Increased thromboembolic risk, history of a major bleed, and high fall risk were the most common procedural indications for implantation with a Watchman device, according to a paper published Aug. 12 in Circulation: Cardiovascular Quality and Outcomes. In addition, high fall risk resulted in a “modestly increased risk” of in-hospital adverse events.

Usama A. Daimee, MD, et al., used data from ACC’s LAAO Registry to look at 38,314 Watchman procedures taking place between 2016 and 2018, identifying key indications of Watchman device use as well as risk of in-hospital adverse events.

Results showed that prior stroke or transient ischemic attack was reported in 40.2% of cases and prior bleeding in 70.1% of cases. Most Watchman implantations (71.9%) had at least 2 procedural indications with the most common being increased thromboembolic risk (64.8%), history of a major bleed (64.3%), and high fall risk (35.5%).

The study also found that only a small number of patients receiving the Watchman implantation and recorded in the LAAO Registry did not meet the Centers for Medicare and Medicaid Services’ stroke risk criteria for use of the device, suggesting “high concordance with regulatory guidance.”

The Watchman device was first approved by the U.S. Food and Drug Administration in March 2015 with the LAAO Registry launching shortly after in December 2015. In the U.S., LAAO procedures with the Watchman device have become increasingly used for the prevention of stroke and thromboembolism. The study’s authors conclude that their findings “highlight the value of a national registry in understanding the adoption of new technology in real world clinical practice.”

Clinical Topics: Geriatric Cardiology

Keywords: Hospitals, Technology, Registries, Thromboembolism, Stroke, Medicare, United States Food and Drug Administration, Ischemic Attack, Transient, Centers for Medicare and Medicaid Services, U.S., United States, Aged, National Cardiovascular Data Registries, LAAO Registry

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