SEAL FLX
The first head-to-head comparison of occlusion properties of the WATCHMAN FLX device and the Amplatzer Amulet device using cardiac computed tomography (CT).
Study Design
- Single-center, retrospective study of LAAO implantation at Aarhus
University Hospital (Denmark) between 2017-2020.
1st cohort: Amplatzer Amulet (n=150) 2017 – 2019
2nd cohort: WATCHMAN FLX (n=150) 2019 – 2020 - Cardiac CT was performed 8 weeks after LAAO
WATCHMAN FLX Demonstrated Statistically Superior Complete Occlusion* vs Amulet (p<0.001)
Complete Occlusion*
Complete Occlusion* on CT Imaging1
The Superior Complete Occlusion* of the WATCHMAN FLX Device Was Consistent Across All Anatomies Analyzed
Peri-Device Leak
Leak Measurements were Significantly Larger with Amulet than WATCHMAN FLX (p=0.019)
Leak Size (mm2)
WATCHMAN FLX’s One-Component Design Translates to Clear Sealing Advantages
Simplified Sizing
WATCHMAN FLX
Single Landing Zone and Overlapping Treatment Ranges
AMPLATZER AMULET2
Complicated, Mis-Matched Measurements
Simplified Placement
WATCHMAN FLX
Precision Placement Control
AMPLATZER AMULET3
Trade-off Between Disc and Lobe Placement
Simplified Assessment
WATCHMAN FLX1
Full Visibility
AMPLATZER AMULET1
Hidden Leaks
1. Korsholm-K et al. Left atrial appendage sealing performance of the Amplatzer Amulet and Watchman FLX device. J Interv Card Electrophysiol. 2022 Aug 11. doi: 10.1007/s10840-022-01336-4.
2. Lakkireddy, Amulet Tips and Tricks in Simple and Complex Anatomy, TVT 2018.
3. Saw, Cardiac CT angiography for device surveillance after endovascular left atrial appendage closure, European Heart Journal - Cardiovascular Imaging, Volume 16, Issue 11, November 2015, Pages 1198–1206, https://doi.org/10.1093/ehjci/jev067
* Complete LAA occlusion defined as no visible peri-device leak (PDL) and absence of contrast patency in the distal LAA (LAA/left atrium Hounsfield ratio <0.25)