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Background: Pulmonary balloon valvuloplasty is the treatment of choice of pulmonary valve stenosis, but early results and long-term follow-up in a numerous and homogeneous pediatric population are poorly known., Material and Methods: From April 1984 to April 1994, 202 valvuloplastic procedures were performed in 197 patients (age 52.5 +/- 150 months). Hemodynamic data were analysed according with valvular morphology and patient's age at procedure. During a follow-up period of 50 +/- 38 months, clinical and instrumental data were collected., Results: After pulmonary valvuloplasty RV pressure decreased from 86 +/- 28 to 41 +/- 21 mm Hg (p < 0.001), transvalvular pressure gradient from 67 +/- 27 to 24 +/- 14 mm Hg (p < 0.001) and RV/LV pressure ratio from 1.01 +/- 0.29 to 0.53 +/- 0.19 (p < 0.001). Overall success rate was 95% (187/197 patients). Pulmonary valve dysplasia and/or annulus hypoplasia significantly influenced the efficacy of the procedure and/or the recurrence of valvar stenosis (18.8% vs 2.7%, p < 0.01). During the follow-up period, clinical examination was unremarkable, and transvalvular pressure gradient did not change (23 +/- 9 vs 24 +/- 6 mm Hg at discharge, p = NS). Freedom from restenosis was 98% at 3 years and 96% at 5 and 10 years., Conclusions: Pulmonary balloon valvuloplasty is a safe, effective and possibly definitive treatment for isolated pulmonary valve stenosis in infants and children. Age at valvuloplasty does not influence the success of the procedure, as opposed to valvular dysplasia and/or annulus hypoplasia that positively relate to the need of surgical valvotomy and/or the recurrence of stenosis during a long-term follow-up. In conclusion, prognosis of the majority of infants and children after a successful valvuloplasty is excellent during a long-term follow-up period.

Objectives: The aim of this study was to assess results 5 years after balloon pulmonary valvuloplasty., Background: Since the technique of balloon pulmonary valvuloplasty was first reported in 1982, it has become the treatment of choice for pulmonary valve stenosis. In contrast to surgical valvotomy, the long-term outcome after balloon pulmonary valvuloplasty is unknown., Methods: We reviewed the findings in 34 patients 5.2 +/- 0.8 (mean +/- SD) years after balloon pulmonary valvuloplasty: 27 with isolated pulmonary stenosis, 5 with Noonan syndrome and 2 with previous surgical valvotomy. In eight patients (three with Noonan syndrome), a second balloon valvuloplasty was the index procedure for analysis., Results: The transpulmonary gradient (mm Hg) was 74 +/- 34 before balloon pulmonary valvuloplasty, 36 +/- 26 immediately after, 22 +/- 9 at cardiac catheterization in 29 patients 6 +/- 0.6 months later and 19 +/- 10 by Doppler study at 5 years. At 5 years 26 patients (group A) had a residual gradient of < or = 20 mm Hg; the remaining 8 (group B) had a gradient of > 20 mm Hg. Four group B patients had Noonan syndrome (p = 0.01). Balloon/pulmonary valve diameter ratio was larger for group A patients than for group B patients with isolated pulmonary stenosis (1.20 +/- 0.10 vs. 1.00 +/- 0.07, p = 0.005); larger balloons were used in group B patients with Noonan syndrome (1.30 +/- 0.10). Group A patients were more likely than group B patients to have significant pulmonary incompetence (6 of 24 vs. 0 of 8) and had a greater right ventricle/left ventricle long-axis diastolic dimension ratio (0.47 +/- 0.10 vs. 0.35 +/- 0.04, p = 0.05). In the subgroup of five patients with Noonan syndrome and two with prior surgical valvotomy, the transpulmonary gradient was reduced from 74 +/- 24 mm Hg before balloon valvuloplasty to 23 +/- 12 mm Hg at 5 years. In addition, two patients with isolated pulmonary valve stenosis had pulmonary valve dysplasia by angiographic criteria: transpulmonary gradients of 85 and 56 mm Hg were reduced to 20 and 11 mm Hg, respectively, at 5 years., Conclusions: Relief of obstruction persists at 5 years especially if oversized balloons are used. Acceptable results can be obtained in patients with a dysplastic valve. More complete relief of right ventricular outflow gradient is associated with increased right ventricular dimension, probably because more pulmonary incompetence is induced. This is well tolerated at 5 years but may be important in the longer term.