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Updated: Aug 12, 2026

The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Left Atrial Appendage and Closure: Who, When, and How
David R Holmes1, Vivek Y Reddy2
1From the Mayo Clinic, Rochester, MN (D.R.H.); and Mount Sinai School of Medicine, New York, NY (V.Y.R.). Holmes.david@mayo.edu.
Insights
Left atrial appendage occlusion devices offer stroke prevention for nonvalvular atrial fibrillation patients. These devices reduce hemorrhagic strokes and cardiovascular death, providing an alternative when anticoagulation is risky.
Area of Science:
- Cardiology
- Neurology
- Medical Devices
Background:
- Nonvalvular atrial fibrillation (NVAF) significantly increases stroke risk, particularly in the elderly.
- The left atrial appendage is the source of thrombus in 90% of NVAF-related strokes.
- Oral anticoagulants are effective but underutilized (40-50%) due to contraindications and bleeding risks.
Purpose of the Study:
- To evaluate the efficacy and safety of left atrial appendage occlusion (LAAO) devices for stroke prevention in NVAF patients.
- To compare outcomes of LAAO devices versus standard care or anticoagulation.
Main Methods:
- Meta-analysis of 2 randomized clinical trials and 2 registries.
- Inclusion of patients with NVAF at increased stroke risk, suitable for anticoagulation but with concerns about its risk/benefit ratio.
- Device used: FDA-approved Watchman device for LAAO.
Main Results:
- Significant reduction in hemorrhagic strokes (HR 0.22, P=0.004) and cardiovascular/unexplained death (HR 0.48, P=0.004) in the device group.
- No significant difference in ischemic strokes when periprocedural events were excluded.
- Significant reduction in nonprocedural bleeding (HR 0.51, P=0.006) with the device compared to control.
Conclusions:
- LAAO devices are a viable option for stroke prevention in select NVAF patients, especially those with contraindications or concerns regarding oral anticoagulation.
- Further research is needed to define optimal patient selection and compare LAAO devices with novel oral anticoagulants.
Abstract:
Patients with nonvalvular atrial fibrillation have a 4- to 5-fold increase in strokes and that rhythm may be responsible for 15% to 20% of all strokes, particularly in the elderly. In this setting, thrombus in the left atrial appendage has been found to be the source of stroke in 90% of cases. Although oral anticoagulants have been found effective in reducing stroke rates, for a variety of issues, they may only be used in 40% to 50% of patients at increased risk for stroke. Given pathophysiology of stroke, site-specific therapy directed at left atrial appendage occlusion has been now studied for stroke prevention, and one device is FDA approved (Watchman). A meta-analysis of 2 randomized clinical trials and 2 registries with this device documented the following: (1) patients receiving the device had significantly fewer hemorrhagic strokes (hazard ratio 0.22, P=0.004); (2) a significant reduction in cardiovascular or unexplained death (hazard ratio 0.48, P=0.004); (3) more ischemic strokes in the device group; however, when periprocedural events were excluded, the difference was not significant; and (4) a significant reduction in nonprocedural bleeding with the device (hazard ratio 0.51, P=0.006) versus control. At present, the only device approved in the United States is indicated in patients with nonvalvular atrial fibrillation with acceptable anatomy who are at increased risk for stroke and would be candidates for anticoagulation in whom there is concern about the risk/benefit ratio for chronic anticoagulation. Unresolved issues include optimal patient selection criteria, the role of devices in patients in whom anticoagulation is contraindicated, and the relative role of novel oral anticoagulants versus the device which has not been tested in randomized trials.
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