This could be explained by the fact that the study was conducted by cardiologists whose aims were, first, to evaluate the success of the procedure and possible early complications and, second, to assess neurological recurrence and residual RLS. Nowadays, the only neurological indication for PFO closure is a cryptogenic stroke or TIA. In our study ∼20% of

the subjects underwent the procedure with other clinical indications. The “enlargement” of indications might be due to a greater effort in primary prevention. The question at issue was, therefore, whether all indications were assessed by neurologists or by other specialists. buy SGI-1776 A closer collaboration between neurologists and cardiologists or other specialists who work together in the patient’s management is desirable. Our study showed an absolute technical procedural success, comparable to previous reports [4], [8], [9], [10] and [11]. The occurrence of early complications are mostly related to cardiac arrhythmias as described in previous reports [12], [13], [14] and [15]. We observed that a 2.7% of patients had neurological recurrences with major complications (i.e. ischemic and hemorrhagic stroke), and up to the 1.3% at the 12-month follow-up. It is noteworthy that about 70% of these patients

had neurological recurrences within the 6-month follow-up. This would indicate that the medical therapy should find more be carefully monitored, mostly during the critical process L-NAME HCl of endothelization. Previous reports described similar incidence of

recurrent thromboembolic events ranging from 0 to 4% per year [16], [17], [18], [19], [20] and [21]. Cardiac and extra-cardiac complications were around 9% up to 12-month follow-up, with 83% of them within the 6th month. Major, even transient, complications (i.e. AF, atrial flutter, myocardial ischemia, apical thrombus) were observed in 19/40 (47.5%) patients. Our data, in line with previous studies [13] and [22], Furlan A. CLOSURE I trial. Presented at the AHA 2010 meeting], draw attention to these critical adverse events, mostly related to cardiac arrhythmias, thus indicating the need to improve the peri- and postprocedural safety and prevention both with technical advances and medical therapy. Finally, given the low rate of large permanent residual RLS at the 6- and 12-month follow-up (<1%), considered crucial for increased risk of paradoxical embolism, we would substantially rule out that the re-occurrence of neurological events in our patients be correlated with the patent foramen ovale, as sole cause. Remarkably, Mono et al. recently described that concurrent etiologies, apart from PFO, were observed in more than one third of recurrent ischemic events in 308 patients with cryptogenic ischemic stroke who received medical therapy or underwent percutaneous PFO closure [4].