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“CHINA VALVE Hangzhou” TAVR Summit Forum Report

Date:2017年9月19日 16:29

On March 26, 2016, CHINA VALVE Hangzhou started the grand opening ceremony by the side of the West Lake with a little cool weather. The conference was hosted by the Second Affiliated Hospital of Zhejiang University School of Medicine, Dean Wang Jian’an of this hospital and Professor Horst Sievert of German Sankt Katharinen Hospital, delivered the welcoming speech. The German expert Grube called "missionary" of Chinese valves mentioned in the conference that a few years ago, the valve session at China Interventional Cardiology Conference (CIT) attracted only 10 people to attend, whereas today there were more than 300 attendee filling this venue, with valve teams made up of experts from cardiology, heart surgery, anesthesia, radiation, heart ultrasound fields of major domestic hospitals. Chinese valve intervention field is lagging behind the world in terms of start and development, can it usher in the long-expected spring and open the era of competitions? We shall wait and see.

  

Academician Ge Junbo: The way to explore the valve intervention in China
Reviewing the research and development history of aortic valve in China, we found that in the long process of exploration, the incidence rate and characteristics of aortic valve disease in Chinese people are not the same as that of Westerners, which means that domestic valve intervention cannot be synchronized with the same development of foreign valves, nor can it just copy the latter’s development. Compared with the Chinese population in Los Angeles, patients in China feature more serious calcification of aortic valve, more bicuspid aortic valve deformity and more aortic valve insufficiency, undoubtedly posing difficulties for valve implantation. Therefore, it is necessary to explore our own path for valve development. Currently, more than 500 cases of transcatheter aortic valve replacement (TAVR) have been performed in 200 hospitals in 9 provinces, of which 1/3 are bicuspid aortic valves. Prof Wang's team has developed a TAVR surgical approach targeting bicuspid aortic valves, and they are sharing the experience with the world. With the aging population of China, the incidence rate of degenerative valvular heart disease will gradually increase, so will patients’ demands.  So Academician Ge predicts the next few years will see the rapid development of TAVR. In the last year, our experts summed up Expert Consensus Decision Pathway for Transcatheter Aortic Valve Replacement based on their experience, and they hoped this consensus would provide assistance and guidance to the centre that would carry out TAVR operation.
Prof. Eberhard Grube: Looking at the pace of the world
Since 2002 Professor Cribier performed the 1st TAVR, it has been over 10 years. Over the past 5 years, TAVR has accumulated more experience and evidence, showing that TAVR has undoubtedly become the gold standard treatment for patients with extremely high risk of symptomatic aortic stenosis (AS). For high-risk patients, studies have shown that TAVR is comparable to surgery regarding the reduction of all-cause mortality rate. According to a study in the United States, TAVR is more advantageous than surgery and it can reduce stroke risk. So for high-risk patients, TAVR has become an alternative to surgery. PVL is a predictive factor for poor prognosis after TAVR implantation. With the improvement of the operation and the development of the devices, TAVR will show its stronger superiority. TAVR indications have been extended from extremely high-risk, high-risk, to intermediate-risk patients and to patients with biological valve failure. The latest study includes low-risk AS patients, and the 2-year follow-up shows that TAVR outcome is comparable to that of surgeries. In the near future, TAVR is expected to provide treatment for younger, low-risk AS patients; future TAVR will also include more indications, such as patients with high-risk multivalvular heart disease and simple aortic insufficiency and the safety of the operation will be further enhanced.

Gaorunlin: Unveil the Veil of the goddess of the moon
Venus is the goddess of love and beauty in Greek mythology and the earliest TAVR test in China is VENUS A produced by Venus Medtech. VENUS A is a kind of self-expandable valve, which is improved on the basis of Corevolve. The three combination points increase the stability and the support force and there are three characteristic marker points added under the valve, which is advantageous to the valve positioning. This valve design is more suitable for Chinese patients with serious calcification, small blood vessels, and more bicuspid aortic valves. The test of Venus A is a single group design, with 5 centers involved. The average age of patients is 75 years, and a total of 101 cases are completed, 40% of which features bicuspid aortic valve deformities. The 30-day and 1-year follow-ups show good results, with the death rate of 5% and Patient-Prosthesis Mismatch (PPM) rate of 18%. Compared with the same period foreign trials, the above data is at a lower level, reflecting the maturity of domestic TAVR valve intervention techniques and domestic valve VENUS A’s superiority and competitiveness.
Domestic Valve VS. Imported Valve
With the development of TAVR, a variety of new valves have sprung up, in addition to the FDA approved Corevalve Evolut R, Edward's Sapien, Boston Scientific’s Lotus, St Jude’s Portico and other new types of valves have completed clinical trials. The new valves have various features, with 30-day mortality lowered below 5%, and reduced PVL incidence rate. Lotus PVL incidence rate can even be reduce to 2%. Except the relatively high installation ratio of Lotus’ new pacemaker, the overall PPM installation rate can be reduced to be below 15%. The incidence of vascular complication after the implantation of the new type of valve is also reduced.
At the same time, a number of domestic enterprises do not fall behind. VENUS A is likely to obtain the approval of the domestic FDA this year. Suzhou J-Valve in West China Hospital has completed 103 cases of trials. The apical implantation can effectively improve valve regurgitation. Academician Ge Junbo from Shanghai Zhongshan Hospital presided over the test of Vita Flow produced by Shanghai MicroPort. The Vita Flow valve has enhanced support at the top and has large side hole to avoid damage to the coronary arteries, with electric release increasing stabilities. The follow-up shall be completed next year. And it is expected to be approved by FDA.
Regarding the question whether domestic valves or imported valves will occupy a large share of the Chinese market, Prof. Ge said: Domestic valve will soon obtain FDA approval, and it will take foreign valves some time to enter Chinese market. So there is no doubt that domestic valve will soon occupy the market. However, combined with the characteristics of Chinese patients like aortic valve stenosis, domestic valve also need continuous improvement to increase the indications of bicuspid aortic valve and reduce the occurrence of PVL. In the future, China's TAVR will embrace not only technological innovation, but also continuous improvement and perfection of equipment. I believe domestic valve will shorten the gap with the imported valve or even walk in the forefront.
TAVR era, are you ready?
Although the whole operation of TAVR is not very complicated, every operation is high-risk due to the old age and poor overall condition of the treated patients. Each step is critical and cannot be overlooked regarding selection of TAVR's team and patients, preoperative CT assessment, anesthesia, all aspects of implantation, postoperative drug management and prevention of complications and so on. At the initial stage, TAVR is limited to relatively larger centres and requires close cooperation between medicine and surgery. As for this, cooperation is ready from the Medicine team represented by Zhou Yujie from Beijing Anzhen Hospital, the surgery team represented by Meng Xu and the team of ultrasound, imaging and anesthesia. 
 
This article is reproduced from the CMT Xunhuan

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