J.Jpn. Surg. Soc.. 119(1): 33-40, 2018

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Feature topic

INTRODUCTION OF TRANSCATHETER AORTIC VALVE REPLACEMENT IN JAPAN

Transcatheter aortic valve replacement (TAVR) has emerged as a minimally invasive treatment for high-surgical risk patients with severe aortic stenosis. A balloon-expandable device was approved in 2013 for the first time in Japan. Until around 2010, TAVR-related trials and registries showed satisfactory efficacy, although there were some issues regarding safety. Therefore, to ensure the safety of this catheter intervention in Japan, four relevant academic societies played a central role in establishing the Consortium of Japanese TAVR Associations under the supervision of the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency of the Japanese government. The consortium set specific criteria for institutions in which TAVR can be performed. They include the necessary results of relevant surgical procedures and examinations, establishing a functional heart team for perioperative management, registering the clinical data of all TAVR cases, and the provision of a hybrid operating suite with adequate cleanliness levels. The number of TAVR procedures has been increasing rapidly in Japan, and the 30-day mortality rate is now 1.4％, which is an acceptable outcome compared with other studies. The introduction of TAVR in Japan by the consortium, healthcare institutions, the government, and industries can therefore be considered successful.

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