title: Transcranial Doppler quantification of residual shunt after percutaneous patent foramen ovale closure: correlation of device efficacy with intracardiac anatomic measures.
abstract: BACKGROUND
  Percutaneous, mechanical closure of defects of the atrial septum fails to completely resolve shunting in up to 20% of cases. Little is known about the factors associated with device failure.
  
  
  METHODS
  We measured the left atrial opening (X), right atrial opening (Z), tunnel length (Y), septum secundum, device-septum primum separation, and tunnel compressibility of the patent foramen ovale (PFO) in 301 patients with cryptogenic neurological events, PFO anatomy, and severe Valsalva shunting (Spencer Grade 5-5+). All patients then underwent percutaneous closure with the GORE®HELEX Septal Occluder device and were evaluated at 3 months for residual shunt by transcranial Doppler (TCD).
  
  
  RESULTS
  Severe residual Valsalva shunt (TCD Grade 5-5+) was found at 3 months in 21 of 301 (7%) patients. X, Y, and Z were associated with failure with a high degree of statistical significance, whereas the width of the septum secundum, device-septum primum separation, and tunnel compressibility were not. An unanticipated finding was that 14 of 35 (40%) patients sized with a large balloon failed compared with 9 of 280 (3%) sized with a small balloon (P < 0.0001). In the multivariate logistic regression model, X (P = < 0.0001) and balloon size (P < 0.0001) were both strong predictors of failure.
  
  
  CONCLUSIONS
  In an intracardiac echocardiography-defined PFO population, characterized by severe baseline Valsalva shunt and a high incidence of persistent (rest) shunting, association of six intracardiac measurements to closure device failure by multivariate logistic regression showed that the width of the left atrial opening was a strong predictor of residual shunting. An unanticipated finding was that use of a large sizing balloon was also strongly associated with failure.
authors.affiliation: Great Basin Cardiovascular Research Foundation, Inc., Salt Lake City, UT, USA. sgs@starband.net
authors.forename: Sherman G
authors.initials: SG
authors.lastname: Sorensen
authors.forename: Spotswood L
authors.initials: SL
authors.lastname: Spruance
authors.forename: Randall
authors.initials: R
authors.lastname: Smout
authors.forename: Susan
authors.initials: S
authors.lastname: Horn
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D054087:Atrial Septum; D005260:Female; D054092:Foramen Ovale, Patent / Q000000981:diagnostic imaging / Q000473:pathology*; D006344:Heart Septal Defects, Atrial / Q000000981:diagnostic imaging* / Q000628:therapy; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D055989:Septal Occluder Device; D016896:Treatment Outcome; D017585:Ultrasonography, Doppler, Transcranial / Q000379:methods*; D014636:Valsalva Maneuver; D055815:Young Adult