The survey lasted 12 months and the patients were enrolled
between November 2007 and October 2008. Ongoing follow-up will continue up to 36 months. Patients’ screening consisted with demographic characteristics, current medical treatment, neurological evaluation, indication for PFO closure and RLS evaluation. Imaging with cardiomorphological data, different devices and possible complications were indicated during the procedures. In the post-procedural phase early complications, length of hospitalization and treatment at discharge were described. Follow-ups were within the 6th, 12th, 24th and 36th month. Data regarding cardiac imaging, residual RLS, neurological recurrences and/or cardiac extra-cardiac complications were specified. Most subjects who underwent PFO closure had a previous history of TIA/cryptogenic ischemic stroke (∼80% of Lumacaftor order patients). The remaining indications were consistent with migraine with aura, other events of paradoxical embolism as myocardial or retinal ischemia, residual PFO after a previous
procedure, platypnea–ortheodoxia syndrome, neurosurgical procedures in sitting/semisitting position, diving, thrombophilic status and asymptomatic patients with neuroradiological ischemic lesions. Fifty Italian cardiology departments accepted to participate. Forty of them enrolled at least one patient in the registry. 1035 patients (mean age 46 years [range 5–75], 619/1035 [60%] females) were included in the registry. PFO diagnosis and right-to-left shunt (RLS) were assessed by contrast-enhanced transesophageal (cTEE) and/or transthoracic echocardiography (cTTE) and/or transcranial Doppler (cTCD). RLS was assessed Metformin supplier in a visual semi-quantitative method by cTEE and cTTE: RLS was Protirelin diagnosed if at least 1 microbubble (MB) appeared early in the left atrium either spontaneously or after provocative manoeuvres, thus indicating no shunt if no MB were revealed up to a severe shunt if >20 MB occurred. cTCD methods regarding RLS diagnosis were previously described [9]. cTCD was performed according to the standardized procedure agreed on in the Consensus Conference of Venice [10]. Briefly, the
total MB count consisted of all MB detected during a time interval of 20 s or less after the appearance of the first MB. The proposed classification is as follows: small (0–10 MB), moderate (>10 MB, without shower or curtain pattern), and large (shower or curtain pattern) RLS. All our patients who exhibited RLS of 5 or more MB were considered to have a positive test result [11]. Aneurysm of the interatrial septum (ASA) was diagnosed in the presence of atrial septal excursion greater than 10 mm beyond the plane of the interatrial septum in the presence of a base width greater than 15 mm. ASA was associated in 423/1035 (41%) patients. Intraprocedural monitoring was assessed by using TEE and fluoroscopy in 70% and intracardiac echocardiography in 30% of subjects.