中国心力衰竭外科治疗进入人工心脏时代

Surgical treatment of heart failure in China:towards the era of artificial heart

我国的心力衰竭患者不仅数量庞大,而且终末期心力衰竭占比也在持续增加。目前药物治疗终末期心力衰竭的临床效果不佳,心脏移植又面临供体数量不足等诸多限制。近年来,我国人工心脏研制工作进展迅速,目前已有三款产品获得国家药品监督管理局批准上市,另有一款正在进行上市前临床试验。自2017年以来,国内已有34家医院开展了超过200例心室辅助装置植入手术。中国医学科学院阜外医院的70例患者术后随访结果显示,2年生存率达到90%,首例接受治疗的患者已带装置生存超过5年。未来在开展人工心脏治疗心力衰竭的实践中,一方面要致力于规范化推广应用和加强质量控制,另一方面要积极开展研究,争取在搏动性血流血泵、全植入无线缆血泵、改良生物材料提升血液相容性等核心技术领域取得突破。

The number of patients with heart failure in China is large,and the proportion of patients with end-stage heart failure continues to increase.The clinical effect of guideline-directed medications therapy for end-stage heart failure is poor.Heart transplantation is the most effective treatment for end-stage heart failure.But it is faced with many limitations such as the shortage of donors.In recent years,the research and development of artificial heart in China has made great progress.Three devices have been approved by the National Medical Products Administration for marketing,and another one is undergoing pre-marketing clinical trial.Since 2017,more than 200 cases of ventricular assist device implantation have been carried out in more than 34 hospitals in China.Among them,70 patients in Fuwai Hospital,Chinese Academy of Medical Sciences had a 2-year survival rate of 90%.The first patient has survived more than 5 years with the device.More efforts should be put into the training of standardized technical team and quality control.Further research should be carried out in the aspects of pulsatile blood flow pump,fully implanted cable-free device,and improved biomaterial with better blood compatibility.