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Updated: Mar 2, 2026
The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
First experience with the Watchman FLX occluder for percutaneous left atrial appendage closure
Julia Seeger1, Ralf Birkemeyer2, Wolfgang Rottbauer1
1Department of Internal Medicine II, Cardiology, University of Ulm, Ulm, Germany.
Insights
Left atrial appendage (LAA) closure using the Watchman FLX device demonstrated high procedural success and safety in high-risk patients with non-valvular atrial fibrillation. This minimally invasive approach effectively sealed the LAA, preventing stroke over a 6-month follow-up period.
Area of Science:
- Cardiology
- Medical Devices
- Interventional Cardiology
Background:
- Non-valvular atrial fibrillation (AF) poses a significant stroke risk, particularly in high-risk patients.
- Left atrial appendage (LAA) closure is an alternative to anticoagulation for stroke prevention in AF.
- The Watchman FLX device is a novel option for LAA closure.
Purpose of the Study:
- To evaluate the efficacy and safety of LAA closure with the Watchman FLX device.
- To analyze procedural features and outcomes in high-risk non-valvular AF patients.
Main Methods:
- A consecutive series of 12 high-risk non-valvular AF patients underwent LAA closure with the Watchman FLX.
- Procedural success, device implantation, repositioning, and complications were assessed.
- Follow-up included transesophageal echocardiography at 3 months and clinical evaluation up to 6 months.
Main Results:
- Successful LAA closure was achieved in all patients.
- The Watchman FLX device demonstrated easy repositioning and effective sealing.
- No disabling or non-disabling strokes occurred within the 6-month follow-up period.
Conclusions:
- LAA closure with the Watchman FLX is a safe and effective procedure for high-risk non-valvular AF patients.
- The device facilitates simple repositioning and achieves complete LAA sealing.
- This approach offers a promising alternative for stroke prevention in this patient population.
Background:
We aimed to evaluate efficacy and safety of left atrial appendage (LAA) closure with the new Watchman FLX and analyze procedural features in a consecutive series of high risk non-valvular atrial fibrillation patients.
Methods And Results:
Twelve consecutive non-valvular atrial fibrillation patients (age 76.6±7.8years) at high risk for stroke (CHA2DS2-VASc-Score 5.5±0.9) and bleeding (HAS-BLED-Score 3.8±0.9), received LAA closure with the Watchman FLX. Bench testing demonstrated easy repositioning as well as optimized sealing and anchoring. Follow-up was done at 30days, and at 3 and 6months including transesophageal echocardiography after 3months. Compression was calculated as occluder size to diameter at shoulder in final position. The device was successfully implanted in all patients. Partial recapture was necessary in 6 (50%) of cases, and full recapture in one (8.3%). There were no procedure-related complications. In 83.3% of cases (N=10/12) compression was between 10 and 27%, and mean compression was 24.0±11.1%. Mean implantation depth was 4.0±4.4mm distal of LAA ostium. There was no residual flow. Proximal shift in device position was noticed in 2 patients. One device was embolized at 30day follow-up, and another device showed thrombus formation. There was no disabling or non-disabling stroke through 6months of follow-up with dual antiplatelet therapy for 3months.
Conclusion:
LAA closure with the new Watchman FLX is associated with a good periprocedural safety, complete sealing of the LAA and simple repositioning.
Summary:
We evaluated the efficacy and safety of left atrial appendage (LAA) closure with the new Watchman FLX and analyzed procedural features in a consecutive series of high risk non-valvular atrial fibrillation patients. This is a first observational study demonstrating procedural safety, complete sealing of the LAA and simple technique for repositioning. There was no stroke within a 6month follow-up.
