首页|期刊导航|中国医学装备|左心耳封堵器综合价值评估专家共识

左心耳封堵器综合价值评估专家共识OA

Expert consensus on assessment for comprehensive value of left atrial appendage closure devices

中文摘要英文摘要

左心耳封堵术(LAAC)已被国内外多个指南推荐用于预防非瓣膜性心房颤动卒中,其安全性和有效性已得到广泛验证.目前国内可供选择的左心耳封堵器种类繁多,每种器械设计的形态、理念不同,器械结构设计对于LAAC的安全性、有效性影响亦不同.国内目前尚缺乏对左心耳封堵器的统一评价体系,在一定程度上阻碍了LAAC的发展.为此,成立左心耳封堵器综合价值评估专家共识项目组,联合国内专家,总结国内外左心耳封堵器相关的注册管理要求、循证医学证据、卫生技术评估结果案例,结合专家临床和医院管理经验,共同制定《左心耳封堵器综合价值评估专家共识》,从临床价值、经济价值和管理价值3个维度提出左心耳封堵器综合价值评估的建议,旨在帮助医疗机构从自身角度更好的理解左心耳封堵器类医疗器械的关键价值点,为医疗机构科学评估和管理遴选该类医疗器械提供参考依据.

Left atrial appendage closure(LAAC)has been recommended by multiple domestic and international guidelines in preventing stroke for patients with non-valvular atrial fibrillation(NVAF),and safety and efficacy of that has been extensively validated.Currently,a wide variety of LAAC devices is available in China.These devices vary significantly in morphology and design principle,and the design of device structure exerts substantial impacts on the safety and efficacy of LAAC.At present,the unified evaluation system of LAAC is lack in China,which has hindered the development of LAAC at a certain extent.In view of this,an Expert Consensus Working Group of the Assessment for Comprehensive Value of Left Atrial Appendage Closure Devices was established,which jointed 30 domestic experts to review the requirement of registration regulations,evidence of evidence-based medicine,and cases about the results of health technology assessment(HTA)that related to worldwide LAAC device.The groups combined management experience of experts in clinical practice and hospital,and then,jointly formulated"Expert Consensus on Assessment for Comprehensive Value of Left Atrial Appendage Closure Devices".This consensus proposed suggestion about the assessment for comprehensive value of LAAC devices from three dimensions:clinical value,economic value,and management value.It aims to help medical institutions to better understand the key value points of the medical apparatus of the kinds of LAAC devices from own perspective of medical institutes,and provide reference basis for medical institutions in scientific assessment,management and selection for this kind of medical apparatus.

中国医学装备协会应用评价分会;胡宏德;蔡葵

中国医学装备协会应用评价分会 北京 100029

医药卫生

左心耳封堵器医疗器械综合价值评估卫生技术评估(HTA)专家共识

Left atrial appendage closure(LAAC)Medical deviceAssessment for comprehensive valueHealth technology assessment(HTA)Expert consensus

《中国医学装备》 2026 (5)

1-11,11

10.3969/j.issn.1672-8270.2026.05.001

评论