Presentation (CTI)

OBJECTIVES: Pulmonary artery banding (PAB) is a palliative intervention performed in approximately 840 pediatric patients annually for congenital heart defects requiring staged hemodynamic optimization. With conventional fixed PAB, the band cannot be modified without reoperation; published data indicate up to 35% of patients require repeat sternotomy, exposing children to additional anesthesia, cardiopulmonary bypass, and extended ICU stays. A novel adjustable PAB (Adj-PAB)—a hydraulic, battery-free, MRI-conditional device—enables post-procedural pressure titration via a subcutaneous port at the bedside, potentially eliminating repeat sternotomies. This study estimated the budget impact of Adj-PAB versus conventional fixed PAB and no-PAB management from US payer and societal perspectives over a 1-year horizon.
METHODS: A budget impact model compared three strategies: (1) Adj-PAB with bedside titration, (2) conventional fixed PAB with surgical reoperation when hemodynamically indicated, and (3) no PAB (medical management or early primary repair) in approximately 840 annual PAB-eligible patients. Direct medical costs were derived from published US databases (2025 USD): index PAB $68,000, reoperation $75,000-$95,000, Adj-PAB bedside adjustment $1,200 per episode. Base case assumed 85% reduction in band-adjustment reoperations; optimistic scenario assumed complete elimination. Sensitivity analyses tested reoperation rate (25%-45%), reoperation cost (±20%), device cost (±30%), and market penetration (10%-50%).
RESULTS: Adj-PAB would prevent approximately 250 reoperations annually. At 25% market penetration, estimated direct medical cost savings were $4.7-$5.9 million, with $1.8-$2.5 million in additional societal savings. The cost-neutrality break-even required only an 18% reoperation reduction. Results were robust across all sensitivity analyses.
CONCLUSIONS: Adj-PAB adoption is projected to generate substantial savings by eliminating repeat sternotomies in pediatric congenital heart disease. From both payer and societal perspectives, Adj-PAB is cost-saving under conservative assumptions, supporting the health-economic rationale for adoption and prospective clinical validation.