title: Balloon valvuloplasty for congenital aortic stenosis: Multi-center safety and efficacy outcome assessment.
abstract: OBJECTIVE
  To describe contemporary outcomes of balloon aortic valvuloplasty (BAVP) performed in 22 US centers.
  
  
  BACKGROUND
  BAVP constitutes first-line therapy for congenital aortic stenosis (cAS) in many centers.
  
  
  METHODS
  We used prospectively-collected data from two active, multi-institutional, pediatric cardiac catheterization registries. Acute procedural success was defined, for purposes of this review, as a residual peak systolic gradient≤35 mm Hg and no more than mild aortic regurgitation (AR) for patients with isolated cAS. For patients with mixed aortic valve disease, a residual peak systolic gradient≤35 mm Hg without worsening of AR was considered successful outcome.
  
  
  RESULTS
  In 373 patients with a median age of 8 months (1 day to 40 years of age) peak systolic gradient had a median of 59 [50, 71] mm Hg pre-BAVP and 22 [15, 30] mm Hg post-BAVP (P<0.001). Procedural success was achieved in 160 patients (71%). The factors independently associated with procedural success were: first time intervention (OR=2.0 (1.0, 4.0) P=0.04), not-prostaglandin dependent, (OR=3.5 (1.5, 8.1); P=0.003), and isolated cAS (absence of AR) (OR=2.1 (1.1-3.9); P=0.03). Twenty percent of patients experienced adverse events, half of which were of high severity. There was no procedural mortality. Neonatal status was the only factor associated with increased risk of high severity adverse events (OR 3.7; 95% CI 1.5-9.0).
  
  
  CONCLUSIONS
  In the current era, BAVP results in procedural success (gradient reduction with minimal increase in AR) in 71% of patients treated at US centers where BAVP is considered first-line therapy relative to surgery.
authors.affiliation: Division of Pediatric Cardiology, Morgan Stanley Children's Hospital of New York Presbyterian, New York, New York.
authors.forename: Alejandro
authors.initials: A
authors.lastname: Torres
authors.affiliation: Division of Pediatric Cardiology, Morgan Stanley Children's Hospital of New York Presbyterian, New York, New York.
authors.forename: Julie A
authors.initials: JA
authors.lastname: Vincent
authors.affiliation: Division of Pediatric Cardiology, Johns Hopkins University, Baltimore, Maryland.
authors.forename: Allen
authors.initials: A
authors.lastname: Everett
authors.affiliation: Division of Pediatric Cardiology, University of Virginia, Charlottesville, Virginia.
authors.forename: Scott
authors.initials: S
authors.lastname: Lim
authors.affiliation: Division of Pediatric Cardiology, Children's Hospital of Wisconsin, Milwaukee, Wisconsin.
authors.forename: Susan R
authors.initials: SR
authors.lastname: Foerster
authors.affiliation: Department of Cardiology, Boston Children's Hospital, Boston Massachusetts, Children's Hospital Boston, Boston, Massachusetts.
authors.forename: Audrey C
authors.initials: AC
authors.lastname: Marshall
authors.affiliation: Division of Pediatric Cardiology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
authors.forename: Robert H
authors.initials: RH
authors.lastname: Beekman
authors.affiliation: Division of Pediatric Cardiology, Washington University in St. Louis, St. Louis, Missouri.
authors.forename: Joshua
authors.initials: J
authors.lastname: Murphy
authors.affiliation: Division of Pediatric Cardiology, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania.
authors.forename: Sara M
authors.initials: SM
authors.lastname: Trucco
authors.affiliation: Department of Cardiology, Boston Children's Hospital, Boston Massachusetts, Children's Hospital Boston, Boston, Massachusetts.
authors.forename: Kimberlee
authors.initials: K
authors.lastname: Gauvreau
authors.affiliation: Division of Pediatric Cardiology, Nationwide Children's Hospital, Columbus, Ohio.
authors.forename: Ralf
authors.initials: R
authors.lastname: Holzer
authors.affiliation: Department of Cardiology, Boston Children's Hospital, Boston Massachusetts, Children's Hospital Boston, Boston, Massachusetts.
authors.forename: Lisa
authors.initials: L
authors.lastname: Bergersen
authors.affiliation: Department of Cardiology, Boston Children's Hospital, Boston Massachusetts, Children's Hospital Boston, Boston, Massachusetts.
authors.forename: Diego
authors.initials: D
authors.lastname: Porras
mesh_terms: D000293:Adolescent; D000328:Adult; D001021:Aortic Valve / Q000503:physiopathology; D001024:Aortic Valve Stenosis / Q000151:congenital / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D063126:Balloon Valvuloplasty / Q000009:adverse effects; D016009:Chi-Square Distribution; D002648:Child; D002675:Child, Preschool; D005260:Female; D006439:Hemodynamics; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D016015:Logistic Models; D008297:Male; D016017:Odds Ratio; D011446:Prospective Studies; D020127:Recovery of Function; D012042:Registries; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult
keywords: adverse events; aortic regurgitation; bicuspid aortic valve; congenital heart disease