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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...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2020
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.
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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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