Study Evaluates Safety and Efficacy of Balloon Valvuloplasty for Congenital Aortic Stenosis

October 22, 2015—In Catheterization and Cardiovascular Interventions, Alejandro Torres, MD, et al published findings from a multicenter safety and efficacy outcomes assessment of the treatment of congenital aortic stenosis using balloon aortic valvuloplasty (BAVP), which constitutes first-line therapy for this condition in many centers (2015;86:808–820). 

As summarized in Catheterization and Cardiovascular Interventions, the investigators used prospectively collected data from two active, multi-institutional, pediatric cardiac catheterization registries. Acute procedural success was defined as a residual peak systolic gradient ≤ 35 mm Hg and no more than mild aortic regurgitation (AR) for patients with isolated congenital aortic stenosis. For patients with mixed aortic valve disease, a residual peak systolic gradient ≤ 35 mm Hg without worsening of AR was considered successful outcome.

The study included 373 patients treated at 22 centers. Median patient age was 8 months (range, 1 day–40 years) with peak systolic gradient median of 59 mm Hg pre-BAVP and 22 mm Hg post-BAVP. Procedural success was achieved in 160 patients (71%). 

The investigators found that the factors independently associated with procedural success were first-time intervention, not prostaglandin dependent, and isolated congenital aortic stenosis (absence of AR). Twenty percent of patients experienced adverse events, half of which were of high severity. There was no procedural mortality. Neonatal status was the only factor associated with increased risk of high-severity adverse events.

In the current era, BAVP results in procedural success (gradient reduction with minimal increase in AR) in 71% of patients treated at US centers where BAVP is considered first-line therapy relative to surgery, concluded the investigators in Catheterization and Cardiovascular Interventions.