Study findings support PFO closure for cryptogenic stroke

16 March 2006

Patent foramen ovale (PFO) closure using the Cardia device is effective in the prevention of recurrent stroke, results presented at the 55th American College of Cardiology annual scientific sessions in Atlanta, Georgia, suggest.

Michael Savage, from Thomas Jefferson University Hospital in Philadelphia, Pennsylvania, and co-workers used the Cardia PFO closure device to treat 90 patients, of whom 89 had recurrent cryptogenic cerebrovascular events while one had a non-cerebrovascular embolic event.

Successful PFO closure was achieved in 89 patients, who were then placed on aspirin and clopidogrel for 6 months. The procedure failed in one patient who suffered device embolization, although the device was successfully retrieved without additional complications.

Compared with the reported rate of recurrent stroke in patients with unclosed PFOs - which can be as high as 15% - the closure device appeared highly effective in preventing recurrent stroke.

During an average follow-up of 12 months, one stroke occurred in a patient who was not compliant with the antiplatelet medication, and two patients had transient ischemic attacks.

Speaking to Medwire News, co-investigator David Fischman explained that reports such as these contribute to the accumulation of clinical experience, in the context of recruitment difficulties to randomized trials of PFO closure for cryptogenic stroke.

"More and more neurologists are buying into this," he said, which creates a situation where doctors will not randomize their patients for PFO closure, leading to slow trial enrollment.

However, the current human-device-exception rules specify that PFO closure can only be used in patients who suffer recurrent cryptogenic stroke while on warfarin, despite the fact that clopidogrel is now more widely used.

Fischman explained that the focus is therefore moving away from cryptogenic stroke, because trials of PFO closure in migraine patients can be completed in less time, due to the far shorter follow-up required to demonstrate efficacy.

"Once the product is on the shelf with no restrictions, doctors can use it for anything," he said.

American College of Cardiology 55th annual scientific sessions: Atlanta, Georgia, USA; 11-14 March 2006