Device-Related Thrombosis After Percutaneous Left Atrial Appendage Occlusion for Atrial Fibrillation
Key result
Device-related thrombus after LAAC is linked to ~339% higher risk of ischemic stroke or TIA.
- HR 4.39
- 95% CI 1.05-18.43
- P=0.04
- n=469
Why the study?
The study sought to determine the incidence, predictors, and prognosis of thrombus formation on devices in patients with AF treated with LAA closure.
What is the incidence, predictors, and prognostic impact of device-related thrombosis after left atrial appendage occlusion in patients with atrial fibrillation?
Key Points
- To analyze the occurrence of device-related thrombosis following percutaneous left atrial appendage occlusion in atrial fibrillation patients.
- 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
Main Result
Hazard Ratio: 4.39 (95% CI 1.05–18.43)
p-value: p=0.04
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Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Therefore, active screening for early detection and treatment of device-associated thrombus should be performed during post-implantation surveillance.”
JSJacqueline SawInterventional cardiologist, Vancouver General Hospital
“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.”
Implication
Device-related thrombosis after LAA occlusion occurs in approximately 7.2% of patients per year and significantly increases the risk of subsequent ischemic stroke.
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).
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Cite This Study
Fauchier et al. (2018) conducted a cohort in Atrial fibrillation (n=469). Device-related thrombus vs. No device-related thrombus was evaluated on Ischemic strokes and transient ischemic attacks (HR 4.39, 95% CI 1.05-18.43, p=0.04). 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).