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Venus A's Chinese clinical trial registered research result appeared in ACC, allowing international experts to learn more about the safe and effective treatment of BAS patients with TAVR. Cheer for Chinese valves!

Date:2017-9-27 18:36

On the afternoon of March 16th, in Washington, D.C., at the ACC2017 annual meeting, a distinctive international symposium on the development and implementation of emerging-countries’ guidelines drew the attention of many scholars. Academician Ge Junbo of Zhongshan Hospital affiliated to Fudan University acted as Chairman of the special session. Professor Jiang Jun from the Second Affiliated Hospital of Zhejiang University School of Medicine, on behalf of Dean Wang Jian’an, reported on the treatment of bicuspid aortic stenosis (BAS)and the consensus and recommendation of our experts on BAS. After the report, Prof. Jiang received an exclusive interview with "Heart Online" to talk about the difficulties and challenges faced by BAS patients undergoing transcatheter aortic valve replacement (TAVR) and the experience from his center.

Academician Ge Junbo presided over the meeting

Professor Jiang delivered the report

1. TAVR in China
In 2010, Academician Ge Junbo completed the first case of TAVR, and so far a total of 28 hospitals carried out about 850 cases, of which around 700 cases adopted the femoral artery pathway. The types of valves used include self-expanding valves, balloon-expanding valves and mechanical expanding valves. It is worth mentioning that some of our self-developed valves are very promising, such as VENUS-A、VitaFlow and J-Valve.
Our country has completed the first multicenter Venus A study, with a total of 101 patients with severe symptomatic aortic stenosis. The follow-ups after 30 days, 180 days and 1 year have all showed good results. Currently, the valve is awaiting the approval of China's regulatory authorities to launch in the market. 
2. BAS is common in China, and TAVR can benefit the patients
In the study of Venus A, the patients with BAV stenosis accounted for 45% of all cases, well above the less than 10% rate of the foreign countries, with higher 0-type BAV and more serious calcification. 
The 2012 European guidelines listed BAV patients as relative contraindications for TAVR and did not recommend TAVR for routine use. Furthermore, the TAVR application to BAV patients faces a series of technical challenges, such as the problems of asymmetric calcification, asymmetric valve closure, aneurysm or arterial dissection, and so on. For example, PARTNER studies exclude BAV patients. However, in 2002, Professor Cribier's first case of human TAVR was a BAS patient.
Comparison of the results of BAV patients with TAVR and tricuspid aortic valve (TAV) stenosis patients with TAVR , it is discovered that in terms of 30-day mortality, 30-day safety results, and 1-year mortality data, BAV patients are no less worse than TAV patients. And there’s no significant differences about the results of middle to severe level of perivalvular leakage(PVL) and pacemaker implantation.
In addition, Prof. Jiang briefly introduced "Hangzhou experience" which referred to his center’s treatment of BAV stenosis, such as the use of progressive balloon measurements to optimize selection of valve size. The center’s TAVR data from 66 patients with BAV stenosis showed that 1-year mortality rate was only 13% and the prognosis was better. Besides, the ejection fraction of these patients increased significantly after operation, from 55% of the baseline to 65% after 1 year. 
Live interview
Q: China has classified BAS as a relative indication of TAVR, while the European guidelines classify it as a relative contraindication. Is there any evidence supporting this strong consensus? 
Prof. Jiang:
Some small sample studies abroad and PARTNER’s large-scale trials have excluded patients with BAS, but some single center retrospective studies have shown that there is no significantly higher incidence rate of BAS patient with TAVR than that of TAV patients with TAVR regarding complications like death, perivalvular leakage and pacemaker implantation. 
In the registered study of VANUS-A valve in China, that of BAS accounted for about 45%. From the experience of our single center, we published an article two years ago in Journal of Zhejiang University, which suggested that the effects of TAVR on BAS patients were close to those of TAV patients, via the use of a number of reasonable techniques such as balloon-assisted measurements and placement from higher positions.
Because of the high incidence rate of BAS of Chinese patients, the treatment of these patients will be a very big problem if our experts consider BAS to be a relative contraindication. Therefore, based on some literature review and our country's data, our experts believe that BAS can be classified as a relative indication of TAVR. Experienced physicians can try to carry out TAVR especially in the experienced centers.
Q: In addition to a high proportion of BAS in patients with severe aortic stenosis in China, what are the other characteristics of those patients compared with western group?
Prof. Jiang:
There is a higher proportion of valve calcification in Chinese population. With serious calcification, perivalvular leakage is more likely to occur after TAVR and valve expansion may also be affected. Therefore, the technical requirements are higher. In a word, BAS and calcification are two distinct characteristics of the patients with aortic stenosis in China.
Q: What is the status of domestic TAVR development?
Prof. Jiang:
Domestic development of TAVR is still subject to relatively large restrictions, the most important reason being that China's Food and Drug Administration has so far not approved the launch of any kind of prosthetic valve in domestic market. Our country has carried out more than 800 cases, basically completed through clinical research. This is a huge restriction. .
Secondly, our country may have certain limitation in the hardware equipment. TAVR has a high demand for surgery and requires a hybrid operating room. At present, China's hybrid operating room is not as advanced as that in western countries.
In addition, there is a relatively big question concerning our country in terms of personnel training. Unlike PCI or radiofrequency catheter ablation (RFCA) where one surgeon could oversee the whole operation, TAVR has relatively higher risk and requires a whole team’s assistance for its operation. The operation involves preoperative ultrasound and CT screening, intraoperative anesthesia cooperation, so the full cooperation of the imaging department, cardiology, cardiac surgery and anesthesia department is very important, especially for high-risk patients. 
Among three kinds of domestic valves, VENUS-A valve has completed clinical research; the selection of Vitaflow valve patients for surgery was completed; and the research on J-Valve, trans-apical valve for surgical use, was also almost completed. Because the patient population of our country is very huge, if our regulatory authorities can approve these valves, the outlook of TAVR will be very promising. After all, our patients are worried about large–scale thoracotomy, and generally there will be a lot of concern. If these valves are approved to launch in the market, more patients will be benefited as a result. 
In short, the smooth development of TAVR will benefit a lot from the strict training of physicians, the mastery of the standardization of technology and the update of expert consensus.
This article is reproduced from Heart Online
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