Italian patent foramen ovale survey (I.P.O.S.): Early results

Abstract

Summary Background Percutaneous patent foramen ovale (PFO) closure is gaining wide acceptance. Aims of the study were to analyse clinical practice regarding PFO closure in Italy, to study indications, devices, results, and the follow-up of large series of patients treated by percutaneous PFO closure. Methods and patients Italian patent foramen ovale survey (IPOS) is a prospective, observational, multi-centric survey that uses a web-based database. The survey lasted 12 months, (November 2007–October 2008). 50 centres participated. Ongoing follow-up will continue up to 36 months. 1035 patients (m.a. 46 years, 60% females) were included in the registry. Most subjects were treated due to a previous history of TIA/ischemic stroke (∼80% of patients). PFO diagnosis and right-to-left shunt (RLS) were assessed by contrast-enhanced transesophageal (cTEE) and/or transthoracic echocardiography and/or transcranial doppler. An aneurysm of the interatrial septum was associated in 41% of patients. Intraprocedural monitoring was assessed by using cTEE and fluoroscopy in 70% and intracardiac echocardiography in 30% of subjects. Procedures were performed under general anesthesia and local anesthesia/conscious sedation in 54% and 46% of patients respectively. The most used device for PFO closure was Amplatzer (∼70% of cases). Results The procedure was successful in all patients. Early complications occurred in 24/1035 patients (2.3%): 12/24 (50%) of them had cardiac arrhythmias, 1 subject had a TIA. Data regarding both clinical and cardio-neurosonological follow-up were assessed in 444/1035 (43%) subjects. The rate of neurological events and cardiac and extra-cardiac complications were around 3% and 9% up to the 24-month follow-up respectively. A large permanent residual RLS and no RLS were observed in less than 1% and in ∼82% of patients at the 1-year follow-up, respectively. Conclusions Our data confirm that percutaneous PFO closure is a safe procedure. Early complications and those during follow-up are mostly related to arrhythmias. Longer follow-up is under way.