Short- and long-term outcomes of balloon pulmonary valvuloplasty in children ≤24 months with critical and haemodynamically significant pulmonary valve stenosis: a 20-year single-centre experience in Medellín, Colombia

Abstract Background: Balloon pulmonary valvuloplasty is the treatment of choice for critical and haemodynamically significant pulmonary stenosis, but long-term outcome data in infants, particularly in Latin America, remain limited. We evaluated long-term outcomes and factors associated with adverse outcomes in children ≤24 months. Methods: We retrospectively included consecutive patients ≤24 months who underwent balloon pulmonary valvuloplasty for critical or haemodynamically significant pulmonary stenosis between January 2004 and July 2024. Outcomes included significant restenosis, moderate-or-greater pulmonary regurgitation, pulmonary valve reintervention, and surgical reintervention. Time-to-event outcomes and predictors were assessed using Kaplan–Meier estimates and Cox regression. Results: A total of 129 patients were included (median age 1.5 months; 37.2% with critical pulmonary stenosis). Procedural success was 94.5%. The median right ventricular-to-pulmonary artery gradient decreased from 44 to 7 mmHg ( p < 0.001). During a median 7 years follow-up (interquartile range 3–10), significant restenosis occurred in 25.6%, moderate-or-greater pulmonary regurgitation in 19.4%, and 17.8% underwent pulmonary valve reintervention. Kaplan–Meier analysis demonstrated sustained freedom from adverse outcomes throughout follow-up. Univariable Cox regression identified predilation and a higher balloon-to-annulus ratio as factors associated with an increased hazard of significant restenosis and moderate-or-greater pulmonary regurgitation, whereas a larger pulmonary annulus Z -score was associated with a lower hazard of restenosis. Conclusions: Ballon pulmonary valvuloplasty is a safe and effective first-line therapy in children ≤24 months, providing sustained haemodynamic improvement and durable long-term outcomes. Patients requiring predilation, larger balloon-to-annulus ratios, or having smaller pulmonary annulus Z -scores may benefit from closer long-term echocardiographic surveillance.