Percutaneous PFO closure for cryptogenic stroke in the setting of a systematic cardiac and neurological screening and a standardised follow-up protocol

BACKGROUND: There are no uniform workup and follow-up (FU) protocols for patients presenting with cryptogenic embolism (CE) who undergo percutaneous closure of a patent foramen ovale (PFO). METHODS: We prospectively performed a systematic cardiac and neurological FU protocol in all patients who underwent percutaneous PFO closure in order to assess the incidence of subsequent cardiac and neurological adverse events. All patients received dual antiplatelet therapy for 6 months and were systematically included in a 12-month standardised FU protocol including: clinical evaluation-transthoracic and transoesophageal echocardiography, 24-hour Holter monitoring and/or 1-week R-test, and transcranial Doppler. Late FU (>12 months) was performed by reviewing medical records. RESULTS: Over a 10-year period, 221 consecutive patients underwent PFO closure for CE and 217 of them (98%) completed the 12-month FU. Ischaemic event recurrence at 12-month and late FU (mean time 69±35 months, median time 65 months, Q1:38 months, Q3:98 months) was observed in 6 (2.8%) and 3 patients (1.4%), respectively. The initial diagnosis of CE was reconsidered in 17 cases (7.8%), as the clinical and paraclinical FU exams showed possible alternative aetiologies for the initial event: 13 patients (6.0%) presented at least 1 episode of atrial fibrillation, while in 4 cases (1.8%) a non-ischaemic origin of the initial symptoms was identified. CONCLUSIONS: Alternative diagnoses explaining the initial symptoms are rarely detected with an in-depth screening for alternative diagnoses before PFO closure. Despite extensive screening, atrial fibrillation is the most frequently observed alternative aetiology for cryptogenic stroke.