Researchers found balloon aortic valvuloplasty (BAV) may be an effective treatment for patients with congenital aortic stenosis (AS), according to a study published Sept. 4 in JACC: Cardiovascular Interventions.

Led by Brian A. Boe, MD, FACC, et al., the study used ACC's IMPACT Registry to analyze 1,026 BAV procedures performed between January 2011 and March 2015, of which 710 were successful. In terms of patient population, neonates (less than a month) and infants (1 to 11 months) made up the majority of the patient population (27.4 percent and 25.2 percent, respectively), followed by adolescents (11 to 17 years, 18.6 percent). Most patients had noncritical AS (n = 916) and underwent elective BAV (71.8 percent) in an outpatient setting (68.8 percent).

Researchers found low rates of mortality and adverse events for patients with congenital AS, while those with critical AS had higher risk for procedure-related adverse events. When stratified by AS type, patients with noncritical AS had a 70.9 percent success rate, whereas those with critical AS had a slightly lower success rate at 62.7 percent. "The majority of unsuccessful procedures were a result of significant or worsening [aortic insufficiency] AI," note the study authors.

After applying a multivariate analysis, they found an association between unsuccessful BAV in the non-critical AS cohort and these pre-catheterization factors: mixed valve disease, baseline aortic valve gradient greater than 60 mm Hg, baseline aortic insufficiency greater than mild, presence of a trainee and multiple balloon inflations. In comparison, they did not find factors associated with unsuccessful procedures in the critical AS group. Adverse events were more frequent in BAV procedures performed on critical vs. non-critical AS patients (30 percent vs. 14.1 percent, p < 0.001), and occurred in 15.8 percent of the total procedures analyzed.

While this 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 authors note it was "limited to the acute outcomes and could not be compared with long-term surgical data." Moving forward, they suggest a multi-institutional prospective study or randomized trial to provide broader context to the outcomes of BAV. "Continued evaluation and comparison of treatment modalities for AS will further improve patient care," they add.

"As practicing interventional cardiologists, we believe an overall success rate of 70 percent leaves much room for improvement," state Ziyad M. Hijazi, MD, MBBS, MPH, FACC, and Damien Kenny, MD, in a related editorial comment. In particular, they found the association between trainee involvement and poorer outcomes troublesome, noting it "may reflect a laissez-faire attitude to this condition" and requires further study to make solid recommendations moving forward.

"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," they conclude.

Keywords: Infant, Infant, Newborn, Adolescent, Aortic Valve, Prospective Studies, Multivariate Analysis, Outpatients, Research Personnel, Follow-Up Studies, Aortic Valve Insufficiency, Treatment Outcome, Heart Valve Diseases, Catheterization, Heart Defects, Congenital, Aortic Valve Stenosis, Registries, Patient Care

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