Tomizawa Yasuko
Department of Cardiovascular Surgery, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.
J Artif Organs. 2012 Dec;15(4):311-24. doi: 10.1007/s10047-012-0651-7. Epub 2012 Jun 23.
Transcatheter closure of atrial septum defect (ASD) with a closure device is increasing, but the history of clinical use of this procedure is still short, and the efficacy and long-term safety remain unproved. The total number of closure devices implanted throughout the world has not been counted accurately. Therefore, the probability of complications occurring after implantation is uncertain. Device-related complications that occur suddenly late after implantation are life-threatening, and quite often necessitate emergency surgical intervention. In Japanese medical journals, authors reporting closure devices have mentioned no complications and problems in their facilities. Detailed studies of device-related complications and device removal have not been reported in Japan. In fact, this literature search found an unexpectedly large number of reports of various adverse events from many overseas countries. When follow-up duration is short and the number of patients is small, the incidence of complications cannot be determined. Rare complications may emerge in a large series with a long observation period. Consequently, the actual number of incidents related to ASD closure devices is possibly several times higher than the number reported. Guidelines for long-term patient management for patients with an implanted closure device are necessary and post-marketing surveillance is appropriate. Development of a national database, a worldwide registration system, and continuous information disclosure will improve the quality of treatment. The devices currently available are not ideal in view of reports of late complications requiring urgent surgery and the need for life-long follow-up. An ideal device should be free from complications during life, and reliability is indispensable.
经导管使用封堵器闭合房间隔缺损（ASD）的情况日益增多，但该手术的临床应用历史仍较短，其疗效和长期安全性尚未得到证实。全球植入封堵器的总数尚未得到准确统计。因此，植入后发生并发症的概率尚不确定。植入后晚期突然出现的与器械相关的并发症会危及生命，且常常需要紧急手术干预。在日本医学期刊中，报道封堵器的作者称其所在机构未出现并发症和问题。日本尚未报道有关器械相关并发症及器械取出的详细研究。事实上，本次文献检索发现，许多海外国家有大量关于各种不良事件的报道。当随访时间短且患者数量少时，并发症的发生率无法确定。在观察期长的大样本研究中可能会出现罕见并发症。因此，与ASD封堵器相关的实际事件数量可能比报道的数量高出数倍。有必要制定针对植入封堵器患者的长期管理指南，进行上市后监测是恰当的。鉴于有报道称出现需要紧急手术的晚期并发症以及需要终身随访，目前可用的器械并不理想。理想的器械应该在使用过程中无并发症，可靠性是必不可少的。
