Safety and efficacy of balloon pulmonary valvuloplasty

Abstract

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. 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. 211 cases were included (45%, 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). 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. © 2012 Wiley Periodicals Inc.