Published online Jun 26, 2018. doi: 10.4330/wjc.v10.i6.41
Peer-review started: January 31, 2018
First decision: February 27, 2018
Revised: March 1, 2018
Accepted: March 18, 2018
Article in press: March 18, 2018
Published online: June 26, 2018
Cryptogenic stroke accounts for one-fourth of the ischemic strokes and the presumed mechanism is venous thromboembolisms entering systemic circulation via patent foramen ovale (PFO). Percutaneous device closure of PFO has been shown to reduce stroke rates but there is lack of evidence on whether percutaneous closure of PFO is better when compared to medical therapy with antiplatelet and/or anticoagulation. Previously published randomized controlled trials (RCTs) comparing PFO closure to medical therapy lacked appropriate patient selection and had large dropout rates at follow up. Based on this available data, the American Association of Neurology (AAN) guidelines recommended against PFO device closure
Though current guidelines do not support PFO device closure, two recently published RCTs showed reduction in incidence of recurrent strokes with PFO closure in appropriately selected patient population with cryptogenic stroke. We therefore performed a systematic review and meta-analysis to evaluate if PFO closure is superior to medical therapy alone including all published RCTs to date.
The purpose of the study is to analyze if PFO closure device is superior to medical therapy alone to prevent recurrent strokes in appropriately selected patient population with cryptogenic stroke.
We searched five databases for studies comparing PFO device closure to medical therapy in patients with cryptogenic stroke. To qualify for inclusion, trials must have a randomized design, include patients > 18 years of age and compare PFO closure to medical therapy in patients with cryptogenic stroke. We obtained a total of five randomized controlled trials for inclusion and performed a meta-analysis. Our primary outcome was incidence of recurrent ischemic stroke. We also looked at secondary outcomes including incidence of atrial fibrillation, all-cause mortality, major bleeding and adverse events.
PFO device closure in appropriately selected patient population with cryptogenic stroke is superior to medical therapy alone in reducing incidence of recurrent strokes. There was no difference between the PFO device closure and the medical therapy groups in terms of overall mortality, major bleeding and adverse events but there was a significant increase in incidence of atrial fibrillation in the closure device group.
Our current meta-analysis including all published randomized controlled trials comparing PFO closure device to medical therapy alone supports PFO device closure in appropriately selected patient population. PFO closure in younger patients with moderate to large PFO and with atrial septal aneurysm is clearly associated with reduction in incidence of recurrent strokes without increasing mortality, major bleeding or adverse events. There is an increase in atrial fibrillation with PFO closure compared to medical therapy alone but this was mostly in the immediate post-operative period.
From this meta-analysis, it could be seen that PFO closure device reduces risk of recurrent stroke in appropriately selected patient population with cryptogenic stroke. PFO closure is associated with increase in atrial fibrillation but this could likely be an organic phenomenon related to atrial irritation from the device itself. Further studies are essential to address whether this increase in atrial fibrillation rates with PFO closure device is associated with adverse outcomes on long term follow up.