title: Initial experience with a transcatheter septal closure system for secondary stroke prevention in patients with interatrial septal defects.
abstract: BACKGROUND
  Percutaneous transcatheter closure of a patent foramen ovale (PFO) has been utilized over the last several years to prevent thromboembolic events in selected patients with a prior cryptogenic stroke. We describe our initial experience at Hartford Hospital with a transcatheter PFO closure system and our multidisciplinary approach.
  
  
  METHODS
  From March to November 2002, we performed percutaneous transcatheter closure of a PFO in 16 patients with a prior history of cryptogenic stroke(s) and/or transient ischemic attack using the CardioSEAL Septal Occluder system. All 16 patients had a PFO visualized on their transesophageal echocardiogram (TEE) study, and 15 patients also had an atrial septal aneurysm. PFO closure was performed with a CardioSEAL Septal Occluder in the cardiac catheterization laboratory under general anesthesia with TEE guidance. Following device placement, all patients were discharged on a regimen of aspirin and clopidigrel, with follow-up in the Stroke Clinic.
  
  
  RESULTS
  Successful deployment of the septal occluder and effective PFO closure was achieved in all 16 patients with no major procedural or in-hospital complications. Short-term clinical follow-up has demonstrated no recurrent neurologic thromboembolic events, but one patient was rehospitalized for de novo atrial fibrillation. Follow-up transthoracic echocardiographic assessment at three to six months postprocedure, obtained in eight patients thus far, has demonstrated no residual interatrial shunting.
  
  
  CONCLUSIONS
  Our early results suggest that percutaneous PFO closure with the CardioSEAL Septal Occluder system is a safe option for secondary stroke prevention in carefully selected patients with interatrial septal defects and a history of cryptogenic stroke or TIA. Patient selection and the long-term effectiveness and safety of this approach require further assessment.
authors.affiliation: Stroke Center, Hartford Hospital, University of Connecticut School of Medicine, CT, USA. isilver@harthosp.org
authors.forename: Isaac E
authors.initials: IE
authors.lastname: Silverman
authors.forename: Francis J
authors.initials: FJ
authors.lastname: Kiernan
authors.forename: Anita M
authors.initials: AM
authors.lastname: Kelsey
authors.forename: James J
authors.initials: JJ
authors.lastname: Brakoniecki
authors.forename: Fawad A
authors.initials: FA
authors.lastname: Kazi
authors.forename: James E
authors.initials: JE
authors.lastname: Dougherty
authors.forename: William E
authors.initials: WE
authors.lastname: Boden
authors.forename: Raymond G
authors.initials: RG
authors.lastname: McKay
mesh_terms: D000328:Adult; D000368:Aged; D006328:Cardiac Catheterization / Q000295:instrumentation / Q000379:methods*; D005260:Female; D006344:Heart Septal Defects, Atrial / Q000150:complications / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D020521:Stroke / Q000209:etiology / Q000517:prevention & control*; D016896:Treatment Outcome