Characterization and Clinical Outcomes of High-Risk Device-Related Thrombus in the Amulet IDE Trial (JCEP July 2025)-Article: Characterization and Clinical Outcomes of High-Risk Device-Related Thrombus in the Amulet IDE Trial

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The Amulet IDE trial examined the long-term outcomes of device-related thrombus (DRT) formation associated with left atrial appendage occlusion (LAAO) devices in patients with atrial fibrillation (AF). The study focused on devices such as the Amulet occluder and the Watchman 2.5 device, involving 1,788 patients, to understand the incidence and impact of high-risk DRTs over a five-year period.<br /><br />The trial observed that DRTs formed in 3.3% of Amulet patients and 4.5% of Watchman patients within 12 months, although this difference was not statistically significant. However, high-risk DRTs were significantly more prevalent in Watchman patients (4.0%) than in Amulet patients (2.2%). High-risk DRTs, characterized by features such as mobility, thickness, and lack of continuation to the left atrial wall, led to worse clinical outcomes. These patients were more likely to experience strokes, systemic embolisms, or cardiovascular deaths compared to those with low-risk or no DRTs, with cardiovascular deaths driving the increased risk.<br /><br />The analysis highlighted the importance of monitoring and potentially treating high-risk DRTs due to their association with increased adverse events. The study found most high-risk DRTs remained unresolved despite treatment, emphasizing the need for effective management strategies. In contrast, low-risk DRTs did not result in clinical events and mostly resolved over time.<br /><br />The trial suggests that the design differences between devices may influence the risk of DRT formation, with the Amulet's dual-seal design potentially offering a protective effect against high-risk DRT. These findings could guide clinical decisions regarding the use of LAAO devices and the management of DRTs, potentially impacting recommendations for follow-up imaging and treatment strategies.

Meta Tag

Concept Device-Related Thrombus

Concept Left Atrial Appendage Occlusion

Concept Imaging Feature

Concept Risk Category

Concept Incidence

Keywords

Amulet IDE trial

device-related thrombus

left atrial appendage occlusion

atrial fibrillation

Amulet occluder

Watchman device

high-risk DRTs

clinical outcomes

cardiovascular deaths

management strategies

Device-Related Thrombus

Left Atrial Appendage Occlusion

Imaging Feature

Risk Category

Incidence