Percutaneous Closure Versus Medical Treatment in Stroke Patients With Patent Foramen Ovale: A Systematic Review and Meta-analysis
Publication: Annals of Internal Medicine
Volume 168, Number 5
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Abstract
Background:
New evidence emerged recently regarding the percutaneous closure of patent foramen ovale (PFO) to prevent recurrent stroke in patients with cryptogenic stroke.
Purpose:
To compare risks for recurrent cerebrovascular events in adults with PFO and cryptogenic stroke who underwent PFO closure versus those who received medical therapy alone.
Data Sources:
PubMed, Scopus, and Google Scholar from 1 December 2004 through 14 September 2017; references of eligible studies; relevant scientific session abstracts; and cardiology Web sites.
Study Selection:
Randomized controlled trials, published in English, that compared PFO closure using a currently available device with medical treatment alone and that reported, at minimum, the rates of stroke or transient ischemic attack (TIA) or of new-onset atrial fibrillation (AF) or atrial flutter (AFL).
Data Extraction:
2 investigators independently extracted study data and assessed study quality.
Data Synthesis:
4 of 5 trials comparing PFO closure with medical therapy used commercially available devices. These 4 trials, involving 2531 patients, found that PFO closure reduced the risk for the main outcome of stroke or TIA (risk difference [RD], −0.029 [95% CI, −0.050 to −0.007]) and increased the risk for new-onset AF or AFL (RD, 0.033 [CI, 0.012 to 0.054]). The beneficial effect of PFO closure was associated with larger interatrial shunts (P = 0.034).
Limitation:
Trials were not double-blind, and inclusion criteria were heterogeneous.
Conclusion:
Compared with medical treatment, PFO closure prevents recurrent stroke and TIA but increases the incidence of AF or AFL in PFO carriers with cryptogenic stroke.
Primary Funding Source:
Italian Ministry of Education, University and Research (MIUR). (PROSPERO: CRD42017074686)
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Published In
Annals of Internal Medicine
Volume 168 • Number 5 • 6 March 2018
Pages: 343 - 350
History
Published online: 9 January 2018
Published in issue: 6 March 2018
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© 2018 American College of Physicians.
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Percutaneous Closure Versus Medical Treatment in Stroke Patients With Patent Foramen Ovale: A Systematic Review and Meta-analysis. Ann Intern Med.2018;168:343-350. [Epub 9 January 2018]. doi:10.7326/M17-3033
Percutaneous Closure Versus Medical Treatment in Stroke Patients With Patent Foramen Ovale: A Systematic Review and Meta-analysis. Ann Intern Med.2018;168:343-350. [Epub 9 January 2018]. doi:10.7326/M17-3033
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MD
As we all know that observational studies have suggested an association between PFO and migraine.
However, randomized studies of PFO closure to prevent migraine recurrence have not shown beneficial effect. Also, I know this outcome was not addressed on recent CLOSE and Gore Trials, but I am wondering if you considered this issue or came through as a secondary outcome through your systematic review.