title: Safety and efficacy of balloon pulmonary valvuloplasty: a multicenter experience.
abstract: BACKGROUND
  Balloon pulmonary valvuloplasty (BPV) is the treatment of choice for patients with pulmonary valve stenosis (PS); however, safety and efficacy outcomes are lacking in the current era.
  
  
  METHODS
  Demographic, procedural, and adverse event (AE) data were prospectively collected using a multicenter registry (C3PO) and cases performed between 02/07 and 06/10 at eight institutions. The registry was queried for cases of isolated BPV. Multivariable models were built to determine risk factors for procedure failure and adverse outcomes.
  
  
  RESULTS
  211 cases were included (45%, <1 month). Procedural success was achieved in 91% procedures, being defined as one or more of the following: post-BPV peak systolic valvar gradient to < 25 mm Hg (88%), decrease in gradient by 50% (79%), or reduction of RV/systemic pressure ratio by 50% (45%). Procedural success was more common in neonates, when compared to older patients (96% vs. 87%, P = 0.03). Risk factors for procedural failure included moderate or severe pulmonary valve thickening (OR 2.9, CI 1-8.3), and presence of supravalve PS (OR 9.6, CI 2.7-33.8). Low severity AEs (levels 1-2) occurred in 9% of patients and higher severity AEs (levels 3-5) occurred in 3% of patient; there were no deaths. Risk factors for any AE (levels 1-5) were age below 1 month (OR 3.5, CI 1.3-8.9), as well as operator experience of less than 10 years (OR 3.8, CI 1.5-9.9).
  
  
  CONCLUSIONS
  Procedural success is common and AEs, especially higher severity AEs, are rare for BPV in patients with isolated PS. Results have improved considerably when compared to historical data.
authors.affiliation: The Heart Center, Nationwide Children's Hospital, Columbus, Ohio 43205, USA. Ralf.Holzer@NationwideChildrens.org
authors.forename: Ralf J
authors.initials: RJ
authors.lastname: Holzer
authors.forename: Kimberlee
authors.initials: K
authors.lastname: Gauvreau
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Kreutzer
authors.forename: Sara M
authors.initials: SM
authors.lastname: Trucco
authors.forename: Alejandro
authors.initials: A
authors.lastname: Torres
authors.forename: Shabana
authors.initials: S
authors.lastname: Shahanavaz
authors.forename: Lisa
authors.initials: L
authors.lastname: Bergersen
mesh_terms: D000367:Age Factors; D063126:Balloon Valvuloplasty / Q000009:adverse effects; D002983:Clinical Competence; D006439:Hemodynamics; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D015999:Multivariate Analysis; D016017:Odds Ratio; D061214:Patient Safety; D011446:Prospective Studies; D011666:Pulmonary Valve Stenosis / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014481:United States; D016278:Ventricular Function, Right