Incidence, Predictors, and Clinical Outcomes of Device-Related Thrombus in the Amulet IDE Trial.
Incidence, Predictors, and Clinical Outcomes of Device-Related Thrombus in the Amulet IDE Trial.
复制标题
Amulet IDE 试验中设备相关血栓的发生率、预测因素和临床结果。
DOI：
10.1016/j.jacep.2022.07.014
复制
发表时间：
2022
期刊：
影响因子：
--
通讯作者：
Dhanunjaya Lakkireddy
中科院分区：
文献类型：
--
作者：
B. Schmidt;J. Nielsen;Christopher R. Ellis;D. Thaler;Sajjad A. Sabir;A. Gambhir;U. Landmesser;N. Shah;W. Gray;V. Swarup;D. Lim;K. Koulogiannis;Jordan A Anderson;Ryan Gage;Dhanunjaya Lakkireddy
背景左心耳封堵术（LAAO）后器械相关血栓（DRT）可导致不良临床结局。DRT率和结果从随机trials are limited.ObjectivesThis analysis investigated the incidence，predictors，and clinical outcomes of DRT following LAAO in the Amulet IDE（AMPLATZER Amulet LAA Occluder Trial）trial.MethodsSuccessful implants occurred in 903 patients with a Amulet occluder（dual occlusive mechanism device）and 885 patients with a Watchman device（single occlusive mechanism device）.这些患者随后通过18个月和DRT进行了评估transesophageal echocardios.ResultsThe DRT的总发病率为3.9%（n = 70）与3.4%（n = 30）在双闭塞机制装置的患者和4.8%（n = 40）在单闭塞机制装置的患者。大多数DRT（n = 19/31）在双封堵机制器械上早期（≤45天）被识别，而大多数DRT（n = 31/42）在单封堵机制器械上晚期（>45天）被识别。DRT的强预测因素包括手术时的房颤（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）和老年（HR：1.04; 95% CI：1.01-1.08;P =0.02）。双闭塞机制器械组在DRT后无卒中事件，单闭塞机制器械组在DRT后有3起卒中事件。与非DRT患者相比，DRT患者的心血管死亡风险更高（8.7% vs 3.9%; HR：2.33; 95%CI：1.01-5.39;P =0.04）。早期DRT见于双闭塞机制器械，晚期DRT见于单闭塞机制器械。应进一步研究DRT患者心血管死亡风险的增加。（AMPLATZER Amulet左心耳封堵器试模; NCT 02879448）
BackgroundDevice-related thrombus (DRT) following left atrial appendage occlusion (LAAO) can lead to adverse clinical outcomes. DRT rates and outcomes from randomized trials are limited.ObjectivesThis analysis investigated the incidence, predictors, and clinical outcomes of DRT following LAAO in the Amulet IDE (AMPLATZER Amulet LAA Occluder Trial) trial.MethodsSuccessful 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.ResultsThe 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).ConclusionsIncidence 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)