title: Comparison between the new Gore septal and Amplatzer devices for transcatheter closure of patent foramen ovale. Short- and mid-term clinical and echocardiographic outcomes.
abstract: BACKGROUND
  The ideal device for percutaneous patent foramen ovale (PFO) occlusion should provide effective closure with long-term biocompatibility and it should have a low profile without interfering with adjacent cardiac structures. Long-term data regarding safety and efficacy of the GORE Septal Occluder (GSO) are lacking. The aim of this study was to investigate the short- and mid-term clinical and echocardiographic outcomes of this device.
  
  
  RESULTS
  Forty-five consecutive patients with clinically significant PFO were treated with GSO and their results were compared with those of 45 consecutive patients treated with Amplatzer PFO device (APO). Primary endpoint was the incidence of 6-month residual right-to-left shunting (rRLS). The procedural results and the recurrence of embolic events (REE) at 1 year were also investigated. No differences in terms of embolic risk profile and echocardiographic parameters were observed between the 2 groups. GSO was successfully implanted in all patients without device-related complication. In 2 patients for whom device position was not optimal, the GSO was easily retrieved and a new GSO was successfully repositioned. Immediate moderate-severe rRLS was similar in 2 groups. No cases of severe 6-month rRLS were registered. Two patients (4%) and 1 patient (2%) had moderate 6-month rRLS in the GSO and APO group, respectively (P=NS). No cases of REE were registered at 1-year follow-up.
  
  
  CONCLUSIONS
  GSO appears a valuable alternative to Amplatzer device for PFO occlusion.
authors.affiliation: Interventional Cardiology Unit, San Camillo Hospital.
authors.forename: Carmine
authors.initials: C
authors.lastname: Musto
authors.forename: Alberta
authors.initials: A
authors.lastname: Cifarelli
authors.forename: Rosario
authors.initials: R
authors.lastname: Fiorilli
authors.forename: Francesco
authors.initials: F
authors.lastname: De Felice
authors.forename: Antonio
authors.initials: A
authors.lastname: Parma
authors.forename: Marco Stefano
authors.initials: MS
authors.lastname: Nazzaro
authors.forename: Elena
authors.initials: E
authors.lastname: Guerra
authors.forename: Francesca
authors.initials: F
authors.lastname: Fiorilli
authors.forename: Roberto
authors.initials: R
authors.lastname: Violini
mesh_terms: D000328:Adult; D006328:Cardiac Catheterization / Q000295:instrumentation* / Q000379:methods*; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D054092:Foramen Ovale, Patent / Q000503:physiopathology* / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged