First Experience With the Biostar-Device for Various Applications in Pediatric Patients With Congenital Heart Disease
First Experience With the Biostar-Device for Various Applications in Pediatric Patients With Congenital Heart Disease
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DOI：
10.1002/ccd.22233
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发表时间：
2010-01-01
影响因子：
2.3
通讯作者：
Peuster, Matthias
中科院分区：
文献类型：
--
作者：
Hoehn, Rene;Hesse, Carola;Peuster, Matthias
背景资料：房间隔缺损（ASD）的介入封堵术和Fontan患者的外科隧道开窗术已成为多年来的首选手术。最近，使用可吸收基质对Starflex器械进行改良的BiosTAR封堵器已经上市。患者：10个Biostar装置被植入9个患有房间隔缺损的儿童，1个在Fontan挡板内，8个患有继发性房间隔缺损。患者年龄11个月~ 17岁，体重12.9 ~ 78 kg。结果：9名患者植入了10件BiosTAR器械。在1例患者中，使用2件BioSTAR器械封堵卵圆窝内的多处缺损。所有缺损均成功且顺利封堵。平均手术时间为56（范围28-125）。平均透视时间为4.8（范围1.1至13.0）分钟。9例患者均未显示器械植入后残余分流。30天后，对照组经胸超声心动图未见分流。所有患者均未发生过敏反应、快速性心律失常或血栓栓塞事件等不良反应。结论：BiosTAR封堵器是一种安全有效的封堵儿童各种房间分流的器械，包括多孔房间缺损和Fontan开窗术，但是，可能的长期后果（例如，骨折、支架降解后的复发性分流）仍有待研究。(C)2009 Wiley-Liss，Inc.
Background: Interventional closure of atrial septal defects (ASD) and surgical tunnel fenestrations in Fontan patients has become the procedure of choice for many years. Recently, the BiosTAR Occluder, a modification of the Starflex device with a resorbable matrix has become available. Patients: Ten Biostar devices were implanted in nine children with interatrial septal defects, one within a fontan baffle, eight with secundum atrial septal defects. The age of the patients ranged from 11 months to 17 years, the body weight ranged from 12.9-78 kg. Results: 10 BiosTAR devices were implanted in nine patients. In one patient, two BioSTAR devices were used to occlude multiple defects within the oval fossa. All defects were successfully and uneventfully occluded. Mean procedure time was 56 (range 28-125). Mean fluoroscopy time was 4.8 (range 1.1 to 13.0) min. None of the nine patients showed residual shunts after device implantation. After 30 days no shunt was seen in the control transthoracic echocardiography. No adverse effects like allergic reactions, tachyarrhythmia or thrombembolic events occurred in any of the patients. Conclusion: The BiosTAR closure device is a safe and effective device for the closure of a variety of interatrial shunts in children including multifenestrated interatrial defects and fontan fenestrations, however, possible long term consequences (e.g., fractures, recurrent shunts after scaffold degradation) remain to be studied. (C) 2009 Wiley-Liss, Inc.