Efficacy and safety of the new generation Watchman FLX device compared to the Watchman 2.5: a systematic review and meta-analysis
Department
Medicine
Additional Department
Cardiology
Document Type
Article
Publication Title
American Journal of Cardiovascular Disease
Abstract
Introduction: The first-generation Watchman 2.5 (W 2.5)TM presented several limitations, such as challenges in implantation within complex left atrial appendage (LAA) anatomies, higher incidence of peri-device leak, device recapture, and device-related thrombus (DRT). The newer generation Watchman FLX (W-FLX)TM was introduced with a modified design aiming to overcome these limitations. The purpose of this meta-analysis is to conduct a comparative assessment of the safety and efficacy of the W-FLX and 2.5 devices in clinical practice.
Method: The meta-analysis was conducted according to the preferred reporting items for systematic review and meta-analysis protocols (PRISMA). Studies were located through a search strategy utilizing PubMed, Cochrane, Google scholar and MEDLINE from inception to March 2023, with a primary objective to compare the safety and efficacy of the W-FLX and W 2.5 devices. After applying the selection criteria, five studies were included in this analysis.
Results: The analysis included five studies comprising 54,727 patients. The W-FLX is associated with an increase in procedural success (OR 7.49 [95% CI 1.98-28.26, P = 0.02; I2 = 0%]), and a significant reduction in mortality (OR 0.52 [95% CI 0.51-0.54, P< 0.01; I2 = 0%], major bleeding 0.57 [95% CI 0.51-0.64, P< 0.01; I2 = 0%]), device embolism (OR 0.35 [95% CI 0.18-0.70, P = 0.02; I2 = 0%]), and pericardial effusion (OR 0.33 [95% CI 0.26-0.41, P< 0.01; I2 = 0%]). The rates of DRT and stroke were similar between the two groups.
Conclusion: Compared to the W 2.5, the W-FLX was associated with a higher procedural success rate and significantly reduced adverse outcomes including mortality, major bleeding, device embolization, and pericardial effusion.
First Page
291
Last Page
299
Volume
13
Issue
5
Publication Date
10-2023
PubMed ID
38026111
Recommended Citation
Najim, M., Reda Mostafa, M., Eid, M. M., Alabdouh, A., Awad, A. K., Elbanna, M., Mohamed, S., Alweis, R., Al-Azizi, K., & Mamas, M. (2023). Efficacy and safety of the new generation Watchman FLX device compared to the Watchman 2.5: a systematic review and meta-analysis. American Journal of Cardiovascular Disease, 13 (5), 291-299. Retrieved from https://scholar.rochesterregional.org/rrhpubs/2066