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The second-generation Watchman-FLX device is the novel LAAO device with design changes compared to its predecessor.
Objective
We aimed to assess clinical outcomes with Watchman-FLX LAAO device.
Methods
The meta-analysis was performed using a meta-package for R version 4.0/RStudio version 1.2 and Freeman Tukey double arcsine method to establish variance of raw proportions. Outcomes measured included acute procedure success, periprocedural pericardial effusion (within 7 days), device embolization, ischemic stroke (within 7 days), device-related thrombosis (DRT), major bleeding and all-cause mortality (compared to Watchman).
Results
Five studies incorporated 724 patients (mean age 73.6 ± 8.4 years, and 60.3% were men). The mean CHA2DS2VASC and HAS-BLED scores were 4.4 ± 1.5, and 3 ± 1, respectively. Watchman-FLX was successfully implanted in 99.7% of patients (vs 95% in PROTECT-AF, PREVAIL, CAP1, CAP2 and EWOLUTION), Pinteraction< 0.01). DRT (1.1% vs 3.8%, Pinteraction = 0.05) and major bleeding (2.2% vs 3.4%, Pinteraction = 0.78), periprocedural ischemic stroke (0.01% vs 0.3%, Pinteraction = 0.87) were similar between Watchman-FLX and Watchman device. Periprocedural pericardial effusion (0.09% vs 1.9%, Pinteraction = 0.04), ischemic stroke (0.8% vs 4.3%, Pinteraction < 0.01) and all-cause mortality (1.9% vs 13.6%, Pinteraction < 0.01) were significantly lower with Watchman-FLX compared with Watchman LAAO. There was no device embolization with Watchman-FLX device during the follow up period (136 ± 63.7 days).
Conclusion
Considering the overall favorable safety and efficacy profile, Watchman-FLX appears to be an effective therapeutic option for LAAO.
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