title: Efficacy of different devices for transcatheter closure of patent foramen ovale assessed by serial transoesophageal echocardiography and rates of recurrent cerebrovascular events in a long-term follow-up.
abstract: OBJECTIVE
  Closure of patent foramen ovale (PFO) is non-inferior to medical treatment for patients with cryptogenic stroke. Results in randomised trials might be based on the different types of used occluders. We determined residual shunting with serial contrast transoesophageal echocardiography (cTEE) and evaluated rates of recurrent cerebrovascular events in a long-term follow-up.
  
  
  RESULTS
  cTEE was repeated three and 12 months after PFO closure using AMPLATZER (n=109), BioSTAR (n=68), Cardia (n=104) or Premere (n=54) occluders. Closure was demonstrated in 91.6% and 95.9% of patients after three and 12 months. Closure rates were not different among groups (p=0.58; p=0.94). The PFO diameter was a risk factor for residual shunting (p=0.02), but not the prevalence of an atrial septal aneurysm (ASA). During follow-up, including 1,815 patient-years (PY), eight patients suffered a stroke (0.44/100 PY) and seven patients a transient ischaemic attack (0.39/100 PY). Rates of recurrent cerebrovascular events were similar among the four groups.
  
  
  CONCLUSIONS
  Closure at three or 12 months (as measured by cTEE) and rates of recurrent cerebrovascular events were similar among occluder groups. PFO diameter was a risk factor for residual shunting, but not the presence of ASA. The rate of recurrent cerebral ischaemic events was low.
authors.affiliation: Clinic of Internal Medicine II, University of Ulm, Ulm, Germany.
authors.forename: Blerim
authors.initials: B
authors.lastname: Luani
authors.forename: Sinisa
authors.initials: S
authors.lastname: Markovic
authors.forename: Ulrike
authors.initials: U
authors.lastname: Krumsdorf
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Rottbauer
authors.forename: Jochen
authors.initials: J
authors.lastname: Wöhrle
mesh_terms: D000328:Adult; D000368:Aged; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D017548:Echocardiography, Transesophageal; D005260:Female; D005500:Follow-Up Studies; D054092:Foramen Ovale, Patent / Q000150:complications / Q000000981:diagnostic imaging / Q000628:therapy*; D006801:Humans; D002546:Ischemic Attack, Transient / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D012008:Recurrence; D012042:Registries; D012307:Risk Factors; D055989:Septal Occluder Device; D020521:Stroke / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome