Pediheart: Pediatric Cardiology Today
Oct 2, 2026 · 30 min · 8 segments
This week we explore a recent PHIS database study assessing clinical outcomes for transcatheter balloon dilation of the aortic valve in the setting of aortic valve stenosis in early life. Why do…
Robert PassHostGeorge NicholsonGuest
The work begins with some comments about congenital aortic stenosis, reminding us of how it is a common congenital heart lesion affecting four to five per 10,000 live births and how it accounts for three to six percent of congenital heart disease lesions.
They speak of how it can affect LV function and cardiac output, and how fibroelastosis of the left ventricle can even occur, and how variable the clinical presentation of aortic stenosis in an infant can be.
They then review how balloon valvuloplasty has evolved to be the preferred approach for this problem in infants in many centers, preferring it over surgical repair.
And they review how some studies have shown balloon valvuloplasty can effectively kick the can down the road as a reasonable palliation.
However, they make the point that in the present era, there are limited data on percutaneous balloon aortic valvuloplasty in infancy.
And so the authors state that, quote, using a large multicenter database, the Pediatric Health Information System, this study provides contemporary, real-world, early outcomes data in this vulnerable patient population.
The authors review for us what the Pediatric Health Information System, or FIST, database is, which you will recall is an administrative database from roughly 50 tertiary children's hospitals, and we have reviewed prior studies using data from this database on the podcast.
The study reviewed data from over a nine-year period, from 2016 to 2024, and essentially was using codes to get patients less than or equal year of age who had a balloon valvuloplasty.
And they categorized the cohort into those who were less than or equal to 28 days, or neonates, versus infants, which were defined as 29 days to one year of age, and critical versus non-critical aortic stenosis based on the requirement for prostaglandin.
They recorded post-procedural things like presence of cardiac arrest, tamponade, arrhythmias, or vascular complications, and also important things like the need for inotropes or ECMO.
And only ECMO use after the dilation was considered an assessment of procedural success.
The primary endpoint for this work was in-hospital mortality and repeat intervention at one year, with secondary endpoints being immediate procedural success and various post-procedural complications, as well as length of stay and hospital cost.
Procedural success was survival to hospital discharge without a post-procedural ECMO run or cardiac arrest or an urgent need for surgery or repeat dilation within 30 days of the initial intervention.
authors review their statistical methodology which is quite robust and i would refer you to the work for the details and on to the results there were 985 neonates in infants who had a balloon aortic valvuloplasty in the nine year period with 53 being neonates and 75 were male 40 of the entire cohort or 398 patients had critical aortic stenosis and perhaps not surprisingly those with critical aortic stenosis were younger at intervention three days versus 58 days, they had a higher prevalence of genetic syndromes, 10% versus 5%, were more frequently needing inotropes, 77% versus 27%, and ECMO was more common in critical aortic stenosis patients, seen in 5.8% versus 1.7% for the non-critical aortic stenosis patients.
When comparing critical AS to non-critical AS patients, critical AS patients had more procedural complications, including cardiac arrest, tamponade, and vascular complications.
Were outcomes in terms of the primary outcome of a good result with living for 30 days beyond the procedure different in critical versus non-critical aortic stenosis? Well, success rates were lower in the critical aortic stenosis group, 85% versus 96% in the non-critical cases of aortic stenosis, and in-hospital mortality was higher at nearly 12% amongst critical aortic stenosis patients versus 1.7% for non-critical aortic stenosis.
Length of stay was also longer with critical stenosis at 19 days versus 2 days for the non-critical aortic stenosis.
Additionally, babies who had a dilation for critical aortic stenosis were nearly four times more likely to need a repeat intervention in the first 12 months, 11.2% versus 3.7%.
the age of the patient didn't matter if it was severe aortic stenosis in regards to success, 96% versus 95% with comparable mortality rates.
Using a multivariable model, features that were predictors or associations with mortality were the presence of critical aortic stenosis, presence of a genetic syndrome, use of ECMO, tamponade, and cardiac arrest.
In their discussion, the authors state, and I quote, "...our study demonstrates several key findings in this high-risk population." Among neonates and infants with non-critical aortic stenosis physiology, percutaneous balloon aortic valvuloplasty can be achieved with a high procedural success rate, low in-hospital mortality, and a high rate of freedom from re-intervention at one-year follow-up.
In contrast, patients with critical aortic stenosis have greater in-hospital mortality, morbidity, healthcare resource utilization, and lower rates of procedural success.
The work begins with some comments about congenital aortic stenosis, reminding us of how it is a common congenital heart lesion affecting four to five per 10,000 live births and how it accounts for three to six percent of congenital heart disease lesions.
They speak of how it can affect LV function and cardiac output, and how fibroelastosis of the left ventricle can even occur, and how variable the clinical presentation of aortic stenosis in an infant can be.
They then review how balloon valvuloplasty has evolved to be the preferred approach for this problem in infants in many centers, preferring it over surgical repair.
And they review how some studies have shown balloon valvuloplasty can effectively kick the can down the road as a reasonable palliation.
However, they make the point that in the present era, there are limited data on percutaneous balloon aortic valvuloplasty in infancy.
And so the authors state that, quote, using a large multicenter database, the Pediatric Health Information System, this study provides contemporary, real-world, early outcomes data in this vulnerable patient population.
The authors review for us what the Pediatric Health Information System, or FIST, database is, which you will recall is an administrative database from roughly 50 tertiary children's hospitals, and we have reviewed prior studies using data from this database on the podcast.
The study reviewed data from over a nine-year period, from 2016 to 2024, and essentially was using codes to get patients less than or equal year of age who had a balloon valvuloplasty.
And they categorized the cohort into those who were less than or equal to 28 days, or neonates, versus infants, which were defined as 29 days to one year of age, and critical versus non-critical aortic stenosis based on the requirement for prostaglandin.
They recorded post-procedural things like presence of cardiac arrest, tamponade, arrhythmias, or vascular complications, and also important things like the need for inotropes or ECMO.
And only ECMO use after the dilation was considered an assessment of procedural success.
The primary endpoint for this work was in-hospital mortality and repeat intervention at one year, with secondary endpoints being immediate procedural success and various post-procedural complications, as well as length of stay and hospital cost.
Procedural success was survival to hospital discharge without a post-procedural ECMO run or cardiac arrest or an urgent need for surgery or repeat dilation within 30 days of the initial intervention.
authors review their statistical methodology which is quite robust and i would refer you to the work for the details and on to the results there were 985 neonates in infants who had a balloon aortic valvuloplasty in the nine year period with 53 being neonates and 75 were male 40 of the entire cohort or 398 patients had critical aortic stenosis and perhaps not surprisingly those with critical aortic stenosis were younger at intervention three days versus 58 days, they had a higher prevalence of genetic syndromes, 10% versus 5%, were more frequently needing inotropes, 77% versus 27%, and ECMO was more common in critical aortic stenosis patients, seen in 5.8% versus 1.7% for the non-critical aortic stenosis patients.
When comparing critical AS to non-critical AS patients, critical AS patients had more procedural complications, including cardiac arrest, tamponade, and vascular complications.
Were outcomes in terms of the primary outcome of a good result with living for 30 days beyond the procedure different in critical versus non-critical aortic stenosis? Well, success rates were lower in the critical aortic stenosis group, 85% versus 96% in the non-critical cases of aortic stenosis, and in-hospital mortality was higher at nearly 12% amongst critical aortic stenosis patients versus 1.7% for non-critical aortic stenosis.
Length of stay was also longer with critical stenosis at 19 days versus 2 days for the non-critical aortic stenosis.
Additionally, babies who had a dilation for critical aortic stenosis were nearly four times more likely to need a repeat intervention in the first 12 months, 11.2% versus 3.7%.
the age of the patient didn't matter if it was severe aortic stenosis in regards to success, 96% versus 95% with comparable mortality rates.
Using a multivariable model, features that were predictors or associations with mortality were the presence of critical aortic stenosis, presence of a genetic syndrome, use of ECMO, tamponade, and cardiac arrest.
In their discussion, the authors state, and I quote, "...our study demonstrates several key findings in this high-risk population." Among neonates and infants with non-critical aortic stenosis physiology, percutaneous balloon aortic valvuloplasty can be achieved with a high procedural success rate, low in-hospital mortality, and a high rate of freedom from re-intervention at one-year follow-up.
In contrast, patients with critical aortic stenosis have greater in-hospital mortality, morbidity, healthcare resource utilization, and lower rates of procedural success.
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