Tzikas Apostolos, Holmes David R, Gafoor Sameer, Ruiz Carlos E, Blomström-Lundqvist Carina, Diener Hans-Christoph, Cappato Riccardo, Kar Saibal, Lee Randal J, Byrne Robert A, Ibrahim Reda, Lakkireddy Dhanunjaya, Soliman Osama I, Näbauer Michael, Schneider Steffen, Brachman Johannes, Saver Jeffrey L, Tiemann Klaus, Sievert Horst, Camm A John, Lewalter Thorsten
AHEPA University Hospital, Thessaloniki, Greece.
EuroIntervention. 2016 May 17;12(1):103-11. doi: 10.4244/EIJV12I1A18.
The increasing interest in left atrial appendage occlusion (LAAO) for ischaemic stroke prevention in atrial fibrillation (AF) fuels the need for more clinical data on the safety and effectiveness of this therapy. Besides an assessment of the effectiveness of the therapy in specific patient groups, comparisons with pharmacological stroke prophylaxis, surgical approaches and other device-based therapies are warranted. This paper documents the consensus reached among clinical experts in relevant disciplines from Europe and North America, European cardiology professional societies and representatives from the medical device industry regarding definitions for parameters and endpoints to be assessed in clinical studies. Adherence to these definitions is proposed in order to achieve a consistent approach across clinical studies on LAAO among the involved stakeholders and various clinical disciplines and thereby facilitate continued evaluation of therapeutic strategies available.
对心房颤动(AF)患者采用左心耳封堵术(LAAO)预防缺血性卒中的兴趣日益浓厚,这使得人们需要更多关于该疗法安全性和有效性的临床数据。除了评估该疗法在特定患者群体中的有效性外,还需要将其与药物性卒中预防、外科手术方法及其他基于器械的疗法进行比较。本文记录了来自欧洲和北美的相关学科临床专家、欧洲心脏病学专业协会以及医疗器械行业代表就临床研究中待评估参数和终点的定义所达成的共识。建议遵循这些定义,以便在参与的利益相关者和各个临床学科之间,就LAAO的临床研究实现一致的方法,从而促进对现有治疗策略的持续评估。