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Wu Yongjian: Innovation and Development of TAVR in China

Date:2016-11-18 14:14

Wu Yongjian, Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)
Vice Director of Coronary Heart Disease Centre of Fuwai Hospital Chinese Academy of Medical Sciences. Conducting in-depth study in the early diagnosis of acute myocardial infarction, treatment of severe myocardial infarction (including cardiogenic shock), heart failure, hyperlipidemia and diabetes, etc. Reviewer of Chinese Journal of Cardiology, Chinese Circulation Journal and Chinese version of BM magazine, and member of medical accident appraisal committee in Beijing.
Aortic valvular heart disease refers to pathological changes of the heart valve, mainly shown as valvular stenosis and incomplete closure caused by various factors. The standard treatment of aortic valvular heart disease is surgical thoracotomy to repair or replace the valve. However, for some patients, especially elderly patients with physical problems, such as previous thoracotomy, severe respiratory dysfunction or intense weakness, surgical thoracotomy means a huge risk and patients lose the chance of receiving conventional surgical treatment. Compared with thoracotomy, TAVR leaves fewer traumas, requires no extracorporeal circulation and brings hope to these patients.
The first case of TAVR was conducted in 2002 and the technology has continued to mature with ten years of development. The surgery is changed from the original atrial septal approach to femoral artery, apical, left subclavian artery, ascending aorta and other approaches; the artificial valve has developed from the initial balloon- expanding to self-expanding mode and at present dozens of valves have entered clinical trials; the delivery system has also constantly evolved from the initial 24F to current 16F and is expected to be further reduced to 12F; the same is with the recovery system. Improvement of artificial valve makes the valve replacement surgery easier and safer. Perivalvular leakage and implantation rate of permanent pacemaker continue to decline. As of August this year, there are 17,000 cases of TAVR surgeries globally.


Although China's transcatheter interventional treatment of valvular heart disease started slowly, it has continued innovating. Firstly, the characteristics of Chinese patients with valvular disease are different from those in the West. While the rate of elected patients with bicuspid aortic valve in the Twelfth Five-Year Plan was more than 50%, while only 1% to 3% in western countries. Secondly, there are more cases of valve calcification in China than that in western countries, leading to the differences of artificial valve used in the surgery and more difficulties in the surgery. Moreover, during implementation of the Twelfth Five-Year Plan, Venus A-valve has been constantly improved and emerged as a reliable artificial valve for Chinese people. This is the biggest innovation based on the characteristics of Chinese people and also provides a foundation for the development of a new generation of valves. Bicuspid aortic valve has always been TAVR contraindication. When the Twelfth Five-Year Plan began, bicuspid aortic valve was not regarded as the selection criteria. 
But in the mid-stage study, researchers found the high rate of bicuspid aortic valve pattern in TAVR population, so they decided to use Venus A-valve to treat patients with bicuspid aortic valve stenosis after extensive and in-depth discussion with CFDA and many experts. After several cautious applications, researchers further demonstrated the safety and feasibility of Venus A-valve in treating patients with bicuspid aortic valve stenosis. The 30-day and 1-year follow-up results showed that there were no significant differences in success rate, pericardial leakage and permanent pacemaker implantation from abroad. China’s research data of bicuspid aortic valve was repeatedly reported at international conference, gaining recognition of counterparts abroad. Therefore, bicuspid aortic valve stenosis is expected to be removed from the TAVR contraindications and included in the relative indications, marking China's contribution to the world.
This article is reproduced from Clinic

TypeInfo: Industry

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