“PROTECT AF研究”和“PREVAIL研究”5年随访结果看左心耳封堵所面临的质疑与挑战
江立生,何奔
摘要(Abstract)：
<正>左心耳封堵自2001年开始临床应用至今已走过17个年头,虽然该项技术在国内外获得了快速发展,但仍然受到不少的质疑、甚至挑战。经过梳理发现,这些质疑与挑战主要集中在"理论上是否站得住脚""技术上是否可行"和"远期效果如何"三个方面,笔者针对这三方面的质疑与挑战,根据公开发表的临床研究数据,尤其是新近合并发布的"PROTECT AF研究"和"PREVAIL研究"的5年随访结果~([1])谈谈
关键词(KeyWords)： PROTECT AF研究;PREVAIL研究;左心耳封堵
基金项目(Foundation):
作者(Author): 江立生,何奔
参考文献(References)：
- [1]Reddy VY,Doshi SK,Kar S,et al.5-Year Outcomes After Left Atrial Appendage Closure:From the PREVAIL and PROTECT AFTrials.J Am Coll Cardiol,2017,70(24):2964-2975.
- [2]De Simone CV,Prakriti BG,Tri J,et al.A review of the relevant embryology,pathohistology,and anatomy of the lef t atrial appendage for the invasive cardiac electrophysiologist.J Atr Fibrillation,2015,8(2):1129.
- [3]Watson T,Shantsila E,Lip GY.Mechanisms of thrombogenesis in atrial fibrillation:Virchow's triad revisited.Lancet,2009,373(9658):155-166.
- [4]Becker RC.Thrombogenesis in atrial fibrillation:contributing mechanisms and natural history.J Thromb Thrombolysis,2008,26(3):262-264.
- [5]Mahajan R,Brooks AG,Sullivan T,et al.Importance of the underlying substrate in determining thrombus location in atrial fibrillation:implications for left atrial appendage closure.Heart,2012,98(15):1120-1126.
- [6]Stoddard MF,Dawkins PR,Prince CR,et al.Left atrial appendage thrombus is not uncommon in patients with acute atrial fibrillation and a recent embolic event:a transesophageal echocardiographic study.J Am Coll Cardiol,1995,25(2):452-459.
- [7]Blackshear JL,Odell JA.Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation.Ann Thorac Surg,1996,61(2):755-759.
- [8]Lip GY,Hammerstingl C,Marin F,et al.Left atrial thrombus resolution in atrial fibrillation or flutter:Results of a prospective study with rivaroxaban(X-TRA)and a retrospective observational registry providing baseline data(CLOT-AF).Am Heart J,2016,178:126-134.
- [9]Holmes DR,Reddy VY,Turi ZG,et al.Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation:a randomised noninferiority trial.Lancet,2009,374(9689):534-542.
- [10]Holmes DR Jr,Kar S,Price MJ,et al.Prospective randomized evaluation of the Watchman Lef t Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy:the PREVAIL trial.J Am Coll Cardiol,2014,64(1):1-12.
- [11]Boersma LV,Schmidt B,Betts TR,et al.Implant success and safety of left atrial appendage closure with the WATCHMANdevice:peri-procedural outcomes from the EWOLUTION registry.Eur Heart J,2016,37(31):2465-2474.
- [12]Reddy VY,Sievert H,Halperin J,et al.Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation:a randomized clinical trial.JAMA,2014,312(19):1988-1998.
- [13]Connolly SJ,Ezekowitz MD,Yusuf S,et al.Dabigatran versus warfarin in patients with atrial fibrillation.N Engl J Med,2009,361(12):1139-1151.
- [14]Patel MR,Mahaffey KW,Garg J,et al.Rivaroxaban versus warfarin in nonvalvular atrial fibrillation.N Engl J Med,2011,365(10):883-891.
- [15]Granger CB,Alexander JH,McMurray JJ,et al.Apixaban versus warfarin in patients with atrial fibrillation.N Engl J Med,2011,365(11):981-992.
- [16]Giugliano RP,Ruff CT,Braunwald E,et al.Edoxaban versus warfarin in patients with atrial fibrillation.N Engl J Med,2013,369(22):2093-2104.