Post-Approval US Experience With Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation
Post-Approval US Experience With Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation
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DOI：
10.1016/j.jacc.2016.10.010
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发表时间：
2017-01-24
影响因子：
24
通讯作者：
Holmes, David R.
中科院分区：
文献类型：
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作者：
Reddy, Vivek Y.;Gibson, Douglas N.;Holmes, David R.
背景：左心耳封堵术（LAAC）已被美国食品药品监督管理局（FDA）批准作为非瓣膜性房颤患者华法林的一种卒中预防替代方案。然而，尽管LAAC降低了抗凝剂相关的出血终生风险，但植入术与前期并发症相关，这一事实混淆了临床决策。因此，LAAC作为一种治疗选择的热情已经得到适当的缓和，特别是当该疗法被引入临床试验地点之外的一般临床实践时。结论本研究评估了自FDA批准以来在美国进行的所有病例的急性手术性能和并发症发生率。我们获得了关于植入手术的手术数据。每一个LAAC程序需要存在的制造商的临床专家和程序参数和围手术期并发症的数据收集使用一个标准化的过程和forms.Results在3,822例连续的情况下，植入成功的3,653（95.6%），与平均手术时间为50分钟（范围10至210分钟）。执行这些手术的植入医生（n = 382）包括71%的新的非临床试验植入者，他们执行了50%的手术。手术并发症发生率包括39例心包填塞（1.02%）（24例接受了治疗，12例接受了手术，3例死亡）; 3例手术相关卒中（0.078%）; 9例器械栓塞（0.24%）（6例需要手术切除）; 3例手术相关死亡结论尽管有很大一部分以前没有经验的操作者，但在LAAC的真实世界FDA批准后的经验中，手术成功率高，并发症发生率低。(C)2017年，作者。由爱思唯尔代表美国心脏病学会基金会出版。
BACKGROUND Left atrial appendage closure (LAAC) was approved by the U.S. Food and Drug Administration (FDA) as a stroke prevention alternative to warfarin for patients with nonvalvular atrial fibrillation. However, clinical decision-making is confounded by the fact that although LAAC attenuates the anticoagulant-related lifetime risk of bleeding, implantation is associated with upfront complications. Thus, enthusiasm for LAAC as a treatment option has been appropriately tempered, particularly as the therapy is introduced beyond the clinical trial sites into general clinical practice.OBJECTIVES This study evaluated the acute procedural performance and complication rates for all cases performed in the United States since FDA approval.METHODS In the absence of a formal national clinical registry since regulatory approval in March 2015, we obtained procedural data on implantation procedures. Every LAAC procedure requires the presence of a manufacturer clinical specialist and for procedural parameter and periprocedural complication data to be collected using a standardized process and forms.RESULTS In 3,822 consecutive cases, implantation was successful in 3,653 (95.6%), with a median procedure time of 50 min (range 10 to 210 min). Implanting physicians performing these procedures (n = 382) included 71% new, nonclinical trial implanters, who performed 50% of the procedures. Procedural complication rates included 39 pericardial tamponades (1.02%) (24 treated percutaneously, 12 surgically, and 3 fatal); 3 procedure-related strokes (0.078%); 9 device embolizations (0.24%) (6 requiring surgical removal); and 3 procedure-related deaths (0.078%).CONCLUSIONS Despite a large fraction of previously inexperienced operators, in the real-world post-FDA approval experience of LAAC, procedural success was high and complication rates were low. (C) 2017 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.