Community Use of the Amplatzer Atrial Septal Defect Occluder: Results of the Multicenter MAGIC Atrial Septal Defect Study
Community Use of the Amplatzer Atrial Septal Defect Occluder: Results of the Multicenter MAGIC Atrial Septal Defect Study
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DOI：
10.1007/s00246-008-9325-x
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发表时间：
2009-04-01
影响因子：
1.6
通讯作者：
Ringel, Richard
中科院分区：
文献类型：
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作者：
Everett, Allen D.;Jennings, Jacky;Ringel, Richard
本研究的目的是确定Amplatzer间隔封堵器（阿索）用于房间隔缺损（ASD）封堵的不受限制的多机构常规社区使用的初始安全性和结果。从2004年11月至2007年9月，在13个儿科心脏病中心进行了一项多中心、非随机前瞻性研究。在心导管插入术和植入后1天收集数据。478例患者接受了心导管插入术，以封堵ASD。中位年龄为6岁（范围，< 1-83岁），平均体重为37.2 kg（范围，2.6-148 kg）。手术成功率为96%（458/478例患者），边缘缺陷是植入失败的主要单一原因（9/20）。严重和轻微并发症发生率分别为1.1%和4.8%，简单和复杂ASD组之间没有差异。单纯ASD组24 h成功率为99.4%（333/335），复杂ASD组为100%（120/120）。存在大缺损、存在多个缺损、使用多个器械和体重< 8 kg与24 h时的残余分流（小至中度）显著相关。总之，阿索器械在用于简单和复杂ASD闭合的常规临床实践中的即时安全性和有效性特征与用于简单ASD的初始关键FDA试验中报告的安全性和有效性特征相同。基于阿索引起的护理演变以及对复杂ASD患者选择缺乏共识，本研究指出需要重新定义最佳患者，并可能扩大ASD器械闭合的适应症。
The objective of this study was to determine the initial safety and results of unrestricted multi-institution routine community use of the Amplatzer Septal Occluder (ASO) for atrial septal defect (ASD) closure. A multicenter, nonrandomized prospective study was performed in 13 pediatric cardiology centers from November 2004 to September 2007. Data were collected at the time of cardiac catheterization and 1 day postimplant. Four hundred seventy-eight patients underwent cardiac catheterization for ASO device closure of an ASD. The median age was 6 years (range, < 1-83 years), and the mean weight was 37.2 kg (range, 2.6-148 kg). Procedural success was 96% (458/478 patients), with deficient rims being the major single reason for failed implantation (9/20). Major and minor complication rates were 1.1% and 4.8%, respectively, and were not different between simple and complex ASD groups. Success at 24 h was 99.4% (333/335) in the simple ASD group and 100% (120/120) in the complex ASD group. The presence of large defects, the presence of multiple defects, the use of multiple devices, and a weight < 8 kg were significantly associated with a residual shunt (small to moderate) at 24 h. In conclusion, the ASO device in routine clinical practice for simple and complex ASD closure has an immediate safety and effectiveness profile equal to that reported in the initial pivotal FDA trial for simple ASDs. Based on the evolution in care posed by the ASO and the lack of consensus on patient selection in complex ASDs, this study points out the need to redefine the optimal patient and possibly broaden the indications for device closure of ASDs.