title: Long-Term Contrast Echocardiography and Clinical Follow-Up after Percutaneous Closure of Patent Foramen Ovale Using Two Different Atrial Septal Occluder Devices.
abstract: BACKGROUND
  Percutaneous patent foramen ovale (PFO) closure by means of a septal occluder device (SOD) is a well-known therapeutic strategy for the secondary prevention of paradoxical embolic neurological events. The aim of this study was to provide long-term echocardiographic and clinical follow-up data on patients who had undergone percutaneous PFO closure with 2 different SOD.
  
  
  METHODS
  We selected 2 groups of patients treated with 2 different SOD: Group A: 52 patients with an Amplatzer(®) PFO Occluder and Group B: 49 patients with a Figulla Flex(®) device. All patients underwent follow-up Bubble Test Transthoracic Echocardiography (BTTE) and clinical examination. The results were compared with those recently reported in a group of patients with similar characteristics, but that had been treated conservatively, which acted as a control group.
  
  
  RESULTS
  The mean follow-up after PFO closure was 53 months. The Amplatzer(®) PFO Occluder and the Figulla Flex were used in 52 (51.5%) and 49 (48.5%) of patients, respectively. We found no significant difference in the rate of effective PFO closure between the devices: Amplatzer 91.4%, Figulla 93.9% (P = 0.71). One patient (1.0%) suffered a recurrent neurologic event. BTTE was positive (BTTE+) in 8 patients (8%), 5 with an Amplatzer, and 3 with a Figulla device (P = 0.516). Only 1 patient with BTTE+ had a recurrent TIA (12.5%). No significant relationship was found between device dimensions and BTTE+ (P = 0.062). In the control group (163 patients), the recurrence of neurologic events was 9.2% (15 events), that was significantly higher in respect to the patients who had undergone percutaneous closure of the PFO.
  
  
  CONCLUSIONS
  Percutaneous PFO closure was associated with a remarkably low risk of recurrent embolic neurological events, and no long-term device-related major complications. No statistically significant difference emerged between the 2 different SODs regarding BTTE positivity. Long-term follow-up showed that the recurrence of neurological events has been significantly higher in the group treated in a conservative way.
authors.affiliation: Department of Interventional Cardiology, Policlinico di Monza, Monza, Italy.
authors.forename: Filippo
authors.initials: F
authors.lastname: Scalise
authors.affiliation: Department of Interventional Cardiology, Policlinico di Monza, Monza, Italy.
authors.forename: Carla
authors.initials: C
authors.lastname: Auguadro
authors.affiliation: Department of Interventional Cardiology, Policlinico di Monza, Monza, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Sorropago
authors.affiliation: Department of Interventional Cardiology, Policlinico di Monza, Monza, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Sorropago
authors.affiliation: Biostatistic Unit, Policlinico di Monza, Monza, Italy.
authors.forename: Eugenio
authors.initials: E
authors.lastname: Novelli
authors.affiliation: Department of Interventional Cardiology, Policlinico di Monza, Monza, Italy.
authors.forename: Marica
authors.initials: M
authors.lastname: Finizio
authors.affiliation: Department of Interventional Cardiology, Policlinico di Monza, Monza, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Specchia
mesh_terms: D000328:Adult; D000368:Aged; D006328:Cardiac Catheterization / Q000379:methods; D004452:Echocardiography / Q000379:methods / Q000706:statistics & numerical data; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D054092:Foramen Ovale, Patent / Q000175:diagnosis / Q000601:surgery; D006801:Humans; D007558:Italy; D000069451:Long Term Adverse Effects / Q000175:diagnosis / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D010043:Outcome and Process Assessment, Health Care / Q000706:statistics & numerical data; D011183:Postoperative Complications / Q000175:diagnosis / Q000453:epidemiology; D019919:Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods / Q000706:statistics & numerical data; D055989:Septal Occluder Device / Q000009:adverse effects / Q000145:classification; D016896:Treatment Outcome