title: Long-term experience and outcomes with transcatheter closure of patent foramen ovale.
abstract: OBJECTIVE
  This study sought to examine the frequency of indications for and the immediate and long-term clinical outcomes of transcatheter closure of patent foramen ovale (PFO).
  
  
  BACKGROUND
  Transcatheter PFO closure is commonly performed for several indications, including cryptogenic stroke, despite conflicting data regarding the efficacy of this intervention.
  
  
  METHODS
  We report the outcomes of 800 consecutive patients (52% male, 50 ± 14 years of age) who underwent PFO closure at our institution after multidisciplinary evaluation over a 16-year period.
  
  
  RESULTS
  Indications for closure included cryptogenic cerebrovascular event (94%), hypoxemia (2%), peripheral embolism (3%), and migraine headaches (2%). Procedural success was 99% with effective closure obtained in 93% of patients. At a mean follow-up of 42.7 ± 33.4 months, 21 patients suffered a recurrent ischemic neurologic event (12 strokes, and 9 transient ischemic attacks) for an incidence rate of 0.79 events per 100 person-years and freedom from recurrent events of 91.6% at 10 years. There was no device-based difference in the rate of recurrent ischemic neurologic events (p = 0.82). Only Eustachian valve prominence (hazard ratio: 9.04; 95% confidence interval: 2.07 to 39.44; p = 0.0034) was associated with recurrent neurologic events.
  
  
  CONCLUSIONS
  Transcatheter PFO closure is safe and feasible in patients with several clinical indications. The long-term efficacy of this intervention in patients with paradoxical embolism appears superb in this observational study. Carefully selected patients with features suggestive of paradoxical embolism are the most likely to benefit from PFO closure and should be the focus of future investigation.
authors.affiliation: Cardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard, Medical School, Boston, Massachusetts.
authors.forename: Ignacio
authors.initials: I
authors.lastname: Inglessis
authors.forename: Sammy
authors.initials: S
authors.lastname: Elmariah
authors.forename: Pablo A
authors.initials: PA
authors.lastname: Rengifo-Moreno
authors.forename: Ronan
authors.initials: R
authors.lastname: Margey
authors.forename: Caitlin
authors.initials: C
authors.lastname: O'Callaghan
authors.forename: Ignacio
authors.initials: I
authors.lastname: Cruz-Gonzalez
authors.forename: Suzanne
authors.initials: S
authors.lastname: Baron
authors.forename: Praveen
authors.initials: P
authors.lastname: Mehrotra
authors.forename: Timothy C
authors.initials: TC
authors.lastname: Tan
authors.forename: Judy
authors.initials: J
authors.lastname: Hung
authors.forename: Zareh N
authors.initials: ZN
authors.lastname: Demirjian
authors.forename: Ferdinando S
authors.initials: FS
authors.lastname: Buonanno
authors.forename: MingMing
authors.initials: M
authors.lastname: Ning
authors.forename: Scott B
authors.initials: SB
authors.lastname: Silverman
authors.forename: Roberto J
authors.initials: RJ
authors.lastname: Cubeddu
authors.forename: Eugene
authors.initials: E
authors.lastname: Pomerantsev
authors.forename: Robert M
authors.initials: RM
authors.lastname: Schainfeld
authors.forename: G William
authors.initials: GW
authors.lastname: Dec
authors.forename: Igor F
authors.initials: IF
authors.lastname: Palacios
mesh_terms: D000328:Adult; D001900:Boston; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality; D019320:Embolism, Paradoxical / Q000209:etiology / Q000517:prevention & control; D005260:Female; D054092:Foramen Ovale, Patent / Q000150:complications / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D006769:Hospitals, General; D006801:Humans; D000860:Hypoxia / Q000209:etiology / Q000517:prevention & control; D002546:Ischemic Attack, Transient / Q000209:etiology / Q000517:prevention & control; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000209:etiology / Q000517:prevention & control; D018579:Patient Selection; D012189:Retrospective Studies; D012307:Risk Factors; D055502:Secondary Prevention; D055989:Septal Occluder Device; D020521:Stroke / Q000209:etiology / Q000517:prevention & control; D013997:Time Factors; D016896:Treatment Outcome
keywords: CI; HR; PFO; TIA; cerebral infarction; confidence interval(s); cryptogenic stroke; embolic stroke; hazard ratio(s); paradoxical embolism; patent foramen ovale; transient ischemic attack