Percutaneous Device Closure of Patent Foramen Ovale in Patients With Presumed Cryptogenic Stroke or Transient Ischemic Attack The Mayo Clinic Experience

Objectives We sought to determine safety, recurrence rates, and novel risk factors for recurrence in patients with cryptogenic stroke/transient ischemic attack (TIA) after patent foramen ovale closure. Background Patent foramen ovale closure in patients with cryptogenic stroke/TIA remains highly controversial. There are limited data on long-term recurrence rates and their predictors in these patients. Methods The records of all patients who underwent patent foramen ovale device closure between December 2001 and June 2006 were reviewed. Patients were seen for clinical follow-up at 3 months then followed annually via telephone. Primary end points were recurrent stroke/TIA. Kaplan-Meier methods were used to estimate recurrent event rates. Cox regression analysis was used to identify risk factors for recurrences. Results There were 352 patients with cryptogenic stroke (n = 225) or TIA (n = 118) with a mean age of 53.4 years. The procedural complication rate was 3.4%. Recurrent events occurred in 8 patients: 7 strokes and 2 TIA, 1 patient had 2 recurrent strokes. The recurrence rate was 0.6% and 2.1% for stroke and 0.3% and 0.7% for TIA at 1 and 4 years, respectively. The combined end point of recurrent stroke/TIA occurred at a rate of 0.9% and 2.8% at 1 and 4 years, respectively. Risk factors for recurrences were elevated pulmonary artery pressure (hazard ratio [HR]: 1.12, p = 0.009), elevated right ventricular pressure (HR: 1.09, p = 0.04), factor V Leiden mutation (HR: 7.42, p = 0.014), and protein S deficiency (HR: 12.2, p = 0.002). Residual shunt and atrial septal aneurysm were not associated with recurrences. Conclusions Patent foramen ovale device closure is safe and is associated with a low recurrence of stroke/TIA. Factors associated with recurrence are thrombophilia and elevated intracardiac pressures. (J Am Coll Cardiol Intv 2009;2:404-11) (C) 2009 by the American College of Cardiology Foundation