BrioHealth Showcases CH-VAD and BrioVAD® Clinical Data at ISMCS 2024, Reinforcing Global Leadership in MCS Innovation

From November 13 to 15, 2024, the 30th International Society for Mechanical Circulatory Support (ISMCS 2024) conference was successfully held in Utsunomiya, Japan. As a prestigious high-level conference in the field of international mechanical circulatory support (MCS), this year's event attracted clinicians, engineers, and experts from around the world to share cutting-edge research findings and practical experiences. BrioHealth Solutions was invited to participate in this international academic conference for the eighth consecutive year and announced its core product, CiFu, at the meeting.^®VAD (Model: CH-VAD) and BrioVAD^®The numerous research achievements have received extensive attention and high praise from the international academic community.

BrioHealth Solutions Founder Dr. Chen Chen Updates Company’s Core Products CH-VAD and BrioVAD at This Conference^®Research Progress. Compared with similar products internationally, CH-VAD and BrioVAD^®Through multidisciplinary optimization design, it demonstrates comprehensive performance advantages in terms of implant invasiveness, blood compatibility, hemodynamics, and infection prevention. The design advantages of this product are being validated in large-scale clinical applications in China. According to the latest full-cohort follow-up data of CH-VAD in Chinese clinical applications, the long-term survival rate of CH-VAD is higher than that of international large-scale clinical studies and INTERMACS data; the incidence rates of severe adverse events such as stroke, gastrointestinal bleeding, and percutaneous cable infections are all lower than those of international large-scale clinical studies and INTERMACS data, continuously showing internationally leading clinical outcomes.

Professor Wang Xianqiang from Fuwai Hospital, Chinese Academy of Medical Sciences, updated the long-term follow-up results of the full cohort of patients who received CH-VAD treatment at Fuwai Hospital during the conference.

The cohort included a total of 88 patients, with follow-up durations ranging from 1.5 months to 7 years. The average duration of pump support per patient was 1.9 years, resulting in a cumulative support time of 173 patient-years. Data showed that, according to Kaplan-Meier survival analysis, the 1-year, 2-year, and 3-year survival rates were 95%, 95%, and 91%, respectively (Figure 1), significantly higher than international clinical studies and real-world levels.

In this cohort, the overall incidence of adverse events was low. No major device malfunctions, pump replacement surgeries, or hemolysis events occurred during the follow-up period, indicating high long-term reliability of the device.

The cohort simultaneously recorded the readmission status of patients. The proportion of patients free from readmission at 1, 2, and 3 years was 80.5%, 67.6%, and 62.7%, respectively, significantly higher than the INTERMACS data levels, suggesting that patients implanted with CH-VAD have a good quality of life in the long term.

Professor Gong Ming from Anzhen Hospital, Capital Medical University, presented complex clinical application cases of CH-VAD and follow-up results from a multi-center real-world study after the product's market launch.

In this case report, Professor Gong Ming's team successfully performed a combined surgery of VAD implantation + aortic valve replacement + aortic root replacement + coronary artery in-situ transplantation (Bentall) + coronary artery bypass grafting (CABG) + tricuspid valve plasty (TVP) + patent foramen ovale closure (PFO), achieving ideal long-term clinical outcomes. This case verifies the feasibility of CH-VAD implantation combined with various cardiovascular surgeries and confirms the stable and effective performance of the CH-VAD device.

Professor Gong Ming synchronously announced the multi-center real-world study results of CH-VAD after its market launch in his report. Participating centers included Beijing Anzhen Hospital, Wuhan Asia Heart Hospital, Sichuan Provincial People's Hospital, Henan Chest Hospital, Zhongshan Hospital Affiliated to Fudan University, Jiangsu Provincial People's Hospital, and Shanghai Chest Hospital, covering 77 patients with an average follow-up time of nearly one year. Data showed that the six-month and one-year postoperative survival rates reached 91.6%. No patients underwent heart transplantation as a bridge, no pump failures or pump replacements occurred, and the average support time on the pump was 320 days, continuously verifying the safety and reliability of the product.

During the follow-up period, no pump thrombosis occurred, and the incidence of thrombotic or bleeding events was extremely low, further verifying the excellent hemocompatibility of CH-VAD.

It is worth mentioning that, thanks to the innovative design of CH-VAD in the percutaneous cable, the incidence of percutaneous cable infection in patients is extremely low, significantly improving the convenience of long-term care and the quality of life for patients.

Professor Cui Yong from Zhejiang Provincial People's Hospital shared an improved minimally invasive VAD implantation surgical technique for patients undergoing re-sternotomy, based on clinical application experience with CH-VAD. Professor Cui designed various minimally invasive surgical approaches tailored to different clinical conditions of the patients to maximize their clinical benefits. The series of cases he shared achieved satisfactory short-term and long-term clinical outcomes. He pointed out that minimally invasive VAD implantation is a viable alternative to median sternotomy, especially for patients undergoing re-sternotomy. This approach has positive clinical significance in reducing surgical trauma, minimizing bleeding, and accelerating recovery.

Professor Hua Zhengdong from Wuhan Asia Heart Hospital shared a highly challenging case of fulminant giant cell myocarditis complicated with cardiogenic shock. The patient was a 52-year-old woman with a small physique, having a left ventricular diameter of only 4.5 cm. Before receiving the CH-VAD implantation, she had been supported by V-A ECMO for 25 days and suffered from multiple organ dysfunction. A short-term right heart assist device was implanted during the same surgery. Postoperatively, through meticulous multidisciplinary management, the patient's organ functions gradually recovered, and she was discharged smoothly. During more than two years of follow-up, the patient regained a high-quality life without any VAD-related complications. Professor Hua emphasized that timely adjustment of circulatory support strategies is crucial for the successful treatment of such patients. In this case, the CH-VAD was easy to implant and provided sufficient perfusion, demonstrating good short-term and long-term outcomes.

At this conference, BrioHealth Solutions organized a simulated surgery training and conducted extensive and detailed exchanges with experts from various countries. The atmosphere on site was very enthusiastic. Experts from different countries showed great interest in CH-VAD and BrioVAD.^®The design features and surgical implantation have attracted strong interest, and there is a clear desire to introduce the product into their domestic and regional markets.

As an internationally renowned expert in artificial hearts, Dr. Chen Chen, founder of BrioHealth Solutions, was invited to the conference.ISMCS-JSAO (Japanese Society for Artificial Organs) Joint ForumPublished a paper titled "The Pulsatile Performance of Fully Magnetically Suspended Blood Pumps" (ThePulsatile Performance of a Fully Magnetically Suspended Blood Pump: An Academic Report. The report, through mock circulation device testing, verified that under cardiac pulsation, the real-time operating point of the blood pump does not move at a constant speed along the static H-Q curve. It conducted an in-depth analysis of the correspondence between dynamic H-Q and different phases of the cardiac cycle, and further elucidated the significant academic value of studying the dynamic H-Q characteristics and "hemodynamic compatibility" of blood pumps under pulsatile conditions for the VAD engineering field and clinical applications, sparking lively discussion and high attention among attending experts.

Promoting academic development in the international MCS field is an important component of BrioHealth Solutions' global development strategy. BrioHealth Solutions made its debut at a high-level conference in the international MCS field with multiple research achievements, further validating the breakthrough technological innovations and outstanding long-term clinical outcomes of the company’s core products. This not only solidified its international academic standing but also significantly enhanced China's global academic influence in the MCS field, injecting strong momentum into the acceleration of BrioHealth Solutions' overseas strategic layout.