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Late presentation of left atrial appendage erosion and perforation by an Amplatzer™ Amulet™ closure device: a case report.

ABSTRACT: Background:Percutaneous left atrial appendage (LAA) closure may reduce the risk of cardioembolic stroke in patients with non-valvular atrial fibrillation. Given the prophylactic nature of the procedure, identifying and managing complications are paramount. Case summary:A 73-year-old man presented 14?months after percutaneous LAA closure with syncope and acute pericardial tamponade which required surgical exploration and haemostasis; the most temporally remote account of this complication albeit amongst very few case reports. Tissue erosion by the Amplatzer™ Amulet™ LAA closure device (Abbott, Plymouth, MN, USA) was noted at two separate anatomical locations, corresponding to the device disc and lobe, which has not been described previously. Discussion:This case report highlights the anatomical relationship between the LAA and its surrounding structures, and the importance of recognizing the risk of late device erosion.

SUBMITTER: Wilkins B

PROVIDER: S-EPMC7319829 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Late presentation of left atrial appendage erosion and perforation by an Amplatzer™ Amulet™ closure device: a case report.

Wilkins Ben B Carranza Christian L CL Søndergaard Lars L De Backer Ole O

European heart journal. Case reports 20200503 3

<h4>Background</h4>Percutaneous left atrial appendage (LAA) closure may reduce the risk of cardioembolic stroke in patients with non-valvular atrial fibrillation. Given the prophylactic nature of the procedure, identifying and managing complications are paramount.<h4>Case summary</h4>A 73-year-old man presented 14 months after percutaneous LAA closure with syncope and acute pericardial tamponade which required surgical exploration and haemostasis; the most temporally remote account of this compl ...[more]

PMID: 32617484

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Project description:Background: Percutaneous closure of the left atrial appendage (LAA) is an alternative to chronic oral anticoagulation to reduce stroke risk in patients with non-valvular atrial fibrillation (NVAF). The Amplatzer™ Amulet™ LAA Occluder IDE Trial (Amulet 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. Methods: Patients with NVAF 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 endpoints included safety (composite of procedure-related complications, all-cause death, or major bleeding at 12 months) and effectiveness (composite of ischemic stroke or systemic embolism at 18 months) and the rate of LAA occlusion at 45 days. Pre-specified secondary endpoints 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 three primary endpoints. Results: A total of 1878 patients were enrolled. The Amulet occluder was noninferior to the Watchman device for the primary safety endpoint (14.5% vs. 14.7%; difference=-0.14, 95% CI, -3.42-3.13; p<0.001 for noninferiority). Major bleeding and all-cause death were similar between groups (10.6% vs 10.0% and 3.9% vs 5.1%, respectively). Procedure-related complications were higher for the Amulet occluder (4.5% vs. 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 endpoint (2.8% vs. 2.8%; difference=0.00, 95% CI, -1.55-1.55; p<0.001 for non-inferiority), and the composite of stroke, systemic embolism or cardiovascular/unexplained death (5.6% vs 7.7%, difference=-2.12, 95% CI, -4.45-0.21; p<0.001 for noninferiority). The rate of major bleeding was similar between groups (11.6% vs. 12.3%; difference=-0.71, 95% CI -3.72-2.31; p=0.32 for superiority). LAA occlusion was higher for the Amulet occluder compared with the Watchman device (98.9% vs. 96.8%; difference=2.03, 95% confidence interval [CI], 0.41-3.66; p<0.001 for noninferiority; p=0.003 for superiority). Conclusions: The Amulet occluder was non-inferior for safety and effectiveness of stroke prevention for NVAF compared with the Watchman device, and superior for LAA occlusion. Procedure-related complications were higher with the Amulet device and decreased with operator experience. Clinical Trial Registration: URL https://clinicaltrials.gov Unique Identifier NCT02879448.

Dataset Information

Late presentation of left atrial appendage erosion and perforation by an Amplatzer™ Amulet™ closure device: a case report.

Publications

Late presentation of left atrial appendage erosion and perforation by an Amplatzer™ Amulet™ closure device: a case report.

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