• Luigi Caputi, Gianfranco Butera, Gian Paolo Anzola, Mario Carminati, Maria Rita Carriero, Massimo Chessa, Eustaquio Onorato, Gianluca Rigatelli, Giuseppe Sangiorgi, Gennaro Santoro, Isabella Spadoni, Gian Paolo Ussia, Carlo Vigna, Mario Zanchetta, Eugenio Parati, and Italian Patent Foramen Ovale Survey investigators.
• Department of Cerebrovascular Diseases, Fondazione Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS) Neurological Institute C. Besta, Milan, Italy. Electronic address: lcaputi@istituto-besta.it.
• J Stroke Cerebrovasc Dis. 2013 Oct 1; 22 (7): e219-26.

BackgroundPercutaneous patent foramen ovale (PFO) closure is accepted as treatment for cryptogenic ischemic stroke/transient ischemic attack in young subjects. However, a thorough evaluation of residual right-to-left shunt (rRLS) after PFO closure is needed. Our aims were to analyze the characteristics related to PFO diagnosis and closure, focusing on rRLS and clinical recurrences until 24-month follow-up. Data were extrapolated from the 12-month Italian PFO Survey.MethodsIn all, 1035 patients were included. PFO diagnosis and right-to-left shunt (RLS) were assessed by contrast-enhanced transesophageal and/or transthoracic echocardiography and/or transcranial Doppler.ResultsPFO diagnosis with RLS data were available in 894 of 1035 (86.4%) patients. rRLS was investigated in 49.6% (6 months), 27.1% (12 months), and 3.5% (24 months), and observed in 19.5% (6 months) and 18.2% (12 months) of subjects. Large permanent rRLS was observed in less than 3% of RLS-positive patients after 1 year. Eleven of 14 and 3 of 14 neurological recurrences were observed in 10 of 444 (2.25%) and 2 of 243 (0.8%) patients within the 6- and 12-month follow-up, respectively. Among these, no large rRLS was reported. There were no neurological events at 2-year follow-up. Forty of 444 subjects had non-neurological complications, mostly cardiac arrhythmias within the sixth month.ConclusionsPFO closure is a safe procedure. rRLS is not uncommon but large rRLS is rare. Clinical complications, mostly related to cardiac arrhythmias, are not unusual. Evaluation of the data of the whole survey is underway.Copyright © 2013 National Stroke Association. Published by Elsevier Inc. All rights reserved.

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