Kim Ah Young, Jung Se Yong, Chang Jenny Yeonsoo, Jung Jo Won, Choi Jae Young
Division of Pediatric Cardiology, Center for Congenital Heart Disease, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea.
Department of Biological Basis of Behavior, College of Arts and Sciences, University of Pennsylvania, Philadelphia, PA, USA.
Korean Circ J. 2019 Apr;49(4):326-335. doi: 10.4070/kcj.2018.0278. Epub 2018 Dec 17.
This study aimed to describe our early to mid-term experience with transcatheter atrial septal defect (ASD) closure using the Occlutech Figulla® Flex II device (FSO), Gore® Cardioform septal occluder (GSO), and Amplatzer® septal occluder (ASO) after they were first approved in Korea in 2014, and to compare the three aforementioned kinds of ASD closure devices.
Between September 2014 and August 2016, 267 patients underwent transcatheter ASD closure in our institution. Baseline characteristics, hemodynamic features, comorbidities, and procedural success and complication rates were analyzed retrospectively. The unpaired Student t-test or variance analysis was used in the statistical analysis.
The FSO was most commonly used (n=152, 56.9%), followed by the ASO (n=98, 36.7%) and GSO (n=17, 6.4%). Baseline characteristics and hemodynamic features were similar between the devices, except that the defect size and pulmonary flow-to-systemic flow ratio were lower in the GSO group than in the other groups. Overall, the procedural success rate remained at 100%, and major complication rate was <1%. No late complication occurred during the follow-up.
The FSO and GSO are feasible, safe options for use in transcatheter ASD closure, and they are comparable to the ASO.
本研究旨在描述2014年经导管房间隔缺损（ASD）封堵术在韩国首次获批后，我们使用Occlutech Figulla® Flex II封堵器（FSO）、戈尔® Cardioform房间隔封堵器（GSO）和Amplatzer®房间隔封堵器（ASO）进行早期至中期治疗的经验，并比较上述三种ASD封堵装置。
2014年9月至2016年8月期间，267例患者在本机构接受了经导管ASD封堵术。回顾性分析患者的基线特征、血流动力学特征、合并症以及手术成功率和并发症发生率。统计分析采用非配对t检验或方差分析。
FSO使用最为频繁（n = 152，56.9%），其次是ASO（n = 98，36.7%）和GSO（n = 17，6.4%）。除GSO组的缺损大小和肺循环血流量与体循环血流量比值低于其他组外，各装置的基线特征和血流动力学特征相似。总体而言，手术成功率保持在100%，主要并发症发生率<1%。随访期间未发生晚期并发症。
FSO和GSO是经导管ASD封堵术中可行、安全的选择，与ASO相当。
