August 8, 2026Journal of the American College of Cardiology359 citationsOpen Access
Device-Related Thrombosis After Percutaneous Left Atrial Appendage Occlusion for Atrial Fibrillation
Key Result
Device-related thrombus after left atrial appendage closure was independently associated with a higher risk of ischemic stroke or TIA (HR 4.39; 95% CI 1.05-18.43; P=0.04).
Key Points
- To analyze the occurrence of device-related thrombosis following percutaneous left atrial appendage occlusion in atrial fibrillation patients.
- Conducted a randomized trial involving patients with atrial fibrillation undergoing percutaneous left atrial appendage occlusion.
- Monitored and assessed thrombosis events post-procedure using imaging techniques and clinical evaluations.
- Device-related thrombosis occurred in a significant percentage of patients, with specific rates not disclosed.
- Findings indicate a potential risk factor for patients undergoing this procedure, stressing the importance of continuous monitoring.
Study Design
Type
Cohort (n=469)
Multicenter
Yes
Structured PICO
What is the incidence, predictors, and prognostic impact of device-related thrombosis after left atrial appendage occlusion in patients with atrial fibrillation?
P
Population
469 patients with atrial fibrillation who underwent left atrial appendage closure across 8 centers in France, followed for a mean of 13 months.
E
Exposure
Transcatheter left atrial appendage (LAA) occlusion using Watchman (n=272) or Amplatzer (n=197) devices.
O
Outcome
Incidence, predictors, and prognosis of thrombus formation on devices.safety
Device-related thrombosis after LAA occlusion occurs in approximately 7.2% of patients per year and significantly increases the risk of subsequent ischemic stroke.
Main Result
Hazard Ratio: 4.39 (95% CI 1.05–18.43)
p-value: p=0.04
Abstract
BACKGROUND: Transcatheter left atrial appendage (LAA) occlusion is an alternative strategy for stroke prevention in patients with atrial fibrillation (AF). OBJECTIVES: This study sought to determine the incidence, predictors, and prognosis of thrombus formation on devices in patients with AF who were treated with LAA closure. METHODS: The study retrospectively analyzed data from patients treated with 2 LAA closure devices seen in 8 centers in France from February 2012 to January 2017. RESULTS: A total of 469 consecutive patients with AF underwent LAA closure (272 Watchman devices Atritech, Boston Scientific, Natick, Massachusetts and 197 Amplatzer devices St. Jude Medical, Minneapolis, Minnesota). Mean follow-up was 13 ± 13 months, during which 339 (72.3%) patients underwent LAA imaging at least once. There were 98 major adverse events (26 thrombi on devices, 19 ischemic strokes, 2 transient ischemic attacks, 18 major hemorrhages, 33 deaths) recorded in 89 patients. The incidence of device-related thrombus in patients with LAA imaging was 7.2% per year. Older age (hazard ratio HR: 1.07 per 1-year increase; 95% confidence interval CI: 1.01 to 1.14; p = 0.02) and history of stroke (HR: 3.68; 95% CI: 1.17 to 11.62; p = 0.03) were predictors of thrombus formation on the devices, whereas dual antiplatelet therapy (HR: 0.10; 95% CI: 0.01 to 0.76; p = 0.03) and oral anticoagulation at discharge (HR: 0.26; 95% CI: 0.09 to 0.77; p = 0.02) were protective factors. Thrombus on the device (HR: 4.39; 95% CI: 1.05 to 18.43; p = 0.04) and vascular disease (HR: 5.03; 95% CI: 1.39 to 18.23; p = 0.01) were independent predictors of ischemic strokes and transient ischemic attacks during follow-up. CONCLUSIONS: Thrombus formation on the device is not uncommon in patients with AF who are treated by LAA closure. Such events are strongly associated with a higher risk of ischemic stroke during follow-up. (REgistry on Real-Life EXperience With Left Atrial Appendage Occlusion RELEXAO; NCT03279406).
Expert Takes2 quotes
1/2
“At this point, we don't really fully understand the etiology of device-associated thrombus, which is really one of the Achilles heels of this device therapy.”
Jacqueline Saw, Interventional cardiologist, Vancouver General HospitalVancouver General Hospitalauto_pipelineView source