Percutaneous balloon valvuloplasty is an alternative to surgical valvotomy for congenital pulmonary valve stenosis. Between 1985 and 1997, 73 valvuloplasties were performed in 70 patients, age range 1 day to 24.7 years. We reviewed the short- and long-term results in regard to transvalvular gradient and pulmonary insufficiency. The gradient was measured pre- and immediately post-valvuloplasty at catheterization and by Doppler echocardiography, and by echocardiography only at follow-up. Valvuloplasty was successful in 61/70 patients whereas surgical valvotomy was necessary in 9/70 because of a very dysplastic valve. A second valvuloplasty was performed in 3 patients presenting with restenosis. A 60% decrease in the gradient was noted immediately after the procedure, from 78.3 +/- 24.5 to 33.7 +/- 19.7 mm Hg (p < 0.05). A follow-up of more than 2 years (4.2 +/- 2.2 years) was obtained in 35 patients. A further decrease in the gradient was noted, to 20 +/- 12 mm Hg, and the degree of pulmonary insufficiency was mild in all patients except 2 with a moderate leak. The mortality was 0% and only 1 patient had a complication (endocarditis). The short- and long-term results of pulmonary percutaneous balloon valvuloplasty are excellent. It can be considered the therapy of choice. The gradient shows a further decrease during follow-up due to regression of the infundibular muscular stenosis. Failure is attributed to very dysplastic valves and these patients may require, in a second stage, a surgical approach (patch enlargement and/or valvulectomy).