Patent foramen ovale closure following cryptogenic stroke or transient ischaemic attack: very long-term follow-up.

Abstract Background Patent foramen ovale (PFO) has been identified as a conduit for paradoxical embolism resulting in cryptogenic stroke or transient ischemic attack (TIA). Long term efficacy of PFO closure beyond 10 years has rarely been studied. Aim We aimed to evaluate long-term rates of recurrent stroke or TIA, death, venous thromboembolism (VTE) and newly diagnosed atrial fibrillation (AF) in a cohort of patients undergoing PFO closure for stroke or TIA at our unit. Methods We reviewed the previously-reported cohort of patient who underwent PFO closure between May 2004 and January 2013.1 Medical notes and imaging records were consulted, and electronic databases assessed. The primary outcome of interest was the incidence of any neurovascular events including stroke and TIA. Secondary outcomes were the incidence of major bleeding, venous thromboembolism (VTE), newly diagnosed AF and all-cause death. Results 298 patients were included in the analysis. Median follow-up duration was 15.1 years (14.8-15.5 years). Follow-up was complete in 285 (95.6%) patients for mortality and in 258 (86.6%) patients for neurovascular events, major bleeding, VTE and newly diagnosed AF. Recurrent neurovascular events were observed in 22 patients (0.55 per 100 patient-years). Major bleeding and VTE occurred in 6 (0.15 per 100 patient-years) and 16 patients (0.40 per 100 patient-years) respectively. 24 patients (0.61 per 100 patient-years) were diagnosed to have atrial fibrillation. 30 patients (0.76 per 100 patient-years) died. Conclusion PFO closure is associated with excellent very long-term safety parameters. Clinical benefits following PFO closure may be maintained given the persistently low incidence of adverse clinical outcomes during follow-up.Comparison on the rates of stroke Table showing rates of clinical events