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

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Left atrial appendage sealing performance of the Amplatzer Amulet and Watchman FLX device. / Korsholm, Kasper; Kramer, Anders; Andersen, Asger et al.

I: Journal of Interventional Cardiac Electrophysiology, 2023.

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisTidsskriftartikelForskningpeer review

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Korsholm K, Kramer A, Andersen A, Saw J, Nørgaard BL, Jensen JM et al. Left atrial appendage sealing performance of the Amplatzer Amulet and Watchman FLX device. Journal of Interventional Cardiac Electrophysiology. 2023. Epub 2023. doi: 10.1007/s10840-022-01336-4

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@article{a4b7d13de44f41fdb490b28446e5a833,
title = "Left atrial appendage sealing performance of the Amplatzer Amulet and Watchman FLX device",
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",
author = "Kasper Korsholm and Anders Kramer and Asger Andersen and Jacqueline Saw and N{\o}rgaard, {Bjarne Linde} and Jensen, {Jesper M{\o}ller} and Nielsen-Kudsk, {Jens Erik}",
note = "{\textcopyright} 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.",
year = "2023",
doi = "10.1007/s10840-022-01336-4",
language = "English",
journal = "Journal of Interventional Cardiac Electrophysiology",
issn = "1383-875X",
publisher = "Springer",

}

RIS

TY - JOUR

T1 - Left atrial appendage sealing performance of the Amplatzer Amulet and Watchman FLX device

AU - Korsholm, Kasper

AU - Kramer, Anders

AU - Andersen, Asger

AU - Saw, Jacqueline

AU - Nørgaard, Bjarne Linde

AU - Jensen, Jesper Møller

AU - Nielsen-Kudsk, Jens Erik

N1 - © 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

PY - 2023

Y1 - 2023

N2 - 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.

AB - 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.

KW - Amulet

KW - Atrial fibrillation

KW - Computed tomography

KW - Left atrial appendage occlusion

KW - Watchman

U2 - 10.1007/s10840-022-01336-4

DO - 10.1007/s10840-022-01336-4

M3 - Journal article

C2 - 35951214

JO - Journal of Interventional Cardiac Electrophysiology

JF - Journal of Interventional Cardiac Electrophysiology

SN - 1383-875X

ER -