From the Marie Lannelongue Hospital-M3C, Department of Pediatric Cardiac Surgery, Paris, France (A.-E.B., J.P., V.L., M.G., D.P., P.B., C.-Y.A., L.H., E.L.B., R.R., M.L., E.B.); Université Paris Sud, Le Kremlin Bicêtre, Paris, France (A.-E.B., A.C.); l'Institut du Thorax, Institut National de la Santé et de la Recherche Médicale (INSERM) 1087, Centre National de la Recherche Scientifique (CNRS) 6291, Université de Nantes, Nantes, France (A.-E.B.); and Institut National de la Santé et de la Recherche Médicale (INSERM) 999, Marie Lannelongue Hospital, Paris, France (V.L., A.C.).
Circ Cardiovasc Interv. 2014 Dec;7(6):837-43. doi: 10.1161/CIRCINTERVENTIONS.113.001254. Epub 2014 Nov 25.
Data are needed on the safety and efficacy of device closure of large atrial septal defects.
Between 1998 and 2013, 336 patients (161 children <15 years) with large, isolated, secundum atrial septal defects (balloon-stretched diameter ≥34 mm in adults or echocardiographic diameter >15 mm/m(2) in children) were managed using the Amplatzer device, at the Marie Lannelongue Hospital. Transthoracic echocardiographic guidance was used starting in 2005 (n=219; 65.2%). Balloon-stretched diameter was >40 mm in 36 adults; mean values were 37.6±3.3 mm in other adults and 26.3±6.3 mm/m(2) in children. Amplatzer closure was successful in 311 (92.6%; 95% confidence interval, 89%-95%) patients. Superior and posterior rim deficiencies were more common in failed than in successful procedures (superior, 24.0% versus 4.8%; P=0.002; and posterior, 32.0% versus 4.2%; P<0.001). Device migration occurred in 4 adults (2 cases each of surgical and transcatheter retrieval); in the 21 remaining failures, the device was unreleased and withdrawn. After a median follow-up of 10.0 years (2.5-17 years), all patients were alive with no history of late complications.
Closure of large atrial septal defects using the Amplatzer device is safe and effective in both adults and children. Superior and posterior rim deficiencies are associated with procedural failure. Closure can be performed under transthoracic echocardiographic guidance in experienced centers. Early device migration is rare and can be safely managed by device extraction. Long-term follow-up showed no deaths or major late complications in our population of 311 patients.
需要了解设备闭合大型房间隔缺损的安全性和有效性的数据。
1998 年至 2013 年期间，在马里隆格医院，共有 336 例（161 例<15 岁的儿童）患有大型孤立性继发房间隔缺损（成人球囊拉伸直径≥34mm 或儿童超声心动图直径>15mm/m2）患者接受了 Amplatzer 装置治疗。自 2005 年开始采用经胸超声心动图引导（n=219；65.2%）。36 例成人球囊拉伸直径>40mm；其他成人平均直径为 37.6±3.3mm，儿童平均直径为 26.3±6.3mm/m2。311 例（92.6%；95%置信区间，89%-95%）患者 Amplatzer 闭合成功。失败组比成功组更常见上、后缘缺陷（上缘，24.0%比 4.8%；P=0.002；和后缘，32.0%比 4.2%；P<0.001）。4 例成人（各有 2 例经手术和经导管取出）发生器械迁移；其余 21 例失败的患者，器械未释放和撤回。中位随访 10.0 年（2.5-17 年）后，所有患者均存活，无晚期并发症史。
Amplatzer 装置闭合大型房间隔缺损在成人和儿童中均安全有效。上缘和后缘缺陷与手术失败有关。在经验丰富的中心，可以在经胸超声心动图引导下进行闭合。早期器械迁移罕见，可通过器械取出安全管理。在我们的 311 例患者人群中，长期随访未发现死亡或重大晚期并发症。
