摘要
Abstract
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.关键词
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Key words
Left atrial appendage closure(LAAC)/Medical device/Assessment for comprehensive value/Health technology assessment(HTA)/Expert consensus分类
医药卫生
