人工心脏掀起术语争议,“全磁悬浮”概念陷入技术迷雾
Hua Xia Shi Bao·2025-12-18 07:30

Core Viewpoint - The article discusses the controversy surrounding the terminology and classification of artificial heart pump technologies, particularly the term "full magnetic suspension," which has implications for patient safety and scientific transparency [1][10]. Industry Overview - Heart failure is a terminal stage of cardiovascular disease, with approximately 5% of cases progressing to severe heart failure. The World Health Organization estimates around 64.3 million heart failure patients globally, with about 13 million in China [2]. - Artificial hearts serve as a "life pump" for end-stage heart failure patients, designed to replace the heart temporarily or permanently, facilitating blood circulation [2]. - There are two types of artificial hearts: partial replacement and total artificial hearts, with the latter being more advanced in terms of technology [2]. Technology Classification - Blood pump bearings are categorized into three main types: contact sliding bearings, fluid dynamic bearings, and magnetic bearings. The latter operates without contact, relying solely on magnetic forces [3]. - The term "full magnetic suspension" is considered the industry benchmark, associated with advanced and safe technologies. However, the precise definition of this term is under dispute [3][10]. - Kurt Dasse emphasizes that if a device requires fluid dynamic effects for stability, it cannot be classified as "full magnetic suspension" [3]. Clinical Implications - The ambiguity surrounding the definition of "full magnetic suspension" may affect the accurate assessment of device performance by clinicians and researchers [10]. - Abbott's HeartMate 3 is highlighted as a benchmark in the industry, demonstrating significant clinical advantages over other devices [11]. - A systematic review comparing three ventricular assist devices showed that HeartMate 3 had the best performance across all major clinical endpoints, reinforcing the link between technology choice and clinical outcomes [11]. Market Competition - Abbott leads the global market with its HeartMate 3 product, while Chinese companies are increasingly participating in the artificial heart sector, with several products approved since 2021 [12][13]. - Major domestic companies are adopting different technological routes, with notable products like the CH-VAD and CorHeart 6 entering the market [12][13]. - The potential market for artificial hearts in China is substantial, with projections indicating that by 2033, the number of implant surgeries could exceed 25,000, corresponding to a market size of over 5.5 billion yuan [14]. Future Outlook - The choice of technology route will significantly influence industry competition, with full magnetic suspension technology being a key focus area [14]. - The transparency and standardization of technology definitions are crucial for building trust among companies and ensuring accurate evaluations by researchers and clinicians [14][15]. - Ongoing discussions aim to standardize definitions and identify high-risk components in various designs, which is essential for independent assessments and patient safety [15].