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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.

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  • Publisher Full Text
  • Authors

    Holzer RJ, Gauvreau K, Kreutzer J, Trucco SM, Torres A, Shahanavaz S, Bergersen L

    Institution

    The Heart Center, Nationwide Children's Hospital, Columbus, Ohio 43205, USA. Ralf.Holzer@NationwideChildrens.org

    Source

    Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions 80:4 2012 Oct 1 pg 663-72

    MeSH

    Age Factors
    Balloon Valvuloplasty
    Clinical Competence
    Hemodynamics
    Humans
    Infant
    Infant, Newborn
    Multivariate Analysis
    Odds Ratio
    Patient Safety
    Prospective Studies
    Pulmonary Valve Stenosis
    Registries
    Risk Assessment
    Risk Factors
    Severity of Illness Index
    Treatment Outcome
    United States
    Ventricular Function, Right

    Pub Type(s)

    Journal Article
    Multicenter Study
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    22422728