EUMS 2024 | Multi-center Follow-up Outcomes of CH-VAD Released on an International Stage!

The 18th European Mechanical Circulatory Support Summit (EUMS), a greatly influential international scientific conference in the field of advanced heart failure, was held in Hannover, Germany, from September 11 to 14, 2024 (local time). EUMS provides a leading international platform for showcasing innovative therapies, setting standards in clinical practice and fostering interdisciplinary treatment strategies in the field of advanced heart failure.

At the special session of “Best Outcomes: Post and Future of MCS” held on the third day, Prof. Gong Ming from Beijing Anzhen Hospital, Capital Medical University presented the multi-center study results of CH-VAD in his study report Clinical Outcomes in Patients With a Novel Fully Magnetically Levitated Left Ventricular Assist Device: A multi-center study on the international stage!

CH-VAD is China’s first fully magnetically levitated left ventricular assist device (LVAD) approved by NMPA for marketing, with complete independent intellectual property rights and multiple key breakthrough technologies. By virtue of its innovative structural design that brings superior performance in hemocompatibility and hemodynamics, CH-VAD guarantees a long-term high-quality postoperative life for patients with advanced heart failure. In the study, patients treated with CH-VAD had high survival rates, low complication rates, and significant improvement in postoperative cardiac function, along with a long-term enhancement in patients’ quality of life. Showcasing the outstanding performance of CH-VAD and the excellence of LVAD in clinical application in China, the study has won high recognition from the international medical field!

Prof. Gong Ming Delivered a Special Report at EUMS 2024

Introduction to the Study

This multi-center, retrospective, observational study aimed to present the real-world clinical outcomes of the CH-VAD. The participating centers included Beijing Anzhen Hospital, Wuhan Asia Heart Hospital, Sichuan Provincial People’s Hospital, Henan Provincial Chest Hospital, Zhongshan Hospital Fudan University, Jiangsu Province Hospital, and Shanghai Chest Hospital. From June 2022 to July 2024, the study enrolled a total of 77 patients with advanced heart failure implanted with CH-VAD (including its first case for commercial use), with an average follow-up time of nearly 1 year.

In this study, both patient selection and LVAD indications were based on internationally acknowledged guidelines. The patients, 85.7% of whom were male, were 56.9 years old on average. The most common cause of heart failure was dilated cardiomyopathy (62.3%), followed by ischemic cardiomyopathy (33.8%), and patients with INTERMACS levels 1 and 2 accounted for 31.2%.

The results of the postoperative follow-up demonstrated:

High Survival Rates: Patients exhibited a 6-month and 1-year postoperative survival rates of 91.6%, with no cases requiring bridge-to-transplant cardiac surgery, pump malfunction, or pump replacement. The mean duration of pump support was 320 days. Notably, the participating centers prioritized long-term postoperative management, exemplified by Beijing Anzhen Hospital’s development of a dedicated LVAD long-term management mobile application.

Significant Quality-of-Life Improvements: Preoperatively, the majority of patients were classified as NYHA IV. Postoperatively, marked enhancements in cardiac function and quality of life were observed, enabling most patients to resume employment, engage in physical activities, and reintegrate into societal life.

Low Rates of Hemocompatibility-related Adverse Events: Attributed to the innovative design of CH-VAD in lowering blood damage, the incidence of thromboembolic or hemorrhagic events was exceptionally low during follow-up, with no pump thrombosis, validating its outstanding hemocompatibility profile.

Low Incidences of Right Heart Failure: The observed 3.9% right heart failure rate (3 cases) reflects rigorous patient selection criteria, meticulous preoperative optimization and management as well as the smaller size of the pump and its hemodynamically optimized design for right ventricular unloading.

Postoperative Anticoagulation Management: For CH-VAD recipients without active bleeding, intravenous heparin is initiated targeting an APTT of 50-60 seconds, followed by transition to oral warfarin (INR 2.0-2.5) combined with aspirin 100 mg daily.

Innovative LVAD Engineering: Pioneering Life-Saving Solutions for Heart Failure

Prof. Gong Ming elucidated the following advantages of CH-VAD in product design and clinical application.

Global first-of-its-kind separate fully magnetically levitated structure ensures superior levitated stiffness: By separating the magnetic levitation coils from the motor, the design maximizes the use of internal pump space. This not only reduces the volume of the pump but also achieves superior levitation stiffness, which can circumvent blood damage resulting from the collision between the impeller and the pump housing.

Optimized flow path design in the pump to fully flush the flow path and reduce blood damage: The main flow path “Nose Cone” of CH-VAD ensures a smooth redirection of the blood in the inflow cannula, preventing stagnation caused by direct impact on the bottom of the pump housing. A secondary flow path of 0.25 mm guarantees a stable unidirectional blood flow and reduces the exposure time of blood to high shear stress, thus delivering excellent hemocompatibility.

Simplified surgical implantation: From the perspective of LVAD surgeries, CH-VAD is easier to implant. Its blood pump is merely 25 mm in thickness and the outlet tube and artificial blood vessel is only 10 mm in diameter, so it is more friendly to patients with short ascending aorta. The unique locking mechanism of CH-VAD makes implantation even simpler: Simply align the two marks on the sewing ring with the corresponding locking marks on the pump and insert the pump into the sewing ring, and a “click” sound will be heard, which indicates the device is securely locked. Such a design significantly shortens the device operation time and ensures safety in operation. Besides, the percutaneous driveline of CH-VAD is only 3.3 mm in diameter with great flexibility, which reduces the risk of infection and makes the daily life of patients more convenient.

Chairman of the conference, Prof. Jan D. Schmitto, from Medical School of Hannover, Germany, highly praised Prof. Gong Ming’s efforts in heart failure device therapy, and he found the brilliant clinical data of China’s device CH-VAD really inspiring. He hoped that global collaboration will promote the development of device therapy for heart failure.

The multi-center follow-up results of CH-VAD in real life corroborate its clinical efficacy, durability, and safety，which also demonstrate China’s major breakthroughs and innovation in the R&D of LVAD. As international adoption expands, CH-VAD is poised to redefine global standards for advanced heart failure management, empowering patients worldwide to reclaim high-quality life.