Characteristics and outcomes of neonatal balloon atrial septostomy for transposition of the great vessels: ORA – TGV study

Introduction

Balloon atrial septostomy (BAS) improves oxygenation in neonates with Transposition of the Great Vessels (TGV). New non-EC marked BAS catheters have obtained temporary approval in France.

Objective

We aim to investigate outcomes of neonatal BAS in the current area.

Methods

An on-going multi-center French prospective observational registry was set up in September 2022 including all neonates undergoing BAS for TGV.

Results/Expected results

To date, 60 neonates (93.5% of term-babies, weight: 3.1 [2.8–3.4] Kg, prenatal diagnosis: 88.5%, isolated form of TGV: 68.9%) underwent 62 BAS (50% on general anaesthesia) in 14 participating centres. The procedure was performed over night or during weekend in 39.3% of cases. BAS was performed most often the day of birth (65.6%), in the catheter lab (59%) using an umbilical venous route (67.2%). The latter required conversion to a femoral route in 22.0% of patients. BAS was guided by ultrasounds and fluoroscopy in 90.2% and 55.7% of cases, respectively. Two to 4 BAS manoeuvre were required in 82.0% of cases. In 14.8% of patients, the use of a second type of BAS catheter was required. Z5 and Z6 catheters were used in 45.6% and 54.4% of cases, respectively. Overall, BAS was successfully achieved in 93.5% of cases. BAS failures included 3 crossing failures (n = 3) and a failure of enlargement of the atrial septum with a low-volume Z5 catheter (n = 1). One transient complete atrio-ventricular block was also reported.

Conclusion/Perspectives

To date, BAS success rate seems lower than expected. The continuation of this study and its expected European extension will likely contribute to clarify these points in a context of world shortage in dedicated low profile/high volume catheters.