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用于房间隔缺损封堵的Occlutech® Figulla® 房间隔封堵器与Amplatzer® 房间隔封堵器的比较。

Comparison of the Occlutech ® Figulla ® septal occluder and Amplatzer ® septal occluder for atrial septal defect device closure.

作者信息

Roymanee Supaporn, Promphan Worakan, Tonklang Nakharin, Wongwaitaweewong Kanjarut

机构信息

Pediatric Cardiology Unit, Department of Pediatrics, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, Thailand,

出版信息

Pediatr Cardiol. 2015 Jun;36(5):935-41. doi: 10.1007/s00246-015-1103-y. Epub 2015 Jan 30.

DOI:10.1007/s00246-015-1103-y
PMID:25633819
Abstract

The Occlutech(®) Figulla(®) septal occluder (OFSO) is a later-generation double-disk device with few reports of its success rates and complications compared with the Amplatzer(®) septal occluder (ASO), which is the worldwide standard device in percutaneous atrial septal defect (ASD) closure. We recruited and compared the results in 149 patients (76.5 % female) who underwent ASD device closure in our center between January 2003 and June 2012. The patients ranged in age from 2.3 to 77.2 years. There were no statistically significant differences between the two groups regarding patient baseline characteristics and procedure variables. The success rate using either device was excellent (ASO 94.4 % and OFSO 97.4 %; p = 0.43). Although the diameter of the ASD and the pulmonary arterial pressure in the OFSO group were slightly higher than in the ASO group, the median fluoroscopic time in the OFSO group was significantly shorter (ASO 13.7 min; OFSO 9.0 min; p < 0.001). The overall median follow-up time was 3.6 years (interquartile range 2.1-9.0 years). There were no significant differences between the major and minor complications when comparing the two devices. Both devices were safe and effective for percutaneous ASD closures. The OFSO had the benefit of a shorter fluoroscopic time.

摘要

Occlutech(®)Figulla(®)房间隔封堵器(OFSO)是一种新一代双盘状装置,与全球经皮房间隔缺损(ASD)封堵标准装置Amplatzer(®)房间隔封堵器(ASO)相比,关于其成功率和并发症的报道较少。我们招募并比较了2003年1月至2012年6月期间在我们中心接受ASD封堵装置治疗的149例患者(女性占76.5%)的结果。患者年龄在2.3岁至77.2岁之间。两组患者的基线特征和手术变量无统计学显著差异。使用任何一种装置的成功率都很高(ASO为94.4%,OFSO为97.4%;p = 0.43)。虽然OFSO组的ASD直径和肺动脉压略高于ASO组,但OFSO组的透视时间中位数明显更短(ASO为13.7分钟;OFSO为9.0分钟;p < 0.001)。总体随访时间中位数为3.6年(四分位间距为2.1 - 9.0年)。比较两种装置时,主要和次要并发症之间无显著差异。两种装置对于经皮ASD封堵都是安全有效的。OFSO的优点是透视时间更短。

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