17 Real-world experience and outcomes after device-led patent foramen ovale closure

Aims A patent foramen ovale (PFO) is a common defect that affects up to 34% of the population. Recent evidence has emerged supporting PFO closure in the event of cryptogenic ischaemic stroke, transient ischaemic attack (TIA), systemic embolism and migraine. We aimed to report real-world experience and outcomes for all consecutive patients that had PFO closure in our hospital between March 2009 and October 2019. Methods We retrospectively analysed baseline clinical characteristics, indications for PFO closure, procedural characteristics and long-term clinical follow-up using our dedicated hospital database and Northern Ireland Electronic Care Record. Results PFO closure was performed in 133 patients between March 2009 and October 2019. 59 (44%) of cases were performed between 2009-2016 with 74 (56%) cases performed between 2017-2019, coinciding with the publication of supporting randomized control trials. The mean patient age was 43 ±15 years and 69 (52%) patients were female. 16 (12.1%) of patients had a history of systemic hypertension, 4 (3%) diabetes mellitus and 35 (26%) had a smoking history. Only one patient had a thrombophilia diagnosis. Cerebrovascular events including ischaemic stroke and TIA’s were the leading indication for PFO closure in 123 (92.5%) cases. Systemic embolism, platypnea-orthodeoxia syndrome and decompressive illness were the indications in 4 (3%), 2 (1.5%) and 1(0.75%) case(s), respectively. ‘Other’ indications made up the remaining 3 patients. The majority of procedures were performed under general anaesthetic (GA) in 129 (97%) cases. All cases were performed using trans-oesophageal echocardiography guidance. The mean procedure time was 38 ± 23minutes and the mean size of percutaneous device used was 25mm. Gore (52%) and Amplatzer (35%) septal occluders were the most commonly used devices. There were no procedural deaths. Cardiac tamponade, major vascular injury, pulmonary embolism and/or device embolism did not occur in any patient. Only one patient had a new arrhythmia (atrial fibrillation (AF)) during the periprocedural period. The median length of stay was 1day. Antithrombotic data at discharge was available for 129 (97%) patients. The main antithrombotic strategy adopted was dual antiplatelets in 112 (87%) cases, single antiplatelet in 10 (8%) cases and oral anticoagulation +/- a single antiplatelet made up the remainder of cases, respectively. No patients were readmitted to hospital for bleeding events on interrogation of NIECR. The median follow-up duration after PFO closure was 31 months (range 2-1439months). 3 patients suffered a recurrent neurological event during follow-up, giving an event rate of 0.6/100 patient-years (PY). Infective endocarditis was not observed for any patients. 5 (3.8%) patients had a diagnosis of new AF or atrial flutter during follow-up, all of which occurred within three months of the procedure. 3 patients (2.3%) died during follow-up (median age 56 years (20-75years)) but all of these deaths were non-cardiac in nature. Conclusions PFO closure was performed safely in our hospital with a very low rate of procedural complications. New arrhythmias and cerebrovascular events occurred in a low proportion of the population. Our real-world outcomes in combination with the previously published major randomized control trials supports the continued application of device-led PFO closure in patients with cryptogenic ischaemic stroke, TIA and/or systemic embolism. Conflict of Interest none