title: Clinically apparent long-term electric disturbances in the acute and very long-term of patent foramen ovale device-based closure.
abstract: OBJECTIVE
  Incidence of electrical disturbances in patients submitted to transcatheter patent foramen ovale (PFO) closure has not been fully clarified in a large population. The aim of the study is to assess the incidence of atrial fibrillation, supraventricular tachi-arrhythmias, and atrio-ventricular block in the acute and very long-term follow-up.
  
  
  METHODS
  We reviewed the medical and instrumental data of 1000 consecutive patients (mean age 47.3±17.1years) prospectively enrolled in two centers over a 13-year period (February 1999 to February 2012) for right-to-left (R-to-L) shunt ICE-aided catheter-based closure using different devices.
  
  
  RESULTS
  Successful transcatheter PFO closure was achieved in 99.8% of the patients. Implanted devices were: Amplatzer PFO Occluder in 463 patients (46.3%), Amplatzer ASD Cribriform Occluder in 420 patients (42.0%), Premere Occlusion System in 95 patients (9.5%), and Biostar Occluder in 22 patients (2.2%). Postprocedural electrical complications occurred in 5.9% of patients. The only independent predictors of electrophysiological complications were female gender (OR 2.3, 0.5-5.1 [95% CI], p<0.001) and device disk >30mm (OR 5.0, 1.2-7.2 [95% CI], p<0.001). On a mean follow-up of 12 .3±0.6years (minimum 4- maximum 17years), electrical complications occurred in 1.4% of patients including one only case of complete AVB and 5 cases of permanent AF. The only independent predictors were female gender (OR 2.3, 0.5-5.1 [95% CI], p<0.001) and device disk >30mm (OR 5.0, 1.2-7.2 [95% CI], p<0.001).
  
  
  CONCLUSIONS
  Device-based closure of PFO using different devices, appeared very safe from an electrophysiological point of view with low incidence of electrical disturbances even in the very long-term follow-up.
authors.affiliation: Section of Adult Congenital and Adult Heart Disease, Cardiovascular Diagnosis and Endoluminal Interventions, Rovigo General Hospital, Rovigo, Italy. Electronic address: jackyheart71@yahoo.it.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Rigatelli
authors.affiliation: Department of Cardiology, Rovigo General Hospital, Rovigo, Italy and Section of Internal and Cardiopulmonary Medicine, Department of Medical Science, University of Ferrara, Ferrara, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Zuin
authors.affiliation: Department of Cardiovascular Disease, Cittadella General Hospital, Padua, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Pedon
authors.affiliation: Department of Cardiovascular Disease, Cittadella General Hospital, Padua, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Zecchel
authors.affiliation: Section of Adult Congenital and Adult Heart Disease, Cardiovascular Diagnosis and Endoluminal Interventions, Rovigo General Hospital, Rovigo, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Dell'Avvocata
authors.affiliation: Department of Cardiovascular Disease, Cittadella General Hospital, Padua, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Carrozza
authors.affiliation: Department of Cardiovascular Disease, Cittadella General Hospital, Padua, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Zennaro
authors.affiliation: Interventional Electrophysiology Unit, Rovigo General Hospital, Rovigo, Italy.
authors.forename: Gianni
authors.initials: G
authors.lastname: Pastore
authors.affiliation: Interventional Electrophysiology Unit, Rovigo General Hospital, Rovigo, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Zanon
mesh_terms: D000208:Acute Disease; D006328:Cardiac Catheterization / Q000295:instrumentation / Q000379:methods; D017548:Echocardiography, Transesophageal / Q000379:methods; D005260:Female; D054092:Foramen Ovale, Patent / Q000453:epidemiology* / Q000601:surgery*; D006801:Humans; D015994:Incidence; D008297:Male; D055989:Septal Occluder Device; D013995:Time; D016896:Treatment Outcome
keywords: Anatomy; Echocardiography; Patent foramen ovale; Stroke