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Meta-Analysis Comparing Watchman(TM) and Amplatzer Devices for Stroke Prevention in Atrial Fibrillation
Background: For patients with atrial fibrillation who are at high risk for bleeding or who cannot tolerate oral anticoagulation, left atrial appendage (LAA) closure represents an alternative therapy for reducing risk for thromboembolic events. Objectives: To compare the efficacy and safety of the Am...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7322993/ https://www.ncbi.nlm.nih.gov/pubmed/32656246 http://dx.doi.org/10.3389/fcvm.2020.00089 |
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author | Basu Ray, Indranill Khanra, Dibbendhu Shah, Sumit Char, Sudhanva Jia, Xiaoming Lam, Wilson Mathuria, Nilesh Razavi, Mehdi Jain, Bhavna Lakkireddy, Dhanunjaya Kar, Saibal Natale, Andrea Adeboye, Adedayo Jefferies, John Lynn Bangalore, Sripal Asirvatham, Samuel Saeed, Mohammad |
author_facet | Basu Ray, Indranill Khanra, Dibbendhu Shah, Sumit Char, Sudhanva Jia, Xiaoming Lam, Wilson Mathuria, Nilesh Razavi, Mehdi Jain, Bhavna Lakkireddy, Dhanunjaya Kar, Saibal Natale, Andrea Adeboye, Adedayo Jefferies, John Lynn Bangalore, Sripal Asirvatham, Samuel Saeed, Mohammad |
author_sort | Basu Ray, Indranill |
collection | PubMed |
description | Background: For patients with atrial fibrillation who are at high risk for bleeding or who cannot tolerate oral anticoagulation, left atrial appendage (LAA) closure represents an alternative therapy for reducing risk for thromboembolic events. Objectives: To compare the efficacy and safety of the Amplatzer and Watchman(TM) LAA closure devices. Methods: A meta-analysis was performed of studies comparing the safety and efficacy outcomes of the two devices. The Newcastle-Ottawa Scale was used to appraise study quality. Results: Six studies encompassing 614 patients were included in the meta-analysis. Overall event rates were low for both devices. No significant differences between the devices were found in safety outcomes (i.e., pericardial effusion, cardiac tamponade, device embolization, air embolism, and vascular complications) or in the rates of all-cause mortality, cardiac death, stroke/transient ischemic attack, or device-related thrombosis. The total bleeding rate was significantly lower in the Watchman(TM) group (Log OR = −0.90; 95% CI = −1.76 to −0.04; p = 0.04), yet no significant differences was found when the bleeding rate was categorized into major and minor bleeding. Total peridevice leakage rate and insignificant peridevice leakage rate were significantly higher in the Watchman(TM) group (Log OR = 1.32; 95% CI = 0.76 to 1.87; p < 0.01 and Log OR = 1.11; 95% CI = 0.50 to 1.72; p < 0.01, respectively). However, significant peridevice leakages were similar in both the devices. Conclusions: The LAA closure devices had low complication rates and low event rates. Efficacy and safety were similar between the systems, except for a higher percentage of insignificant peridevice leakages in the Watchman(TM) group. A randomized controlled trial comparing both devices is underway, which may provide more insight on the safety and efficacy outcomes comparison of the devices. |
format | Online Article Text |
id | pubmed-7322993 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-73229932020-07-09 Meta-Analysis Comparing Watchman(TM) and Amplatzer Devices for Stroke Prevention in Atrial Fibrillation Basu Ray, Indranill Khanra, Dibbendhu Shah, Sumit Char, Sudhanva Jia, Xiaoming Lam, Wilson Mathuria, Nilesh Razavi, Mehdi Jain, Bhavna Lakkireddy, Dhanunjaya Kar, Saibal Natale, Andrea Adeboye, Adedayo Jefferies, John Lynn Bangalore, Sripal Asirvatham, Samuel Saeed, Mohammad Front Cardiovasc Med Cardiovascular Medicine Background: For patients with atrial fibrillation who are at high risk for bleeding or who cannot tolerate oral anticoagulation, left atrial appendage (LAA) closure represents an alternative therapy for reducing risk for thromboembolic events. Objectives: To compare the efficacy and safety of the Amplatzer and Watchman(TM) LAA closure devices. Methods: A meta-analysis was performed of studies comparing the safety and efficacy outcomes of the two devices. The Newcastle-Ottawa Scale was used to appraise study quality. Results: Six studies encompassing 614 patients were included in the meta-analysis. Overall event rates were low for both devices. No significant differences between the devices were found in safety outcomes (i.e., pericardial effusion, cardiac tamponade, device embolization, air embolism, and vascular complications) or in the rates of all-cause mortality, cardiac death, stroke/transient ischemic attack, or device-related thrombosis. The total bleeding rate was significantly lower in the Watchman(TM) group (Log OR = −0.90; 95% CI = −1.76 to −0.04; p = 0.04), yet no significant differences was found when the bleeding rate was categorized into major and minor bleeding. Total peridevice leakage rate and insignificant peridevice leakage rate were significantly higher in the Watchman(TM) group (Log OR = 1.32; 95% CI = 0.76 to 1.87; p < 0.01 and Log OR = 1.11; 95% CI = 0.50 to 1.72; p < 0.01, respectively). However, significant peridevice leakages were similar in both the devices. Conclusions: The LAA closure devices had low complication rates and low event rates. Efficacy and safety were similar between the systems, except for a higher percentage of insignificant peridevice leakages in the Watchman(TM) group. A randomized controlled trial comparing both devices is underway, which may provide more insight on the safety and efficacy outcomes comparison of the devices. Frontiers Media S.A. 2020-06-22 /pmc/articles/PMC7322993/ /pubmed/32656246 http://dx.doi.org/10.3389/fcvm.2020.00089 Text en Copyright © 2020 Basu Ray, Khanra, Shah, Char, Jia, Lam, Mathuria, Razavi, Jain, Lakkireddy, Kar, Natale, Adeboye, Jefferies, Bangalore, Asirvatham and Saeed. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Cardiovascular Medicine Basu Ray, Indranill Khanra, Dibbendhu Shah, Sumit Char, Sudhanva Jia, Xiaoming Lam, Wilson Mathuria, Nilesh Razavi, Mehdi Jain, Bhavna Lakkireddy, Dhanunjaya Kar, Saibal Natale, Andrea Adeboye, Adedayo Jefferies, John Lynn Bangalore, Sripal Asirvatham, Samuel Saeed, Mohammad Meta-Analysis Comparing Watchman(TM) and Amplatzer Devices for Stroke Prevention in Atrial Fibrillation |
title | Meta-Analysis Comparing Watchman(TM) and Amplatzer Devices for Stroke Prevention in Atrial Fibrillation |
title_full | Meta-Analysis Comparing Watchman(TM) and Amplatzer Devices for Stroke Prevention in Atrial Fibrillation |
title_fullStr | Meta-Analysis Comparing Watchman(TM) and Amplatzer Devices for Stroke Prevention in Atrial Fibrillation |
title_full_unstemmed | Meta-Analysis Comparing Watchman(TM) and Amplatzer Devices for Stroke Prevention in Atrial Fibrillation |
title_short | Meta-Analysis Comparing Watchman(TM) and Amplatzer Devices for Stroke Prevention in Atrial Fibrillation |
title_sort | meta-analysis comparing watchman(tm) and amplatzer devices for stroke prevention in atrial fibrillation |
topic | Cardiovascular Medicine |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7322993/ https://www.ncbi.nlm.nih.gov/pubmed/32656246 http://dx.doi.org/10.3389/fcvm.2020.00089 |
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