Rao PS
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. 2000 Nov;2(4):367-376.
A large number of atrial septal defect (ASD) closure devices have been investigated in an attempt to develop a nonsurgical, transvenous method of occlusion of ASD. Some of the devices have been discontinued and several are in clinical trials at this time, but none are approved for general clinical use. There are no prospective, randomized clinical trials to compare the available devices. Based on separate clinical trials, the feasibility, safety, and effectiveness of all devices appear similar. Considerations pertaining to the size of the device delivery sheath, ease of implantation, cost and availability are different with each of the devices; some devices have advantages in some aspects, and others with another. Approval by the regulatory authorities and larger clinical use with longer follow-up results may eventually determine the most appropriate device for a given clinical use.
为了开发一种非手术经静脉封堵房间隔缺损(ASD)的方法,人们对大量的ASD封堵装置进行了研究。一些装置已停止研发,目前有几种正在进行临床试验,但均未获批用于一般临床。尚无前瞻性随机临床试验来比较现有装置。基于各自的临床试验,所有装置的可行性、安全性和有效性似乎相似。每种装置在输送鞘管尺寸、植入难易程度、成本和可及性方面的考量各不相同;一些装置在某些方面具有优势,而其他装置则在其他方面有优势。监管机构的批准以及更大规模的临床应用和更长时间的随访结果最终可能会确定最适合特定临床应用的装置。