Percutaneous closure of patent foramen ovale in patients with cryptogenic embolism: a network meta-analysis

Eur Heart J. 2015 Jan 7;36(2):120-8. doi: 10.1093/eurheartj/ehu292. Epub 2014 Aug 11.


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.

Methods and 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.

Keywords: Cryptogenic; Embolism; PFO; Patent foramen ovale; Stroke; Transcatheter closure.

Publication types

  • Meta-Analysis
  • Review

MeSH terms

  • Adult
  • Atrial Fibrillation / etiology
  • Atrial Fibrillation / therapy
  • Balloon Occlusion / instrumentation
  • Cardiovascular Agents / therapeutic use
  • Embolism, Paradoxical / complications*
  • Female
  • Foramen Ovale, Patent / complications
  • Foramen Ovale, Patent / therapy*
  • Humans
  • Male
  • Randomized Controlled Trials as Topic
  • Septal Occluder Device
  • Stroke / etiology
  • Stroke / prevention & control
  • Treatment Outcome


  • Cardiovascular Agents