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.

Links

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