Lin Ming-Chih, Fu Yun-Ching, Jan Sheng-Ling, Lin Wei-Wen, Chu Kuang-Hua, Ting Chih-Tai, Chen Ying-Tsung, Chi Ching-Shiang
Department of Pediatrics, Taichung Veterans General Hospital, Taichung, Taiwan.
Acta Paediatr Taiwan. 2005 Jan-Feb;46(1):17-23.
The Amplatzer Septal Occluder (ASO) is the first and only device to receive full approval for clinical use in patients with secundum atrial septal defect (ASD) from the United States Food and Drug Administration. This study reports the device's initial results in Taichung Veterans General Hospital, a tertiary medical center in central Taiwan. Between October 2001 and December 2004, 39 consecutive patients (31 females, 8 males) with secundum ASD underwent attempt at transcatheter closure using the ASO under general anesthesia and transesophageal echocardiographic guidance. Six patients were excluded due to deficient rims (2 patients), multiple ASDs (1 patient), too large a defect (1 patient), too small a defect (1 patient) and 1 patient with associated atrial flutter. A total of 33 patients (26 females, 7 males) underwent the device closure procedure. The median age was 10.6 years (range 3.1-57.5 years) and median weight was 42 kg (range 13.5-73 kg). The median Qp/Qs ratio was 2.12 (range 1.02-5.52). The median balloon stretched diameter of the defect by sizing plate was 16 mm (range 5-37 mm). A total of 33 devices (median size 17 mm, range 7-38 mm) were implanted in 33 patients. The median fluoroscopy time was 10.1 minutes (range 5.9-29 minutes) and the median procedure time was 55 minutes (range 30-105 minutes). Complications included asymptomatic device embolization to the right ventricle in 1 patient (surgical removal) and transient complete atrioventricular block in 1 patient. Follow-up echocardiography at 10 minutes, 24 hours, 1 month, 6 months, 1 year and 2 years after the procedure showed complete closure rates of 76% (25/33), 91% (30/33), 100% (32/32), 100% (22/22), 100% (22/22), and 100% (9/9), respectively. In conclusion, transcatheter closure of secundum ASD using the Amplatzer Septal Occluder is safe and effective, with a very low complication rate.
Amplatzer房间隔封堵器（ASO）是首个也是唯一获得美国食品药品监督管理局全面批准可用于继发孔型房间隔缺损（ASD）患者临床治疗的器械。本研究报告了该器械在台湾中部的三级医疗中心——台中荣民总医院的初步应用结果。2001年10月至2004年12月期间，39例连续的继发孔型ASD患者（31例女性，8例男性）在全身麻醉和经食管超声心动图引导下，尝试使用ASO进行经导管封堵。6例患者因边缘不足（2例）、多发ASD（1例）、缺损过大（1例）、缺损过小（1例）以及1例合并心房扑动而被排除。共有33例患者（26例女性，7例男性）接受了器械封堵手术。患者年龄中位数为10.6岁（范围3.1 - 57.5岁），体重中位数为42 kg（范围13.5 - 73 kg）。Qp/Qs比值中位数为2.12（范围1.02 - 5.52）。使用测量板测得缺损的球囊扩张直径中位数为16 mm（范围5 - 37 mm）。33例患者共植入33个器械（尺寸中位数为17 mm，范围7 - 38 mm）。透视时间中位数为10.1分钟（范围5.9 - 29分钟），手术时间中位数为55分钟（范围30 - 105分钟）。并发症包括1例患者器械无症状性栓塞至右心室（手术取出）和1例患者出现短暂性完全房室传导阻滞。术后10分钟、24小时、1个月、6个月、1年和2年的随访超声心动图显示完全封堵率分别为76%（25/33）、91%（30/33）、100%（32/32）、100%（22/22）、100%（22/22）和100%（9/9）。总之，使用Amplatzer房间隔封堵器经导管封堵继发孔型ASD安全有效，并发症发生率极低。
