Balloon aortic valvuloplasty (BAV), the most common treatment for isolated congenital aortic stenosis (AS), demonstrated a 70 percent success rate in a study of more than 1,000 patients.

Lead researcher Brian A. Boe, MD, with Nationwide Children’s Hospital in Columbus, Ohio, and colleagues published their findings in JACC: Cardiovascular Interventions. It is the largest cohort study to date on BAV for congenital AS.

“We found that the majority of BAV procedures are effective, with more than two-thirds resulting in procedural ‘success,’” wrote Boe et al. “Adverse events, when they occurred, were more likely to occur in those patients undergoing BAV for critical AS. Our study is the largest of its kind and supports the notion that BAV is a relatively safe and effective means of treating patients with AS.”

The researchers analyzed 1,026 BAV procedures performed between January 2011 and March 2015. Patients younger than one month were the most prevalent age group (27.4 percent), followed by infants one to 11 months old (25.2 percent) and adolescents aged 11 to 17 (18.6 percent). About 10 percent of patients had critical AS, while 89 percent had noncritical AS.

Critical AS patients were less than a month old at the time of the procedure and receiving prostaglandin infusion within one day of the catheterization date.

Across both groups, unsuccessful procedures were most often attributed to significant aortic insufficiency (AI) as determined by the operator (12.1 percent). A significant aortic valve gradient (greater than 35 millimeters of mercury) occurred in 11.4 percent of procedures, and a combination of the two occurred in 6.5 percent of overall procedures.

Patients with severe AS had a 30 percent incidence of adverse events compared to 14.1 percent in the noncritical AS group.

“We found that the following six factors were associated with unsuccessful BAV in the noncritical AS cohort: previous cardiac catheterization, mixed valve disease, baseline aortic valve gradient greater than 60 mm Hg, baseline AI greater than mild, presence of a trainee, and multiple balloon inflations,” Boe and colleagues noted. “Four of these six factors are patient related and support a growing body of research linking BAV outcomes with the intrinsic characteristics of the aortic valve.”

The study only included data up to hospital discharge, which could’ve led to underreporting of adverse outcomes. In addition, it relied on operators to grade aortic insufficiency.

Despite the authors’ assertion that BAV is safe and effective in treating patients with congenital AS, a pair of practicing interventional cardiologists wrote “an overall success rate of 70 percent leaves much room for improvement.”

In their related editorial, Ziyad M. Hijazi, MD, of Weill Cornell Medicine in New York, and Damien Kenney, MD, of Our Lady’s Children’s Hospital in Dublin, suggested longer-term studies and a standardized approach could reduce adverse events for patients with congenital AS.

Even though BAV has been popular since the mid-1980s, they said it has yet to be proven superior to surgery.

“Ultimately, we believe a randomized trial with surgical valvotomy including longer-term follow-up is warranted to ensure we do not spend another 30 years in the dark as to the optimal approach for this troublesome disease,” Hijazi and Kenney wrote. “Our surgical colleagues are very keen on participating in such a trial. We owe it to our patients and their families to answer this question once and for all: is BAV as good, better, or inferior to surgical aortic valvotomy?”