Long-term outcome of transcatheter patent foramen ovale closure in patients with paradoxical embolism

Abstract

Background Optimal management of patients with PFO and paradoxical embolic events is still debated. Moreover, data from long-term studies on large patient populations are lacking. Aim of the study is to assess immediate and long-term clinical outcome of patients with PFO and paradoxical thrombo-embolic events submitted to transcatheter PFO closure. Methods Only patients with PFO-related transient ischemic attack or stroke underwent PFO closure. Patients were evaluated clinically and echocardiographically at 1, 6 and 12 months after the procedure and yearly thereafter. Primary endpoints were death, recurrent stroke or TIA. Residual right-to left shunt (RLS) was monitored by transthoracic echocardiography (TTE) or transcranial Doppler (TCD) at 6 months'follow-up. Results 202 consecutive patients underwent percutaneous PFO closure for secondary prevention of TE. Device migration was observed in one patient 24 h after the procedure. No cases of procedure-related death or stroke occurred during a median follow-up of 3 ± 1.3 years. Three recurrent TIAs were observed within the first 6 months of follow-up. The cumulative estimated probability of recurrent TE-free survival rate after PFO closure was 99% in patients ≤ 55 years, 84% in patients > 55 years ( p < 0.05) and 94% and 100% in patients with PFO, with or without atrial septal aneurysm (ASA), respectively ( p < 0.05). Of the 188 (93%) patients submitted to TTE or TCD at 6 months' follow-up, 8 (4%) presented a small RLS. Conclusion Transcatheter PFO closure is associated with low incidence of in-hospital complications and low frequency of recurrent TE at long-term follow-up.