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

IF 18 Q4 Medicine
H. Lucron , S.G. Malekzadeh-Milani , T. Perouse De Montclos , A.E. Baruteau , C. Ovaert , Z. Jalal , L. Bonnemains , C. Karsenty , O. Domanski , H. Bouvaist , P. Maragnes , A. Charbonneau , J.M. Jellimann , S. Hascoët , D. Bonnet
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引用次数: 0

Abstract

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.

新生儿球囊心房间隔造口术用于大血管移位的特点和结果:ORA-TGV研究
气囊房间隔造口术(BAS)改善新生儿大血管转位(TGV)的氧合。新的非ec标记的BAS导管在法国获得临时批准。目的了解本地区新生儿BAS的预后。方法于2022年9月在法国建立了一个正在进行的多中心前瞻性观察登记,包括所有因TGV接受BAS治疗的新生儿。结果/预期结果迄今为止,在14个参与中心,60名新生儿(93.5%的足月婴儿,体重:3.1 [2.8-3.4]Kg,产前诊断:88.5%,TGV分离形式:68.9%)接受了62例BAS(50%为全身麻醉)。39.3%的病例在夜间或周末进行手术。BAS最常在出生当天(65.6%),在导管实验室(59%)使用脐静脉路径(67.2%)进行。后者在22.0%的患者中需要转换到股路。超声和透视引导下BAS分别占90.2%和55.7%。82.0%的病例需要2 ~ 4次BAS操作。14.8%的患者需要使用第二种类型的BAS导管。使用Z5和Z6导管的比例分别为45.6%和54.4%。总体而言,93.5%的病例成功实现了BAS。BAS失败包括3例交叉失败(n = 3)和使用小容量Z5导管扩大房间隔失败(n = 1)。还报道了1例短暂性完全性房室传导阻滞。结论/观点迄今为止,BAS的成功率似乎低于预期。这项研究的继续进行及其预期在欧洲的推广可能有助于在全球专用低姿态/大容量导尿管短缺的背景下澄清这些问题。
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来源期刊
Archives of Cardiovascular Diseases Supplements
Archives of Cardiovascular Diseases Supplements CARDIAC & CARDIOVASCULAR SYSTEMS-
自引率
0.00%
发文量
508
期刊介绍: Archives of Cardiovascular Diseases Supplements is the official journal of the French Society of Cardiology. The journal publishes original peer-reviewed clinical and research articles, epidemiological studies, new methodological clinical approaches, review articles, editorials, and Images in cardiovascular medicine. The topics covered include coronary artery and valve diseases, interventional and pediatric cardiology, cardiovascular surgery, cardiomyopathy and heart failure, arrhythmias and stimulation, cardiovascular imaging, vascular medicine and hypertension, epidemiology and risk factors, and large multicenter studies. Additionally, Archives of Cardiovascular Diseases also publishes abstracts of papers presented at the annual sessions of the Journées Européennes de la Société Française de Cardiologie and the guidelines edited by the French Society of Cardiology.
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