Working Group on Balloon Atrial Septostomy Catheter, Japanese Society of Congenital Interventional Cardiology; Division of Pediatric Cardiology, Interventional Radiology Center, Okayama University Hospital, 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan.
Working Group on Balloon Atrial Septostomy Catheter, Japanese Society of Congenital Interventional Cardiology; Department of Pediatrics and Child Health, Kurume University School of Medicine, Fukuoka, Japan.
J Cardiol. 2021 Sep;78(3):219-223. doi: 10.1016/j.jjcc.2021.04.008. Epub 2021 May 13.
The supply of Rashkind balloon atrial septostomy (BAS) catheters (Medtronic, Minneapolis, MN, USA) has suddenly been discontinued in the world due to its recall. Consequently, Japan fell into a critical shortage of standard BAS catheters. Although the use of static BAS is off-label in Japan, its importance is increasing in such a situation. A nationwide survey of static BAS is needed in such a critical period.
A questionnaire survey was conducted among centers in Japan regarding BAS performed between October 1, 2020, and December 15, 2020, while the supply of Rashkind BAS catheter was discontinued.
We received answers from 70 of the 90 centers, for a response rate of 78%. In this survey, 25 patients who underwent static BAS were enrolled, and a total of 47 BAS procedures were performed. Median age and weight at static BAS were 10 days of life and 3001 g, respectively. The most common diagnosis was transposition of the great arteries without pulmonary stenosis and hypoplastic left heart syndrome and its variants, with 8 cases each. The most frequently used balloon diameter was 10 mm (13 balloons), followed by 12 mm (10 balloons), and 3 cases required double-balloon techniques. The 3-point scale of the efficacy of static BAS rated by physicians were 10 excellent, 15 good, and 0 poor, respectively. Complications included cardiac tamponade during the procedure in 1 patient and the need for Rashkind BAS later in 2 patients. Comparing the share of static BAS in all transcatheter atrial septostomy, its share in the current survey (28/53) is significantly higher compared to the annual registry data in 2018 (86/304) (p < 0.01).
This survey shows that static BAS is widely performed in Japan and is effective and safe. Static BAS cases have increased significantly due to a shortage of standard BAS catheters.
由于召回，拉什金球囊房间隔造口术（BAS）导管（美敦力，明尼苏达州明尼阿波利斯，美国）在全球范围内的供应突然中断。因此，日本标准 BAS 导管严重短缺。尽管在日本使用静态 BAS 是超适应证的，但在这种情况下其重要性正在增加。在这种关键时期，需要对全国范围内的静态 BAS 进行调查。
对 2020 年 10 月 1 日至 2020 年 12 月 15 日 Rashkind BAS 导管供应中断期间在日本进行 BAS 的中心进行了问卷调查。
我们收到了 90 个中心中的 70 个中心的答复，答复率为 78%。在这项调查中，有 25 名患者接受了静态 BAS，共进行了 47 次 BAS 手术。静态 BAS 的中位年龄和体重分别为 10 天和 3001g。最常见的诊断是大动脉转位无肺动脉瓣狭窄和左心发育不全综合征及其变异，各有 8 例。最常用的球囊直径为 10mm（13 个球囊），其次是 12mm（10 个球囊），有 3 例需要双球囊技术。医生对静态 BAS 效果的 3 分评分分别为 10 分（非常好）、15 分（好）和 0 分（差）。并发症包括 1 例术中心脏压塞和 2 例后续需要 Rashkind BAS。与 2018 年年度登记数据相比（86/304），当前调查中静态 BAS 占所有经导管房间隔造口术的比例（28/53）明显更高（p<0.01）。
这项调查表明，静态 BAS 在日本广泛应用，并且有效且安全。由于标准 BAS 导管短缺，静态 BAS 病例显著增加。
