Guidelines for Transcatheter Aortic Valve Replacement in Korea: Past Obstacles and Future Perspectives

Abstract

Background: Analyses of the efficacy and safety of transcatheter aortic valve replacement (TAVR) in most countries have been based on outcomes obtained in accordance with national practice guidelines and monitoring protocols. The purpose of this study is to share our experience regarding the process for establishing guidelines and monitoring protocols for the use of TAVR in Korea, in the hopes that it may be helpful to others undergoing a similar process in their own country. Methods: The Korean guidelines for TAVR were established on June 1, 2015 in through a tri-party agreement involving the Department of Health and Welfare, the Korean Society of Thoracic and Cardiovascular Surgery and the Korean Society of Cardiology. We agreed to monitor the guidelines transparently and to exchange opinions regarding amendments or continuation of its contents after 3 years of monitoring. Results: The monitoring meetings were not held as regularly as agreed, and monitoring was also made difficult by insufficient and incomplete data. Nevertheless, during the meetings, measures to improve the monitoring process were discussed, and accordingly, an agreement was made to continue the monitoring process, with the aim of completing data collection by 2018. Conclusion: Compliance with guidelines is critical for assessing the efficacy and safety of TAVR. Moreover, the TAVR monitoring process must be properly conducted for an accurate evaluation to be made. Any country planning to introduce TAVR may encounter difficulties with regards to the optimal initiation strategy and subsequent monitoring. Nevertheless, continued efforts should be made to persuade the government and the corresponding medical societies to facilitate the optimal application of TAVR.

Keywords

• Transcatheter aortic valve replacement/implantation
• Aortic valve stenosis
• Guidelines
• Monitoring
• Safety and efficacy