Long-term outcome of transcatheter patent foramen ovale closure in patients with paradoxical embolism.
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.
Cifarelli
Alberta
A
Interventional Cardiology Unit, S Camillo/Forlanini Hospital, Circonvallazione Gianicolense 87, 00151 Rome, Italy.
Musto
Carmine
C
Parma
Antonio
A
Pandolfi
Claudia
C
Pucci
Edoardo
E
Fiorilli
Rosario
R
De Felice
Francesco
F
Nazzaro
Marco Stefano
MS
Violini
Roberto
R
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