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Updated: Sep 1, 2025
The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Left atrial appendage sealing performance of the Amplatzer Amulet and Watchman FLX device
Kasper Korsholm1, Anders Kramer1, Asger Andersen1
1Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens, Boulevard 99, 8200, Aarhus, Denmark.
Insights
The Watchman FLX device achieved significantly higher complete left atrial appendage (LAA) occlusion rates compared to the Amplatzer Amulet device. The FLX also demonstrated smaller peri-device leak (PDL) areas, suggesting improved sealing properties in LAA occlusion procedures.
Area of Science:
- Cardiology
- Medical Devices
- Interventional Procedures
Background:
- The Amplatzer Amulet and Watchman FLX are devices used for left atrial appendage occlusion (LAAO).
- Assessing the sealing efficacy of these devices is crucial for preventing thromboembolic events.
Purpose of the Study:
- To compare the left atrial appendage (LAA) sealing properties of the Amplatzer Amulet and Watchman FLX devices.
- To evaluate the rates of complete LAA occlusion and peri-device leaks (PDL) using cardiac computed tomography (CT).
Main Methods:
- A single-center cohort study included 300 patients undergoing LAAO (150 Amulet, 150 Watchman FLX).
- Cardiac CT was performed two months post-procedure to assess LAA occlusion.
- Primary outcome was complete LAA occlusion; secondary outcomes included PDL, contrast patency, and complications.
Main Results:
- Complete LAA occlusion was achieved in 71.8% of the FLX group versus 30.5% of the Amulet group (p < 0.001).
- Peri-device leak (PDL) was significantly less frequent and smaller in the FLX group compared to the Amulet group.
- Periprocedural complication rates were similar between the two device groups.
Conclusions:
- The Watchman FLX device demonstrates superior efficacy in achieving complete LAA occlusion compared to the Amplatzer Amulet.
- Smaller PDL with the FLX device suggests improved sealing, though device design differences warrant further investigation.
- Additional studies focusing on clinical outcomes are necessary to fully interpret these findings.
Background:
The left atrial appendage (LAA) sealing properties of the Amplatzer Amulet and Watchman FLX devices were compared using cardiac computed tomography (CT) follow-up.
Methods:
Single-center cohort study of patients undergoing LAAO between 2017 and 2020. Two consecutive cohorts were enrolled, one treated with the Amplatzer Amulet (n = 150) up till 2019, and a second cohort treated with the Watchman FLX (n = 150) device from 2019. Cardiac CT was performed 2 months postprocedure. The primary outcome was complete LAA occlusion defined as no visible peri-device leak (PDL) and absence of contrast patency in the distal LAA. Secondary outcomes included PDL, contrast patency without visible PDL, PDL area, and periprocedural complications.
Results:
Complete occlusion was achieved in 39 (30.5%) of the Amulet group, compared to 89 (71.8%) of the FLX group, p < 0.001. A PDL at the Amulet disc was present in 65 (50.8%), at the lobe in 16 (12.5%), and at both the disc and lobe in 13 (10.2%). For FLX, a PDL was present in 20 (16.1%). Contrast patency without visible PDL was observed in 24 (18.8%) and 15 (12.1%) of the Amulet and FLX group, respectively. The PDL area at the Amulet mid-lobe was 92 mm2 (59-158) and 32 mm2 (IQR 28-96) for FLX, p = 0.019. Device-related thrombosis occurred in 1 (0.7%) and 2 (1.3%), respectively (p = 0.99), with periprocedural adverse events occurring in 6 (4%) and 8 (5.3%) of the Amulet and FLX group (p = 0.79).
Conclusion:
Complete LAA occlusion was achieved in a significantly higher proportion treated with the Watchman FLX compared to the Amulet device. PDL was smaller with the FLX than the Amulet. Conceptual device design differences make interpretation of results complex, and additional studies with clinical outcomes are needed.
