Safety and efficacy of balloon pulmonary valvuloplasty

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.