TY - JOUR
T1 - Meta-Analysis Comparing WatchmanTM and Amplatzer Devices for Stroke Prevention in Atrial Fibrillation
AU - Basu Ray, Indranill
AU - Khanra, Dibbendhu
AU - Shah, Sumit
AU - Char, Sudhanva
AU - Jia, Xiaoming
AU - Lam, Wilson
AU - Mathuria, Nilesh
AU - Razavi, Mehdi
AU - Jain, Bhavna
AU - Lakkireddy, Dhanunjaya
AU - Kar, Saibal
AU - Natale, Andrea
AU - Adeboye, Adedayo
AU - Jefferies, John Lynn
AU - Bangalore, Sripal
AU - Asirvatham, Samuel
AU - Saeed, Mohammad
N1 - Publisher Copyright:
© Copyright © 2020 Basu Ray, Khanra, Shah, Char, Jia, Lam, Mathuria, Razavi, Jain, Lakkireddy, Kar, Natale, Adeboye, Jefferies, Bangalore, Asirvatham and Saeed.
PY - 2020/6/22
Y1 - 2020/6/22
N2 - 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 WatchmanTM 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 WatchmanTM 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 WatchmanTM 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 WatchmanTM 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.
AB - 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 WatchmanTM 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 WatchmanTM 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 WatchmanTM 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 WatchmanTM 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.
KW - Amplatzer Amulet
KW - Amplatzer Cardiac Plug
KW - Watchman device
KW - atrial fibrillation
KW - left atrial appendage closure
KW - stroke
UR - http://www.scopus.com/inward/record.url?scp=85096779687&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85096779687&partnerID=8YFLogxK
U2 - 10.3389/fcvm.2020.00089
DO - 10.3389/fcvm.2020.00089
M3 - Review article
AN - SCOPUS:85096779687
SN - 2297-055X
VL - 7
JO - Frontiers in cardiovascular medicine
JF - Frontiers in cardiovascular medicine
M1 - 89
ER -