Patent Foramen Ovale Transcatheter Closure vs. Medical Therapy on Recurrent Vascular Events: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Study Questions:

What is the recurrence rate of vascular events after transcatheter closure of patent foramen ovale (PFO), as compared with medical therapy?


A meta-analysis was performed of three recent randomized, controlled trials assessing the impact of transcatheter PFO closure. The trials included the RESPECT and PC trials using the Amplatzer PFO occluder, and the CLOSURE I trial, using the STARFlex device. The primary endpoints prespecified for the meta-analysis were recurrent vascular events (including transient ischemic attack [TIA] and stroke), and composite endpoint of death and recurrent vascular events.


The three studies in the meta-analysis included a total of 2,303 patients, of which 1,150 patients were randomized to transcatheter PFO closure and 1,153 were randomized to medical therapy, with a mean follow-up of 3.5 years. Baseline demographics were similar between the three studies. Intention-to-treat analyses showed a significant risk reduction in stroke and/or TIA in the transcatheter PFO group as compared with medical therapy (pooled hazard ratio [HR], 0.59; 95% confidence interval [CI], 0.36-0.97; p = 0.04). When assessing stroke alone, there was no benefit from transcatheter PFO closure when compared with medical therapy (pooled HR, 0.62; 95% CI, 0.36-1.07; p = 0.09). On subgroup analysis, patients with a substantial PFO shunt seemed to benefit the most with transcatheter PFO closure (pooled HR, 0.35; 95% CI, 0.12-1.03); p = 0.06).


The authors concluded that the transcatheter device closure may be beneficial in reducing the risk of recurrent vascular events when compared to medical treatment.


Despite the recent publication of three randomized, controlled trials, the debate regarding device closure of PFO for the prevention of recurrent neurological events continues. None of the individual trials demonstrated a significant benefit of device closure. This meta-analysis demonstrated a modest decrease in recurrent neurologic events in patients undergoing device closure, mostly due to reduction in recurrent TIA (as opposed to stroke). It seems likely that a subpopulation of patients with PFO and previous neurologic events may benefit from device closure, although this patient group remains to be clarified. This study did not suggest a greater benefit of device closure in younger patients or patients with atrial septal aneurysm, but did suggest that patients with large defects may have increased benefit from device closure.

Clinical Topics: Congenital Heart Disease and Pediatric Cardiology, Congenital Heart Disease

Keywords: Stroke, Foramen Ovale, Patent

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