title: Percutaneous closure of patent foramen ovale in patients with anatomical and clinical high-risk characteristics: long-term efficacy and safety.
abstract: BACKGROUND
  Transcatheter closure of patent foramen ovale (PFO) is a widespread procedure, but no randomized study on its outcome in high-risk patients is available. Our aims were to determine the efficacy and safety of this procedure in a cohort of high-risk patients through the observation of clinical adverse events and residual shunt, to evaluate the impact of transesophageal echocardiography (TEE) guidance during the procedure, and investigate the relationship between the anatomical and clinical characteristics and the outcome.
  
  
  RESULTS
  Ninety-five patients underwent PFO closure for cryptogenic cerebral ischemia; each of them presented one or more of the following risk factors: recurrent cerebral ischemia (9.5%), atrial septum aneurysm (ASA, 74.5%), prominent Eustachian valve (EV, 23.2%), severe basal shunt (9.5%), thrombophilic factors (20%), deep vein thrombosis (4.2%). The procedure was performed successfully in all patients. On median follow-up of 18 months, the neurologic recurrent events rate was 1.1% and the major adverse cardiac event (MACE) rate was 1.1%. At 6-month TEE follow-up, the residual shunt rate was 12.6% (3.1% moderate to severe). A significant correlation was found between residual shunt and prominent EV alone (P = 0.036) or in association with ASA (P = 0.021). All adverse events occurred in the first 8 months, and the event-free survival rate was 86.2%.
  
  
  CONCLUSIONS
  Our study suggests that transcatheter PFO closure is a safe procedure even in a selected population of high-risk patients, presenting satisfactory efficacy and safety. The presence of a prominent EV alone or with ASA correlates positively with the occurrence of residual shunt.
authors.affiliation: Department of Cardiology 2, University Hospital S. Giovanni Battista, Turin, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Scacciatella
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Butera
authors.forename: Ilaria
authors.initials: I
authors.lastname: Meynet
authors.forename: Mauro
authors.initials: M
authors.lastname: Giorgi
authors.forename: Maurizio
authors.initials: M
authors.lastname: D'Amico
authors.forename: Mauro
authors.initials: M
authors.lastname: Pennone
authors.forename: Gianluca
authors.initials: G
authors.lastname: Alunni
authors.forename: Valeria
authors.initials: V
authors.lastname: Frisenda
authors.forename: Elisa
authors.initials: E
authors.lastname: Pelloni
authors.forename: Sebastiano
authors.initials: S
authors.lastname: Marra
mesh_terms: D000328:Adult; D000368:Aged; D002545:Brain Ischemia / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D017115:Catheter Ablation / Q000295:instrumentation / Q000379:methods*; D015331:Cohort Studies; D017548:Echocardiography, Transesophageal; D005260:Female; D054092:Foramen Ovale, Patent / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D006344:Heart Septal Defects, Atrial / Q000628:therapy; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012042:Registries; D018570:Risk Assessment; D013223:Statistics as Topic; D013997:Time Factors; D055815:Young Adult