title: Percutaneous patent foramen ovale closure: outcomes with the Premere and Amplatzer devices.
abstract: BACKGROUND
  Transcatheter closure of patent foramen ovale (PFO) has rapidly evolved as the preferred management strategy for the prevention of recurrent cerebrovascular events in patients with cryptogenic stroke and presumed paradoxical embolus. There is limited outcome data in patients treated with this therapy particularly for the newer devices.
  
  
  METHODS
  Data from medical records, catheter, and echocardiography databases on 70 PFO procedures performed was collected prospectively.
  
  
  RESULTS
  The cohort consisted of 70 patients (mean age 43.6 years, range 19 to 77 years), of whom 51% were male. The indications for closure were cryptogenic cerebrovascular accident (CVA) or transient ischemic attack (TIA) in 64 (91%) and peripheral emboli in two (2.8%) patients and cryptogenic ST-elevation myocardial infarction in one (1.4%), refractory migraine in one (1.4%), decompression sickness in one (1.4%), and orthodeoxia in one (1.4%) patient, respectively. All patients had demonstrated right-to-left shunting on bubble study. The procedures were guided by intracardiac echocardiography in 53%, transesophageal echocardiography in 39%, and the remainder by transthoracic echo alone. Devices used were the Amplatzer PFO Occluder (AGA Medical) (sizes 18-35 mm) in 49 (70%) and the Premere device (St. Jude Medical) in 21 (30%). In-hospital complications consisted of one significant groin hematoma with skin infection. Echocardiographic follow-up at 6 months revealed that most patients had no or trivial residual shunt (98.6%), while one patient (1.4%) had a mild residual shunt. At a median of 11 months' follow-up (range 1 month to 4.3 years), no patients (0%) experienced further CVA/TIAs or paradoxical embolic events during follow-up.
  
  
  CONCLUSIONS
  PFO causing presumed paradoxical embolism can be closed percutaneously with a low rate of significant residual shunting and very few complications. Recurrent index events are uncommon at medium-term (up to 4 years) follow-up.
authors.affiliation: The Prince Charles Hospital, Chermside, Brisbane, Queensland, Australia; Gold Coast Hospital, Queensland, Australia; Genomics Research Centre, Griffith Institute Medical Research, Griffith University, Southport, Queensland, Australia; University of California, Los Angeles, Los Angeles, CA, USA. Electronic address: naylinbissessor@hotmail.com.
authors.forename: Naylin
authors.initials: N
authors.lastname: Bissessor
authors.affiliation: University of California, Los Angeles, Los Angeles, CA, USA.
authors.forename: Allison W
authors.initials: AW
authors.lastname: Wong
authors.affiliation: The Prince Charles Hospital, Chermside, Brisbane, Queensland, Australia.
authors.forename: Lisa A
authors.initials: LA
authors.lastname: Hourigan
authors.affiliation: Gold Coast Hospital, Queensland, Australia; Genomics Research Centre, Griffith Institute Medical Research, Griffith University, Southport, Queensland, Australia.
authors.forename: Rohan S
authors.initials: RS
authors.lastname: Jayasinghe
authors.affiliation: The Prince Charles Hospital, Chermside, Brisbane, Queensland, Australia.
authors.forename: Greg S
authors.initials: GS
authors.lastname: Scalia
authors.affiliation: The Prince Charles Hospital, Chermside, Brisbane, Queensland, Australia.
authors.forename: Darryl J
authors.initials: DJ
authors.lastname: Burstow
authors.affiliation: Genomics Research Centre, Griffith Institute Medical Research, Griffith University, Southport, Queensland, Australia.
authors.forename: Lyn R
authors.initials: LR
authors.lastname: Griffiths
authors.affiliation: The Prince Charles Hospital, Chermside, Brisbane, Queensland, Australia.
authors.forename: Michael
authors.initials: M
authors.lastname: Savage
authors.affiliation: The Prince Charles Hospital, Chermside, Brisbane, Queensland, Australia.
authors.forename: Darren L
authors.initials: DL
authors.lastname: Walters
mesh_terms: D000328:Adult; D000368:Aged; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D018618:Echocardiography, Doppler, Color; D017548:Echocardiography, Transesophageal; D019320:Embolism, Paradoxical / Q000209:etiology / Q000517:prevention & control; D005260:Female; D054092:Foramen Ovale, Patent / Q000150:complications / Q000000981:diagnostic imaging / Q000628:therapy*; D006801:Humans; D002546:Ischemic Attack, Transient / Q000209:etiology / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D011793:Queensland; D012008:Recurrence; D055989:Septal Occluder Device; D020521:Stroke / Q000209:etiology / Q000517:prevention & control; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional; D055815:Young Adult