Closure of patent foramen ovale in "cryptogenic" stroke: Has the story come to an end?
Contrasting with three randomized trials that failed to show any superiority of patent foramen ovale closure over antithrombotic therapy, two trials recently reported lower rates of stroke recurrence among patients assigned to patent foramen ovale closure than among those assigned to antiplatelet therapy. In addition, one of the initially negative trials concluded in favor of patent foramen ovale closure after an extended follow-up period. A better selection of patients, the use of reference treatment groups that included patients who received antiplatelet therapy alone (rather than antiplatelet drugs or oral anticoagulants, according to physician preference), and a longer follow-up of patients, may explain the divergent findings across studies. Procedural complications were reported in 1.5% to 5.9% of the patients, none of which led to permanent disability or death. Patent foramen ovale closure was associated with an increased risk of new-onset atrial fibrillation in several studies and of venous thromboembolism in one study.