Smaller size, less friction, better blood compatibility
Artificial heart made in China brings hope to patients
As the most effective treatment for heart failure, the 5-year survival rate of patients after heart transplantation can reach 80%-90%, and the 10-year survival rate can reach 70%.
At present, there are nearly 1 million patients with end-stage heart failure in my country, but there are only about 400 to 700 heart transplant donors each year.
In the absence of donors for heart transplantation, artificial hearts have a lot of room for development.
Its demand will grow exponentially in the future.
For a long time, heart transplantation has been the best treatment for patients with end-stage heart failure, but due to the scarcity of donors, in recent years, people have begun to turn their attention to the "life-prolonging machine"-artificial heart.
The European Commission approved the commercial use of an artificial heart manufactured by French Chalmatt; in the Heart Surgery Center of Sichuan Provincial People’s Hospital, the first domestic patient with a commercial artificial heart implanted successfully recovered and discharged... Recently, there have been frequent good events in the field of commercial artificial hearts. Commercialization also gives patients with advanced heart failure (hereinafter referred to as heart failure) a chance to survive.
So currently, how many iterations of artificial heart technology have gone through?
Is my country's artificial heart technology mature?
What about the future development trend of artificial hearts?
The only effective way to replace heart transplant
With the increasing aging of our country's population, the incidence of chronic diseases such as coronary heart disease and hypertension has been increasing year by year. Heart failure is the "last battlefield" of cardiovascular disease, and its morbidity and mortality have remained high.
According to the "China Cardiovascular Disease Report 2019", a survey involving 15,518 people in 20 cities and rural areas in China showed that the prevalence of chronic heart failure among people aged 35 to 74 in China was 0.9%.
According to Hu Shengshou, academician of the Chinese Academy of Engineering and president of Fuwai Hospital of the Chinese Academy of Medical Sciences, the long-term effect of medical drugs for end-stage heart failure is not good, and the 5-year survival rate of patients with heart failure is only 35%.
As the most effective treatment for heart failure, the 5-year survival rate of patients after heart transplantation can reach 80%-90%, and the 10-year survival rate can reach 70%.
“However, there are currently close to 1 million patients with end-stage heart failure in my country, but the annual supply of heart transplants is about 400 to 700. Heart transplant donors are scarce.” said Wang Wenyan, chief physician of the Heart Failure Center of Sichuan Provincial People’s Hospital, in the United States There are about 60,000 to 100,000 patients waiting for a heart transplant each year, but only about 2,000 patients complete a heart transplant each year.
Artificial heart is known as the "jewel in the crown of medical devices". Its main function is to use biomechanical means to partially or completely replace the pumping function of the heart and maintain the blood circulation of patients. It is an effective treatment method for patients with end-stage or severe heart failure. It is also the only effective treatment to replace heart transplantation.
Wang Wenyan said: "In the absence of donors for heart transplantation, artificial hearts have a lot of room for development. The industry believes that the demand for artificial hearts will grow geometrically in the future."
Technology has matured after three generations of innovation and optimization
So far, the global artificial heart technology has experienced three generations of technological route evolution, innovation and development: the first-generation pulsatile pump, which is larger in size, and produces blood flow similar to that produced by human heart beats; the second-generation axial flow pump , The body is only larger than a fist, but the blood flow produced cannot simulate the blood flow produced by the human heart beat; the third-generation centrifugal pump, the body is further reduced, the mechanical friction is small during operation, and the friction and heat generation can be avoided as much as possible The blood is destroyed and the blood flow is similar to the blood flow produced by the beating of the human heart.
Previously, only developed countries such as Europe, the United States, and Japan had mature technologies for artificial hearts. There is no similar product on the market in my country. In order to achieve a domestically produced artificial heart with international cutting-edge standards and reasonable prices as soon as possible, under the promotion of the Chongqing Municipal Government, Chongqing Yong Renxin Medical Devices Co., Ltd. introduced Japanese technology and produced the implantable left ventricular assist system-"Yongrenxin" artificial heart, which was successfully approved by the State Food and Drug Administration on August 26, 2019.
As the only auxiliary artificial heart currently on the market in China, the "Yongren Heart" artificial heart belongs to the third generation of artificial heart, which has been greatly improved and optimized on the basis of the second generation.
According to reports, the "Yongren Heart" artificial heart adopts an implantable left ventricular assist system with a centrifugal pump structure. It consists of internal and external components. By setting up a bypass from the left ventricle of the heart to the aorta, the heart pump function of the patient is improved. Play a partial replacement or auxiliary role.
The artificial heart has physical characteristics such as "low speed, large flow, and easy to produce physiological pulsating blood flow", and has excellent biocompatibility, which can significantly reduce the risk of common complications after artificial heart implantation. Among the patients in clinical trials of the device, the longest survival time after surgery has exceeded 10 years.
"The'Yongrenxin' artificial heart has a self-innovated pure water system, which allows the artificial heart's devices to be suspended in water, greatly reducing the friction between the devices during operation, thereby reducing friction and heat generation to blood cells The damage caused. At present, the "Yongrenxin" artificial heart has started the second generation of miniaturized blood pumps and new types of blood vessel technology improvements." Zhang Benyan, chairman of Chongqing Yongrenxin Company, said that the second generation of miniaturized blood pumps is compared with the first The weight and volume of the first-generation product are reduced by about half, making it more compact.
With it, surgical procedures will be simplified, surgical trauma will be less, and the incidence of stroke can be effectively reduced.
Wang Wenyan said that the first domestic patient with a commercial artificial heart implant was successfully recovered and discharged from the Sichuan Provincial People's Hospital, indicating that my country is technically mature for commercial artificial heart.
At present, another artificial heart is undergoing clinical trials in China. It is an ultra-small all-magnetic levitation artificial heart produced by Suzhou Tongxin Medical Equipment Co., Ltd. (hereinafter referred to as Suzhou Tongxin Medical).
This product also belongs to the third generation of artificial heart, which is characterized by a non-contact bearing, which drives the impeller to rotate through a magnetic suspension, which eliminates the mechanical friction of traditional bearings, avoids blood damage caused by heat generation, and has good blood compatibility.
Someone in the industry believes that among the various technical approaches of artificial hearts, the full magnetic levitation technology is the only way to fundamentally improve the blood compatibility of artificial hearts.
As long as the challenge of size is overcome, artificial heart technology can be pushed to a new level.
Since 2014, Suzhou Tongxin Medical and State Key Laboratory of Cardiovascular Diseases has conducted in-depth research on the complete magnetic levitation technology of blood pump impellers. Through 37 large animal experiments, the device's anti-electromagnetic interference, pump operating temperature monitoring, Hemocompatibility, surgical tools, and anticoagulation strategies have been further optimized, and in June 2017, the report of 6 large animals that survived 60 days required by the China Institute for Food and Drug Control was completed.
From June to October 2017, Beijing Fuwai Hospital passed ethical approval in the form of humanitarian exemption, using Suzhou Tongxin Medical’s third-generation all-magnetic levitation artificial heart, which had completely independent intellectual property rights and had not yet entered the clinic, to treat three critically ill patients , Succeeded.
It is worth noting that regardless of the generations of artificial hearts, they must rely on external power sources to supply energy. A pump cable passes through the "tunnel" in the body to supply power, which brings certain inconvenience to patients.
At present, domestic and foreign research and development are under way to design wireless charging methods for artificial hearts.
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Multi-disciplinary close cooperation is required for implantation and management
In the past, my country's traditional medical model was mostly professional-centered, divided into multiple relatively independent specialized departments, such as intestinal problems, go to the gastroenterology department, and heart problems to go to the cardiology department. The work between the departments is relatively independent.
Wang Wenyan, the chief physician of the Heart Failure Center of Sichuan Provincial People's Hospital, pointed out that this is only suitable for traditional disease management. Projects such as artificial hearts that require close multi-disciplinary cooperation also place extremely high requirements on medical management.
“Artificial heart implantation is not only a technology, but the management after implantation is also a very complicated project.” Wang Wenyan said, “Artificial heart implantation requires the formation of a multidisciplinary team of diagnosis and treatment, which is performed before, during and after implantation. Comprehensive management tools are required, and this involves multidisciplinary cross-cooperation."
In the future, will artificial hearts become popular among patients with heart failure?
Wang Wenyan said that in order for artificial hearts to benefit more patients, it is first necessary to integrate medical and industrial technology to reduce the cost of materials and technologies for artificial hearts; secondly, it is necessary to take the lead in the medical insurance part of artificial heart implant surgery in some areas. Coverage and improve patient acceptance; at the same time, speed up the network management of artificial heart surgery, so that patients who have completed surgical transplantation can still receive remote network guidance from doctors after they return to their families and lives.
"The in-depth development of the multidisciplinary diagnosis and treatment model in the future will make the domestic artificial heart project more mature." Wang Wenyan said.
Li Di Chen Ke