Journal of Pediatric Cardiology and Cardiac Surgery

Online ISSN: 2433-1783 Print ISSN: 2433-2720
Japanese Society of Pediatric Cardiology and Cardiac Surgery
Japanese Society of Pediatric Cardiology and Cardiac Surgery Academy Center, 358-5 Yamabuki-cho, Shinju-ku, Tokyo 162-0801, Japan
Journal of Pediatric Cardiology and Cardiac Surgery 3(1): 1-7 (2019)

Original ArticleOriginal Article

A Clinical Survey on Current Status of Ductal Stenting in Congenital Heart Disease in Japan

Department of Health Insurance Committee, Japanese Society of Pediatric Interventional Cardiology ◇ Osaka, Japan

受付日:2017年11月4日Received: November 4, 2017
受理日:2018年5月8日Accepted: May 8, 2018
発行日:2019年1月31日Published: January 31, 2019

Background: Although ductal stenting (DS) has been performed in patients with severe congenital heart disease in Japan, the frequency of DS performed in Japan remains unclear; moreover, no stent has been approved for arterial duct (AD) under Japanese health insurance (JHI).

Methods: The Health Insurance Committee of the Japanese Society of Pediatric Interventional Cardiology conducted a questionnaire-based survey to investigate the current status of DS performed and its necessity in Japan and evaluated the efficacy and safety of the procedure to seek approval for its use under JHI.

Results: DS was performed in 64 cases at 12 institutions between April 2013 and March 2016. A total of 62 DS were performed for restoring the systemic circulation in patients with hypoplastic left heart syndrome, subaortic stenosis with interrupted aortic arch, and others. The three major indications for performing DS were high risk of alternative surgery such as the Norwood procedure, urgent procedures owing to the closure of AD, and based on own institutional principle. Complete success was achieved in all the 62 procedures, and prostaglandin E1 was withdrawn in 60 cases (97%). Major complications included stent migration/embolization in 6 cases (9.7%), 4 of which were replaced using a balloon, and dissection in 3 cases (4.8%). Mortality related to the procedures or complications was absent. Majority of the patients reached the next stage surgery.

Conclusions: The present study strongly recommends that both balloon-expandable and self-expandable stents must be approved for the safe and effective ductal intervention under JHI as soon as possible.

Key words: off-label use; congenital heart disease; ductal stenting; Norwood; hypoplastic left heart syndrome

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