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China Valve (Hangzhou) | The first homemade transcatheter aortic valve Venus A-valve is about to be launched in the market: striding forward in the TAVR era

Date:2016-11-18 23:52

During China Valve (Hangzhou), experts in the field of TAVR (transcatheter aortic valve replacement) from China and abroad attended the conference, significantly promoting in-depth discussion for the development of China in this field. At the conference, Clinic magazine invited Professor Wang Jian’an, Dean of the Second Affiliated Hospital of Zhejiang University School of Medicine,to be interviewed together with Professor Horst Sievert of Sankt Katharinen Hospital, Germany. In the dialogue, the two experts comprehensively discussed Chinese and foreign TAVR research and the characteristics of Chinese–made TAVR valves, and imagined how China's TAVR technology would "stand on the shoulders of giants", and continue to stride forward.
 
Globe vs. China: The stage of TAVR development
Q: In the context of the rapid development of TAVR Technology, Professor Wang founded China Valve (Hangzhou) Conference. What is the purpose of your founding this conference? What is the focus of China Valve (Hangzhou) Conference?

Prof. Wang:
Talking about the original intention of the conference, the Second Affiliated Hospital of Zhejiang University School of Medicine founded China Valve (Hangzhou) Conference to promote the rapid development of the treatment of Chinese structural heart disease, especially valvular heart disease. In recent years, the most active part of the cardiovascular field is structural heart disease and valvular heart disease. And China's heart valve technology in the whole lies in the stage between the start and the rapid development. Relatively speaking, the interventional therapy technology of coronary heart disease gradually enters the platform period. At the same time, our center has accumulated a certain number of cases and considerable experience, ever since the development of TAVR. And, in other areas of structural heart disease, such as Mitral clip and left atrial appendage closure, we have also played a powerful role in promoting the country. In this context, our center feels the need to introduce and share our experience to the country and even the global industry in a timely manner, so that more centers in China can also carry out this series of technology. 
This China Valve (Hangzhou) Conference focuses mainly on TAVR technology. In particular, we have invited Horst Sievert and other world's top TAVR experts. I hope that this academic conference of China Valve will contribute to the overall development of China's structural heart disease. 
 
Q: In the last two years, TAVR technology has developed rapidly. FDA has approved the first TAVR test for low-risk patients. Would Horst Sievert make an analysis as to what stage the global TAVR field has reached? What is the situation in China at present?
Prof. Horst Sievert:
On a global scale, the phase of TAVR technology is very different from place to place. Even in Europe, the development of TAVR technologies in different countries varies greatly. In Germany, for example, TAVR surgery is completely covered by medical insurance, while many European countries have not realized this coverage. Looking at some Asian countries such as China, TAVR technology can be said to have just started. So there are obvious differences among countries and regions.  
Whether it is clinical prognosis or technical level, I dare say that TAVR therapy has almost replaced surgical aortic valve replacement (SAVR), at least in high-risk patients. Through full practice and clinical trial, we have clearly confirmed that even if TAVR is not superior to SAVR, it is comparable with SAVR. It is unclear, however, how the TAVR treatment results in low-risk patients, such as those aged below 60 or 50 years of age. We do not have data on these patients with low risk or relatively lower age. This is the direction of TAVR 's next breakthrough.
 
An interpretation of the first TAVR study in China
Q: How can Venus A-valve research strictly select patients group? What are the characteristics of patients?

Prof. Wang:
Venus A-valve is a strict clinical study. We initially selected a group of patients with the average STS score of over 4 points, and they belonged to the middle-risk patients. Afterward, Fuwai Hospital of the Chinese Academy of Medical Sciences put forward more stringent standards, so we re-selected the group of patients, with STS score consistently higher than 8 points, who were the absolute high-risk patients. Therefore, it can be said that the safety and validity of Venus A-valve are effectively confirmed through such a group of patients. 

 

Q: At present, China has completed the first TAVR clinical study, as an academic advisor to Venus A-valve research, professor Horst Sievert, would you please share the design ideas of the research? How do you evaluate the reliability and rigorousness of Venus A-valve test?

Prof. Horst Sievert:
Venus A-valve Study is the first clinical study of this valve. Since we have never used this valve before, this is not a random clinical trial, but rather a prospective registration study. The design of the study is rigorous, and the results are compared with those of other valves. The final results are gratifying, as the results of Venus A-valve are comparable to the effectiveness and safety of international mainstream valves, including Corevalve valves and sapien valves.
On the other hand, through this study, we also clarified the direction in which Venus A-valve still needs to be improved. We have learned that Venus A-valve rack is similar to that of Corevalve. We also understand that Chinese patients have a higher degree of calcification, so the valve needs to have a stronger support. Overall, current data can be used to confirm that Venus A-valve is superior to other international valves when applied to Chinese patients. 
Finally, as a forward-looking study, each parameter of Venus A-valve is strictly monitored, and the results are very reliable. There is no doubt that the research data are completely reliable. I can fully illustrate this point because I have been involved in the treatment of most cases.
 
The first Chinese-made aortic valve plans to enter the market this year
Q: Venus A-valve, as the first domestically produced aortic valve, is due to enter the market in China in 2016. What are the characteristics of the valve developed independently in China?  Is there a unique advantage of Venus A-valve for Chinese patients?

Prof. Wang:
The Venus A-valve is the aortic valve developed independently by Venus Meditech. We expect this valve to be put on the market in China. 
The Venus A-valve valve has many characteristics compared with the mainstream foreign valve: 1. Its supportive force is stronger; 2.Valve fixation is more optimized, because the fixed point for the valve is added from the traditional 2 to 3; 3. The lower end of the valve design is different from the transverse design of the CoreValve valve, inclined to the vertical design, so the proportion of the conduction block will decline; 4. Stable and reliable. Therefore, I believe that this is a very potential aortic valve.
Regarding the application of Chinese patients, as there are many Chinese patients with bicuspid aortic valve, Venus A-valve proves  suitable for this kind of patients through practice and test analysis, with  very satisfactory results after implantation.
 
Q: What advice do you have for Chinese Intervention physicians and engineers as the Venus A-valve is about to be put on the market?How could China take a place in the global market for its domestic valves? 

Prof. Horst Sievert:
Venus A-valve is of the same type as CoreValve. In the past 1 to 2 years, CoreValve ’s role has been recognized in the United States and the valve is put into a lot of applications. In the process, the valve itself has undergone many improvements. So I believe that in the future use, many Chinese-made valves, including Venus A-valve, must also go through many improvements in the process.
In the technical aspects of the valve, I think three points are most important. The most important thing now is that Venus A-valve needs to be recyclable. The valve can be recycled in the event of an implanted ectopic condition. Second, it is important to further reduce the leakage complications of Venus A-valve. The third point is the need to reduce the release system’s (release sheath) damage ratio. All three points are  very important to China, and even the whole of Asia.
 
Future Road for China’s TAVR 
Q:  For the two experts, do you both  believe that we should carry out TAVR training for young intervention physicians?
Prof. Wang Jianan:
It is essential to provide technical training to young physicians. The training program of our center has already been implemented. The country has more than a dozen centers who have come to our center to receive a longer period of training. As the training of the actual site operation is very important, we have carried out a large number of simulation operation courses. According to experience, a TAVR surgeon requires at least 50 cases of surgical operation of the learning curve. Usually intervention physicians do not have any certainty before the surgical operation of 50 patients,after 50 cases, they can gradually cross the platform period.
Prof. Horst Sievert:
TAVR training is extremely important. TAVR is actually a very safe operation, but requires that the surgeon should be well trained. Otherwise, the surgeon in the course of the operation may make a lot of mistakes, some of which even bring disaster. Therefore, periodic training is necessary. For example, this  China Valve conference is a good training opportunity. In addition, companies need to carry out relevant technical training courses.
 
Q: TAVR technology has been very advanced in Europe and the United States, so how  should China learn from the achievements and experience from Europe and the United States as China is now standing on the shoulders of the giants?
Prof. Wang Jianan:
We need to fully learn from foreign experience, thus shortening our learning curve. But on the other hand, we still need to combine the actual situation of Chinese patients. The West also recognized that Chinese patients suffer from more severe calcification, and thus have higher aortic brittleness, with more bicuspid aortic valves.  In terms of these characteristics, the technical challenge in the treatment of patients with aortic stenosis in China is greater than in Western patients. Therefore, the treatment of Chinese patients must be combined with the clinical characteristics of Chinese patients.
According to the experience of our center, for the patients with bicuspid aortic valve, we choose a smaller valve, and implant it at higher levels. These are our summary of the experience, which has also been affirmed by Western experts. For the next step, our country needs to expand the sample scale of the study, and gather a larger amount of data for further summary.
Prof. Horst Sievert:
The core of this question is "who is the giant?" And "who stands on the shoulder?" It takes time to prove. Because when I see the progresses made by China over the past three years, I think that China may become the giant in the next three years, and perhaps soon physicians from the United States and Europe will rush to China to study TAVR technology.
 
Q: FDA has recently approved clinical trials of the first TAVR in the treatment of low-risk patients. In this context, how should China's future TAVR research be carried out; what aspects or directions should be focused on in research?
Prof. Horst Sievert:
I think that the most urgent need for China is the improvement of valve technology. At present, many people in the industry are talking about random controlled trials of TAVR, and I must say that I do not agree with this. Now that we have made sure that the treatment of TAVR is comparable to SAVR through test, I think the most important thing is to improve valve technology. As far as current evidence is concerned, the test data for different valves are comparable, so we need R & D and improve valve technology, rather than do more repetitive clinical trials.
 
This article is reproduced from the magazine Clinic

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