title: Percutaneous closure of patent foramen ovale in patients with cryptogenic embolism: a network meta-analysis.
abstract: BACKGROUND
  Up to 40% of ischaemic strokes are cryptogenic. A strong association between cryptogenic stroke and the prevalence of patent foramen ovale (PFO) suggests paradoxical embolism via PFO as a potential cause. Randomized trials failed to demonstrate superiority of PFO closure over medical therapy.
  
  
  RESULTS
  Randomized trials comparing percutaneous PFO closure against medical therapy or devices head-to-head published or presented by March 2013 were identified through a systematic search. We performed a network meta-analysis to determine the effectiveness and safety of PFO closure with different devices when compared with medical therapy. We included four randomized trials (2963 patients with 9309 patient-years). Investigated devices were Amplatzer (AMP), STARFlex (STF), and HELEX (HLX). Patients allocated to PFO closure with AMP were less likely to experience a stroke than patients allocated to medical therapy [rate ratio (RR) 0.39; 95% CI: 0.17-0.84]. No significant differences were found for STF (RR 1.01; 95% CI: 0.44-2.41), and HLX (RR, 0.71; 95% CI: 0.17-2.78) when compared with medical therapy. The probability to be best in preventing strokes was 77.1% for AMP, 20.9% for HLX, 1.7% for STF, and 0.4% for medical therapy. No significant differences were found for transient ischaemic attack and death. The risk of new-onset atrial fibrillation was more pronounced for STF (RR 7.67; 95% CI: 3.25-19.63), than AMP (RR 2.14; 95% CI: 1.00-4.62) and HLX (RR 1.33; 95%-CI 0.33-4.50), when compared with medical therapy.
  
  
  CONCLUSIONS
  The effectiveness of PFO closure depends on the device used. PFO closure with AMP appears superior to medical therapy in preventing strokes in patients with cryptogenic embolism.
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Stefan
authors.initials: S
authors.lastname: Stortecky
authors.affiliation: Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland Department of Clinical Research, Clinical Trials Unit, Bern, Switzerland.
authors.forename: Bruno R
authors.initials: BR
authors.lastname: da Costa
authors.affiliation: Department of Neurology, Bern University Hospital, Bern, Switzerland.
authors.forename: Heinrich P
authors.initials: HP
authors.lastname: Mattle
authors.affiliation: Department of Medicine/Cardiology, University of Colorado Denver, Aurora, CO, USA.
authors.forename: John
authors.initials: J
authors.lastname: Carroll
authors.affiliation: Cardiovascular Centre Frankfurt, Frankfurt am Main, Frankfurt, Germany.
authors.forename: Marius
authors.initials: M
authors.lastname: Hornung
authors.affiliation: Cardiovascular Centre Frankfurt, Frankfurt am Main, Frankfurt, Germany.
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
authors.affiliation: Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland Department of Clinical Research, Clinical Trials Unit, Bern, Switzerland.
authors.forename: Sven
authors.initials: S
authors.lastname: Trelle
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.affiliation: Department of Cardiology, Bern University Hospital, Bern, Switzerland.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Meier
authors.affiliation: Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland Department of Clinical Research, Clinical Trials Unit, Bern, Switzerland juni@ispm.unibe.ch.
authors.forename: Peter
authors.initials: P
authors.lastname: Jüni
mesh_terms: D000328:Adult; D001281:Atrial Fibrillation / Q000209:etiology / Q000628:therapy; D021721:Balloon Occlusion / Q000295:instrumentation; D002317:Cardiovascular Agents / Q000627:therapeutic use; D019320:Embolism, Paradoxical / Q000150:complications*; D005260:Female; D054092:Foramen Ovale, Patent / Q000150:complications / Q000628:therapy*; D006801:Humans; D008297:Male; D016032:Randomized Controlled Trials as Topic; D055989:Septal Occluder Device; D020521:Stroke / Q000209:etiology / Q000517:prevention & control; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents
keywords: Cryptogenic; Embolism; PFO; Patent foramen ovale; Stroke; Transcatheter closure