P3733Long term follow-up after percutaneous closure of patent foramen ovale for secondary prevention of stroke

Abstract Background Recent randomized trials have demonstrated the superiority of percutaneous patent foramen ovale (PFO) closure for the secondary prevention of stroke compared to antithrombotic therapy. However, real-world data on long-term outcomes after percutaneous PFO closure are scarce. Purpose To describe real-world long-term outcomes following PFO percutaneous closure and the impact of the use of intracardiac echocardiography under local anesthesia for the procedure Methods All consecutive patients undergoing PFO closure in a single high-volume tertiary center from January 2006 to December 2018, for secondary prevention of stroke, transient ischemic attack (TIA) or any other paradoxical arterial embolism were prospectively studied. A systematic contrast transthoracic echocardiography (TTE) was performed 3 months after closure. Clinical endpoints of interest were the occurrence of death, stroke or transient ischemic attack, as defined in previous randomized trials. Results Of the 242 closure procedures performed, a total of 208 (86.3%) were performed in secondary prevention of stroke, TIA or paradoxical arterial embolism (mean age 49.8±12.7 years; 62.0% male). An atrial septal aneurysm and a large shunt were present in 137 (66.8%) and 172 (84.7%) patients, respectively. General anesthesia associated with transesophageal echocardiography was initially used in all patients with a temporal trend towards the use of local anesthesia associated with either intracardiac echocardiography (Viewflex catheter, Abbott) in 23 more cases or micro transesophageal probe in 7 cases, without periprocedural complications. Discharge medication comprised of dual antiplatelet therapy, oral anticoagulation and single antiplatelet therapy in 80.7%, 16.8% and 2.5% of the patients, respectively. Contrast TTE with Valsalva maneuver was performed at a mean delay of 3.2±0.7 months after intervention and found no or minimal residual shunt in 87.0% of patients. Clinical follow-up was available up to 12.8 years (mean 2.1±3.0 years). A total of 3 patients died from cancer or unknown cause while stroke and TIA occurred in 2 and 1 patients, respectively. Event rate for death was 0.69 events per 100 patients-years. The event rates for stroke, TIA and stroke or TIA were 0.46, 0.23 and 0.70 events per 100 patients-year of observation, respectively, which compare favorably with reported outcomes following percutaneous closure in randomized clinical trials (Figure). Conclusion In an experienced center, percutaneous PFO closure appears to be a safe procedure providing adequate protection against recurrent strokes over a long follow-up. Acknowledgement/Funding ACTION study group