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Balloon aortic valvuloplasty safe, effective in treating congenital aortic stenosis
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Balloon aortic valvuloplasty for treatment of congenital aortic stenosis was associated with low rates of mortality and adverse events, according to data published in JACC: Cardiovascular Interventions.
“Despite several early studies documenting the risk factors and outcomes for [balloon aortic valvuloplasty], current procedural outcomes are less understood,” Brian A. Boe, MD, from The Heart Center at Nationwide Children’s Hospital in Columbus, Ohio, and colleagues wrote. “Given the significant improvement in catheter-based equipment ... and techniques ... over the past few decades, an understanding of contemporary practice patterns and outcomes is important.”
According to the study, the IMPACT registry is the largest available dataset of patients undergoing catheterization for congenital cardiac catheterization for congenital heart disease.
Boe and colleagues used the registry to evaluate practices and acute outcomes of balloon aortic valvuloplasty in a contemporary group of patients between January 2011 and March 2015.
The researchers separated procedures into those performed for critical vs. noncritical aortic stenosis.
The primary outcomes were procedural success and the occurrence of adverse events. These outcomes were stratified into optimal, adequate and inadequate, with optimal and adequate outcomes defining “successful” procedures.
Patient and procedural characteristics associated with unsuccessful balloon aortic valvuloplasty were identified using multivariate logistic regression.
The researchers compared mortality and adverse events across patient cohorts.
Procedural success
The IMPACT registry documented 1,026 isolated balloon aortic valvuloplasty procedures, 718 (70%) of which were defined as successful.
The study showed a 70.9% success rate for noncritical aortic stenosis (n = 916) and 62.7% success rate for critical aortic stenosis (n = 110).
A multivariate analysis showed prior cardiac catheterization, 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 were associated with unsuccessful balloon aortic valvuloplasty in the noncritical aortic stenosis cohort.
There were no factors linked to unsuccessful procedures in the critical aortic stenosis group, and there were no occurrences of procedural death; however, 2.4% of patients did not survive to hospital discharge.
Adverse events occurred in 15.8% of procedures and were more frequent in procedures performed for critical aortic stenosis (30% vs. 14.1%; P < .001), Boe and colleagues wrote.
New trial warranted
According to an accompanying editorial from Ziyad M. Hijazi, MD, MPH, of the cardiac program at the Sidra Medical and Research Center in Doha, Qatar, and Weill Cornell Medicine in New York, and Damien Kenny, MD, of the division of pediatric cardiology at Our Lady’s Children’s Hospital in Dublin, the 70% overall success rate leaves room for improvement, and a randomized trial with surgical valvotomy with long-term follow-up is warranted.
“Our surgical colleagues are very keen on participating in such a trial,” they wrote. “We owe it to our patients and their families to answer this question once and for all: Is [balloon aortic valvuloplasty] as good, better or inferior to surgical aortic valvotomy?” – by Dave Quaile
Disclosures: One author reports she receives research grants from Abbott, Edwards Lifesciences, Medtronic, PFM Medical and W.L. Gore and Associates; serves as a consultant and proctor for Abbott and Edwards Lifesciences; and serves as a proctor for B. Braun Interventional Systems. Hijazi reports he is a consultant for and receives honoraria from NuMED. Kenny reports no relevant financial disclosures.
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