Outcomes of the roll-in cohort of the Amulet IDE trial of left atrial appendage occlusion

Dhanunjaya Lakkireddy; David Thaler; Christopher R Ellis; Vijendra Swarup; Lars Sondergaard; John Carroll; Michael R Gold; James Hermiller; Hans-Christoph Diener; Boris Schmidt; Lee MacDonald; Moussa Mansour; Brijeshwar Maini; Jordan A Anderson; Ryan Gage; Stephan Windecker; Amulet IDE Investigators

doi:10.1016/j.hroo.2022.07.004

Outcomes of the roll-in cohort of the Amulet IDE trial of left atrial appendage occlusion

Dhanunjaya Lakkireddy, David Thaler, Christopher R Ellis, Vijendra Swarup, Lars Sondergaard, John Carroll, Michael R Gold, James Hermiller, Hans-Christoph Diener, Boris Schmidt, Lee MacDonald, Moussa Mansour, Brijeshwar Maini, Jordan A Anderson, Ryan Gage, Stephan Windecker, Amulet IDE Investigators

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2 Citationer (Scopus)

Abstract

BACKGROUND: Left atrial appendage (LAA) occlusion is an alternative therapy to oral anticoagulants to reduce stroke risk in patients with nonvalvular atrial fibrillation (NVAF). The Amulet IDE trial compared the Amplatzer™ Amulet™ occluder (Abbott) with the Watchman™ 2.5 device (Boston Scientific) for LAA occlusion in patients with NVAF.

OBJECTIVE: The purpose of this study was to describe outcomes of the Amulet IDE trial roll-in cohort.

METHODS: At US sites up to 3 patients per implanter could be implanted with the Amulet occluder in the roll-in phase. The primary Endpoints in the Amulet IDE trial included safety (composite of procedure-related complications, all-cause death, or major bleeding at 12 months), effectiveness (composite of ischemic stroke or systemic embolism at 18 months), and rate of LAA occlusion at 45 days.

RESULTS: A total of 201 roll-in patients were enrolled. Device success occurred in 99% of patients, and device closure (residual jet ≤5 mm) was observed in 98.9% of patients at 45 days. The safety endpoint rate was numerically higher (worse) in the roll-in cohort compared to the randomized Amulet occluder cohort (18.4% vs 14.5%). Six patients (3.1%) experienced an ischemic stroke and 0 patients with a systemic embolism within 18 months, which was similar to the primary effectiveness endpoint rate in the randomized Amulet occluder cohort (2.8%).

CONCLUSIONS: Despite lack of experience of the operators with the Amulet occluder in the roll-in phase, device implant success was high, a high rate of device closure was achieved, and low stroke rates were observed in patients with NVAF.

Originalsprog	Engelsk
Tidsskrift	Heart rhythm O2
Vol/bind	3
Udgave nummer	5
Sider (fra-til)	493-500
Antal sider	8
ISSN	2666-5018
DOI	https://doi.org/10.1016/j.hroo.2022.07.004
Status	Udgivet - okt. 2022

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10.1016/j.hroo.2022.07.004

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Lakkireddy, D., Thaler, D., Ellis, C. R., Swarup, V., Sondergaard, L., Carroll, J., Gold, M. R., Hermiller, J., Diener, H.-C., Schmidt, B., MacDonald, L., Mansour, M., Maini, B., Anderson, J. A., Gage, R., Windecker, S., & Amulet IDE Investigators (2022). Outcomes of the roll-in cohort of the Amulet IDE trial of left atrial appendage occlusion. Heart rhythm O2, 3(5), 493-500. https://doi.org/10.1016/j.hroo.2022.07.004

Lakkireddy, D, Thaler, D, Ellis, CR, Swarup, V, Sondergaard, L, Carroll, J, Gold, MR, Hermiller, J, Diener, H-C, Schmidt, B, MacDonald, L, Mansour, M, Maini, B, Anderson, JA, Gage, R, Windecker, S & Amulet IDE Investigators 2022, 'Outcomes of the roll-in cohort of the Amulet IDE trial of left atrial appendage occlusion', Heart rhythm O2, bind 3, nr. 5, s. 493-500. https://doi.org/10.1016/j.hroo.2022.07.004

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title = "Outcomes of the roll-in cohort of the Amulet IDE trial of left atrial appendage occlusion",

abstract = "BACKGROUND: Left atrial appendage (LAA) occlusion is an alternative therapy to oral anticoagulants to reduce stroke risk in patients with nonvalvular atrial fibrillation (NVAF). The Amulet IDE trial compared the Amplatzer{\texttrademark} Amulet{\texttrademark} occluder (Abbott) with the Watchman{\texttrademark} 2.5 device (Boston Scientific) for LAA occlusion in patients with NVAF.OBJECTIVE: The purpose of this study was to describe outcomes of the Amulet IDE trial roll-in cohort.METHODS: At US sites up to 3 patients per implanter could be implanted with the Amulet occluder in the roll-in phase. The primary Endpoints in the Amulet IDE trial included safety (composite of procedure-related complications, all-cause death, or major bleeding at 12 months), effectiveness (composite of ischemic stroke or systemic embolism at 18 months), and rate of LAA occlusion at 45 days.RESULTS: A total of 201 roll-in patients were enrolled. Device success occurred in 99% of patients, and device closure (residual jet ≤5 mm) was observed in 98.9% of patients at 45 days. The safety endpoint rate was numerically higher (worse) in the roll-in cohort compared to the randomized Amulet occluder cohort (18.4% vs 14.5%). Six patients (3.1%) experienced an ischemic stroke and 0 patients with a systemic embolism within 18 months, which was similar to the primary effectiveness endpoint rate in the randomized Amulet occluder cohort (2.8%).CONCLUSIONS: Despite lack of experience of the operators with the Amulet occluder in the roll-in phase, device implant success was high, a high rate of device closure was achieved, and low stroke rates were observed in patients with NVAF.",

author = "Dhanunjaya Lakkireddy and David Thaler and Ellis, {Christopher R} and Vijendra Swarup and Lars Sondergaard and John Carroll and Gold, {Michael R} and James Hermiller and Hans-Christoph Diener and Boris Schmidt and Lee MacDonald and Moussa Mansour and Brijeshwar Maini and Anderson, {Jordan A} and Ryan Gage and Stephan Windecker and {Amulet IDE Investigators}",

note = "{\textcopyright} 2022 Heart Rhythm Society. Published by Elsevier Inc.",

year = "2022",

month = oct,

doi = "10.1016/j.hroo.2022.07.004",

language = "English",

volume = "3",

pages = "493--500",

journal = "Heart rhythm O2",

issn = "2666-5018",

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TY - JOUR

T1 - Outcomes of the roll-in cohort of the Amulet IDE trial of left atrial appendage occlusion

AU - Lakkireddy, Dhanunjaya

AU - Thaler, David

AU - Ellis, Christopher R

AU - Swarup, Vijendra

AU - Sondergaard, Lars

AU - Carroll, John

AU - Gold, Michael R

AU - Hermiller, James

AU - Diener, Hans-Christoph

AU - Schmidt, Boris

AU - MacDonald, Lee

AU - Mansour, Moussa

AU - Maini, Brijeshwar

AU - Anderson, Jordan A

AU - Gage, Ryan

AU - Windecker, Stephan

AU - Amulet IDE Investigators

PY - 2022/10

Y1 - 2022/10

N2 - BACKGROUND: Left atrial appendage (LAA) occlusion is an alternative therapy to oral anticoagulants to reduce stroke risk in patients with nonvalvular atrial fibrillation (NVAF). The Amulet IDE trial compared the Amplatzer™ Amulet™ occluder (Abbott) with the Watchman™ 2.5 device (Boston Scientific) for LAA occlusion in patients with NVAF.OBJECTIVE: The purpose of this study was to describe outcomes of the Amulet IDE trial roll-in cohort.METHODS: At US sites up to 3 patients per implanter could be implanted with the Amulet occluder in the roll-in phase. The primary Endpoints in the Amulet IDE trial included safety (composite of procedure-related complications, all-cause death, or major bleeding at 12 months), effectiveness (composite of ischemic stroke or systemic embolism at 18 months), and rate of LAA occlusion at 45 days.RESULTS: A total of 201 roll-in patients were enrolled. Device success occurred in 99% of patients, and device closure (residual jet ≤5 mm) was observed in 98.9% of patients at 45 days. The safety endpoint rate was numerically higher (worse) in the roll-in cohort compared to the randomized Amulet occluder cohort (18.4% vs 14.5%). Six patients (3.1%) experienced an ischemic stroke and 0 patients with a systemic embolism within 18 months, which was similar to the primary effectiveness endpoint rate in the randomized Amulet occluder cohort (2.8%).CONCLUSIONS: Despite lack of experience of the operators with the Amulet occluder in the roll-in phase, device implant success was high, a high rate of device closure was achieved, and low stroke rates were observed in patients with NVAF.

AB - BACKGROUND: Left atrial appendage (LAA) occlusion is an alternative therapy to oral anticoagulants to reduce stroke risk in patients with nonvalvular atrial fibrillation (NVAF). The Amulet IDE trial compared the Amplatzer™ Amulet™ occluder (Abbott) with the Watchman™ 2.5 device (Boston Scientific) for LAA occlusion in patients with NVAF.OBJECTIVE: The purpose of this study was to describe outcomes of the Amulet IDE trial roll-in cohort.METHODS: At US sites up to 3 patients per implanter could be implanted with the Amulet occluder in the roll-in phase. The primary Endpoints in the Amulet IDE trial included safety (composite of procedure-related complications, all-cause death, or major bleeding at 12 months), effectiveness (composite of ischemic stroke or systemic embolism at 18 months), and rate of LAA occlusion at 45 days.RESULTS: A total of 201 roll-in patients were enrolled. Device success occurred in 99% of patients, and device closure (residual jet ≤5 mm) was observed in 98.9% of patients at 45 days. The safety endpoint rate was numerically higher (worse) in the roll-in cohort compared to the randomized Amulet occluder cohort (18.4% vs 14.5%). Six patients (3.1%) experienced an ischemic stroke and 0 patients with a systemic embolism within 18 months, which was similar to the primary effectiveness endpoint rate in the randomized Amulet occluder cohort (2.8%).CONCLUSIONS: Despite lack of experience of the operators with the Amulet occluder in the roll-in phase, device implant success was high, a high rate of device closure was achieved, and low stroke rates were observed in patients with NVAF.

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U2 - 10.1016/j.hroo.2022.07.004

DO - 10.1016/j.hroo.2022.07.004

M3 - Journal article

C2 - 36340489

SN - 2666-5018

VL - 3

SP - 493

EP - 500

JO - Heart rhythm O2

JF - Heart rhythm O2

IS - 5

ER -

Outcomes of the roll-in cohort of the Amulet IDE trial of left atrial appendage occlusion

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