Browsing by Subject "safety"

Background To prevent further stroke, patent foramen ovale (PFO) can be closed from patients with cryptogenic stroke, meaning a stroke without an identified cause. Alternatively, medical therapy can be used. Methods Patients with cryptogenic stroke were signed for PFO closure if they were under 60 years old, had an imaging confirmed stroke, and no other obvious reason for the stroke. For older patients PFO closure was performed in case of recurring stroke during medical therapy. PFO closure procedures were initiated at Helsinki University Hospital in 2003. Patients who met the closure criteria until the end of 2019 (n = 238) were included in the study. We followed the patients for a median of 1.2 years (first quartile 1,0; third quartile 2,7). Results The closure procedure was shown to be safe and well tolerated. It was successfully performed on 96 % of patients. Of these patients 97 % underwent the pre-planned follow-up without significant complications or prolonged hospitalisation. After 12 months of planned follow-up, three patients (1.4 %) died and four (1.9 %) developed a new stroke or transient ischemic attack (n = 5; 0.96 %/year). Conclusions Adverse events after PFO closure are rare. PFO closure significantly reduces the risk of recurrent stroke.