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The "Product of a Village": FDA as a Partner in Evidence Generation.

作者信息

Coylewright Megan, Zeitler Emily P

机构信息

The Erlanger Heart Institute, Chattanooga, Tennessee.

Dartmouth Health and The Dartmouth Institute, Lebanon, New Hampshire.

出版信息

J Soc Cardiovasc Angiogr Interv. 2023 Jan 2;2(1):100561. doi: 10.1016/j.jscai.2022.100561. eCollection 2023 Jan-Feb.

DOI:10.1016/j.jscai.2022.100561
PMID:39132516
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11308859/
Abstract
摘要

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本文引用的文献

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Sex Differences in Safety and Effectiveness of LAAO: Insights From the Amulet IDE Trial.左心耳封堵术安全性和有效性的性别差异：Amulet IDE 试验的见解。
JACC Cardiovasc Interv. 2022 Nov 14;15(21):2143-2155. doi: 10.1016/j.jcin.2022.06.037. Epub 2022 Oct 12.
2
Sex Differences in Procedural Outcomes Among Patients Undergoing Left Atrial Appendage Occlusion: Insights From the NCDR LAAO Registry.左心耳封堵术患者的手术结局的性别差异：来自 NCDR LAAO 注册研究的见解。
JAMA Cardiol. 2021 Nov 1;6(11):1275-1284. doi: 10.1001/jamacardio.2021.3021.
3
Left Atrial Appendage Occlusion during Cardiac Surgery to Prevent Stroke.心脏手术中的左心耳封堵术预防中风。
N Engl J Med. 2021 Jun 3;384(22):2081-2091. doi: 10.1056/NEJMoa2101897. Epub 2021 May 15.
4
Sex-stratified analysis of the safety of percutaneous left atrial appendage occlusion.经皮左心耳封堵安全性的性别分层分析。
Catheter Cardiovasc Interv. 2021 Apr 1;97(5):885-892. doi: 10.1002/ccd.29282. Epub 2020 Oct 13.
5
Early Rhythm-Control Therapy in Patients with Atrial Fibrillation.心房颤动患者的早期节律控制治疗。
N Engl J Med. 2020 Oct 1;383(14):1305-1316. doi: 10.1056/NEJMoa2019422. Epub 2020 Aug 29.
6
Long-Term Safety and Efficacy in Continued Access Left Atrial Appendage Closure Registries.延续性左心耳封堵器使用登记研究的长期安全性和有效性。
J Am Coll Cardiol. 2019 Dec 10;74(23):2878-2889. doi: 10.1016/j.jacc.2019.09.064.
7
Left Atrial Appendage Closure as an Alternative to Warfarin for Stroke Prevention in Atrial Fibrillation: A Patient-Level Meta-Analysis.左心耳封堵术预防心房颤动患者卒中：一项基于患者的荟萃分析。
J Am Coll Cardiol. 2015 Jun 23;65(24):2614-2623. doi: 10.1016/j.jacc.2015.04.025.
8
Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial.经皮左心耳封堵术与华法林治疗心房颤动的随机临床试验。
JAMA. 2014 Nov 19;312(19):1988-98. doi: 10.1001/jama.2014.15192.
9
Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial.经皮左心耳封堵术与华法林治疗预防心房颤动患者卒中的随机非劣效性试验
Lancet. 2009 Aug 15;374(9689):534-42. doi: 10.1016/S0140-6736(09)61343-X.
10
Effect of dronedarone on cardiovascular events in atrial fibrillation.决奈达隆对房颤心血管事件的影响。
N Engl J Med. 2009 Feb 12;360(7):668-78. doi: 10.1056/NEJMoa0803778.