Rao P. Syamasundar
Division of Pediatric Cardiology, Saint Louis University School of Medicine, Cardinal Glennon Children's Hospital, 1465 South Grand Boulevard, St. Louis, MO 63104, USA.
Curr Interv Cardiol Rep. 2001 Aug;3(3):268-274.
A number of patent ductus arteriosus (PDA) occluding devices have been studied in an attempt to develop a transcatheter method of closure of PDA. Some devices were tested in only animal models, whereas others progressed to clinical trials in human subjects. Some devices have been discontinued, some received approval for general clinical use, and many have not yet received approval by regulatory authorities. No prospective randomized clinical trials have been undertaken and, therefore, data on separate clinical trials are used to determine relative efficacy of the devices. Selection of a method of PDA closure depends largely on its minimal diameter and to some degree on its shape. Silent PDAs do not need occlusion. Very small to small PDAs may be occluded by free or detachable Gianturco coils (Cook Cardiology, Bloomington, IN). Moderate-to-large PDAs require closure by devices, conventional surgery, and videothoracoscopic interruption. The choice in the latter group depends largely on the availability of a given method at a given institution at that particular time. Approval of several of the devices by regulatory authorities may result in conduct of prospective randomized clinical trials and use of a device or method most appropriate to the size and shape of the PDA.
为了开发一种经导管闭合动脉导管未闭(PDA)的方法,人们对多种PDA封堵装置进行了研究。一些装置仅在动物模型中进行了测试,而其他装置则进入了人体临床试验阶段。一些装置已停止研发,一些已获得一般临床使用的批准,还有许多尚未获得监管机构的批准。目前尚未进行前瞻性随机临床试验,因此,通过单独临床试验的数据来确定这些装置的相对疗效。PDA闭合方法的选择很大程度上取决于其最小直径,在一定程度上也取决于其形状。无症状的PDA无需封堵。非常小至小的PDA可用游离或可脱卸的弹簧圈(库克心脏病学公司,印第安纳州布卢明顿)封堵。中至大的PDA需要通过装置、传统手术和电视胸腔镜阻断来闭合。后一组中的选择很大程度上取决于特定时间特定机构中某种方法的可获得性。监管机构对几种装置的批准可能会导致进行前瞻性随机临床试验,并使用最适合PDA大小和形状的装置或方法。