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Updated: Jul 27, 2026
The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Sex-specific Long-term Outcomes of Watchman Left Atrial Appendage Closure for Stroke Prevention in Atrial
Hongying Jiang1, Qi Zheng1, Yun-Ju Cheng1
1Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.
Insights
Sex does not significantly impact the 5-year outcomes of the Watchman device for atrial fibrillation patients. Both males and females experienced similar safety and effectiveness, suggesting broad applicability of this left atrial appendage closure.
Area of Science:
- Cardiology
- Medical Devices
- Clinical Trials
Background:
- Previous registry analysis indicated sex-based differences in Watchman device periprocedural outcomes.
- Investigating long-term (5-year) event rates in males and females is crucial for understanding device efficacy across sexes.
Purpose of the Study:
- To analyze the 5-year event rates of the Watchman left atrial appendage closure device in males versus females.
- To compare the safety and effectiveness of the Watchman device between sexes in patients with nonvalvular atrial fibrillation.
Main Methods:
- Patient-level meta-analysis of 2256 patients from 4 studies (PROTECT AF, PREVAIL, CAP1, CAP2).
- Evaluation of ischemic stroke, systemic embolism, hemorrhagic stroke, and all-cause mortality.
- Utilized mixed-effects Cox regression and Kaplan-Meier analysis to compare Watchman device versus warfarin, with a focus on treatment-by-sex interaction.
Main Results:
- No significant sex-by-treatment interaction was observed for ischemic stroke, systemic embolism, hemorrhagic stroke, or all-cause mortality.
- Both sexes showed comparable outcomes when treated with the Watchman device across pooled studies.
- Males treated with Watchman had a significantly lower adjusted hazard ratio for hemorrhagic stroke compared to warfarin.
Conclusions:
- Sex does not appear to significantly influence the long-term safety and effectiveness of the Watchman device for nonvalvular atrial fibrillation.
- The findings support the Watchman device as a viable treatment option for both male and female patients.
- Further research is warranted to fully elucidate any potential sex-specific nuances in device performance.
Background:
A recent analysis of a large registry showed differences in periprocedural outcomes of the Watchman left atrial appendage closure device in males compared with females. The objective of our study was to investigate the 5-year event rate in males and females enrolled in the Watchman device premarket clinical studies submitted for US Food and Drug Administration review.
Methods:
We conducted a patient-level meta-analysis of 2256 patients from 4 studies: the PROTECT AF (Embolic Protection in Patients with Atrial Fibrillation) and PREVAIL (Prospective Randomized Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients with Atrial Fibrillation vs Long-Term Warfarin Therapy) randomized controlled trials and their continued-access registries-CAP1 (Continued Access to PROTECT AF) and CAP2 (Continued Access to PREVAIL). The outcomes evaluated were ischemic stroke (IS), IS/systemic embolism, hemorrhagic stroke (HS), and all-cause mortality. Mixed-effects Cox regression models and statistical testing for treatment-by-sex interaction were used to compare left atrial appendage closure vs warfarin in males and females. Hazard ratios adjusted (aHRs) for CHADS2 scores were generated using the same model with CHADS2 score as a covariate. Time-to-event end points were evaluated using the Kaplan-Meier method and log-rank test.
Results:
For Watchman vs warfarin in the 2 randomized controlled trials, there was no significant interaction between sex and treatment for IS, IS/systemic embolism, HS, and all-cause mortality (P > .05); both males and females in the Watchman group had a lower aHR for HS than that in the warfarin group, which was statistically significant for males (aHR, 0.163; 95% CI, 0.045-0.593). In addition, there were no differences in outcomes between females and males treated with the Watchman device when pooling all studies.
Conclusions:
These data suggest that sex does not significantly affect the long-term safety and effectiveness of the Watchman device in patients with nonvalvular atrial fibrillation; however, further studies are needed.
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