Open a new era of treatment of senile valvular heart disease in China

Release date: 2014-07-11

Open a new era of treatment of senile valvular heart disease in China

——The national “Twelfth Five-Year” Science and Technology Support Program has undergone a major progress in the transcatheter aortic valve implantation project.

There are four valves in the heart called the mitral, tricuspid, aortic, and pulmonary valves. The first two are responsible for blood returning to the heart, and the latter two are responsible for blood ejection from the heart. Each time the heart contracts and relaxes, the four valves open and close once. The heart's valve is as thin as paper, but it is the hardest part of the body.

When the valve is narrow, it will affect the forward flow of blood, affecting the blood supply of the various organs of the body and the exchange of oxygen in the lungs. When the valve is closed, blood reflux will occur, and it will be useless. It will also supply blood to the main organs of the body. After a certain period of time, the shape of the heart changes, cardiac hypertrophy, atrial or (and) ventricular enlargement, decreased cardiac systolic function, and eventually pump failure.

Many systemic factors may affect the function of the valve, such as rheumatic fever and syphilis infection. Although these diseases are first manifested in other parts, the heart valve can be damaged by the autoimmune system, respectively, rheumatic heart disease and syphilitic heart disease. With the increase of age, the degenerative changes of heart valves become the main cause of valvular disease, which is characterized by thickening, calcification, fusion of the valve, and varying degrees of stenosis and regurgitation. Compared with 20 years ago, the etiology of Chinese valvular heart disease has undergone tremendous changes. Take the National Cardiovascular Center Fuwai Hospital as an example. In the 1980s, most patients in all wards were rheumatic heart disease. Today, valvular patients in adult surgical wards are mostly degenerative valvular disease. From a therapeutic point of view, the treatment of senile valvular disease is more challenging than rheumatic heart disease, mainly due to the decline of the body organs of the elderly, combined with a variety of diseases such as lung disease, renal insufficiency and Stroke, physical weakness, treatment difficulty and risk increased significantly.

The treatment of conventional valvular disease is thoracotomy, which removes the damaged valve and implants a new prosthetic valve. Prosthetic valves are divided into biological valves and mechanical valves, which require life-long anticoagulation. The operation needs to be performed under cardiopulmonary bypass, that is, an extracorporeal circulatory system is first established during the operation to temporarily replace the heart work. When the valve is removed and replaced, the patient's heart must stop. This requires the patient's other organs to be normal or relatively normal, otherwise complications will occur after surgery.

With the aging of China, the number of elderly patients with valvular heart disease has increased year by year. Although conventional surgical thoracotomy is the standard surgery for valvular disease, due to age, patients have multiple diseases, and the risk of thoracotomy is too high. High, and lost the chance of surgery. According to the clinical epidemiological survey, about one-third of the elderly patients are not treated with surgery because of comorbidities. At least 50% of the elderly patients can only receive conservative treatment, and the conservative effect of the drug is very limited.

Interventional therapy began in the 1980s, and most patients with coronary heart disease and arrhythmia can achieve good results through interventional therapy. The method of interventional valvular valve replacement surgery has been stalled, mainly due to the large volume of the artificial valve, which is difficult to implant into the body through the catheter. Foreign countries have tried and succeeded at the beginning of this century, and have made great progress in recent years. After nearly 20 years of continuous exploration, it was not until 2002 that the first transcatheter aortic valve replacement was born in France. This patient has been the end stage of valvular disease, manifested as cardiogenic shock, life dying. There was no possibility of thoracotomy. The doctor performed transcatheter valve replacement on the basis of animal experiments. At the time, the doctors who performed the operation had no experience in operation. The procedure of the operation is as follows: through the patient's femoral vein, the catheter is sent to the right atrium, across the interatrial septum into the left atrium, through which the wire is fed, the wire is advanced, through the mitral valve, into the left ventricle, and then to the left ventricle The outflow tract continues to climb across the aortic valve to the ascending aorta, and finally the wire travels to the contralateral femoral artery to establish a surgical pathway. A prosthetic valve is delivered along the pathway to the valve of the lesion for release. Immediately after surgery, the patient's cardiogenic shock is effectively treated. This marks the arrival of a new era of valvular disease treatment. In the following period, the world's major research centers have invested in the exploration of this technology, including the optimization of artificial valves, the delivery system is more minimally invasive, and the experience is accumulating. More than 100,000 patients worldwide have undergone this procedure, and clinical studies (PARTNER study) show that the mortality rate from one to three years is reduced by more than 50% compared with those without treatment, and these patients are unable to Patients with high risk of routine thoracotomy or surgery.

Transcatheter valve replacement, although minimally invasive, requires more technical conditions. The need for multidisciplinary collaboration, including intracardiac, surgical, preoperative imaging assessment and intraoperative imaging guidance is very important. Surgery needs to be performed in the hybrid operating room. Under the support of the 863 project and the “12th and 5th” science and technology support plan, the VENUS-A transcatheter aortic valve insertion device developed by Hangzhou Qiming Company passed the animal test and passed the in vitro test. Approved by the ethics committee of Fuwai Hospital and various research units, it began to enter clinical trials on September 7, 2011, mainly for surgical inoperable and high-risk patients with severe aortic stenosis.

The project was organized and implemented by our famous cardiologist Gao Runlin. The National Cardiovascular Center Fuwai Hospital was the leader unit of Sichuan Huaxi Hospital, Zhejiang University Second Hospital, Jiangsu Provincial People's Hospital and Shanghai Ruijin Hospital. All participating hospitals have been carefully selected and have strong capabilities in the Cardiology, Surgery and Imaging departments and can form a true heart team. Due to the difficulty and high risk of surgery, each patient needs to be carefully discussed and developed by the cardiac team before the operation, and how to deal with the failure of the operation. The study enrolled 80 patients, and now all of them have been selected. The national mortality rate is 5% in 30 days of surgery, which is at a good level internationally. In the early stage of research abroad, the perioperative mortality rate is as high as 10-15%. Therefore, all hospitals have invested in elite soldiers, and almost all hospitals are directly led by the dean. It can be seen that this study is different from general clinical research. The project entered the implementation phase in September 2011. It should be said that the early experiencing a very difficult exploration phase, from the continuous transformation of the prosthetic valve to the understanding of the lesion, to the problems and solutions in the operation, the researchers have worked hard and wisdom. It went smoothly in the middle and late stages. It can be said that the project is an exploratory study that constantly discovers problems and solves problems, full of panic, confusion, excitement and joy. The completion of the project marks the dawn of the transcatheter treatment of valvular heart disease in China. This is the first clinical trial of transcatheter valvular disease in China and was the first to succeed. This is a study of China's scientific and technological innovation in the true sense.

Multi-center clinical trials led by the National Cardiovascular Center are expected to be completed by the end of this year. The project has also achieved some exciting results:
1. It can provide a artificial valve that is completely independent research and development, independent innovation, safe, effective, cheap and beautiful, and safe to use.

2. Created a complete set of technical routes from valve evaluation to interventional operation, laying the foundation for the spread of this technology in the country in the future.

3. For the first time in the true sense, there is a huge difference in the characteristics and pathological morphology of Chinese valvular disease, which also illustrates the necessity of self-developed Chinese valve.
4. Reflects the trend of multidisciplinary integration under the conditions of new technology.

It is reported that clinical trials are expected to complete a one-year follow-up of all patients in June 2015. The valve developed by China is expected to be listed in the next year, which is of great significance to the aging China.

Source: Sina

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