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Percutaneous left atrial appendage closure using the LAmbre device. First clinical results in Poland

机译:使用LAmbre装置经皮左心耳封堵术。波兰的第一批临床结果

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Introduction In adult populations, atrial fibrillation (AF) is the major arrhythmia and successful treatment rates are low [1]. In recent years, left atrial appendage occlusion (LAAO) has become an alternative method for stroke prevention in patients in whom oral anticoagulation (OAC) is ineffective or contraindicated or in patients with life-threatening complications [2, 3]. Previous studies have demonstrated that the LAAO procedure is safe and effective in the prevention of thromboembolic events, including in high risk patients [4–10]. In the medical market, there are a?number of available devices including endocardial and epicardial devices [4, 5, 9]. However, in some cases, the anatomy of the left atrial appendage (LAA) may constitute a?contraindication to implantation of these devices. The LAmbre device is a?novel system, designed especially for LAA closure when problematic morphology is present [11, 12]. Aim Herein, we present the first use of the LAmbre device in Poland in patients with AF. Material and methods A?retrospective, single-center study was performed in 24 consecutive patients with non-valvular AF, who underwent LAAO with the LAmbre device (Lifetech Scientific Corp., Shenzhen, China) between 2016 and 2018 (Figure 1). The LAmbre occluder system was previously described [13]. LAmbre device selection was based on operators’ decision. All procedures were performed under general anesthesia. Patient characteristics are presented in Table I. The LAA anatomy was assessed with computed tomography angiography before each procedure. Oral anticoagulation therapy was discontinued and unfractionated heparin was used during the procedure. After the procedure, aspirin (75?mg/dose/day) and clopidogrel (75?mg/dose/day) for 6 months were recommended in each patient. Leak was defined as the presence of flow from the left atrium to the LAA 3?mm [14]. Follow-up visits, including transesophageal echocardiography, were performed at 3 and 6 months post-procedure. Data on mortality, causes of mortality and serious adverse events (SAE) were collected. Statistical analysis Data are expressed as mean ± standard deviation or median (interquartile range; Q1 – 25th percentile and Q3 – 75th percentile), unless otherwise stated. Categorical variables were expressed as counts and percentages. Results All procedures were successfully completed with no perioperative complications. The LAAO...
机译:简介在成人人群中,房颤(AF)是主要的心律失常,成功的治疗率很低[1]。近年来,对于口服抗凝药(OAC)无效或禁忌或危及生命的并发症的患者,左心耳闭塞(LAAO)已成为预防中风的另一种方法[2,3]。先前的研究表明,LAAO程序对于包括高危患者在内的血栓栓塞事件的预防是安全有效的[4-10]。在医疗市场上,有许多可用的设备,包括心内膜和心外膜设备[4、5、9]。但是,在某些情况下,左心耳(LAA)的解剖结构可能会限制这些装置的植入。 LAmbre设备是一个新颖的系统,专为存在问题形态的LAA封闭而设计[11,12]。目的在此,我们介绍了LAmbre装置在波兰首次用于房颤患者。材料和方法回顾性,单中心研究在2016年至2018年之间连续进行的24例非瓣膜性房颤患者中,他们接受了LAmbre装置(中国深圳生命科技有限公司)进行的LAAO治疗(图1)。 LAmbre封堵器系统先前已有描述[13]。 LAmbre设备的选择基于运营商的决定。所有程序均在全身麻醉下进行。患者的特征列于表I。在每次手术前用计算机断层摄影血管造影术评估LAA解剖结构。停止口服抗凝治疗,在此过程中使用普通肝素。手术后,建议每例患者服用阿司匹林(75?mg /剂量/天)和氯吡格雷(75?mg /剂量/天)6个月。泄漏的定义是从左心房到LAA <3?mm [14]。术后3个月和6个月进行随访,包括经食道超声心动图检查。收集了有关死亡率,死亡原因和严重不良事件(SAE)的数据。统计分析除非另有说明,否则数据表示为均值±标准差或中位数(四分位数范围; Q1 – 25%百分位和Q3 – 75%百分位)。分类变量表示为计数和百分比。结果所有手术均成功完成,无围手术期并发症。老挝...

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