I can’t hear my heartbeat, and I can still live a normal life! When will artificial hearts reach 400,000 patients?

  Sino-Singapore Jingwei, October 29th (Wang Yuling) Recently, the topic of #Cannot hear the heartbeat and still live normally# has been on the hot search on Weibo. According to news reports, talk show actor Wang Shiqi had suffered severe heart failure and his life was at stake. The artificial heart independently developed by China allowed him to survive in a desperate situation. Wang Shiqi, who has been given death notices four times, lives as usual now, cycling 15 kilometers every two days.

  The artificial heart here is a general term for the scientific name of ventricular assist device (VAD) and total artificial heart (TAH). According to public information, heart transplantation is the best treatment for end-stage heart failure, but it is limited by factors such as shortage of donor hearts, isolated heart preservation, and immune rejection after transplantation. Mechanical circulatory assist devices represented by TAH) have gradually become the only option for end-stage heart failure and long-term treatment during the transition period of heart transplantation.

  In function, the artificial heart uses mechanical methods to provide power for blood circulation and transport blood from the heart to various organs, thereby partially or completely replacing the natural heart. Some people therefore call it the “water pump” of the heart.

  Behind Wang Shiqi’s successful treatment, the artificial heart is moving from dream to reality and to maturity. When will this new therapy be available for ordinary patients?

  Once at the gate of hell

  On the “Talk Show Conference” broadcast some time ago, Wang Shiqi carried a small black box. This is not a decoration or a small stereo, but Wang Shiqi’s “charging heart”, this “charging heart” , once brought back Wang Shiqi, who was on the verge of dying in 2019, and sent him to the highly anticipated stage.

  The turning point of Wang Shiqi’s life was in 2004. That was his third year as a high school math teacher. At the autumn sports meeting that year, due to the conflict between his classmates and other classes, Wang Shiqi rushed to the fight without hesitation. “I didn’t expect that as soon as I rushed up, I didn’t get up in one breath, and I fainted among the two students first,” he said.

  Only then did Wang Shiqi know that he had dilated cardiomyopathy. According to an article written by Kang Yunpeng, deputy chief physician of the Department of Cardiology, Beijing Anzhen Hospital Affiliated to Capital Medical University, the disease itself is characterized by significant enlargement of the left and right ventricles, or both ventricles. With the expansion of the ventricle, it is bound to be accompanied by a decrease in the systolic function of the heart, and heart failure will occur. After the discovery of such diseases, in addition to traditional anti-heart failure and anti-arrhythmic treatments, when heart failure is extremely difficult to correct, only artificial heart assistance or allograft transplantation can be used.

  In 2019, Wang Shiqi, who was dying and had difficulty finding a suitable donor, chose to undergo a clinical trial of an artificial heart.

  ”This operation is to install a small magnetic levitation pump on the heart, so that it can assist the heart to work.” Wang Shiqi described his experience in the program. After receiving treatment, Wang Shiqi can live as a normal person. According to him, he rides a mountain bike of about 15 kilometers every two days, and he also develops the habit of brisk walking every night. The doctor said that in the future, Wang Shiqi will have the opportunity to remove the artificial heart and work and live like a normal person.

  There are many patients of the same type

  As a “survivor”, Wang Shiqi said on Weibo: “When I thought my life was coming to an end, I encountered a magical artificial heart, which kept me alive, thanks to the power of technology!”

  Behind the scenes, there are many patients with the same situation as Wang Shiqi. According to the “China Cardiovascular Health and Disease Report 2020”, there are currently about 8.9 million people with heart failure in China; among adults aged 35 and over, the prevalence of heart failure is about 1.3%, an increase from 0.9% in 2000. 44%. According to public information, the proportion of heart failure disease progressing to end-stage is about 5% to 7%. Based on this calculation, the number of patients in China will exceed 400,000.

  But finding a suitable donor for transplantation is extremely difficult. According to data from the China Heart Transplant Registration System, as of 2020, a total of 56 medical institutions in China are qualified for heart transplants, and the annual number of heart transplants performed and reported is only 557 .

  Why is it difficult to match? Wang Wenyan, chief physician of the Heart Failure Center of Sichuan Provincial People’s Hospital, once wrote that heart donors are mainly from brain-dead patients, that is, they are harvested when the heart is still beating almost normally, and the heart transplant is completed within 6 hours. This is because after the heart stops beating, the organs will gradually deteriorate due to warm ischemia, which will lead to transplant failure; at the same time, many issues such as immune matching between the heart transplant donor and the recipient must be considered.

  At the same time, Professor Liu Xiaocheng, president of TEDA International Cardiovascular Hospital, explained to Sino-Singapore Jingwei that, from the point of view of the reasons, Chinese law still only recognizes cardiac death. This means that death is not counted until the heart stops beating. In a situation where the modern concept of brain death is widely accepted in most countries, this difference in the way of determination makes it more difficult for Chinese patients to obtain heart donors.

  In a state of severe imbalance between supply and demand, the vast majority of patients unfortunately passed away while waiting for a heart donor. Therefore, replacing part of the function of the heart with an artificial heart, striving for a longer period of time for heart transplantation or allowing patients with heart failure to coexist with the artificial heart for a long time has become a more urgent direction for the joint efforts of Chinese science, industry and medical circles.

  According to Haitong International Securities, in 2017, the FDA-approved third-generation fully magnetic levitation left ventricular assist device (ie LVAD, editor’s note: VAD is divided into left ventricular assist device LVAD, right ventricular assist device RVAD and biventricular assist device BiVAD) is increasing in While the survival rate is significantly reduced, the 2-year survival rate is comparable to that of heart transplantation. The heart failure treatment guidelines published by the American Heart Association have listed LVAD as a long-term replacement therapy for heart failure to address the serious shortage of heart donors worldwide.

  According to public information, there are currently three clinical applications of ventricular assist devices (VADs): first, as a transition for waiting for heart transplantation, to buy more time for patients to wait for a suitable donor; second, to provide short-term support for patients with acute heart failure, After the heart function recovers, it will be removed; the third is to provide long-term support for patients with end-stage heart failure, so that patients can live with the artificial heart for a long time. Long-term replacement therapy has become the mainstream clinical application of ventricular assist devices.

  It is reported that the 2-year survival rate of the third-generation artificial hearts used in the world is comparable to the survival rate of allograft transplantation.

  Then, as a treatment method for heart failure, how long will the “charging heart” on Wang Shiqi be used by the majority of patients?

  It has progressed to three generations of artificial hearts, and many products have been approved

  According to reports, the “artificial heart” on Wang Shiqi’s body is a magnetic levitation ventricular assist device manufactured by Suzhou Tongxin Medical. It was officially approved on November 25, 2021, and the name is implantable left ventricular assist system CH-VAD.

  Sino-Singapore Jingwei inquired by the State Food and Drug Administration and found that the product provides mechanical support for the blood circulation of patients with advanced refractory left heart failure, and is used for transitional treatment before heart transplantation or restoring cardiac function.

  From the time line, the artificial heart has undergone several dynasties. The first generation is a pulsatile pump, which can simulate the principle of natural heart contraction and relaxation, but it is large in size, difficult to assemble, prone to infection, damage, serious coagulation problems, and high mortality; the second generation is an axial flow pump, which is more convenient to install. However, thrombosis is still prone to occur, and there is a risk of complications such as cerebral infarction and sudden death. The third generation is a centrifugal pump.

  The “Guidelines for the Technical Review of Implantable Left Ventricular Assist System Registration” (hereinafter referred to as the “Guidelines”) issued by the State Food and Drug Administration in March 2020 pointed out that centrifugal pumps can also be subdivided into magnetic fluid suspension centrifugal pumps and full magnetic suspension centrifugal pumps. Pumps and hydrodynamic bearing centrifugal pumps.

  Judging from the current market products, three domestic implantable artificial hearts have been approved for marketing. On August 26, 2019, the implantable LVAD produced by Chongqing Yongrenxin Medical Device Co., Ltd. was approved by the State Drug Administration.

  In July 2022, the implantable left ventricular assist system developed by Aerospace Taixin Technology Co., Ltd. was approved for marketing. The State Food and Drug Administration wrote in the approval document that the product is the first implantable magnetic fluid suspension left ventricular assist system using magnetic fluid suspension technology in China, and its key technical indicators have reached the same international level.

  Dean Liu Xiaocheng analyzed that the difference between full magnetic suspension and magnetic fluid suspension is more of a process difference, as long as the design is reasonable, the technology is superb, and the short-term and long-term clinical effects are the same. The differences are mainly due to patient selection criteria, comprehensive medical level, degree of patient cooperation and long-term refined management.

  In addition to the listed products, there are also some products under research.

  Tianyancha shows that there are more than 800 patent applications related to artificial hearts in China. In addition to the implantable artificial hearts that have obtained 11 patents of higher standards, there are still low-level and low-tech applications for the treatment of various heart diseases. Equipment, such as “artificial heart valve”, “artificial heart valve angioplasty ring”, “artificial cardiac pacemaker”, “extracorporeal artificial heart blood pump”, etc. Among them, there are more than 600 invention patents and nearly 200 utility model patents. Among these patent application information, nearly 400 patents have been authorized, and nearly 190 patents have been published or are in the stage of substantive examination. In terms of application time, there will be more than 110 related patent application information in 2021, and the number of applications will exceed 100 for the first time. Since the beginning of this year, the number of applications has also exceeded 110. 

  How far is the expensive artificial heart from the common people?

  At present, the research and development of artificial heart is in rapid development. Haitong International Securities Research Report predicts that there are about 10 million heart failure patients in China, and the estimated patient pool is about 400,000. If the ex-factory price of LVAD is reduced to 300,000 yuan, plus medical expenses, it will cost at least 600,000-700,000 yuan.

  Therefore, the artificial heart is still a great distance from ordinary patients. Yan Shu, an assistant researcher at the Institute of Medical Information, Chinese Academy of Medical Sciences, and others published an article stating that the price of mainstream implantable VAD products is between US$80,000 and US$100,000, and the total cost of superimposed surgery and nursing usually exceeds US$150,000. Although the cost is high, medical insurance or commercial insurance in Europe and the United States and other countries can cover most of them, and the proportion of patients paying out of pocket is relatively low. In China, VAD is a high-end medical device that has newly entered the market. The pricing and medical insurance policies are still unclear, and it is difficult for domestic commercial medical insurance to cover its costs. If the out-of-pocket cost exceeds one million, the promotion of the device will undoubtedly be restricted. Make the patient look at the pump and sigh.

  ”As far as the patients I have been in clinical contact with, most of the patients with end-stage heart failure have a poor family condition. I hope the national medical insurance department can include the medical expenses for the treatment of end-stage heart failure patients into special diseases of medical insurance and special planning.” President Liu Xiaocheng said.

  VAD has not yet been fully rolled out in China. According to the aforementioned report, up to now, more than 20 hospitals in China have carried out nearly 100 cases of left ventricular assist device implantation.

  First of all, for Chongqing Yongrenxin’s products, the State Food and Drug Administration recommends that it continue to complete clinical trials in accordance with the clinical trial protocol. Conduct annual analysis of post-marketing clinical use. In the product instructions of Tongxin Medical and Aerospace Taixin Technology, the State Food and Drug Administration requires them to continue to carry out product reliability research, formulate follow-up plans for all implanters, and conduct follow-up follow-up. The relevant post-market follow-up needs to form an annual report Follow-up report.

  According to the U.S. FDA recall data, VAD products have been recalled many times, the main reasons include power charging problems, power connection problems, system failures, controller alarm problems, broken access vessels, aging or leakage problems, and equipment shells falling off or broken, etc.

  Secondly, Sino-Singapore Jingwei noticed that the artificial heart is expensive.

  It is worth noting that President Liu Xiaocheng said to Sino-Singapore Jingwei, “Actually, the artificial heart implantation is not very difficult and can be successfully completed by a skilled attending physician in cardiac surgery. The key lies in the quality of the long-term postoperative effect. Long-term management. This should be another major challenge in addition to the cost issue.”

  Sino-Singapore Jingwei learned from people familiar with the matter that the National Health and Health Commission is planning to issue the standard matters for artificial heart implantation hospitals in my country. Only hospitals with an annual operation volume of 2,000 cases can be allowed to engage in LVAD implantation. Industry insiders believe that this sets a scientific and reasonable threshold for the extremely challenging artificial heart business in the treatment of end-stage heart failure.

  Part of the information is synthesized from People’s Daily Online, Health Times, The Paper, etc.

  (The opinions in this article are for reference only and do not constitute investment advice. Investment is risky, and you need to be cautious when entering the market.)

  All rights reserved by Sino-Singapore Jingwei. Without written authorization, no unit or individual may reproduce, extract or use in other ways.

Responsible editor: Luo Kun