Incidence, Characterization, and Clinical Impact of Device-Related Thrombus Following Left Atrial Appendage Occlusion in the Prospective Global AMPLATZER Amulet Observational Study.

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Citation: Jacc: Cardiovascular Interventions. 12(11):1003-1014, 2019 06 10.PMID: 31103540Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Atrial Appendage/pp [Physiopathology] | *Atrial Fibrillation/th [Therapy] | *Cardiac Catheterization/ae [Adverse Effects] | *Cardiac Catheterization/is [Instrumentation] | *Thrombosis/ep [Epidemiology] | Aged | Aged, 80 and over | Atrial Appendage/dg [Diagnostic Imaging] | Atrial Fibrillation/dg [Diagnostic Imaging] | Atrial Fibrillation/ep [Epidemiology] | Atrial Fibrillation/pp [Physiopathology] | Brain Ischemia/ep [Epidemiology] | Female | Humans | Incidence | Ischemic Attack, Transient/ep [Epidemiology] | Male | Progression-Free Survival | Prospective Studies | Prosthesis Design | Risk Assessment | Risk Factors | Stroke/ep [Epidemiology] | Thrombosis/dg [Diagnostic Imaging] | Time FactorsYear: 2019ISSN:
  • 1936-8798
Name of journal: JACC. Cardiovascular interventionsAbstract: BACKGROUND: DRT is a potential serious complication of LAAO, but the incidence and clinical impact of DRTs in a real-world setting are not well characterized.CONCLUSIONS: Following LAAO with the AMPLATZER Amulet device, DRT was observed infrequently. Although the presence of DRT was associated with an increased rate of ischemic stroke or transient ischemic attack as compared with patients without DRT, the large majority of DRT patients (82%) did not experience any ischemic neurologic events.Copyright (c) 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.METHODS: A total of 1,088 patients were enrolled in a multicenter prospective study and followed for 1 year. All events were adjudicated by an independent committee, including the presence of DRT. Patients with DRT were reviewed for suboptimal device implantation and characterization of DRT formation. Multiple Cox regression was performed to identify predictors of DRT formation.OBJECTIVES: This study sought to report the incidence, characteristics, and clinical impact of device-related thrombus (DRT) following left atrial appendage occlusion (LAAO) with the AMPLATZER Amulet device (Abbott, Plymouth, Minnesota).RESULTS: Device implantation was successful in 1,078 (99%) patients, with 1-year follow-up completed in 96.3% of patients. A total of 18 DRTs occurred in 17 patients (1.7%/year), as a second DRT developed following complete resolution of an initial DRT in 1 patient. The left upper pulmonary vein ridge was not covered by the Amulet disc in 82% of DRT patients, indicating suboptimal implantation, with most thrombus developing in the untrabeculated area of the LAA ostium between the pulmonary vein ridge and the upper edge of the disc. Three (18%) DRT patients had an ischemic stroke, all within 3 months of DRT diagnosis. Patients with a DRT were at a greater risk for ischemic stroke or transient ischemic attack compared with non-DRT patients (hazard ratio: 5.27; 95% confidence interval: 1.58 to 17.55; p = 0.007). Larger LAA orifice width was a predictor of DRT formation (hazard ratio: 1.09; 95% confidence interval: 1.00 to 1.19; p = 0.04).All authors: Aminian A, Asch FM, Berti S, Cruz-Gonzalez I, Fischer S, Gage R, Lam SCC, Lund J, Mazzone P, Montorfano M, Nielsen-Kudsk JE, Omran H, Schmidt B, Tarantini GOriginally published: Jacc: Cardiovascular Interventions. 12(11):1003-1014, 2019 Jun 10.Fiscal year: FY2020Fiscal year of original publication: FY2019Digital Object Identifier: Date added to catalog: 2019-06-21
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Journal Article MedStar Authors Catalog Article 31103540 Available 31103540

BACKGROUND: DRT is a potential serious complication of LAAO, but the incidence and clinical impact of DRTs in a real-world setting are not well characterized.

CONCLUSIONS: Following LAAO with the AMPLATZER Amulet device, DRT was observed infrequently. Although the presence of DRT was associated with an increased rate of ischemic stroke or transient ischemic attack as compared with patients without DRT, the large majority of DRT patients (82%) did not experience any ischemic neurologic events.

Copyright (c) 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

METHODS: A total of 1,088 patients were enrolled in a multicenter prospective study and followed for 1 year. All events were adjudicated by an independent committee, including the presence of DRT. Patients with DRT were reviewed for suboptimal device implantation and characterization of DRT formation. Multiple Cox regression was performed to identify predictors of DRT formation.

OBJECTIVES: This study sought to report the incidence, characteristics, and clinical impact of device-related thrombus (DRT) following left atrial appendage occlusion (LAAO) with the AMPLATZER Amulet device (Abbott, Plymouth, Minnesota).

RESULTS: Device implantation was successful in 1,078 (99%) patients, with 1-year follow-up completed in 96.3% of patients. A total of 18 DRTs occurred in 17 patients (1.7%/year), as a second DRT developed following complete resolution of an initial DRT in 1 patient. The left upper pulmonary vein ridge was not covered by the Amulet disc in 82% of DRT patients, indicating suboptimal implantation, with most thrombus developing in the untrabeculated area of the LAA ostium between the pulmonary vein ridge and the upper edge of the disc. Three (18%) DRT patients had an ischemic stroke, all within 3 months of DRT diagnosis. Patients with a DRT were at a greater risk for ischemic stroke or transient ischemic attack compared with non-DRT patients (hazard ratio: 5.27; 95% confidence interval: 1.58 to 17.55; p = 0.007). Larger LAA orifice width was a predictor of DRT formation (hazard ratio: 1.09; 95% confidence interval: 1.00 to 1.19; p = 0.04).

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