title: 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 <or=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.
  
  
  CONCLUSIONS
  Transcatheter PFO closure is associated with low incidence of in-hospital complications and low frequency of recurrent TE at long-term follow-up.
authors.affiliation: Interventional Cardiology Unit, S Camillo/Forlanini Hospital, Circonvallazione Gianicolense 87, 00151 Rome, Italy.
authors.forename: Alberta
authors.initials: A
authors.lastname: Cifarelli
authors.forename: Carmine
authors.initials: C
authors.lastname: Musto
authors.forename: Antonio
authors.initials: A
authors.lastname: Parma
authors.forename: Claudia
authors.initials: C
authors.lastname: Pandolfi
authors.forename: Edoardo
authors.initials: E
authors.lastname: Pucci
authors.forename: Rosario
authors.initials: R
authors.lastname: Fiorilli
authors.forename: Francesco
authors.initials: F
authors.lastname: De Felice
authors.forename: Marco Stefano
authors.initials: MS
authors.lastname: Nazzaro
authors.forename: Roberto
authors.initials: R
authors.lastname: Violini
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D006328:Cardiac Catheterization; D015331:Cohort Studies; D019320:Embolism, Paradoxical / Q000401:mortality* / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D054092:Foramen Ovale, Patent / Q000401:mortality* / Q000601:surgery*; D006344:Heart Septal Defects, Atrial / Q000401:mortality / Q000601:surgery; D006801:Humans; D002546:Ischemic Attack, Transient / Q000401:mortality; D008297:Male; D008875:Middle Aged; D015995:Prevalence; D012008:Recurrence; D012307:Risk Factors; D055989:Septal Occluder Device; D020521:Stroke / Q000401:mortality; D016896:Treatment Outcome; D055815:Young Adult