Recurrent ischemic stroke/transient ischemic attack after patent foramen ovale closure: A cohort study

BACKGROUND: Patent foramen ovale (PFO) has been associated with ischemic stroke and transient ischemic attack (TIA). Guidelines recommend PFO closure for stroke prevention in selected patients, but the risk of recurrent stroke remains high compared to the background population. We aimed to evaluate the causes of recurrent stroke/TIA and post-interventional complications in patients after PFO closure. METHODS: Patients from the Central Denmark Region who underwent PFO closure at Aarhus University Hospital between November 5, 2018, and May 12, 2023, following an ischemic stroke, TIA, amaurosis fugax, or retinal emboli were included. Data on patient demographics, risk factors, procedural details, post-interventional complications, and recurrent stroke/TIA were collected from electronic medical records. RESULTS: PFO closure was performed in 310 patients (median age: 49 years). During a median follow-up of 2.6 years (interquartile range: 1.5-3.6, 814 total patient-years), recurrent stroke/TIA was observed in 8 patients (2.6%), or 0.98 recurrent strokes per 100 patient-years. Recurrent stroke/TIA was more frequent in patients with hypertension (50.0% vs. 16.9%, p = 0.039). Recurrent stroke/TIA was related to thrombophilia or hematologic conditions entailing hypercoagulability in 62.5% of patients. New-onset atrial fibrillation was observed in 9.4% of patients within 45 days after the procedure. None of these patients subsequently developed an ischemic event. Other adverse outcomes were uncommon. CONCLUSION: Rates of recurrent ischemic stroke/TIA after PFO closure were comparable to findings in previous trials. Pre-existing vascular risk factors (hypertension), and a hypercoagulable state were associated with recurrent ischemic stroke/TIA.