Department of Pediatric Cardiology and Intensive Care, Childrens Hospital, University of Rostock, Rembrandtstrasse 16/17, 18057 Rostock, Germany.
Catheter Cardiovasc Interv. 2010 Jan 1;75(1):72-7. doi: 10.1002/ccd.22233.
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.
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.
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.
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.
介入性房间隔缺损（ASD）封堵术和 Fontan 患者的手术隧道开窗术多年来一直是首选治疗方法。最近，BioSTAR 封堵器，一种带有可吸收基质的 Starflex 装置的改良版，已经问世。
10 个 Biostar 装置被植入 9 名患有房间隔缺损的儿童中，一个在 Fontan 隔瓣内，8 个为继发孔型房间隔缺损。患者年龄为 11 个月至 17 岁，体重为 12.9-78kg。
10 个 BioSTAR 装置被植入 9 名患者中。在一名患者中，使用两个 BioSTAR 装置来闭塞卵圆窝内的多个缺陷。所有缺陷均成功且无并发症地闭塞。平均手术时间为 56 分钟（范围 28-125 分钟）。平均透视时间为 4.8 分钟（范围 1.1 至 13.0 分钟）。在装置植入后，9 名患者中均无残余分流。30 天后，在控制经胸超声心动图中未发现分流。在任何患者中均未发生过敏反应、心动过速或血栓栓塞等不良事件。
BioSTAR 封堵器是一种安全有效的封堵儿童多种房间隔分流的装置，包括多窗房间隔缺损和 Fontan 开窗，但可能的长期后果（如支架降解后再次出现分流）仍需进一步研究。
