Schmidt Boris, Nielsen-Kudsk Jens Erik, Ellis Christopher R, Thaler David, Sabir Sajjad A, Gambhir Alok, Landmesser Ulf, Shah Neeraj, Gray William, Swarup Vijendra, Lim D Scott, Koulogiannis Konstantinos, Anderson Jordan A, Gage Ryan, Lakkireddy Dhanunjaya
Cardioangiologisches Centrum Bethanien, Frankfurt, Germany.
Aarhus University Hospital, Aarhus, Denmark.
JACC Clin Electrophysiol. 2023 Jan;9(1):96-107. doi: 10.1016/j.jacep.2022.07.014. Epub 2022 Sep 28.
Device-related thrombus (DRT) following left atrial appendage occlusion (LAAO) can lead to adverse clinical outcomes. DRT rates and outcomes from randomized trials are limited.
This analysis investigated the incidence, predictors, and clinical outcomes of DRT following LAAO in the Amulet IDE (AMPLATZER Amulet LAA Occluder Trial) trial.
Successful implants occurred in 903 patients with an Amulet occluder (dual occlusive mechanism device) and 885 patients with a Watchman device (single occlusive mechanism device). These patients were then followed through 18 months and DRT was assessed by transesophageal echocardiography.
The overall incidence of DRT was 3.9% (n = 70) with 3.4% (n = 30) in dual occlusive mechanism device patients and 4.8% (n = 40) in single occlusive mechanism device patients. Most DRTs (n = 19 of 31) were identified early (≤45 days) on the dual occlusive mechanism device, whereas most of the DRTs (n = 31 of 42) were identified late (>45 days) on the single occlusive mechanism device. Strong predictors of DRT included atrial fibrillation at time of procedure (HR: 2.44; 95% CI: 1.42-4.22; P < 0.01), female sex (HR: 1.65; 95% CI: 1.01-2.71; P = 0.04), and older age (HR: 1.04; 95% CI: 1.01-1.08; P = 0.02). There were no stroke events following DRT in the dual occlusive mechanism device group and 3 stroke events following DRT in the single occlusive mechanism device group. Patients with DRT were at a greater risk for cardiovascular mortality compared with non-DRT patients (8.7% vs 3.9%; HR: 2.33; 95% CI: 1.01-5.39; P = 0.04).
Incidence of DRT following LAAO was low. Early DRTs are seen with the dual occlusive mechanism device and late DRTs are seen with the single occlusive mechanism device. Increased cardiovascular mortality risk in patients with DRT should be further investigated. (AMPLATZER Amulet LAA Occluder Trial; NCT02879448).
左心耳封堵术（LAAO）后与器械相关的血栓（DRT）可导致不良临床结局。随机试验中的DRT发生率及结局数据有限。
本分析调查了Amulet IDE（美敦力Amulet左心耳封堵器试验）试验中LAAO后DRT的发生率、预测因素及临床结局。
903例植入Amulet封堵器（双闭塞机制器械）和885例植入Watchman封堵器（单闭塞机制器械）的患者手术成功。随后对这些患者进行18个月的随访，并通过经食管超声心动图评估DRT。
DRT的总体发生率为3.9%（n = 70），双闭塞机制器械组患者为3.4%（n = 30），单闭塞机制器械组患者为4.8%（n = 40）。双闭塞机制器械上的大多数DRT（31例中的19例）在早期（≤45天）被发现，而单闭塞机制器械上的大多数DRT（42例中的31例）在晚期（>45天）被发现。DRT的强预测因素包括手术时的心房颤动（HR：2.44；95%CI：1.42 - 4.22；P < 0.01）、女性（HR：1.65；95%CI：1.01 - 2.71；P = 0.04）和高龄（HR：1.04；95%CI：1.01 - 1.08；P = 0.02）。双闭塞机制器械组DRT后无卒中事件，单闭塞机制器械组DRT后有3例卒中事件。与无DRT的患者相比，发生DRT的患者心血管死亡风险更高（8.7%对3.9%；HR：2.33；95%CI：1.01 - 5.39；P = 0.04）。
LAAO后DRT的发生率较低。双闭塞机制器械可见早期DRT，单闭塞机制器械可见晚期DRT。DRT患者心血管死亡风险增加的情况应进一步研究。（美敦力Amulet左心耳封堵器试验；NCT02879448）
