Safety and efficacy of device closure for patent foramen ovale for secondary prevention of neurological events: Comprehensive systematic review and meta-analysis of randomized controlled trials

Abdul Hakeem, Konstantinos Marmagkiolis, Yalcin Hacioglu, Barry F. Uretsky, Betul Gundogdu, Massoud Leesar, Steven R. Bailey, Mehmet Cilingiroglu

Research output: Contribution to journalReview articlepeer-review

32 Scopus citations

Abstract

Background: Controversy persists regarding the management of patients with cryptogenic stroke and patent foramen ovale (PFO). We performed a meta-analysis of randomized controlled trials comparing PFO closure with medical therapy. Methods and Results: A prospective protocol was developed and registered using the following data sources: PubMed, Cochrane Register of Controlled Trials, conference proceedings, and Internet-based resources of clinical trials. Primary analyses were performed using the intention-to-treat method. Three randomized trials comparing percutaneous PFO closure vs. medical therapy for secondary prevention of embolic neurological events formed the data set. Baseline characteristics were similar. During long-term follow-up, the pooled incidence of the primary endpoint (composite of stroke, death, or fatal stroke) was 3.4% in the PFO closure arm and 4.8% in the medical therapy group [risk-reduction (RR) 0.7 (0.48-1.06); p = 0.09]. The incidence of recurrent neurological events (secondary endpoint) was 1.7% for PFO closure and 2.7% for medical therapy [RR 0.66 (0.35-1.24), p = 0.19]. There was no difference in terms of death or adverse events between the two groups. Conclusions: While this meta-analysis of randomized clinical trials demonstrated no statistical significance in comparison to medical therapy, there was a trend towards overall improvement in outcomes in the PFO closure group.

Original languageEnglish (US)
Pages (from-to)349-355
Number of pages7
JournalCardiovascular Revascularization Medicine
Volume14
Issue number6
DOIs
StatePublished - Nov 1 2013

Keywords

  • Meta-analysis
  • Patent foramen ovale
  • Structural interventions

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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