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Review of Data and Discussion - Who Should Undergo Patent Foramen Ovale Closure in 2014?

ABSTRACT: A patent foramen ovale is a relatively common finding in the general population and is associated with a number of conditions, including cryptogenic stroke. In 2014, percutaneous patent foramen ovale (PFO) closure is a frequently performed procedure; the bulk of these procedures being carried out for secondary prevention of cryptogenic stroke, along with other indications, such as prevention of decompression illness, platypnoea-orthodeoxia syndrome and migraine. Of these conditions the largest body of evidence available is for cryptogenic stroke and there is ongoing debate of the benefit of PFO closure over medical therapy. This article will review the available evidence of PFO closure in each of these contexts, with a particular focus on randomised controlled trials, and endeavour to outline in whom the evidence suggests closure should be considered.

SUBMITTER: Bhan A

PROVIDER: S-EPMC5808728 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature

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Review of Data and Discussion - Who Should Undergo Patent Foramen Ovale Closure in 2014?

Bhan Amit A Clapp Brian B

Interventional cardiology (London, England) 20140401 2

A patent foramen ovale is a relatively common finding in the general population and is associated with a number of conditions, including cryptogenic stroke. In 2014, percutaneous patent foramen ovale (PFO) closure is a frequently performed procedure; the bulk of these procedures being carried out for secondary prevention of cryptogenic stroke, along with other indications, such as prevention of decompression illness, platypnoea-orthodeoxia syndrome and migraine. Of these conditions the largest b ...[more]

PMID: 29588788

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Project description:OBJECTIVE:To examine the relative impact of three management options in patients aged <60 years with cryptogenic stroke and a patent foramen ovale (PFO): PFO closure plus antiplatelet therapy, antiplatelet therapy alone and anticoagulation alone. DESIGN:Systematic review and network meta-analysis (NMA) supported by complementary external evidence. DATA SOURCES:Medline, EMBASE and Cochrane CENTRAL. STUDY SELECTION:Randomised controlled trials (RCTs) addressing PFO closure and/or medical therapies in patients with PFO and cryptogenic stroke. REVIEW METHODS:We conducted an NMA complemented with external evidence and rated certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. RESULTS:Ten RCTs in eight studies proved eligible (n=4416). Seven RCTs (n=3913) addressed PFO closure versus medical therapy. Of these, three (n=1257) addressed PFO closure versus antiplatelet therapy, three (n=2303) addressed PFO closure versus mixed antiplatelet and anticoagulation therapies and one (n=353) addressed PFO closure versus anticoagulation. The remaining three RCTs (n=503) addressed anticoagulant versus antiplatelet therapy. PFO closure versus antiplatelet therapy probably results in substantial reduction in ischaemic stroke recurrence (risk difference per 1000 patients over 5 years (RD): -87, 95% credible interval (CrI) -100 to -33; moderate certainty). Compared with anticoagulation, PFO closure may confer little or no difference in ischaemic stroke recurrence (low certainty) but probably has a lower risk of major bleeding (RD -20, 95% CrI -27 to -2, moderate certainty). Relative to either medical therapy, PFO closure probably increases the risk of persistent atrial fibrillation (RD 18, 95% CI +5?to +56, moderate certainty) and device-related adverse events (RD +36, 95%?CI +23?to +50, high certainty). Anticoagulation, compared with antiplatelet therapy, may reduce the risk of ischaemic stroke recurrence (RD -71, 95% CrI -100 to +17, low certainty), but probably increases the risk of major bleeding (RD +12, 95% CrI -5 to +65, moderate certainty). CONCLUSIONS:In patients aged <60 years, PFO closure probably confers an important reduction in ischaemic stroke recurrence compared with antiplatelet therapy alone but may make no difference compared with anticoagulation. PFO closure incurs a risk of persistent atrial fibrillation and device-related adverse events. Compared with alternatives, anticoagulation probably increases major bleeding. PROSPERO REGISTRATION NUMBER:CRD42017081567.

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Review of Data and Discussion - Who Should Undergo Patent Foramen Ovale Closure in 2014?

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Review of Data and Discussion - Who Should Undergo Patent Foramen Ovale Closure in 2014?

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