Long-Term Outcome After Percutaneous Closure of Patent Foramen Ovale for Cryptogenic Ischemic Events.

BACKGROUND

Randomized trials for percutaneous closure of patent foramen ovale (PFO) have demonstrated a lower rate of recurrent ischemic events compared with medical therapy. The aim of this long-term follow-up analysis was to validate the impact of PFO closure on recurrent ischemic events.

METHODS AND RESULTS

A total of 570 patients were enrolled. Patients were followed for recurrent ischemic events for a median of 7.2 years. Mean age at the time of procedure was 49.3 ± 13.1 years. PFO closure was performed with the Amplatzer occluder in 44.9% of patients and with BioStar, Cardia or Premere occluders in 55.1% of patients. Within 10 years of follow-up, recurrent ischemic stroke occurred in 5.1% of patients in the Amplatzer group vs 7.6% with the other occluders (log rank P=.61). There was no difference in the rate of recurrent transient ischemic attack (1.86% vs 1.51%; log rank P=.52) or all-cause mortality (2.9% vs 3.8%; log rank P=.84) between the two groups, in patients with or without an atrial septal aneurysm or with respect to grade of preprocedural shunt. Recurrent stroke was lower in patients <45 years old at the time of occluder implantation (hazard ratio, 4.14; 95% confidence interval, 0.94-18.8; log rank P=.05).

CONCLUSION

In this long-term follow-up after PFO closure, the rate of recurrent stroke was low. There were no significant differences in event rates between different occluder devices, the existence of an atrial septal aneurysm, or grade of preprocedural shunt at baseline. Patients <45 years old had lower rates of recurrent ischemic stroke.