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

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

Author information

1
Department of Cardiology, Bern University Hospital, Bern, Switzerland.
2
Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland Department of Clinical Research, Clinical Trials Unit, Bern, Switzerland.
3
Department of Neurology, Bern University Hospital, Bern, Switzerland.
4
Department of Medicine/Cardiology, University of Colorado Denver, Aurora, CO, USA.
5
Cardiovascular Centre Frankfurt, Frankfurt am Main, Frankfurt, Germany.
6
Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland Department of Clinical Research, Clinical Trials Unit, Bern, Switzerland juni@ispm.unibe.ch.

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.

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

PMID:
25112661
DOI:
10.1093/eurheartj/ehu292
[Indexed for MEDLINE]

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