Efficacy and safety of the new generation Watchman FLX device compared to the Watchman 2.5: a systematic review and meta-analysis.

Najim, Mostafa; Reda Mostafa, Mostafa; Eid, Mohamed Magdi; Alabdouh, Ahmad; Awad, Ahmed K; Elbanna, Mostafa; Mohamed, Sarah; Alweis, Richard; Al-Azizi, Karim M; Mamas, Mamas A

Abstract

The first-generation Watchman 2.5 (W 2.5) 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) 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. 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. 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; = 0%]), and a significant reduction in mortality (OR 0.52 [95% CI 0.51-0.54, P<0.01; = 0%], major bleeding 0.57 [95% CI 0.51-0.64, P<0.01; = 0%]), device embolism (OR 0.35 [95% CI 0.18-0.70, P = 0.02; = 0%]), and pericardial effusion (OR 0.33 [95% CI 0.26-0.41, P<0.01; = 0%]). The rates of DRT and stroke were similar between the two groups. 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. [Abstract copyright: AJCD Copyright © 2023.]

Citation

Najim, M., Reda Mostafa, M., Eid, M. M., Alabdouh, A., Awad, A. K., Elbanna, M., Mohamed, S., Alweis, R., Al-Azizi, K. M., & Mamas, M. A. (in press). 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

• Journal Article Type: Article
• Acceptance Date: Aug 31, 2023
• Online Publication Date: Oct 15, 2023
• Deposit Date: Dec 18, 2023
• Publicly Available Date: Dec 18, 2023
• Journal: American journal of cardiovascular disease
• Electronic ISSN: 2160-200X
• Publisher: e-Century Publishing
• Peer Reviewed: Peer Reviewed
• Volume: 13
• Issue: 5
• Pages: 291-299
• Keywords: left atrial appendage occlusion, Watchman, Left atrial appendage closure, new generation Watchman
• Public URL: https://keele-repository.worktribe.com/output/669830
• Publisher URL: https://e-century.us/files/ajcd/13/5/ajcd0151504.pdf
• Related Public URLs: https://e-century.us/web/journal_toc.php?journal=ajcd&volume=13&number=5; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10658049/