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. 2023 Mar;66(2):391-401.
doi: 10.1007/s10840-022-01336-4. Epub 2022 Aug 11.

Left atrial appendage sealing performance of the Amplatzer Amulet and Watchman FLX device

Kasper Korsholm  1 , Anders Kramer  1 , Asger Andersen  1 , Jacqueline Saw  2 , Bjarne Linde Nørgaard  1 , Jesper Møller Jensen  1 , Jens Erik Nielsen-Kudsk  3
Affiliations

Left atrial appendage sealing performance of the Amplatzer Amulet and Watchman FLX device

Kasper Korsholm et al. J Interv Card Electrophysiol. 2023 Mar.

Erratum in

Abstract

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.

Keywords: Amulet; Atrial fibrillation; Computed tomography; Left atrial appendage occlusion; Watchman.

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Conflict of interest statement

Dr. Korsholm has received lecture fees from Boston Scientific and Abbott. Dr. Andersen has received consulting fees from Boston Scientific. Dr. Nielsen-Kudsk is proctor for Boston Scientific and Abbott. The remaining authors have nothing to disclosure in relation to the present work.

Figures

Fig. 1
Fig. 1
Patient flow chart. *LAAO performed in trials restricted to Watchman 2.5 use. **LAAO closure performed in clinical trials or educational sessions restricted to Amulet device use. Patient enrolment or inclusion in educational sessions were prior to preprocedural CT acquisition and knowledge of the LAA anatomy. LAAO, left atrial appendage occlusion
Fig. 2
Fig. 2
Cardiac CT multiplanar reconstructed views for investigation of peridevice leak. The dotted lines represent the proximal and mid-device cross-sectional views (Watchman FLX device, top panel) and disc and mid-lobe cross-sectional views (Amplatzer Amulet device, bottom panel)
Fig. 3
Fig. 3
Complete LAA occlusion stratified by device cohorts into implant tertiles. Primary outcome stratified by tertiles of each device implantation cohort to assess for potential operator learning curve. The y-axis shows percent of patients having complete LAA occlusion defined as no visible PDL and absence of distal LAA contrast patency. LAA, left atrial appendage
Fig. 4
Fig. 4
Complete occlusion and contrast patency stratified by LAA morphology. Primary outcome and contrast patency stratified by left atrial appendage morphology. LAA left atrial appendage, W-FLX Watchman FLX
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