The most used device for PFO closure was Amplatzer (∼70% of cases). The procedure was successful in all patients. They occurred in 24/1035 (2.3%) patients in the peri-procedural phase. 12/24 (50%) subjects experienced
cardiac arrhythmia: 5 patients had transient atrial fibrillation (AF), one patient a transient bradycardia, one patient a I° atrioventricular block, 4 had AF and 1 had a wide QRS tachycardia, before starting the procedure, and needed electrical cardioversion. 2/24 (8.3%) patients had a femoral arteriovenous Z VAD FMK fistula, thus needing vascular surgery. 4/24 (16.6%) subjects had respiratory problems after general anesthesia. One patient experienced a device embolization, retrieved percutaneously. One patient had a transient visual loss and 4 patients had a vagal reaction,
allergy to antibiotics, right coronary spasm and mild pericardial effusion. Both clinical and cardio-neurosonological follow-ups were assessed in 444/1035 (43%), 243/1035 (23.5%) and in 31/1035 (3%) subjects, at the 6- 12- 24-month follow-up, respectively. Up to the 12-month follow-up, fourteen neurological recurrences were observed in 12/444 (2.7%) patients: 8 TIA and 2 hemorrhagic and 4 ischemic strokes. 10/14 (71.5%) neurological recurrences occurred within the 6-month follow-up. 41 cardiac and extra-cardiac complications occurred in 40/444 (9%) subjects, up to the 12th month. 34/41 (83%) complications were related to arrhythmias, 16 of Everolimus price them had AF, one atrial flutter, 10 supraventricular many paroxysmal tachycardia and the remaining 7 patients non specific arrhythmic patterns. 7/41 (17%) complications were related to myocardial ischemia, atrial erosion, device malposition, gluteal hematoma, apical thrombus, pericardial effusion and
dyspnoea. Most cardiac complications (34/41, 83%) occurred within the 6-month follow-up. Neither neurological recurrences nor cardiac-extra-cardiac complications were observed at the 24-month follow-up. Data concerning residual RLS were available in 401/444 (90.3%) and in 198/243 (81.5%) subjects, at the 6- and 12-month follow-up, respectively. A large permanent residual RLS was observed in 1/401 (0.25%) and 1/198 (0.5%) patient at the 6- and 12-month follow-up, respectively. cTTE was the most utilized diagnostic technique during the follow-up (47.1%, 42.4% and 74.2% at the 6- 12- 24-month follow-up, respectively); successively, in a lesser extent, were the data obtained by cTTE plus cTCD (23.2%, 24.3% and 16.1% at the 6- 12- 24-month follow-up, respectively). The aim of our study was to analyse the clinical practice regarding PFO closure in Italy by a prospective, observational and multi-centric survey using a web-based database. The number of the entire population that underwent PFO closure was, to our knowledge, one of the highest among similar studies.