hr5vo2a5SSMaNSm1aSMWRy0g0ggey6Utm2MQi6yNvO6gJSTZPCYplLgZps1WqNTQEb9nmVnb37s1CI9dgHS8OwPlNLVVXJIgU6oZ_-QXdu8encRJVGlJArIxOlVsp6F4Knrp59P6Lf11LUhyDqtyDqQxD1GkRau3oVX5qR2velN-cTsF2BZtz9n-Rf0FGXiQ</recordid><startdate>20140301</startdate><enddate>20140301</enddate><creator>Wolfrum, Mathias</creator><creator>Froehlich, Georg M</creator><creator>Knapp, Guido</creator><creator>Casaubon, Leanne K</creator><creator>DiNicolantonio, James J</creator><creator>Lansky, Alexandra J</creator><creator>Meier, Pascal</creator><general>BMJ Publishing Group LTD</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88I</scope><scope>8AF</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M2P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20140301</creationdate><title>Stroke prevention by percutaneous closure of patent foramen ovale: a systematic review and meta-analysis</title><author>Wolfrum, Mathias ; Froehlich, Georg M ; Knapp, Guido ; Casaubon, Leanne K ; DiNicolantonio, James J ; Lansky, Alexandra J ; Meier, Pascal</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b441t-e758d1e88e82e5b3ae31ff74cdb8a3562dfc56362dcdb6ca7210a5ec9d55ab63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Bias</topic><topic>Cardiac arrhythmia</topic><topic>Cardiac Catheterization</topic><topic>Confidence intervals</topic><topic>Embolisms</topic><topic>Foramen Ovale, Patent - complications</topic><topic>Foramen Ovale, Patent - therapy</topic><topic>Global Health</topic><topic>Handbooks</topic><topic>Humans</topic><topic>Incidence</topic><topic>Quality</topic><topic>Risk Assessment - methods</topic><topic>Secondary Prevention - methods</topic><topic>Septal Occluder Device</topic><topic>Stroke</topic><topic>Stroke - epidemiology</topic><topic>Stroke - etiology</topic><topic>Stroke - prevention & control</topic><topic>Studies</topic><topic>Survival Rate - trends</topic><topic>Thrombolytic Therapy - methods</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Wolfrum, Mathias</creatorcontrib><creatorcontrib>Froehlich, Georg M</creatorcontrib><creatorcontrib>Knapp, Guido</creatorcontrib><creatorcontrib>Casaubon, Leanne K</creatorcontrib><creatorcontrib>DiNicolantonio, James J</creatorcontrib><creatorcontrib>Lansky, Alexandra J</creatorcontrib><creatorcontrib>Meier, Pascal</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Science Database (Alumni Edition)</collection><collection>STEM Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Science Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Heart (British Cardiac Society)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Wolfrum, Mathias</au><au>Froehlich, Georg M</au><au>Knapp, Guido</au><au>Casaubon, Leanne K</au><au>DiNicolantonio, James J</au><au>Lansky, Alexandra J</au><au>Meier, Pascal</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Stroke prevention by percutaneous closure of patent foramen ovale: a systematic review and meta-analysis</atitle><jtitle>Heart (British Cardiac Society)</jtitle><addtitle>Heart</addtitle><date>2014-03-01</date><risdate>2014</risdate><volume>100</volume><issue>5</issue><spage>389</spage><epage>395</epage><pages>389-395</pages><issn>1355-6037</issn><eissn>1468-201X</eissn><abstract>Context The role of percutaneous closure of patent foramen oval (PFO) in patients with cryptogenic stroke has been very controversial for years due to a lack of clear evidence. Objective Systematic review and meta-analysis of the effect of percutaneous PFO closure for secondary prevention of cryptogenic strokes as compared to best medical therapy (BMT). Data sources Trials were identified through a literature search until 28 May 2013. Study selection Controlled clinical trials (randomised and non-randomised) comparing percutaneous PFO closure with BMT. Data extraction and synthesis Main end point of interest was stroke. A random effects model was used to calculate the pooled relative risks (RR) with 95% CIs. Results A total of 14 studies (three randomised controlled trials (RCT) and 11 non-randomised observational studies (non-RCT)), and a total of 4335 patients were included for this analysis. There was no significant treatment effect of PFO closure regarding stroke among the RCT (RR 0.66, 95% CI 0.37 to 1.19, p=0.171). However, among non-RCT stroke was reduced (RR 0.37, 95% CI 0.20 to 0.67, p<0.001) after PFO closure. A time-to-event (stroke) analysis, combining all three RCT and the two non-RCT which applied strict multivariate adjustments, showed a borderline significant risk reduction after PFO closure (HR 0.58, 95% CI 0.33 to 0.99, p=0.047). Neither risk of bleeding nor mortality differed significantly between the groups. However, there was a higher incidence of new onset atrial fibrillation in the closure group (RR 3.50, 95% CI 1.47 to 8.35, p=0.005). Conclusions Percutaneous closure of PFO in patients with cryptogenic stroke does not appear superior to medical therapy according to currently available randomised data. Furthermore, it is associated with an increased incidence of atrial fibrillation. However, there are signals pointing towards a potential benefit and more research should be strongly encouraged.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>23793373</pmid><doi>10.1136/heartjnl-2013-304394</doi><tpages>7</tpages></addata></record> |
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| subjects | Bias Cardiac arrhythmia Cardiac Catheterization Confidence intervals Embolisms Foramen Ovale, Patent - complications Foramen Ovale, Patent - therapy Global Health Handbooks Humans Incidence Quality Risk Assessment - methods Secondary Prevention - methods Septal Occluder Device Stroke Stroke - epidemiology Stroke - etiology Stroke - prevention & control Studies Survival Rate - trends Thrombolytic Therapy - methods |
| title | Stroke prevention by percutaneous closure of patent foramen ovale: a systematic review and meta-analysis |
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