Long-term follow-up outcomes after percutaneous balloon pulmonary valvuloplasty in 357 children with pulmonary stenosis

Background Pulmonary stenosis (PS) accounts for 8%-10% of congenital heart defects. Percutaneous balloon pulmonary valvuloplasty (PBPV) is the primary treatment, but long-term outcomes and its effects in PS with patent foramen ovale (PFO) require further study. Purpose To assess PBPV's long-term efficacy/safety and PFO closure patterns in pediatric PS patients. Methods Retrospective analysis of 357 PS children undergoing PBPV (1987-2024) at Shandong Provincial Hospital. Data included procedural parameters (balloon-to-annular ratio, pressure gradients) and follow-up outcomes (1 month-24 years). Results Cohort: 357 patients (mean age 3.43±3.41 years), 37.5% with PFO. Procedural outcomes: Trans-pulmonary pressure gradient decreased from 53.14±27.72 mmHg to 20.03±17.61 mmHg (p<0.05). Major complications: 1.6% (6/357), including pericardial effusion (n=2) and arrhythmias (n=1). Restenosis: 66 cases (20.4%) during follow-up; 3 required reintervention. Risk factors: Smaller pulmonary annulus and severe baseline stenosis. Predictive thresholds: Pre-op ΔP≥68 mmHg, flow velocity≥414 cm/s, post-op ΔP≥19 mmHg. Pulmonary regurgitation (PR): Incidence increased from 54% pre-op to 64% post-op; 21 cases worsened during follow-up. Risk factors: Younger age, higher balloon-to-annular ratio, severe stenosis. PFO closure: 25/134 (18.7%) achieved spontaneous closure; 6 required reintervention. Faster pre-op pulmonary flow velocity correlated with closure. Conclusion PBPV is safe and effective for pediatric PS with durable outcomes. Restenosis associates with anatomical severity, while PR progression relates to procedural factors. Hemodynamic improvements may promote spontaneous PFO closure.