Balloon atrial septostomy using a new low-profile balloon catheter: initial clinical results

Balloon atrial septostomy remains an important interventional procedure in the pediatric age group. The incidence of potential complications using the conventional balloon ranges from 0-11%. The purpose of this study was to evaluate a new low-profile end-hole septostomy balloon catheter with dual lumen, inserted via a 5F or 6F sheath. Seventeen neonates and infants with various forms of congenital heart disease requiring palliation underwent septostomy using the new catheter at a median age of 19 days (with a range of 1-593 days), and a median weight of 3.4 kg (a range of 2.5-8.4 kg). The aortic saturation increased from 72 +/- 20% to 87 +/- 7%, p < .001; and the gradient across the atrial septum decreased (a-wave gradient from 11.2 +/- 10.3 to 2.1 +/- 3.6 mm Hg; v-wave from 10.4 +/- 7.7 to 1.2 +/- 1.2 mm Hg; and mean gradient from 8.5 +/- 6.9 to 0.9 +/- 1.3 mm Hg, p < .002). The diameter of the defect increased from 2.7 +/- 1.7 mm to 8 +/- 2.3 mm, p < .001. There were no complications. We conclude that this new low-profile septostomy catheter is safe and effective in creating a large defect size between the atria. Because of the smaller inflation size of the balloon and smaller introducer sheath compared with the conventional catheter, this new septostomy catheter should be especially useful in small neonates.