학술논문

Systematic Review And Meta-analysis Of All The Currently Available Left Atrial Appendage Closure Device's Peri Device Leak Rate At 45-Day Follow Up.
Document Type
Article
Source
Journal of Atrial Fibrillation & Electrophysiology. Sep2022, Vol. 15 Issue 5, p39-47. 9p.
Subject
*ATRIAL fibrillation treatment
*ANTICOAGULANTS
*TRANSESOPHAGEAL echocardiography
*SURGICAL complications
Language
ISSN
2831-7335
Abstract
Background: Atrial fibrillation is the most frequent cardiac arrhythmia affecting 15 - 20% of all ischemic strokes.In patients who are at high risk of this stroke, oral anticoagulation has been used as a mode of treatment. For those who are at risk of bleeding and complications of anticoagulation, LAAC has been proven to be equally effective as greater than 90% of the thrombi are formed in the left atrial appendage. Objectives: The purpose of this study was to report visible peri-device leak rates identified by either transesophageal echocardiography or cardiac CTA at a 45-day follow-up from device implantation. The data for each device was gathered by pooling data together from the available studies. Methods: We searched PubMed, AHA, JACC, and Science Direct and article references for randomized controlled trials of patients with LAAC devices and the rate of leaks on45-dayfollow-ups. With clear inclusion criteria, we identified ten studies eligible for this study. We carried out a meta-analysis of the relative odds based on a random-effects model using the Mantel-Haenszel method for the primary outcome of peri-device leaks identified by either transesophageal echocardiography or cardiac CTA at 45-day follow-up from device implantation. Heterogeneity was assessed using the I² test, Comprehensive Meta-Analysis Version 3 software was used for analysis. Can refer to the graphs showing the studies used in this meta-analysis with the total number of devices and their leak rates in Table A, B, and C. Results: The first comparison was performed between the Watchman 2.5 VS Watchman FLX (Table 1), which favored Watchman FLX P value of 0.02 and RR of 5 suggesting 5 times increased risk of the leak with Watchman 2.5. Next, Amulet was compared to Watchman 2.5 (Table 2) which favored Amulet with a P value of 0.01 and RR of 0.5 suggesting Amulet was associated with a 50% less rate of leaks in comparison. The last comparison was between Amulet vs Watchman FLX (Table 3), no statistically significant difference exists between these 2 devices with a P value of 0.2. I² tests indicated the presence of substantial to considerable heterogeneity in all 3 comparisons. Conclusion: Our study found that both Amulet and Watchman FLX are superior to Watchman 2.5 in terms of Peri device leak rate of any size and the leak rate between Amulet and Watchman FLX is not statistically significant at 45 daysfollow-up with either TEE or CCTA. There was significant heterogeneity in the results because of variation in sample sizes across the studies and the difference in study methodology. We need more studies focusing on PDL rates to better understand its complications. [ABSTRACT FROM AUTHOR]