Amulet IDE试验中高危器械相关血栓的特征和临床结果

IF 8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
Jens Erik Nielsen-Kudsk, Boris Schmidt, Stephan Windecker, Neeraj Shah, William Gray, Christopher R Ellis, Konstantinos Koulogiannis, Jordan A Anderson, Ryan Gage, Dhanunjaya Lakkireddy
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引用次数: 0

摘要

背景:器械相关血栓(DRT)的特征在不同类型的左心耳闭塞装置之间可能不同,不同DRT特征与临床结果的关系在很大程度上是未知的。目的:在AMPLATZER护身符左心耳闭塞器(AMPLATZER Amulet左心耳闭塞器[LAAO]研究性器械豁免[IDE]试验)中评估5年高风险和低风险drt的发生率、特征和临床结果。方法:一个独立的核心实验室分析了所有可获得的45天和12个月的随访图像,并报告了左心耳闭塞后5年的临床事件。结果:在1788例成功植入装置的患者中,Amulet和Watchman 2.5装置患者在12个月内分别有3.3%(903例中的30例)和4.5%(885例中的40例)观察到DRT (P = 0.192)。如果有带梗,可移动,厚度为30mm,或没有延续到左房壁,DRTs被成功地归类为高风险。Watchman 2.5设备的高危drt发生率(4.0%[35 / 885])明显高于Amulet闭塞器(2.2% [20 / 903])(P = 0.030)。大多数低风险drt得以解决(15个中的12个),而高风险drt大部分仍未解决(55个中的34个)。在5年中,高危DRT组的所有临床转转率均高于低危或无DRT组;在卒中、全身性栓塞或心血管死亡的组合中观察到显著性(30.4% vs 19.9%;人力资源:1.74;95% ci: 1.03-2.92;P = 0.037)和心血管死亡(26.4% vs 14.5%, HR: 2.09;95% ci: 1.20-3.66;p = 0.009)。结论:与Amulet闭塞器患者相比,Watchman 2.5装置患者的drt高危率更高。与低风险drt或无drt患者相比,高风险drt患者卒中、全身性栓塞或心血管死亡的发生率更高。AMPLATZER护身符左心房附件闭塞器[LAAO]研究性器械豁免[护身符IDE试验];NCT02879448)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Characterization and Clinical Outcomes of High-Risk Device-Related Thrombus in the Amulet IDE Trial.

Background: Characteristics of device-related thrombus (DRT) may differ between types of left atrial appendage occlusion devices, and the association of different DRT characteristics to clinical outcomes is largely unknown.

Objectives: The incidence, characteristics, and clinical outcomes through 5 years of high- and low-risk DRTs were assessed in the Amulet IDE trial (AMPLATZER Amulet Left Atrial Appendage Occluder [LAAO] Investigational Device Exemption [IDE] Trial).

Methods: An independent core laboratory analyzed all available images at the required 45-day and 12-month visits, and clinical events were reported through 5 years' post-left atrial appendage occlusion.

Results: Of the 1,788 patients with a successful device implant, DRT was observed in 3.3% (30 of 903) and 4.5% (40 of 885) of Amulet and Watchman 2.5 device patients throughout 12 months, respectively (P = 0.192). DRTs were successfully classified as high risk if pedunculated, mobile, >3 mm in thickness, or without continuation onto the left atrial wall. A significantly higher incidence of high-risk DRTs was observed on the Watchman 2.5 device (4.0% [35 of 885]) compared with the Amulet occluder (2.2% [20 of 903]) (P = 0.030). Most low-risk DRTs resolved (12 of 15), whereas high-risk DRTs remained mostly unresolved (34 of 55). Through 5 years, all clinical outcome rates were numerically higher in the high-risk DRT group compared with the low-risk DRT or no-DRT group; significance was observed in the composite of stroke, systemic embolism, or cardiovascular death (30.4% vs 19.9%; HR: 1.74; 95% CI: 1.03-2.92; P = 0.037) and cardiovascular death (26.4% vs 14.5%, HR: 2.09; 95% CI: 1.20-3.66; P = 0.009).

Conclusions: High-risk DRTs were observed in a higher number of Watchman 2.5 device patients compared with Amulet occluder patients. The composite of stroke, systemic embolism, or cardiovascular death occurred more often in patients with high-risk DRTs compared with those with low-risk DRTs or no DRTs. (AMPLATZER Amulet Left Atrial Appendage Occluder [LAAO] Investigational Device Exemption [Amulet IDE Trial]; NCT02879448).

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来源期刊
JACC. Clinical electrophysiology
JACC. Clinical electrophysiology CARDIAC & CARDIOVASCULAR SYSTEMS-
CiteScore
10.30
自引率
5.70%
发文量
250
期刊介绍: JACC: Clinical Electrophysiology is one of a family of specialist journals launched by the renowned Journal of the American College of Cardiology (JACC). It encompasses all aspects of the epidemiology, pathogenesis, diagnosis and treatment of cardiac arrhythmias. Submissions of original research and state-of-the-art reviews from cardiology, cardiovascular surgery, neurology, outcomes research, and related fields are encouraged. Experimental and preclinical work that directly relates to diagnostic or therapeutic interventions are also encouraged. In general, case reports will not be considered for publication.
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