Introduction: Closure of a PFO is recommended in patients less than 65 years with cryptogenic stroke and high- risk PFO. A variety of closure devices have been introduced are but real world data on long- term efficacy are rare.  

Aim of the current study was to evaluate the short-and long term effects of interventional PFO closure in a large single center cohort. 

Results: Between 2003 and 2021, 368 patients were treated with a PFO closure device due to previous stroke (n= 339) or migraine (n= 162) by using a Occlutech device (n= 231), Amplatzer device (n= 73) or other devices (n=64). The majority of patients presented high risk PFO 69.9 % with atrial septal aneurysm, 78.5% a positive bubble test, 56.3% showed a detectable L-R shunt. Implantation was done by transoesophageal echocardiography (TOE) guidance in 41.8% of cases, and in 56.8% of the cases by fluoroscopy guidance only.Patients had a mean age of 53.1±13.5 (18-84) years, 51.9 % were male.Mean fluoroscopy time was 9.13±6.9 min, radiation dose was 8901±143128 cGy*cm² and mean amount of contrast dye used (n=295 of 368 (77.6%) pts) was 34.8±35.3 ml. The overall complication rate until discharge was 3.1 %. There were 2 air embolism, 2 device embolization, 2 relevant bleedings, 6 new episodes of atrial fibrillation/flutter. There was no stroke / TIA, no pericardial effusion or need for pericardiocentesis.
Mean time of last contact after PFO closure was 74.3+66.6 month for 366 of 368 patients. Two patients were lost to follow up.
Long term follow up was available in 155 of 368 patients (41.2%) with a mean follow up time of 112.4+65.6 month.
12 patients (3.3%) died during follow-up (4 cardiovascular deaths, 4 new strokes (1.1%) and 6 patients with pulmonary emboli (1.6%) and 9 deep venous thromboses (2.4%)).
Age >65 years was associated with significant increased mortality (p= 0.002) within the Kaplan – Meier analysis.  

Conclusion:
In a large single center registry study of patients after interventional PFO closure, we are able to show very low rates on periinterventional complications and, within a long term follow up period of 9.6 years in mean, very low rates of mortality, new strokes or thromboembolic complications.