Closing a patent foramen ovale (PFO) using certain devices may be a better option than medication in preventing cryptogenic stroke or transient ischemic attack (TIA), according to a meta-analysis published online Sept. 16 in the International Journal of Cardiology.
The authors, led by George Ntaios, MD, of the University of Thessaly in Larissa, Greece, analyzed three previous studies to determine whether PFO closure offers any stroke prevention advantage over medical therapy. The studies included more than 2,300 patients who had cryptogenic stroke or a TIA and PFO. Half the patients were assigned to PFO closure and half were assigned to medical therapy. PFO closure was performed with either the AMPLATZER PFO Occluder or the STARFlex device. As outcomes, they assessed ischemic stroke recurrence, TIA and death.
Overall analysis did not yield any significant differences between the two groups in terms of the three outcomes. However, when broken down by device, the authors found a significant decrease in ischemic strokes in the AMPLATZER PFO Occluder group compared with medical therapy (1.4 percent vs. 3.04 percent). There was no statistically significant difference between the STARFlex device group and the medical therapy group in terms of TIA and death.
PFO closure, however, was associated with a higher rate of new-onset atrial fibrillation compared with medical therapy (2.78 percent vs. 0.69 percent). Patients in the STARFlex device had significantly more atrial fibrillation episodes (5.14 percent of patients) than the patients in the medical therapy group (0.64 percent).
“[O]ur meta-analysis does not support PFO closure for secondary prevention with unselected devices in patients with cryptogenic stroke or TIA,” the authors wrote. “In the subgroup analysis, PFO closure using the AMPLATZER-PFO Occluder was superior to medical therapy without increasing the risk of new-onset atrial fibrillation, but this finding needs to be further confirmed before it can be incorporated in clinical practice."