In-Hospital Outcomes of Balloon Aortic Valvuloplasty in Neonates and Infants with Congenital Aortic Stenosis: a PHIS Database Analysis

Percutaneous balloon aortic valvuloplasty (PBAV) remains the initial preferred intervention for congenital aortic stenosis (CAS). Data regarding outcomes of PBAV in infancy are lacking. A retrospective review from 50 children’s hospitals in the United States participating in Pediatric Health Information System (PHIS) database for neonates (≤ 28 days) and infants (≤ 1 year of age) who underwent PBAV for CAS from 2016 to 2024. Critical AS was defined by prostaglandin E1 (PGE1) use. The primary endpoints were in-hospital mortality and repeat intervention within one year. Immediate procedural success was defined as survival to discharge without post-procedural ECMO, cardiac arrest, and rescue surgery/repeat PBAV during index hospitalization or within 1 month of initial PBAV. We identified 985 patients (525 neonates and 460 infants). Of them, 398 patients (40%) had critical AS. Compared to non-critical AS, the critical AS group had higher postprocedural complications including cardiac arrest, cardiac tamponade, and vascular complications. Procedural success was lower in the critical AS group (85% vs. 96%, p < 0.01), and in-hospital mortality was higher (11.8% vs. 1.7%, p < 0.01). Among the non-critical AS group, procedural success was similar between neonates and infants (96% vs. 95%, p = 0.6). Mortality and complications were comparable. Kaplan-Meier analysis showed freedom from re-intervention of 94.7% at 1 year. A multivariable analysis demonstrated critical AS, genetic syndrome, ECMO, tamponade and cardiac arrest were predictors of mortality. PBAV in infancy demonstrates high immediate procedural success and one year durability in those with non-critical AS. In contrast, patients with critical AS experience substantial mortality, morbidity and resource utilization.