BALLOON ATRIAL SEPTOSTOMY USING A NEW LOW-PROFILE BALLOON CATHETER - INITIAL CLINICAL-RESULTS

Balloon atrial septostomy remains an important interventional procedur e 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 c atheter with dual lumen, inserted via a 5F or 6F sheath. Seventeen neo nates and infants with various forms of congenital heart disease requi ring palliation underwent septostomy using the new catheter at a media n 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 7 2 +/- 20% to 87 +/- 7%, p < .001; and the gradient across the atrial s eptum 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 f rom 8.5 +/- 6.9 to 0.9 +/- 1.3 mm Hg, p < .002). The diameter of the d efect increased from 2.7 +/- 1.7mm to 8 +/- 2.3 mm, p < .001. There we re 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 s maller introducer sheath compared with the conventional catheter, this new septostomy catheter should be especially useful in small neonates . (C) 1997 Wiley-Liss, Inc.