ABSTRACT
BACKGROUND: Patent foramen ovale (PFO) has a high estimated prevalence (25% of the general population) and has been implicated in the pathogenesis of cryptogenic stroke and transient ischemic attack (TIA), as well as in the pathogenesis of migraine headache. This study evaluated the effectiveness of percutaneous transcatheter PFO closure with Amplatzer™ (Abbott Laboratories, Abbott Park, IL, USA) devices, from a large single-center experience. METHODS: From January 1998 to December 2014, 577 patients (243 males and 334 females, mean age 50 years, range 11-82 years) with documented PFO and history of at least one episode of cryptogenic stroke/TIA (N.=356) or occasional finding of previous ischemic lesions on MRI (N.=221) underwent percutaneous transcatheter closure of PFO using an Amplatzer™ Occluder (Abbott Laboratories). All the procedures were performed under general anesthesia or mild sedation and were assisted by transesophageal or intracardiac echocardiography. RESULTS: Procedural success was 100%. After a median follow-up period of 2.7 years with echocardiographic evaluations, the rate of recurrent adverse cerebral events was 0.4%. Two patients (0.4%) required a secondary procedure for significant residual shunt. Of 36 patients with minor residual shunt, 30 (83%) showed spontaneous shunt regression at follow-up. There was a consistent decrease after procedure in headache migraine, platypnea-orthodeoxia, fainting episodes, syncope, and coenesthesia phenomena. CONCLUSIONS: Transcatheter PFO closure is an effective and safe therapy for the prevention of thromboembolic events in the patients with cryptogenic stroke/TIA or an occasional finding of a positive cerebral MRI. Late follow-up shows device stability and clinical improvement in the majority of patients.
