Lucron Hugues, Malekzadeh-Milani Sophie-Guiti, de Montclos Thomas Perouse, Baruteau Alban-Elouen, Mendoza Soto Alberto, Butera Gianfranco, Michel-Behnke Ina, Ovaert Caroline, Bautista-Rodriguez Carles, Bentham James, Jalal Zakaria, Betrian Blasco Pedro, Bouvaist Hélène, Vincenti Marie, Ferreira Matins José Diego, Jellimann Jean-Marc, Callegari Alessia, Bonnemains Laurent, Bonnefoy Ronan, Castaldi Biagio, Charbonneau Anne, Dauphin Claire, Lefort Bruno, Schubert Stephan, Brard Mélanie, Domanski Olivia, Denis Charlotte, Wacker Julie, Maragnes Pascale, Karsenty Clément, Loureiro Petra, Jakob André, Hascoët Sébastien, Bonnet Damien
Paediatric Cardiology Department, Hospital Marie-Lannelongue, M3C National reference center, Faculté de Médecine Paris-Saclay, University Paris-Saclay, France; Paediatric Cardiology, Children's University Hospital, Geneva, Switzerland.
Paediatric Cardiology Department, M3C National reference center, Hospital Necker-Enfants Malades, Assistance Publique-Hôpitaux de Paris, University Paris Cité, Paris, France.
Rev Esp Cardiol (Engl Ed). 2025 Aug;78(8):694-706. doi: 10.1016/j.rec.2024.12.011. Epub 2025 Jan 10.
Balloon atrial septostomy (BAS) improves oxygenation in neonates with transposition of the great arteries (TGA) and restrictive foramen ovale. Currently, there is a global shortage of dedicated BAS catheters, while new unmarked catheters have recently become available at some European centers. This study aimed to characterize BAS outcomes using the currently available BAS catheters in Europe.
A 2-year multicenter observational registry was conducted, including all neonates undergoing BAS for TGA. We report preliminary results (September 2022-February 2024) focusing on BAS characteristics and outcomes.
A total of 250 BAS procedures were performed in 29 centers. The median neonatal weight was 3.16kg, and 88% of neonates had a prenatal diagnosis. Most procedures were performed often on the first day of life during working hours (72.8%), mainly in catheterization laboratories (59.2%). Guidance primarily involved ultrasound with or without fluoroscopy. A guidewire was used in 41.2% of procedures. A total of 290 catheters (286 Z-5 or Z-6) were used, achieving an overall BAS success rate of 96%. Complete procedural failure was associated with the use of the umbilical venous route (OR, 3.62; P=.001) and lower-volume catheters (OR, 7.01; P<.001). The occurrence of significant complications (8%; OR, 9.33; P<.001) was associated with complete procedural failure. For complex procedures, significant risk factors were the absence of fluoroscopy (OR, 3.32; P=.001), use of the umbilical venous route (OR, 2.28; P=.005), and lower-volume catheters (OR, 2.43; P=.03).
In the current era, BAS can be challenging, and significant complications and complete failures are not uncommon. The use of the umbilical venous route, low-volume BAS catheters, absence of fluoroscopy guidance, and the occurrence of complications negatively impact procedural outcomes.
球囊房间隔造口术（BAS）可改善患有大动脉转位（TGA）和卵圆孔受限的新生儿的氧合情况。目前，全球范围内专用的BAS导管短缺，而一些欧洲中心最近有了新的未标记导管。本研究旨在利用欧洲目前可用的BAS导管来描述BAS的结果。
进行了一项为期2年的多中心观察性登记研究，纳入所有接受BAS治疗TGA的新生儿。我们报告了侧重于BAS特征和结果的初步结果（2022年9月至2024年2月）。
29个中心共进行了250例BAS手术。新生儿中位体重为3.16kg，88%的新生儿有产前诊断。大多数手术常在出生后第一天的工作时间内进行（72.8%），主要在导管室进行（59.2%）。引导主要涉及超声，有或没有荧光透视。41.2%的手术使用了导丝。共使用了290根导管（286根Z - 5或Z - 6），BAS总体成功率为96%。完全手术失败与使用脐静脉途径（比值比，3.62；P = 0.001）和小容量导管（比值比，7.01；P < 0.001）相关。严重并发症的发生（8%；比值比，9.33；P < 0.001）与完全手术失败相关。对于复杂手术，显著的危险因素是没有荧光透视（比值比，3.32；P = 0.001）、使用脐静脉途径（比值比，2.28；P = 0.005）和小容量导管（比值比，2.43；P = 0.03）。
在当前时代，BAS可能具有挑战性，严重并发症和完全失败并不罕见。脐静脉途径的使用、小容量BAS导管、缺乏荧光透视引导以及并发症的发生对手术结果有负面影响。
