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Updated: May 28, 2025
The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Quantitative considerations for choosing between Amulet and Watchman FLX and management of device related
Alexander Kushnir1, Chirag R Barbhaiya2, Lior Jankelson2
1Leon H. Charney Division of Cardiology, Cardiac Electrophysiology, NYU Langone Health, New York University Grossman School of Medicine, 424 East 34th Street, KP 4th Floor, New York, NY, 10016, USA. Alexander.kushnir@nyulangone.org.
Insights
Watchman FLX is recommended for patients with favorable left atrial appendage anatomy to reduce pericardial effusions, though it may increase peridevice leak. Combined procedures reduce complications.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Left atrial appendage occlusion (LAA-O) devices, including Amulet and Watchman FLX, are FDA-approved for stroke risk reduction in atrial fibrillation patients.
- Real-world data on clinical outcomes and imaging are crucial for device selection and complication management.
Purpose of the Study:
- To compare the clinical outcomes and imaging findings of Amulet and Watchman FLX left atrial appendage occlusion devices.
- To evaluate the impact of patient anatomy and combined procedures on device efficacy and safety.
Main Methods:
- Retrospective analysis of clinical, transesophageal echocardiography (TEE), and computed tomography (CT) data.
- Inclusion of 364 Watchman FLX and 292 Amulet procedures over a 4-year period.
- Assessment of procedural success, implant success, pericardial effusions, device-related thrombus, and peridevice leak (PDL).
Main Results:
- High procedural success rates for both FLX (96.7%) and Amulet (97.3%).
- FLX showed lower rates of late pericardial effusion (0.3% vs. 3.1% for Amulet), but higher rates of clinically relevant PDL (16% vs. 10% for Amulet).
- Combined AF ablation and LAA-O procedures demonstrated reduced PDL and late pericardial effusions.
Conclusions:
- Watchman FLX may be preferred for patients with favorable LAA anatomy to minimize pericardial effusions, accepting a higher PDL risk.
- Amulet may be a suitable alternative, particularly when PDL is a primary concern.
- Combined AF ablation and LAA-O procedures offer improved outcomes regarding PDL and effusions.
Background:
Left atrial appendage occlusion (LAA-O) with Amulet and Watchman FLX are approved for reducing stroke risk in patients with atrial fibrillation when oral anticoagulation is not tolerated. Real world clinical outcomes reported along with imaging data are needed to help clinicians choose between these two technologies and manage device-related complications.
Methods:
The study retrospectively analyzed clinical, transesophageal (TEE), and available computed tomography (CT) data from 364 FLX and 292 Amulet procedures performed at an academic medical center over a 4-year period.
Results:
LAA-O procedures were successful in 96.7% FLX and 97.3% Amulet cases. FLX implant success rate increased to 98.9% when only patients with LAA diameter to depth ratio < 1.8 and LAA area < 4.4 cm2 were included. TTE LAA-orifice area correlated with CT-derived measurements. There were more late pericardial effusions for Amulet (3.1%) compared to FLX (0.3%), though the majority were conservatively managed. Mean procedure times were similar (FLX 64 ± 24, Amulet 65 ± 21 min) as were the rates of device related thrombus (FLX 1% and Amulet 1.4%). Clinically relevant peridevice leak (PDL) on follow-up TEE imaging was greater for FLX (16%) compared to Amulet (10%). Combined AF ablation-LAA-occlusion procedures exhibited lower rates of PDL and late pericardial effusions compared to solo procedures.
Conclusions:
Based on retrospective analysis, an initial strategy with Watchman FLX in patients with favorable LAA anatomy would reduce the risk of late pericardial effusions at the expense of a higher rate of clinically relevant PDL compared to Amulet. Combined AF ablation and LAA-O procedures exhibit less PDL.
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