Heart Failure Treatment Enters the "Artificial Heart" Era: No Longer Waiting for Transplants with Independent R&D Breakthroughs

Source: Reporter Gao Yang Interviewed

Expert: Hu Shengshou, Member of the Chinese Academy of Engineering, Director of the National Center for Cardiovascular Diseases, President of Fuwai Hospital, Chinese Academy of Medical Sciences

A circular mechanical device the size of a ping-pong ball and as light as a mobile phone will bring new hope to millions of patients with heart failure by replacing the function of a failing heart. This special "artificial heart" is independently developed in China, breaking foreign technological monopolies and matching the world's leading performance standards. At present, the "Chinese Heart" has been officially approved for marketing and entered clinical application. At the recently held 2nd Severe Heart Disease Conference, Hu Shengshou, the aforementioned academician, announced: "China's surgical treatment for heart failure has officially entered the era of clinical application of artificial hearts!"

Millions of Patients in Need of Heart Transplants

According to statistics, the global number of heart failure patients reached 29.7 million in 2019, and the figure is expected to rise to 38.7 million by 2030. Heart failure is the severe and terminal stage of various heart diseases. In addition to primary myocardial diseases, patients with underlying cardiac conditions such as coronary heart disease, hypertension and valvular heart disease are also prone to develop heart failure in their advanced stages. Characterized by high prevalence, high mortality and high rehospitalization rates, heart failure is currently the most difficult and high-risk disease to treat in the cardiovascular field, and has become a major public health issue that seriously threatens the health of Chinese residents.

The prevalence and total number of heart failure cases in China continue to rise. The latest survey shows that the prevalence of heart failure among people aged 35 and above in China has reached 1.3%, which translates to approximately 13.7 million patients, marking a 44% increase compared with 15 years ago. Once heart failure progresses to the end stage, anti-heart failure medications can barely reverse the condition, leaving extremely limited treatment options. Heart transplantation is currently the universally recognized effective treatment for this stage.

However, only hundreds of heart transplant procedures can be performed in China each year. In 2020, only 557 heart transplants were conducted to treat heart failure, which is far from enough for the 1.3 to 1.5 million end-stage heart failure patients in the country. The small number of transplant cases is not only due to the shortage of donor hearts and strict medical requirements for donor heart quality, but also restricted by multiple factors including the patient's age, weight, pulmonary artery pressure, complications and matching results. Even if patients meet the physical conditions for transplantation, they still have to wait for a suitable donor. Taking Wuhan Union Hospital as an example, the waiting period for heart transplantation ranges from 2 months to 3 years, and many patients pass away while waiting for a new heart.

Against this backdrop, the research and application of artificial hearts have drawn global attention for years. The core expectation is that artificial hearts can replace the "pumping" function of the human heart, act as a new "engine" for blood circulation, and make blood bypass the damaged heart to perfuse the whole body and meet the body's blood supply demands.

Back in the 1930s, French medical scientist Alexis Carrel and his American assistant Lindbergh jointly developed the world's first artificial heart. It was a temporary auxiliary artificial heart, essentially an extracorporeal circulation machine. In 1958, American scientists made a plastic artificial heart and completed a "heart replacement surgery" on a dog, but the dog only survived for 90 minutes. In 1969, a patient was temporarily sustained by an artificial heart for 64 hours before a suitable donor was found. In 1982, physician William DeVries from the University of Utah implanted an artificial heart in a man with cardiomyopathy, and the patient survived for 112 days after the surgery. With technological development, the clinical application of artificial hearts in developed countries has advanced rapidly, and they have now become a vital treatment for end-stage heart failure.

The "Chinese Heart" Reaches Global Cutting-edge Standards

The academic name for artificial heart is Ventricular Assist Device (VAD), whose core component is a blood pump. When the patient's heart cannot generate enough force to pump blood into the arteries, the artificial heart works in tandem with the patient's native heart to deliver blood to the arteries. The clinical applications of artificial hearts mainly fall into three categories: first, serving as a bridge to heart transplantation to win more waiting time for patients; second, providing short-term circulatory support for patients with acute heart failure, which can be removed after the heart function recovers; third, offering long-term circulatory replacement for end-stage heart failure patients, allowing them to survive with the artificial heart for a long period.

Known as "the gem on the crown of medical devices", the artificial heart is one of the most complex and precise medical devices. Due to its extremely high manufacturing technical requirements and high surgical difficulty, its production was long monopolized by developed countries such as the United States. The artificial heart industry has gone through three generations of technological iterations: the first generation in the 1990s was a large-volume pulsatile blood pump placed outside the body; the second generation, which emerged in the early 21st century, was an implantable mechanical axial flow pump; the current third generation is the implantable "fully magnetically levitated centrifugal pump". Compared with the previous two generations, it features a smaller size, better blood compatibility, can reduce blood stasis and thrombosis, and significantly improves clinical treatment outcomes.

Although the R&D of the "Chinese Heart" started late, it boasts a high starting point and rapid progress, and has entered the world's latest third-generation technology camp. In June 2017, Academician Hu Shengshou's team took the lead in completing the first domestic third-generation magnetically levitated artificial heart implantation surgery in China, achieving success and opening a new era of artificial heart treatment for heart failure. In recent years, artificial heart has become the field with the fastest technological progress in severe heart disease treatment. Follow-up data from Fuwai Hospital on patients implanted with the "Chinese Heart" shows that their survival outcomes are comparable to those of heart transplantation.

Before marketing approval, the clinical trials and technical applications of the "Chinese Heart" have also achieved satisfactory results. Follow-up data shows that no blood compatibility-related adverse events such as in-pump thrombosis, stroke or gastrointestinal bleeding occurred in the enrolled clinical patients. This indicates that the blood compatibility of the "Chinese Heart" is not only better than that of other types of artificial hearts, but also potentially superior to existing fully magnetically levitated artificial heart products in the international market.

Up to now, there are very few artificial heart products worldwide that adopt the full magnetic levitation technology. Compared with the new generation of fully magnetically levitated artificial heart products globally, this Chinese artificial heart has reached the same or even better blood compatibility level. Its blood pump has a smaller size, which reduces the invasiveness of implantation, and it is equipped with a thinner percutaneous cable that helps improve anti-infection performance. It also meets the global cutting-edge standards in key performance indicators applicable to all artificial hearts, including system reliability and portability.

The recent approval of the "Chinese Heart" means that China's homegrown full magnetic levitation artificial heart technology has broken foreign monopolies and filled the domestic gap. Once the commercialization process starts, it will occupy a huge first-mover advantage in the Chinese market. As a model of medical-engineering integrated innovation, this "Chinese Heart" holds completely independent intellectual property rights in China, and is a genuine fully magnetically levitated centrifugal pump.

Strict Quality Control and Standardized Application

Although the third-generation artificial heart has many advantages, its development history is relatively short, and it still faces many challenges. Only by strictly controlling the product quality of artificial hearts, strengthening industry supervision, formulating and promoting relevant technical specifications across the country, can we truly benefit heart failure patients.

Standardizing the clinical application of ventricular assist technology to ensure medical quality and safety is the core priority. The *Management Specifications for Ventricular Assist Technology (2021 Edition)* issued by the National Health Commission has set clear regulations for medical institutions and their medical staff to carry out ventricular assist technology. Medical institutions that intend to perform artificial heart implantation surgeries must meet certain technical thresholds. For example, the institution is required to have engaged in clinical diagnosis and treatment of cardiovascular surgery for more than 10 years, with no less than 50 beds, and complete no less than 1000 extracorporeal circulation cardiac surgery cases every year, with its technical level ranking among the leading positions in medical institutions of the province (autonomous region or municipality directly under the central government). Surgeons are required to have more than 10 years of clinical diagnosis and treatment experience in the field of cardiovascular and cardiothoracic surgery, and have obtained the professional technical title of chief physician for no less than 3 years.

Artificial heart implantation technology imposes high requirements on hospitals and medical teams. In addition to the cooperation of doctors from cardiac surgery, anesthesiology and extracorporeal circulation departments to complete the implantation surgery, doctors from cardiology, imaging and other departments are also needed to conduct objective evaluations for patients. Furthermore, proper postoperative rehabilitation and long-term follow-up management for patients are also of great importance. This requires strengthening standardized training for medical and nursing staff, and cultivating more professional multidisciplinary teams with effective collaboration, so as to ensure that patients can achieve normal clinical outcomes after artificial heart implantation.

Artificial heart technology still needs continuous improvement. At present, the power cord driving the artificial heart still needs to pass through the skin, which may lead to complications such as infection. Therefore, wireless charging technology will be a major highlight of future artificial heart development. Due to its advanced technology and expensive materials, the third-generation artificial heart is relatively costly. Reducing production costs is of great significance for expanding its application scope in the future. After the artificial heart enters the full magnetic levitation era, the global goal of artificial heart therapy is not only to keep patients alive, but more importantly, to help them return to normal work and daily life. 

Disclaimer: The information in this article is for popular science reference only and does not constitute medical diagnosis advice.