title: Long-Term Outcomes and Complications of Intracardiac Echocardiography-Assisted Patent Foramen Ovale Closure in 1,000 Consecutive Patients.
abstract: BACKGROUND
  Long-term fate of patients submitted to patent foramen ovale (PFO) closure is still unclear. The aim of the study was to evaluate the incidence of atrial fibrillation (AF), aortic or atrial free wall erosion, device thrombosis (DT), new onset or worsening of mitral valve regurgitation (MVR), and recurrent cerebral ischemic events in the long-term follow up after intracardiac echocardiography (ICE)-aided PFO closure in a large population.
  
  
  METHODS
  We reviewed the medical and instrumental data of 1,000 consecutive patients (mean age 47.3 ± 17.1 years, females) prospectively enrolled in 2 centres over a 13 years period (February 1999-February 2012) for R-to-L shunt ICE-aided catheter-based closure using different devices.
  
  
  RESULTS
  Immediate success was 99.8%. 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%). On a mean follow-up of 12.3 ± 0.6 years (minimum 4- maximum 17 years), permanent AF occurred in 0.5%, DT was apparent in 0.5%, new onset or worsening of MVR was observed in 0.2%, whereas recurrent cerebral ischemic events were 0.8%. Occlusion rate was 93.8%. No aortic or atrial free wall erosion has been observed.
  
  
  CONCLUSIONS
  ICE-aided closure of PFO using different devices, appeared very safe and effective on very long-term follow up with low incidence of erosion, DT, recurrent ischemic events, MVR new onset or worsening, and permanent AF.
authors: Section of Adult Congenital and Adult Heart Disease, Cardiovascular Diagnosis and Endoluminal Interventions, Rovigo General Hospital, Rovigo, Italy. jackyheart71@yahoo.it.|Department of Cardiovascular Disease, Cittadella General Hospital, Padua, Italy. jackyheart71@yahoo.it.
authors: Gianluca
authors: G
authors: Rigatelli
authors: Department of Cardiovascular Disease, Cittadella General Hospital, Padua, Italy.
authors: Luigi
authors: L
authors: Pedon
authors: Department of Cardiovascular Disease, Cittadella General Hospital, Padua, Italy.
authors: Roberto
authors: R
authors: Zecchel
authors: Section of Adult Congenital and Adult Heart Disease, Cardiovascular Diagnosis and Endoluminal Interventions, Rovigo General Hospital, Rovigo, Italy.
authors: Fabio
authors: F
authors: Dell'Avvocata
authors: Department of Cardiovascular Disease, Cittadella General Hospital, Padua, Italy.
authors: Antonio
authors: A
authors: Carrozza
authors: Department of Cardiovascular Disease, Cittadella General Hospital, Padua, Italy.
authors: Marco
authors: M
authors: Zennaro
authors: Department of Medical Sciences, Rovigo General Hospital, Rovigo, Italy.
authors: Alberto
authors: A
authors: Mazza
authors: Section of Adult Congenital and Adult Heart Disease, Cardiovascular Diagnosis and Endoluminal Interventions, Rovigo General Hospital, Rovigo, Italy.
authors: Marco
authors: M
authors: Zuin
authors: Department of NeuroSciences, Rovigo General Hospital, Rovigo, Italy.
authors: Monia
authors: M
authors: Russo
authors: Department of Cardiovascular Disease, Cittadella General Hospital, Padua, Italy.
authors: Mario
authors: M
authors: Zanchetta
mesh_terms: D000328:Adult; D001281:Atrial Fibrillation / Q000453:epidemiology / Q000209:etiology; D002545:Brain Ischemia / Q000453:epidemiology / Q000209:etiology; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D004452:Echocardiography / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D054092:Foramen Ovale, Patent / Q000175:diagnosis / Q000601:surgery*; D006801:Humans; D015994:Incidence; D007558:Italy / Q000453:epidemiology; D000069451:Long Term Adverse Effects / Q000453:epidemiology*; D008297:Male; D008875:Middle Aged; D008944:Mitral Valve Insufficiency / Q000453:epidemiology / Q000209:etiology; D010043:Outcome and Process Assessment, Health Care; D011183:Postoperative Complications / Q000453:epidemiology*; D055989:Septal Occluder Device; D025321:Surgery, Computer-Assisted