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Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation
Published on: February 26, 2013
Left atrial appendage closure for stroke prevention in atrial fibrillation: Final report from the French left atrial
Emmanuel Teiger1, Jean-Benoit Thambo2, Pascal Defaye3
1Department of Cardiology, Henri Mondor University Hospital, AP-HP, Creteil, France.
Insights
Left atrial appendage (LAA) closure is a viable option for preventing stroke in non-valvular atrial fibrillation (NVAF) patients. The FLAAC registry showed a 3.3% annual stroke/embolism rate, suggesting significant risk reduction.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Left atrial appendage (LAA) closure offers an alternative to anticoagulation for preventing thromboembolic events (TE) in non-valvular atrial fibrillation (NVAF).
- Real-world clinical data on LAA closure efficacy and safety remains limited.
Purpose of the Study:
- To assess the safety and efficacy of LAA closure in routine clinical practice.
- To evaluate the rate of TE events following successful LAA closure in a large patient cohort.
Main Methods:
- A nationwide, prospective study conducted across 36 French centers.
- Inclusion of 816 patients with high TE and bleeding risks, and contraindications to anticoagulation.
- Primary endpoint: TE rate post-successful LAA closure; secondary: adverse events and mortality.
Main Results:
- The annual rate of ischemic stroke/systemic embolism was 3.3%, indicating a 57% relative reduction compared to historical untreated NVAF populations.
- Procedure or device-related serious adverse events occurred in 6.0% of patients.
- History of TE was the sole predictor of stroke/systemic embolism during follow-up (HR, 3.3; p=0.001).
Conclusions:
- LAA closure is a feasible option for selected NVAF patients.
- High long-term mortality (10.2% annually) was primarily attributed to comorbidities, underscoring the need for comprehensive patient management.
Objectives:
The French left atrial appendage (LAA) closure registry (FLAAC) aimed to assess the safety and efficacy of LAA closure in daily practice.
Background:
LAA closure has emerged as an alternative for preventing thromboembolic events (TE) in patients with non-valvular atrial fibrillation (NVAF). Clinical data in this field remains limited and few investigator-initiated, real-world registries have been reported.
Methods:
This nationwide, prospective study was performed in 36 French centers. The primary endpoint was the TE rate after successful LAA closure.
Results:
The FLAAC registry included 816 patients with a mean age of 75.5 ± 0.3 years, mean follow-up of 16.0 ± 0.3 months, high TE (CHA2 DS2 -VASc score: 4.6 ± 0.1) and bleeding risks (HAS-BLED score: 3.2 ± 0.05) and common contraindications to long-term anticoagulation (95.7%). Procedure or device-related serious adverse events occurred in 49 (6.0%) patients. The annual rate of ischemic stroke/systemic embolism was 3.3% (2.4-4.6). This suggests a relative 57% reduction compared to the risk of stroke in historical NVAF populations without antithrombotic therapy. By multivariate analysis, history of TE was the only factor associated with stroke/systemic embolism during follow-up (HR, 3.3 [1.58-6.89], p = 0.001). The annual mortality rate was 10.2% (8.4-12.3). Most of the deaths were due to comorbidities or underlying cardiovascular diseases and unrelated to the device or to TE.
Conclusions:
Our study suggests that LAA closure can be an option in patients with NVAF. Long-term follow-up mortality was high, mostly due to comorbidities and underlying cardiovascular diseases, highlighting the importance of multidisciplinary management after LAA closure.
Registration:
NCT02252861.

