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Updated: Feb 22, 2026
Closure of a Patent Foramen Ovale PFO: An Intervention Sequence
Published on: December 23, 2022
Safety Outcomes After Percutaneous Transcatheter Closure of Patent Foramen Ovale
Alexander E Merkler1, Gino Gialdini2, Shadi Yaghi2
1From the Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute (A.E.M., G.G., C.I., B.B.N., H.K.), Department of Neurology (A.E.M., C.I., B.B.N., H.K.), and Division of Cardiology (P.M.O.), Weill Cornell Medicine, New York; and Department of Neurology, the Warren Alpert Medical School of Brown University, Providence, RI (S.Y.). alm9097@med.cornell.edu.
Background And Purpose:
We sought to evaluate the real-world rate of safety outcomes after patent foramen ovale (PFO) closure in patients with ischemic stroke or transient ischemic attack (TIA).
Methods:
We performed a retrospective cohort study using administrative claims data on all hospitalizations from 2005 to 2013 in New York, California, and Florida. Using International Classification of Diseases, Ninth Revision, Clinical Modification codes, we identified patients who underwent percutaneous transcatheter PFO closure within 1 year of ischemic stroke or TIA. Our outcome was an adverse event occurring during the hospitalization for PFO closure, defined as in prior studies as atrial fibrillation or flutter, cardiac tamponade, pneumothorax, hemothorax, a vascular access complication, or death. Crude rates were reported with exact confidence intervals.
Results:
We identified 1887 patients who underwent PFO closure after ischemic stroke or TIA. The rate of any adverse outcome during the hospitalization for PFO closure was 7.0% (95% confidence interval [CI], 5.9%-8.2%). Rates of adverse outcomes varied by age and type of preceding cerebrovascular event. In patients >60 years of age, the rate of adverse outcomes was 10.9% (95% CI, 8.6%-13.6%) versus 4.9% (95% CI, 3.8%-6.3%) in patients ≤60 years of age. The rate of adverse outcomes was 9.9% (95% CI, 7.3%-12.5%) in patients with preceding ischemic stroke versus 5.9% (95% CI, 4.7%-7.1%) after TIA.
Conclusions:
Approximately 1 in 14 patients who underwent percutaneous transcatheter PFO closure after ischemic stroke or TIA experienced a serious periprocedural adverse outcome or death. The risk of adverse outcomes was highest in older patients and in those with preceding ischemic stroke.
