China's Domestic LVAD Opens a New Era of Heart Failure Treatment

Published: September 17, 2020, Source: BioDiscovery

As of today, there has been a lack of effective treatments for Heart Failure (HF), also known as the "Cancer of heart disease". Beijing Fuwai Hospital and Suzhou CH Biomedical achieved successful results in the first clinical application of the miniaturized fully magnetically levitated left ventricular assist device (LVAD) in China. The author interviewed the CEO of the company, Dr. Chen Chen.

1. “Cancer of heart disease”

According to Dr. Chen, in USA, once patients are diagnosed with heart failure, about 50% of them will die within 5 years, and 50% of advanced (NYHA III, IV) heart failure patients will die within 2 years. At present, the only well-known effective treatment for advanced heart failure is heart transplantation. However, due to the extremely limited number of heart donors, only about 300 heart transplants can be performed in China every year, but hundreds of thousands of new heart failure cases are reported every year. Therefore, heart transplantation cannot be a universal medical therapy that benefits the public.

Based on this background, the emergence of a new ventricular assist device offers improved therapy for patients with advanced heart failure. It pumps blood mechanically replacing the pumping function of the heart temporarily or permanently, thus keeps blood circulating in patients with advanced heart failure. "The heart is probably one of the easiest organs to be replaced with an artificial organ  because it functions without any chemical reactions," Dr. Chen said, “The purpose of a VAD is to pump blood from the heart to aorta. Our device is a ventricular assist device, the patient's natural heart is still there, and the ventricular assist device will work with it once the device is implanted. Ventricular assist device takes over the work that the weakened heart was unable to do."

At present, the clinical applications of VAD mainly include: 1. As a transition bridge to heart transplantation allowing patients time to wait for a suitable donated heart; 2. Provide a Short-Term support for patients with heart failure due to acute diseases, and to be removed after the heart function is recovered. 3. Provide Long-Term support for patients with end-stage heart failure, in other words, lifetime support for patients with advanced heart failure. 

2. Dr. Chen founded CH Biomedical in China

Dr. Chen worked as the project leader in the research and development of Levacor™, a fully magnetically levitated VAD developed by World Heart (the World's second largest VAD company at that time) in the United States since 1999. The product was approved for clinical use in 2006. However, Levacor™ was not accepted by the market because it was too large to be implanted in a human chest. 

The failure of Levacor™ as the pioneer brought fully magnetically levitated VAD research to its knees in the entire medical device industry. Only Thoratec, the world's largest VAD company, continued to develop the technology quietly. Dr. Chen believes that among the various technical approaches to be used for development of VAD, the full magnetic levitation is the only way that can improve hemocompatibility fundamentally. If the challenge of its size is overcome, the VAD technology will be pushed to a new level. Therefore, Dr. Chen decided to quit his job at World Heart to go back to China, and to continue the path of the full-magnetic levitation VAD development. His decision was fully supported by all Chinese American experts in the VAD field at that time, and everyone unanimously called the conceptual product "a Chinese Heart", which was later named CH-VAD officially. 

After his return to China Dr. Chen established the company in Suzhou BioBay in 2008, named "Tong Xin", which literally means “the one heart”. The name implies that the company's product works together with the natural heart, also represents the commitment made by the Chinese experts both, domestically and abroad, and all employees together to be united in a concerted effort to serve the motherland.

Recalling the experience of being named the Leading Talent of the 2nd Science and Technology Conference of Suzhou Industrial Park, Dr. Chen said with a smile, "I honestly told the evaluation experts that all the leading companies in the world did not believe that the full-magnetic levitation VAD could be successful, but I was still honored as the Science and Technology Leading Talent. The government of the industrial park is respectful for having the foresight and courage. As an entrepreneur, even though Dr. Chen was always optimistic at that time, he did not anticipate the way ahead will be so long. "We succeeded because we made right decisions in key steps. First, we were lucky to settle in Suzhou industrial park; second, the technical leadership team in developing world-leading LVAD has rich experience. All these right decisions have brought us where we are today." Chen said.

After WorldHeart went bankrupt, Thoratec announced HeartMate 3 in 2014, a miniaturized full magnetic levitation LVAD entered clinical trials in the United States and Europe, and immediately showed overwhelming performance advantages. As other VAD companies around the world did not have the accumulated experience in this technological approach, they lost their competence.  But interestingly, a Chinese company, Suzhou CH Biomedical, has made great progress in the field of full magnetic levitation and announced more advanced technical parameters at international conference." Suzhou CH biomedical is the only company capable of competing with the largest VAD company in the world on the latest generation of VAD". Dr. Chen said proudly.

3. Three advanced heart failure patients were successfully treated in Fuwai Hospital

Since the ventricular assist device can help the heart to complete the pumping function, why hasn't it been widely used in clinical practice? Dr. Chen explained that this is due to the clinical adverse events of the existing products, including blood compatibility problems (gastrointestinal bleeding, stroke, thrombus in the blood pump, etc.), surgical aggression issues (blood pump size), infections caused by the percutaneous driveline, and device reliability and durability problems. The performance of ventricular assist device mainly depends on the bearing of the rotor inside the blood pump. So far, three kinds of technologies have been developed: (1) Mechanical contact type (mechanical bearing), represented by the HeartMate II of Thoratec Company, which was the best-seller in the world at present (2) Hydronic suspended bearing, represented by HVAD of HeartWare, the world's second best-selling company (3) Full magnetic levitation. Full magnetic levitation avoids the weakness associated with hydrodynamic pressure bearing such as poor blood compatibility and weak suspension strength, providing the possibility of fundamental blood compatibility improvement. However, it faces great challenges in blood pump miniaturization. Only Thoratec's HeartMate 3 and Suzhou CH Biomedical’s CH-VAD have entered the clinical application stage, and no other companies have announced any finalized prototype.

According to the following comparison table provided by Dr. Chen, CH-VAD has shown obvious advantages compared to HeartMate 3 in key performance indicators such as surgical aggression, risk of infection, and device reliability. The hemocompatibility is the most important index of ventricular assist devices, a series tests have been conducted, flow field analysis, in vitro testing, and animal studies have also shown better performance indicators, head-to-head clinical trial also is planned.  Dr. Chen Chen said: "Our goal is to surpass our competitor in blood compatibility, we will strive for the best in all aspects to be the number one in the world!"

From June to October 2017, Member Hu Shengshou’s team of Beijing Fuwai Hospital received the ethical approval via Humanitarian Device Exemption (HDE), applied the miniaturized fully magnetically levitated VAD of CH Biomedical to treat three critically ill patients, and achieved great success.

At present, the first patient has been living normally with the VAD for over three years. The second patient received a heart transplant at 192 days after the implantation. The third patient has been living with the VAD for more than 5 months, and his heart function has recovered significantly, and the VAD is expected to be removed after a complete recovery. The satisfactory clinical results have indicated that China has made leap-forward achievements in the VAD field and is on its way to become a pacesetter in the industry worldwide.

4. Open a new era of heart failure treatment

VAD is one of the most expensive one-off medical devices with the average price of about $100,000 per set in the United States. With the idea of serving the world, CHB is also pondering over how to better serve our own people.

In Dr. Chen's opinion, "The world is looking forward to having an artificial heart at lower price. We hope to lead the price reduction in this field globally through continuous technological innovation. In addition, the overall cost of treatment is further reduced by cutting medical costs of nonconformities. More importantly, we should fully embody the idea of service in the clinical application of VAD, so that Chinese patients can enjoy not only the same medical technology of high quality as those in developed countries, but also the same superior medical services. "As a special expert of the National “Thousand Talents Plan” entrusted by a team of Chinese experts in the United States, Chen Chen said with deep passion: “CH Biomedical will comprehensively reach the same level with those in the developed countries in the field. Chinese patients deserve the most advanced medical device and the best patient management service in the world.”