Key result
Between 2015 and 2017, Watchman implantation volume increased significantly while in-hospital complications declined from 26.4% to 7.9% and inpatient mortality declined from 1.3% to 0.1% (p<0.01).
Why the study?
To evaluate trends in real-world utilization and in-hospital adverse events of Watchman left atrial appendage occlusion following its FDA approval in 2015.
What are the trends in utilization and in-hospital adverse events for Watchman left atrial appendage occlusion in the United States from 2015 to 2017?
Cohort (n=17,700)
Yes
What are the trends in utilization and in-hospital adverse events for Watchman left atrial appendage occlusion in the United States from 2015 to 2017?
Absolute Event Rate: 7.9% vs 26.4%
p-value: p=<0.01
Real-world utilization of the Watchman device has significantly increased in the US since 2015, accompanied by a significant decrease in procedural complications and in-hospital mortality.
May reflect procedural learning curve; leaves open causal volume-outcome effects in current LAA closure practice.
Objective To determine trends in real‐world utilization and in‐hospital adverse events from Watchman implantation since its approval by the Food and Drug Administration in 2015. Background The risk of embolic stroke caused by atrial fibrillation is reduced by oral anticoagulants, but not all patients can tolerate long‐term anticoagulation. Left atrial appendage occlusion with the Watchman device has emerged as an alternative therapy. Methods This was a retrospective cohort study utilizing data from National Inpatient Sample for calendar years 2015–2017. The outcomes assessed in this study were associated complications, in‐hospital mortality, and resource utilization trends after Watchman implantation. Trends analysis were performed using analysis of variance. Multivariable adjusted logistic regression analysis was performed to determine predictors of mortality. Results A total of 17 700 patients underwent Watchman implantation during the study period. There was a significantly increased trend in the number of Watchman procedures performed over the study years (from 1195 in 2015 to 11 165 devices in 2017, p < .01). A significant decline in the rate of complications (from 26.4% in 2015% to 7.9% in 2017, p < .01) and inpatient mortality (from 1.3% in 2015% to 0.1% in 2017, p < .01) were noted. Predictors of in‐hospital mortality included a higher CHA 2 DS 2 ‐VASc score (odds ratio [OR]: 2.61 per 1‐point increase, 95% confidence interval [CI]: 1.91–3.57), chronic blood loss anemia (OR: 3.63, 95% CI: 1.37–9.61) and coagulopathy (OR: 4.90, 95% CI: 2.32–10.35). Conclusion In contemporary United States clinical practice, Watchman utilization has increased significantly since approval in 2015, while complications and in‐patient mortality have declined.
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Munir et al. (2020) conducted a cohort in Atrial fibrillation (n=17,700). Watchman implantation (2017 cohort) vs. Watchman implantation (2015 cohort) was evaluated on in-hospital complications (p=<0.01). Between 2015 and 2017, Watchman implantation volume increased significantly while in-hospital complications declined from 26.4% to 7.9% and inpatient mortality declined from 1.3% to 0.1% (p<0.01).
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