Department of Cardiology, Pneumology and Vascular Medicine, Heinrich Heine University Düsseldorf, Duesseldorf, Nordrhein-Westfalen, Germany.
Department of Cardiology, Aarhus University, Aarhus, Denmark.
BMJ Open. 2021 Mar 24;11(3):e040455. doi: 10.1136/bmjopen-2020-040455.
To evaluate the safety and efficacy of percutaneous left atrial appendage occlusion (LAAO) using conscious sedation (CS).
Several percutaneous structural heart disease interventions are safely and efficiently performed using CS instead of general anaesthesia (GA). This concept has not been evaluated in a large multicenter cohort of patients undergoing LAAO.
Patients from the prospective, global Amplatzer Amulet Occluder Observational Study were divided into two groups (GA vs CS). Baseline information, periprocedural and postprocedural efficacy and complications, as well as outcomes through 7 days post implant were compared.
Patients undergoing transesophageal-guided implants were categorised by GA (n=607, 64%) or CS (n=342, 36%) usage. Mean age was 75 years in both groups. LAAO technical success was achieved in 99% of both groups. The procedure duration (GA: 35±22 min vs CS: 27±19 min, p<0.001), total amount of contrast medium (GA: 105±81 mL vs CS: 86±66 mL, p<0.001) and fluoroscopic time (GA: 13±9 min vs CS: 12±13 min, p<0.001) were less in CS cases. Procedure-related or device-related serious adverse events during the first 7 days were numerically higher in the CS group (GA: 4.9% vs CS: 7.6%, p=0.114). Peridevice residual flow was absent or ≤5 mm 1-3 months after the procedure in 99.7% of the GA and in 100% of the CS group (p=1.000).
In a large global study, LAAO with the Amplatzer Amulet occluder is safe and feasible using CS. Procedure duration and total amount of contrast were less with CS than GA cases.
NCT02447081; Results.
评估清醒镇静（CS）下经皮左心耳封堵（LAAO）的安全性和有效性。
多项经皮结构性心脏病介入治疗已通过 CS 而非全身麻醉（GA）安全有效地实施。这一概念尚未在接受 LAAO 的大型多中心患者队列中进行评估。
前瞻性、全球性的 Amplatzer Amulet 封堵器观察研究的患者被分为两组（GA 组与 CS 组）。比较了两组患者的基线资料、围手术期和术后疗效及并发症，以及植入后 7 天内的结局。
接受经食管引导植入的患者根据 GA（n=607，64%）或 CS（n=342，36%）使用情况进行分类。两组患者的平均年龄均为 75 岁。两组患者的 LAAO 技术成功率均达到 99%。CS 组的手术时间（GA：35±22min 比 CS：27±19min，p<0.001）、造影剂总用量（GA：105±81mL 比 CS：86±66mL，p<0.001）和透视时间（GA：13±9min 比 CS：12±13min，p<0.001）均较少。CS 组在术后 7 天内与手术或器械相关的严重不良事件发生率略高（GA：4.9%比 CS：7.6%，p=0.114）。术后 1-3 个月，GA 组 99.7%和 CS 组 100%的患者无或残余分流≤5mm（p=1.000）。
在一项大型全球研究中，使用 Amplatzer Amulet 封堵器行 LAAO 治疗安全可行，且可在 CS 下进行。CS 组的手术时间和造影剂总用量均少于 GA 组。
NCT02447081；结果。
