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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 6.68%. While tricuspid aortic valve occupied 55.2%, bicuspid aortic valve accounted for 44.8%.The ascending aorta-access, right transfemoral-access and left transfemoral-access accounted respectively for 15%, 46% and 39%. The results showed that the overall success rate of TAVR was about 96%, of which tricuspid aortic valve was 98% and bicuspid aortic valve was 93%; the all-cause mortality rate after 30 days was 4.9%,the same as the international level; 20.75% of the patients had atrioventricular block; the incidence rate of FAS population with composite endpoints events like all-cause mortality or severe stroke was 7.6% at 12 months, which was similar to that of foreign products and clinical trials. The implantation rate of pacemaker was 18.5%. The follow-up after one year also revealed that postoperative patients’ cardiac function and MVPG improved significantly, with much less aortic regurgitation. Conclusion: VENUS-A with strong supporting force, was a valve stent suitable for Chinese valve disease characterized by more calcification. The success rate of valve implantation was high and the incidence rate of complications was similar to that of foreign reports. Therapeutic effect of hemodynamics maintained one year after the implantation. The implantation rate of permanent pacemaker after operation was comparable to that of foreign products or lower than that of similar products. Developed in China and with independent intellectual property right, the Venus –A TAVR systematic treatment was not suitable for patients with severely calcified aortic stenosis in conventional surgery. The incidence of composite endpoint (all-cause mortality or cerebral stroke) at 12 months after surgery was lower than the pre-set target threshold level. The trial result showed good clinical safety, efficacy and handling performance. 
About Venus A Trial
The project is invested by DNV Capital. Although transcatheter valve replacement is minimally invasive, it is more technically demanding, requiring multidisciplinary cooperation and operation in hybrid operation room. Supported by Project 863 and Twelfth Five-Year Plan, Venus Medtech developed the transcatheter Aortic Valve Implantation device of VENUS-A, Proved by animal experiments and passed vitro test, it is qualified for clinical trials. Venus A trial was organized by the famous cardiologist Gao Runlin,member of the 11th national committee of CPPCC and academician of China Engineering Academy. Fuwai Cardiovascular Hospital as the head of the unit,West China Hospital of Sichuan University,the Second Affiliated Hospital Zhejiang University School of Medicine,Jiangsu Province Hospital,and Shanghai Ruijin Hospital collectively completed this project. This was the first clinical trial of transcatheter valvular heart disease in China,which was not only a success but also a scientific and technological innovation in China in the true sense.
At present, the project has also achieved the following exciting results: (1) providing our people with a completely self-developed and innovative artificial valve which is safe, effective and of high quality and low price. (2) creating a set of technical route,ranging from valve evaluation to interventional procedure which has laid a foundation for the spread of this technology. (3) truly investigating the huge difference in features of onset and morphologic characteristics of Chinese valvular heart disease,which stresses the importance of developing Chinese valve.(4) reflecting the trend of multi-disciplinary integration under new technical conditions.
 
Future Prospect of Domestic TAVR
At present, Venus A valve has completed the national “Twelfth Five-Year Plan " science and technology support program, becoming the new technology product with independent intellectual property rights in our country and valve stent suitable for Chinese valve disease (Venus MedTech); the implantation rate of permanent pacemaker after operation was comparable to that of foreign products or lower than that of similar products. TAVR is effective and is cheaper than SAVR. Therefore, with the popularization and development of technology, TAVR surgery cost and the incidence of complications are expected to further reduce and cost-effectiveness will be greatly improved as well.
It is imperative to carry our TAVR in China. Although it was difficult to perform early domestic TAVR,continuous improvement was made in the accumulation of clinical experience to better serve Chinese patients with severe calcification and bicuspid aortic valve. In the future, the development of domestic TAVR will require cooperation between the government, the society, enterprises and hospitals so that TAVR can truly experience orderly development at home and benefit more patients.

TypeInfo: Venus A 试验

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