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Kong Xiangqing Interview: transcatheter valve implantation into hot equipment localization is expected to break the "bottleneck"

Release date:2014-11-12Collect
365 Medicine: Professor Kong, Hello! Thank you for the interview! We learned that because the incidence of senile valvular degeneration rising, aortic stenosis (AS) has become the West valve replacement in elderly patients undergoing primary cause. In China, with the accelerated pace of aging, valvular disease is becoming Following coronary heart disease, arrhythmias are highly valued one elderly cardiovascular disease. Can you tell us about the occurrence and treatment status and development trend of China's valve disease?

Professor Kong Xiangqing: Aortic stenosis is a common type of senile degeneration is the most severe valvular heart disease, especially when severe stenosis (pressure difference across the valve is greater than 40mmHg). Previous rheumatic aortic valve disease primarily, but now gradually reduce the incidence of rheumatic heart disease, valvular degeneration gradually increased. Aortic valve stenosis due to heart blood can not pass through the narrow aortic valve normal shot from the left ventricle, resulting in insufficient blood supply to vital organs such as heart and brain, syncope, arrhythmia, angina, heart failure and even sudden death and other serious problems . According to incomplete statistics, in patients with severe aortic stenosis life expectancy of 3-5 years, once clinical symptoms, life expectancy will be reduced to six months.

The number of patients with aortic valve disease in China leads the world, with the economic level, the average life expectancy has been increasing, the incidence of aortic stenosis continues to improve, a conservative estimate of Chinese patients with aortic stenosis annual increase of 20 new ten thousand cases.

Aortic valve stenosis can be divided into: Surgical valve replacement therapy and conservative treatment to surgical valve replacement therapy, medical treatment can simply control the symptoms. Surgical valve replacement therapy has its limitations, especially for elderly patients with aortic valve stenosis, due to its often associated with other diseases, such as coronary heart disease, heart failure, pulmonary heart disease is not suitable for open heart surgery or thoracic surgery risky annual unsuitable thoracotomy or thoracotomy approximately 50,000 high-risk, apparently these people there is no treatment, only waiting for death in hopelessness. As our population ages, more and more of these patients, to challenge the health care industry. We have a responsibility to research and develop new methods of treatment for these patients in the hope of life extension.

2002 Professor Criber worldwide lead in transcatheter aortic valve implantation, and create a precedent for the treatment of minimally invasive aortic valve. Nearly a decade of development has proved that this technology is not well suited to solve the patient's surgical treatment of patients with aortic stenosis, but also provides a way for these patients, so transcatheter aortic valve implantation has become in recent years, heart hot content vascular areas by cardiology and cardiac surgeons of all ages. In recent years the world's major cardiovascular meetings will focus on the content as transcatheter aortic valve implantation, and has opened special academic exchanges, it is certain that transcatheter aortic valve implantation in the field of interventional cardiology very active, and a shining pearl shining in the forthcoming treatment of cardiovascular disease. But we should also see that due to the technological development of only 10 years or so, there are many questions waiting to be answered and solved, such as the treatment of a wide range of indications is not enough, patients over 70 years old is a basic requirement; equipment is great transported to the body but also a great delivery system; equipment is not recyclable, requires a one-time release of success; valvular life is not long, usually not more than 10 years; there are all kinds of complications during surgery, and some concurrent very serious disease, stroke, aortic valvular regurgitation, and local vascular complications sometimes fatal. For some of these problems transcatheter aortic valve implantation, doctors around the world in continuous efforts in research and development, optimization and other new instruments surgical procedure.

365 Medicine: Statistics show that after untreated patients with symptomatic aortic stenosis 2-year mortality rate of 50%. Compared to traditional surgical face the trauma, the need cardiopulmonary bypass, the risk of higher challenge, percutaneous aortic valve replacement (TAVI) as a new treatment is being received extensive attention. Can you please tell us about our country percutaneous aortic valve replacement therapy research and clinical development, the main challenges currently facing what?

  Professor Kong Xiangqing: It should be said that our enthusiasm in transcatheter aortic valve implantation aspect that is not lower than that of foreign countries, either cardiology or cardiac surgeon, also had a very good attempt. But our transcatheter aortic valve implantation than foreign but also many behind, for two main reasons: China has not yet market-oriented transcatheter aortic valve implantation equipment, whether imported or domestically. Some hospitals have been carried out transcatheter aortic valve implantation, but did not carry out as a routine surgery. Imported products are also very expensive, for the Chinese people is still a luxury, ordinary people have no chance to enjoy the fruits of this new technology. China has not yet fixed transcatheter aortic valve implantation treatment team, the lack of sufficient experience. Our group started in 2004 to design and develop transcatheter aortic valve implantation related equipment and Hangzhou Qiming Medical Corporation, through hard work, in 2007 with the support of high technology projects in 863 countries, the developed transcatheter main arterial transcatheter valve implantation and pulmonary valve implantation-related equipment, in 2011 completed a national in vitro testing and large animals. 2011 Heart Center in Vietnam, we first performed the first human transcatheter aortic valve implantation and transcatheter pulmonary valve implantation, and through the SFDA's record in 2012, is honored to have the heart of Chinese Academy of Medical Sciences Fu Wai multi-center clinical study of high Runlin disease hospital as chief investigator began Chinese Academy of transcatheter aortic valve implantation, has completed nearly 20 cases of transcatheter aortic valve implantation, initially made good clinical results. This research embodies the hospitals, medical device companies the wisdom and efforts of doctors and engineers, will be our transcatheter aortic valve implantation is a major progress and improvement, will offer price of aortic valve stenosis Wumart inexpensive treatment, they become gospel. The work of transcatheter aortic valve implantation has just started, and the world transcatheter aortic valve implantation, faces many challenges. Preliminary clinical trial results prompted domestic transcatheter aortic valve implantation equipment is not inferior to similar foreign equipment, although in terms of stroke prevention and other domestic equipment made reforms, but a large delivery system, local vascular complications, aortic valve implantation within the valve and paravalvular leakage, also become a problem in clinical application of this technology.

365 Medical: At present, China percutaneous aortic valve replacement is still relatively high cost of treatment, which to some extent restricts the active treatment patients. From the doctor's point of view, can you talk about patients with aortic stenosis valve replacement surgery indications choice? In other words, what the patient can not do what the patient must do?

Professor Kong Xiangqing: questions about indications of percutaneous aortic valve implantation, experienced different periods. Primarily for those who carried out the clinical needs of the beginning of percutaneous aortic valve implantation for aortic valve replacement (patients with definite calcified aortic stenosis and preoperative echocardiographic 45 days following manifestations: aortic transvalvular pressure> 40mmHg or mitral valve flow velocity> 4.0 m / s and the aortic valve area <0.8cm2 or effective orifice area <0.5cm2 / m2), but patients with severe comorbidities or poor cardiac function without the ability patients affected by surgical thoracotomy, large-scale clinical trials (eg PARTNER study) have confirmed percutaneous aortic valve implantation does provide a way out for this part of the patient, to extend their life and improve their symptoms. With percutaneous aortic valve implantation technology is more mature, there are several studies are attempting to broaden the indications, the following aspects:

(1) age, current general requirements for over 70 years, mainly on account of life issues Percutaneous aortic valve implantation of the valve, usually the life of the valve implanted in about eight years, plus once implanted valve percutaneous aortic valve dysfunction, and then implanted a valve, is another eight years, so add maximum term of 16 years. We are conducting research, mainly for calcification of the valve, the surface modification is expected in the future percutaneous aortic valve implantation valve life can be extended to 15 years, if so then implanted in a patient may have two valves, the total life can be to 30 years. This percutaneous aortic valve implantation of the valve may require an initial implantation of age to 60 years or even 50 years old.

(2) aortic valve regurgitation indications now is not the main consideration is implanted valve stability problems. The results show that if an existing application is accompanied by calcified aortic valve regurgitation can intervene valve implantation therapy. Studying pure aortic valvular regurgitation patients with calcification is not whether therapeutic intervention implantation, clinical success has been reported, you can look forward to.

(3) bicuspid aortic valve has not been a percutaneous aortic valve implantation indications, but our elderly patients with aortic valve stenosis is about 80% bicuspid aortic valve, we also have to consider the two-leaf percutaneous aortic valve stenosis aortic valve implantation included indications go. China also has experience in probably less than 20 cases of bicuspid aortic valve stenosis with the percutaneous aortic valve implantation treatment, a better clinical outcome.

(4) thoracic surgery is low-risk, high even people who are not in favor of early percutaneous aortic valve implantation for aortic valve stenosis, a recent study in expanding the range of PARTNER study, the more open-chest surgery or even a low risk and high people thoracotomy and the merits of interventional treatment is a key content, if verified interventional therapy is superior to thoracotomy, then we must broaden the indications for interventional therapy.

365 Medical: We understand that self-expandable aortic valve implant device has hosted our intellectual property you own research and development, animal studies have been completed, are entering clinical trials. Can you please explain the involvement of various foreign R & D compared to valvular apparatus, domestic valves have what characteristics? The indications are there? The successful development of domestic valve for changing the status quo of China's treatment of senile valvular disease will play what role?

  Professor Kong Xiangqing: I have already mentioned about the domestic research course in front of the instrument, although some hardships, but has achieved some results. Domestic valve is similar in function and mechanism of valvular MEDTRONIC companies, domestic and foreign compared valve has the following characteristics: the operation more simple, the main design aspects of the different instruments (such as the top of the valve has three recesses for easy loading); transport system more small (foreign 18F, domestic 16F), reduce peripheral vascular requirements, ease of operation, wide indications. Domestic valve undergoing clinical trials, if achieved SFDA clinical use permit, it would be China's first market-based valve, the hospital can be percutaneous aortic valve implantation as a routine work carried out. China has not yet market-based aortic valve implantation device, greatly limits the patient to use, many patients died waiting, unfortunately. We sincerely hope that the valve can be quickly listed domestically, while doctors in the treatment of severe aortic valve stenosis patients one more effective way, on the other hand patients with severe aortic valve stenosis can have some hope that their life has been extended. All in all, the success of the domestic valve will be a major event of China's medical and health services, but also to improve the health of our people to contribute.

365 Medical: localization of equipment is a major event benefits the country, but compared with mature foreign Combination mode, our relationship to be further rationalize production and research related companies also face relatively backward technology and smaller and other constraints. China-made equipment for the promotion of innovation and clinical applications, through scientific research in recent years, what are your experience and suggestions?

Professor Kong Xiangqing: Through these years of cooperation with enterprises, I deeply feel that our country is necessary to establish a set of research coordination mechanisms, many doctors now have many ideas in clinical work, especially the idea of solving the practical problems of patients very precious, we do not have a series of policies and environment to help them turn ideas into reality, a lot of valuable ideas and thus abortion; there are some ideas of engineers and technicians, they acquire knowledge materials, engineering, etc., enthusiastically, but either do not know how to do, or do they imagine, made product does not meet the clinical practice, clinical no way to use. I therefore propose to establish a research closely integrated model that allows health workers to participate in the work of engineers and technicians, while allowing engineers and technicians involved in the medical and health work, let them seamless. CIC is a very good platform for communication and innovation incubator, which consists initiated the creation of the country's top medical experts, is a direct echo of translational medicine in the cardiovascular field

. CIC's first summit held in January 2014 was the first attempt to Chinese medicine in the cardiovascular field conversion done, the purpose is to explore the establishment of an effective mechanism to Chinese needs of patients and clinical treatment concept and product design together, eventually forming solutions to meet these needs. CIC for clinical experts, public health policy makers and industry and investors to build a platform for close communication explore, go through this platform collaborative research, development and transformation based on patient demand for innovative therapies and products for the benefit of patients. I believe that the emergence of the CIC will bring together the strengths of all the clinical concept transformed into medical applications, and to indicate the direction for the development of China's medical industry, opening up ideas, to lay the foundation, and ultimately promote the improvement of China cardiovascular disease treatment technology.