进展期心力衰竭治疗器械技术的研究现状及发展趋势思考  

Research Status and Trend of Devices for Treating Advanced Heart Failure

作　　者：焦国慧 徐绍鹏[2] 苗晶晶 王玉姬 吴琨 JIAO Guohui;XU Shaopeng;MIAO Jingjing;WANG Yuji;WU Kun(Center for Medical Device Evaluation,NMPA,Beijing 100081,China;Department of Cardiac Disease,Tianjin Medical University General Hospital,Tianjin 300000,China)

机构地区：[1]国家药品监督管理局医疗器械技术审评中心,北京100081 [2]天津医科大学总医院心脏内科,天津300000

出　　处：《中国医学科学院学报》2023年第5期840-852,共13页Acta Academiae Medicinae Sinicae

摘　　要：心力衰竭(HF)是慢性、进展性疾病,是全球人口死亡的主要原因。HF的病理生理异常主要包括心脏结构(心肌与瓣膜)异常、电生理活动紊乱、心肌收缩能力减弱等。除了药物和心脏移植治疗,进展期HF还可以使用介入治疗,包括经导管介入、机械循环辅助装置等。本文总结了在全球已上市或被认证为创新或突破性设备称号、用于进展期HF患者的器械研究现状和发展趋势,为医疗器械研发和监管人员提供参考。HF器械治疗方案呈现多样化组合特点,基于个体化HF治疗方案和器械设计的风险-获益评估、医疗保险支付、上市后监管体系以及保护高端技术的知识产权等方面进步和完善,会推动医疗器械技术和行业发展,让患者更大获益。Heart failure(HF),a chronic progressive disease,is a global health problem and the leading cause of deaths in the global population.The pathophysiological abnormalities of HF mainly include abnormal cardiac structure(myocardium and valves),disturbance of electrophysiological activities,and weakened myocardial contractility.In addition to drug therapy and heart transplantation,interventional therapies can be employed for advanced-stage HF,including transcatheter interventions and mechanical circulatory assist devices.This article introduces the devices used for advanced HF that have been marketed or certified as innovative or breakthrough devices around the world and summarizes the research status and prospects the trend in this field.As diversified combinations of HF devices are used for the treatment of advanced HF,considerations regarding individualized HF therapy,risk-benefit evaluation on device design,medical insurance payment,post-market supervision system,and protection of intellectual property rights of high-end technology are needed,which will boost the development of the technology and industry and benefit the patients.

关 键 词：心力衰竭 结构 电生理 介入 医疗器械 

分 类 号：R54[医药卫生—心血管疾病] R65[医药卫生—内科学]