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.
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.


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.
University of Arkansas for Medical Sciences, Little Rock, AR, USA.
Abdul
A
Hakeem
Konstantinos
K
Marmagkiolis
Yalcin
Y
Hacioglu
Barry F
BF
Uretsky
Betul
B
Gundogdu
Massoud
M
Leesar
Steven R
SR
Bailey
Mehmet
M
Cilingiroglu
D000328:Adult; D000368:Aged; D006328:Cardiac Catheterization / Q000295:instrumentation* / Q000379:methods; D004617:Embolism / Q000517:prevention & control; D005260:Female; D054092:Foramen Ovale, Patent / Q000601:surgery*; D006344:Heart Septal Defects, Atrial / Q000601:surgery; D006801:Humans; D015994:Incidence; D002546:Ischemic Attack, Transient / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D055502:Secondary Prevention; D055989:Septal Occluder Device / Q000009:adverse effects; D016896:Treatment Outcome
Meta-analysis; Patent foramen ovale; Structural interventions