Balloon Atrial Septostomy: Does the Balloon Size Matter?

Abstract

Dextro-transposition of the great arteries is a congenital heart defect with eventually lethal life-threatening consequences of hypoxic low cardiac output. When a balloon atrial septostomy (BAS) is needed, it is performed shortly after birth to create an interatrial shunt and improve systemic blood oxygenation and haemodynamic conditions. In 2019 and 2020, the withdrawal of some balloon atrioseptostomy catheters from the market led to increased use of catheters with different materials, shapes, and sizes. The main objective of this study was to investigate whether the size of the Miller and Fogarty balloon (Edwards Lifesciences) in its 2 variations, the 4.0 cc and the 1.8 cc, had a different impact on the systemic oxygen saturation, on the atrial septal defect (ASD) size, or on the type and frequency of procedure-related complications. We conducted a retrospective study on 134 consecutive patients diagnosed with dextrotransposition of the great arteries between 2002 and 2018 who underwent BAS in a tertiary paediatric hospital in Canada. BAS resulted in a significant increase in oxygen saturation of 18.91% ± 12.95% points (P < 0.0001) and a significant increase in the resulting ASD by 3.92 ± 1.58 mm (P < 0.0001). There was no significant difference in resulting oxygen saturation (P= 0.8370) or the final ASD size (P= 0.2193) based on the balloon size. Severe or life-threatening complications were rare (1%) with no subsequent patient demise. This is the first study to show that the small balloon is as efficient as the large balloon catheter including in premature patients. This raises the question whether different balloon sizes are necessary.