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Left Atrial Appendage Occlusion with Amplatzer Cardiac Plug and Amplatzer Amulet: a Clinical Trials Update.

ABSTRACT: It has been over a decade since dedicated Amplatzer devices have been used for left atrial appendage occlusion (LAAO) in patients with atrial fibrillation. The first was the Amplatzer Cardiac Plug (ACP) that is now replaced in most countries by the Amplatzer Amulet device. Most of the clinical data for ACP come from the ACP multicenter registry that included 1047 patients from 22 sites, whereas the largest to date report on the Amplatzer Amulet is a recently published prospective multicenter study in 1088 patients from 64 sites. Two important randomized clinical trials the Amulet IDE trial and the STROKECLOSE trial are currently enrolling patients and expected to provide more data on LAAO with Amplatzer Amulet in the near future.

SUBMITTER: Tzikas A

PROVIDER: S-EPMC5821631 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Left Atrial Appendage Occlusion with Amplatzer Cardiac Plug and Amplatzer Amulet: a Clinical Trials Update.

Tzikas Apostolos A

Journal of atrial fibrillation 20171231 4

It has been over a decade since dedicated Amplatzer devices have been used for left atrial appendage occlusion (LAAO) in patients with atrial fibrillation. The first was the Amplatzer Cardiac Plug (ACP) that is now replaced in most countries by the Amplatzer Amulet device. Most of the clinical data for ACP come from the ACP multicenter registry that included 1047 patients from 22 sites, whereas the largest to date report on the Amplatzer Amulet is a recently published prospective multicenter stu ...[more]

PMID: 29487680

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Project description:BackgroundPercutaneous closure of the left atrial appendage (LAA) is an alternative to chronic oral anticoagulation to reduce stroke risk in patients with nonvalvular atrial fibrillation. The Amulet IDE trial (Amplatzer Amulet Left Atrial Appendage Occluder IDE Trial) was designed to evaluate the safety and effectiveness of the dual-seal mechanism of the Amulet LAA occluder compared with the Watchman device.MethodsPatients with nonvalvular atrial fibrillation at increased risk of stroke were randomly assigned (1:1) to undergo percutaneous implantation of a LAA occluder with the Amulet occluder or Watchman device. The primary end points 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 the rate of LAA occlusion at 45 days. Prespecified secondary end points included a composite of all stroke, systemic embolism, or cardiovascular/unexplained death at 18 months, major bleeding at 18 months, and superiority test of the 3 primary end points.ResultsA total of 1878 patients were enrolled. The Amulet occluder was noninferior to the Watchman device for the primary safety end point (14.5% versus 14.7%; difference=-0.14 [95% CI, -3.42 to 3.13]; P<0.001 for noninferiority). Major bleeding and all-cause death were similar between groups (10.6% versus 10.0% and 3.9% versus 5.1%, respectively). Procedure-related complications were higher for the Amulet occluder (4.5% versus 2.5%), largely related to more frequent pericardial effusion and device embolization. The Amulet occluder was noninferior to the Watchman device for the primary effectiveness end point (2.8% versus 2.8%; difference=0.00 [95% CI, -1.55 to 1.55]; P<0.001 for noninferiority), and the composite of stroke, systemic embolism, or cardiovascular/unexplained death (5.6% versus 7.7%, difference=-2.12 [95% CI, -4.45 to 0.21]; P<0.001 for noninferiority). The rate of major bleeding was similar between groups (11.6% versus 12.3%; difference=-0.71 [95% CI, -3.72 to 2.31]; P=0.32 for superiority). LAA occlusion was higher for the Amulet occluder than for the Watchman device (98.9% versus 96.8%; difference=2.03 [95% CI, 0.41-3.66]; P<0.001 for noninferiority; P=0.003 for superiority).ConclusionsThe Amulet occluder was noninferior for safety and effectiveness of stroke prevention for nonvalvular atrial fibrillation compared with the Watchman device and superior for LAA occlusion. Procedure-related complications were higher with the Amulet occluder and decreased with operator experience. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02879448.

Dataset Information

Left Atrial Appendage Occlusion with Amplatzer Cardiac Plug and Amplatzer Amulet: a Clinical Trials Update.

Publications

Left Atrial Appendage Occlusion with Amplatzer Cardiac Plug and Amplatzer Amulet: a Clinical Trials Update.

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