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ISSN: 1734-1922
Archives of Medical Science
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vol. 16
Letter to the Editor

Closure of patent foramen ovale for secondary prevention of cryptogenic stroke: current perspectives

Rakhee R. Makhija
Chandrasekar Palaniswamy
Wilbert S. Aronow

Department of Medicine, Regional Medical Center, San Jose, CA, USA
Department of Medicine, Division of Cardiology, UCSF Fresno Medical Education Program, Fresno, CA, USA
Department of Medicine, Division of Cardiology, New York Medical College at Westchester Medical Center, Valhalla, NY, USA
Arch Med Sci 2020; 16 (5): 1243–1246
Online publish date: 2019/01/30
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Patent foramen ovale (PFO) is found in about 25% of the population from autopsy studies. In patients with cryptogenic stroke (which accounts for about 30% of strokes), the prevalence of PFO is even higher (about 40–50%). In patients younger than 55 years of age with cryptogenic stroke, the odds ratio for the prevalence PFO is 6 (95% CI: 3.72–9.68), suggesting a very strong association between the two [1]. Over the past decade, PFO closure has been studied as a non-pharmacologic means of secondary prevention of stroke. The earlier devices used for PFO closure were the CardioSEAL and STARFlex devices (NMT Medical, Boston, MA). Currently, the Amplatzer PFO Occluder (Abbott, St. Paul, MN) and Gore Cardioform septal occluder (W. L. Gore & Associates, Inc, Flagstaff, AZ) are widely used. Essentially, these devices have a double-disc design with left and right atrial discs, deployed percutaneously through a femoral venous approach.
Earlier trials [2–4] had failed to show a significant benefit of PFO closure over medical therapy. Accordingly, in 2014, the American Heart Association/American Stroke Association guidelines recommended against routine use of PFO closure for secondary prevention of cryptogenic stroke in patients with a PFO without evidence of deep venous thrombosis [5]. However, recent trials [6–9] have shown superiority of PFO closure over medical therapy alone to prevent recurrent strokes in this population. The essential details of the individual trials are summarized in Table I. Recently published meta-analyses have also confirmed the findings from the recent trials. In a meta-analysis of 2892 patients enrolled in 4 randomized control trials [3, 6–8], PFO closure decreased the absolute risk for recurrent stroke by 3.2% (risk difference: –0.032; 95% CI: –0.050 to –0.014) compared with medical therapy [10]. In another meta-analysis that included 3440 patients enrolled in 5 major randomized trials [2, 3, 6–8], PFO closure significantly reduced recurrent stroke (OR = 0.41; 95% CI: 0.19–0.90; p = 0.03) compared to medical therapy alone [11]. Of note, new onset atrial fibrillation was significantly more frequent after PFO closure (OR = 5.75, 95% CI: 3.09–10.70; p < 0.00001).
What should the current evidence-based practice in patients with PFO and cryptogenic stroke be? Interpretation of conflicting results from individual trials is compounded by significant heterogeneity in study population, medical therapy and the...

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