Letter by Furlan Regarding “Critique of Closure or Medical Therapy for Cryptogenic Stroke With Patent Foramen Ovale: The Hole Truth?”

Thaler and Wahl1 repeatedly characterize the CLOSURE I2 trial as having gone wrong. Such moralistic (mis)characterizations betray the prevalent bias toward devices in patients with cryptogenic stroke and a patent foramen ovale (PFO). Although disappointing to some, better to say CLOSURE I failed to prove that the StarFlex device was superior to medical therapy for stroke prevention, in this particular cryptogenic population with PFO. This result is neither wrong nor right.Wrong patient–Contrary to clinical practice, CLOSURE I used an independently adjudicated and rigorous definition of transient ischemic attack (TIA). In clinical practice, failure to use a rigorous definition of TIA can lead to inappropriate device closure of a PFO for spells unrelated to ischemia or paradoxical embolism. If by wrong, Thaler and Wahl also meant patients were randomized …