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Updated: Jun 5, 2026

The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Atrial fibrillation and stroke management: present and future
1Department of Internal Medicine and Cardiology, Mayo Clinic, Rochester, Minnesota 55905, USA. holmes.david@mayo.edu
Insights
Left atrial appendage occlusion devices offer a stroke prevention alternative for atrial fibrillation patients, proving non-inferior to warfarin with improved safety profiles in clinical trials.
Area of Science:
- Cardiovascular Medicine
- Neurology
- Medical Devices
Background:
- Stroke is a leading cause of death and disability, with atrial fibrillation a major risk factor.
- Warfarin, a traditional anticoagulant, has limitations in stroke prevention for atrial fibrillation patients due to contraindications and INR control issues.
- Left atrial appendage (LAA) thrombus is implicated in 90% of strokes in nonvalvular atrial fibrillation (NVAF).
Purpose of the Study:
- To evaluate left atrial appendage occlusion as an alternative to anticoagulant therapy for stroke prevention in NVAF patients.
- To compare the efficacy and safety of LAA occlusion devices versus warfarin.
Main Methods:
- A randomized clinical trial comparing LAA device closure to warfarin therapy.
- Assessment of outcomes including all-cause stroke, cardiac death, and systemic embolization.
- Monitoring for safety, including periprocedural complications like pericardial effusions.
Main Results:
- Left atrial appendage occlusion was non-inferior to warfarin in preventing stroke, cardiac death, and systemic embolization.
- An initial safety concern was periprocedural pericardial effusions.
- Subsequent data indicate excellent efficacy and improved safety profiles with LAA occlusion.
Conclusions:
- Left atrial appendage occlusion is a viable alternative to anticoagulation for stroke prevention in NVAF patients.
- Ongoing trials and registries are further exploring the role of LAA device placement.
- Device-based strategies offer a promising approach to mitigate stroke risk in specific patient populations.
Abstract:
Stroke remains the leading cause of disability and the third leading cause of death. Despite advances in treatment, the early and later outcomes remain poor with a high rate of death and or disability. Strategies for prevention have assumed a central role. Given the close relationship between advancing age, atrial fibrillation, and increasing stroke, there is great interest in this large specific population of patients. Although warfarin has been the cornerstone of therapy for stroke prevention in patients with atrial fibrillation, it is often not used because of absolute or relative contraindications, or is ineffective because of poor control of the international normalized ratio (INR). The relative risk-benefit ratio of stroke prevention versus bleeding hazard plays a central role in therapeutic decisions. New pharmacologic approaches have been studied, most recently direct thrombin inhibitors. These drugs may be associated with less bleeding than warfarin, although there continues to be incremental bleeding risk over a patient's lifetime. In patients with nonvalvular atrial fibrillation, device strategies are being tested. These are based upon the information that in such patients, stroke arises from thrombus in the left atrial appendage in 90% of cases. Left atrial appendage occlusion has now been tested in a randomized clinical trial. In this trial, device closure was found to be noninferior to warfarin for prevention of all-cause stroke, cardiac death, and systemic embolization. There was an early safety hazard typically related to periprocedural pericardial effusions; however, subsequent experience has continued to document excellent efficacy and improved safety profiles. New randomized trials and registries continue to explore the potential for device placement as an alternative to anticoagulant therapy for stroke prevention in this group of patients.
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