Outcomes After Neonatal Balloon Pulmonary Valvuloplasty: A Contemporary Multicenter Analysis

Balloon pulmonary valvuloplasty (BPV) is the standard treatment for neonates with pulmonary stenosis (PS), but outcomes in this population remain undefined. We performed a retrospective study using Pediatric Health Information System data, including neonates undergoing BPV for isolated PS from 2016 to 2025. Patients with other congenital heart disease, except atrial septal defect or patent foramen ovale, were excluded. The cohort was divided into critical PS (requirement of Prostaglandin E1) and non-critical PS. The primary safety outcome was a composite of in-hospital mortality or cardiac arrest. The primary efficacy outcome included pulmonary valve reintervention (repeat BPV or surgical pulmonary valvotomy) after the index BPV. Among 1,519 neonates, 1,004 (66%) had critical PS and 515 (34%) had non-critical PS. The reintervention rate was 3.5%, similar between groups. BW ≤ 2 kg (aOR = 4.7) and genetic syndrome (aOR = 7.3), were all independently associated with adverse composite outcome. BW ≤ 2 kg was strongly associated with pulmonary valve reintervention (aOR = 3.2). Critical PS was not independently associated with adverse safety outcome or pulmonary valve reinterventions. Critical PS was associated with more vascular complications, longer hospitalization, and higher costs. Among neonates undergoing BPV for isolated PS, low birth weight was independently associated with both major safety events and pulmonary valve reinterventions. Although critical PS increased resource utilization but was not independently associated with adverse safety outcomes or reinterventions. Low birth weight increased procedural risk, highlighting physiologic vulnerability.