Long-Term Propensity-Score Matched Comparison of Percutaneous Closure of Patent Foramen Ovale With Medical Treatment After Paradoxical Embolism

Study Questions:

What are the differences in long-term clinical outcomes in patients with ischemic stroke or transient ischemic attack (TIA) related to patent foramen ovale (PFO) who undergo device closure, as compared with medical therapy?


A total of 308 consecutive patients with cerebrovascular events presumably related to PFO underwent either percutaneous PFO closure with a variety of devices, or medical therapy. Choice of therapy was dependent on consensus between the treating neurologist and the patient. Analysis of 103 propensity-score matched pairs of patients was performed. The primary outcome was a composite of stroke, TIA, or peripheral embolism.


At a median follow-up period of 9 years, the primary composite outcome occurred in 11 (11%) patients in the PFO closure group and 22 (21%) patients in the medical therapy group (hazard ratio [HR], 0.43; 95% confidence interval [CI], 0.2-0.94; p = 0.33). Most of this benefit was due to a decreased risk of TIA of 5% in the PFO group, as compared with 14% in the medical therapy group (HR, 0.31; 95% CI, 0.1-0.94; p = 0.039). There was no difference in all-cause or cardiovascular mortality. There was no difference in stroke, with a stroke occurring in six (6%) patients in the PFO closure group and eight (8%) patients in the medical therapy group (p = 0.59).


The authors concluded that over the course of a median follow-up period of 9 years, PFO closure appears to reduce the rate of recurrent TIA, but not of stroke.


This study will renew the debate over PFO closure for prevention of recurrent TIA or stroke. The as yet unpublished CLOSURE I study (presented at the American Heart Association Scientific Sessions, Chicago, 2010) was a randomized trial, which enrolled a similar patient population. The CLOSURE I trial used the STARFlex device, and followed patients for 2 years. No difference was seen in the composite endpoint, or the rate of TIA or stroke. The strength of the current study is the relatively long follow-up (median 9 years). The weakness is lack of randomization. Although the definitive answer to the question of efficacy of device closure for PFO may not be known, clinicians have a much more robust body of data with which to counsel patients.

Clinical Topics: Congenital Heart Disease and Pediatric Cardiology, Congenital Heart Disease, CHD and Pediatrics and Quality Improvement

Keywords: Risk, Follow-Up Studies, Ischemic Attack, Transient, Heart Septal Defects, Atrial, Chicago, Psychotherapy, Group, Foramen Ovale, Patent, Embolism, Paradoxical, United States

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