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Updated: Jan 31, 2026
The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Incidence and Clinical Impact of Device-Related Thrombus Following Percutaneous Left Atrial Appendage Occlusion: A
Mohamad Alkhouli1, Tatiana Busu1, Kuldeep Shah1
1Division of Cardiology, West Virginia School of Medicine, Morgantown, West Virginia.
Insights
Device-related thrombus (DRT) after left atrial appendage occlusion (LAAO) is uncommon at 3.8%. However, DRT significantly increases the risk of ischemic events by 4- to 5-fold, necessitating further research into its management.
Area of Science:
- Cardiology
- Medical Devices
- Thrombosis
Background:
- Device-related thrombus (DRT) is a recognized complication of left atrial appendage occlusion (LAAO).
- Existing data on the incidence and clinical significance of DRT following LAAO procedures are limited.
Purpose of the Study:
- To evaluate the incidence of DRT after LAAO.
- To determine the clinical impact of DRT on ischemic events.
Main Methods:
- A meta-analysis was conducted, incorporating data from randomized and observational studies.
- Pooled incidence of DRT and odds ratios (OR) for ischemic events in patients with and without DRT were calculated.
Main Results:
- The pooled incidence of DRT across 66 studies was 3.8% (351/10,153), with no significant difference between AMPLATZER and WATCHMAN devices.
- DRT was associated with a 5.27-fold increased risk of ischemic events (OR: 5.27, 95% CI: 3.66 to 7.59).
- Sensitivity analysis confirmed DRT's association with higher ischemic event rates (OR: 4.15, 95% CI: 2.77 to 6.22).
Conclusions:
- DRT following LAAO is infrequent but significantly elevates the risk of ischemic events.
- Further investigation is required to elucidate DRT mechanisms and optimize surveillance and treatment strategies.
Objectives:
This study sought to assess the incidence and clinical impact of device related thrombus (DRT) following precautions left atrial appendage occlusion (LAAO).
Background:
Device-related thrombus is a known complication of LAAO. However, data on the incidence of DRT and its impact on outcomes are limited.
Methods:
The authors performed a meta-analysis of randomized and observational studies to calculate the pooled incidence of DRT and the pooled odds ratio (OR) of ischemic events in patients with DRT and those without DRT.
Results:
In the 66 included studies; the incidence of DRT was 351/10, 153 (3.8%, range 0% to 17%, I2 = 56.8). The diagnosis was made in <90, 90 to 365, and >365 days in 42%, 57%, and 1% of patients, respectively. There was no difference in DRT rates between the AMPLATZER (AMPLATZER, AGA Medical Corporation, Golden Valley, Minnesota) and WATCHMAN (WATCHMAN, Boston Scientific Corporation, Marlborough, Massachusetts) devices (3.6% vs. 3.1%, p = 0.24). In a meta-regression, age, gender, heart failure, diabetes, CHA2DS2-VASc score, previous stroke, and post-LAAO antithrombotic regimen did not explain the heterogeneity in the incidence of DRT. The pooled incidence of ischemic events in studies that compared outcomes of patients with and without DRT (32 studies; n = 7,689) was 13.2% (37 of 280) in patients with DRT and 3.8% (285 of 7,399) in those without DRT (OR: 5.27, 95% confidence interval [CI]: 3.66 to 7.59; p < 0.001, I2 = 0). In a sensitivity analysis including randomized trials and prospective multicenter registries, the incidence of DRT was 3.7%, and DRT remained associated with higher rates of ischemic events (13.5% vs. 4.4%, OR: 4.15, 95% CI: 2.77 to 6.22; p < 0.001, I2 = 0).
Conclusions:
DRT after LAAO is uncommon (3.8%) but is associated with a 4- to 5-fold increase in ischemic events. Further studies are needed to understand the underlying mechanisms and the optimal surveillance and management of DRT.
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