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Updated: Jul 6, 2025
The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Outcomes Associated With Left Atrial Appendage Occlusion Via Implanted Device in Atrial Fibrillation
Baptiste Maille1, Pascal Defaye2, Sid Ahmed Bentounes3
1Service de Cardiologie, Centre Hospitalier Universitaire La Timone, Assistance Publique - Hôpitaux de Marseille, Aix Marseille University, Marseille, France.
Insights
Left atrial appendage occlusion (LAAO) in atrial fibrillation (AF) patients reduced overall events and death but increased stroke risk. LAAO is most effective for patients with prior stroke or bleeding history.
Area of Science:
- Cardiology
- Medical Devices
- Public Health
Background:
- Atrial fibrillation (AF) increases stroke risk, often managed with anticoagulation.
- Left atrial appendage occlusion (LAAO) is an alternative stroke prevention strategy in AF.
- Patient selection for LAAO requires careful consideration of risks and benefits.
Purpose of the Study:
- To compare clinical outcomes between patients with AF undergoing LAAO and a matched cohort without LAAO.
- To evaluate the efficacy of LAAO in reducing composite outcomes, ischemic stroke, major bleeding, and all-cause death.
- To identify patient subgroups that may benefit most from LAAO.
Main Methods:
- Retrospective, longitudinal cohort study using a French national hospital database (2015-2020).
- Inclusion of adult patients hospitalized with AF.
- Propensity score matching to create comparable LAAO and no-LAAO groups (n=1216 each).
Main Results:
- LAAO was associated with a significantly lower risk of the composite outcome (ischemic stroke, major bleeding, or all-cause death) (HR 0.48).
- Patients undergoing LAAO experienced fewer total events and lower annual event rates compared to controls.
- LAAO significantly reduced all-cause death (HR 0.39) but was associated with a higher risk of ischemic stroke (HR 1.75).
Conclusions:
- LAAO demonstrated effectiveness in reducing overall clinical events and mortality in AF patients.
- The procedure showed a higher risk of stroke but a lower risk of death compared to no LAAO.
- LAAO appears particularly beneficial for patients with a history of ischemic stroke or bleeding.
Objective:
To compare outcomes after left atrial appendage occlusion (LAAO) via implanted device vs no LAAO in a matched cohort of patients with atrial fibrillation (AF).
Methods:
This longitudinal retrospective cohort study was based on the national database covering hospital care for the entire French population. Adults (≥18 years of age) who had been hospitalized with AF (January 1, 2015, to January 1, 2020) who underwent LAAO were identified. Propensity score matching was used to control for potential confounders of the treatment-outcome relationship. The primary outcome was a composite of ischemic stroke, major bleeding, or all-cause death during follow-up.
Results:
After propensity score matching, 1216 patients with AF who were treated with LAAO were matched with 1216 controls (patients AF who were not treated with LAAO). Mean follow-up was 14.5 months (median, 13 months; IQR, 7-21 months). Patients with LAAO had a lower risk of the composite outcome (HR, 0.48; 95% CI, 0.42 to 0.55). Total events (309 for LAAO vs 640 for controls) and event rates (23.3% vs 44.0%/year, respectively) were lower for LAAO, driven primarily by a decreased risk of all-cause death (HR, 0.39; 95% CI, 0.33 to 0.46; P<.0001), whereas ischemic stroke risk was higher (HR, 1.75; 95% CI, 1.17 to 2.64). Significant interactions were observed in subgroups with a history of ischemic stroke (P<.001) and of bleeding (P=.002).
Conclusion:
Among AF patients at high bleeding risk, our nationwide study highlights a high risk of clinical events during follow-up. LAAO appeared less effective than no LAAO in preventing stroke but more effective in preventing death. Left atrial appendage occlusion is particularly effective in patients with previous ischemic stroke or any episode of bleeding.
