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Clinical Research of Venus A aortic valve in China

Date:2016年11月7日 15:20
Since the world's first transcatheter aortic valve replacement surgery in 2002, more than 150,000 TAVR surgeries have been performed worldwide. TAVR was carried out in China since 2010. On September 10, 2012, TAVR were successfully performed on two elderly patients with severe AS who could not undergo surgical "valve replacement" and domestic valves were implemented for the first time by Fuwai Hospital of Chinese Academy of Medical Sciences, marking the start of clinical trial of domestic valve.
 
Background of Venus A Trial 
China's retrospective non-randomized study suggests that the incidence of AVC in middle and old aged patients over 50 years old is 49.38%. With the aging of the population, the incidence of CAS increases, which will become the primary cause of valvular disease in our country. Many AS patients, because of high-risk surgical / contraindications, are unable to accept surgery, so they can only rely on drug treatment. However, drugs only relieve symptoms of heart failure, but fail to solve the problem of valvular stenosis or insufficiency, seriously affecting the quality of life and bringing heavy burden to family and society. Therefore, it is imperative to initiate domestic active valve research.
Status of AS Patients In China
According to retrospective analyses of 12 heart centers in China, older patients (≥ 65 years) have more complications, higher degree of calcification and higher proportion of bicuspid aortic valve, resulting in the difficulties to carry out early domestic TAVR. It is very hard to select appropriate patients strictly conforming to the international TAVR inclusion criteria. Moreover, physicians are not aware of the diseases treated by surgical methods. Therefore, the research is also a continuous learning process for physicians, which enables them to constantly adjust and improve TAVR to make it more suitable for domestic patients through practicing.
 
VenusA Research Results
In view of the characteristics of AS patients in China, a meeting was held halfway through the research and improvement suggestions such as enhancing Venus A valve’s support and delivery system pressure were put forward. It was also proposed to increase the number of bicuspid aortic valve patients that accounted for a large proportion of AS patients. The data of the improved valve implantation showed that the success rate increased significantly. At 2014 TCT, researchers successfully broadcast a case of aortic valve stenosis(bicuspid aortic valve). The operation was a success with no paravalvular leakage after surgery, indicating that Chinese valve products were more suitable for domestic patients. 
Among the 101 high-risk AS patients in the five national heart centers, the average age was 75 with the average STS score 6.