Watchman device controversy: Did marketing outpace the science?

Atrial fibrillation can increase a person's risk of stroke fivefold, according to STAT. Historically, stroke protection conversations centered primarily on oral anticoagulation, but long-term use may not fit every patient. Up to 40 percent of patients prescribed oral anticoagulations are non-adherent due to bleeding concerns, medication costs, and the practical demands of daily treatment, potentially compromising their stroke protection. STAT reported that left atrial appendage closure with the Watchman device offers a nonpharmacologic approach to stroke-risk reduction by closing the left atrial appendage, which is a major source of thrombus in nonvalvular atrial fibrillation. The evidence base supporting the Watchman device includes more than 30 randomized clinical trials, prospective studies, and large real-world registries. Two large randomized trials, OPTION and CHAMPION-AF, provide informative data across different patient populations and clinical circumstances. In the OPTION trial, 1,600 patients with elevated stroke risk who underwent atrial fibrillation ablation were randomized to left atrial appendage closure with the Watchman FLX device or oral anticoagulation. At 36 months, left atrial appendage closure with the Watchman FLX device was noninferior to oral anticoagulation for the primary composite efficacy endpoint of death, stroke, or systemic embolism and was superior for the primary safety endpoint of non-procedure-related major or clinically relevant nonmajor bleeding. The CHAMPION-AF trial extended evidence to a broader population of 3,000 atrial fibrillation patients who were candidates for anticoagulation. At 36 months, left atrial appendage closure with the Watchman FLX device was noninferior to anticoagulation for the primary efficacy endpoint. Ischemic stroke rates were low in all trial participants, though numerically higher in those with left atrial appendage closure, and rates aligned with prior seminal clinical studies of oral anticoagulators. Furthermore, left atrial appendage closure showed superiority to anticoagulation for the primary non-procedure-related bleeding endpoint and significantly reduced bleeding in a secondary analysis including procedural bleeding. A 2026 meta-analysis of seven randomized trials found similar rates of stroke or systemic embolism with left atrial appendage closure and oral anticoagulation, alongside lower rates of clinically significant bleeding with left atrial appendage closure. Real-world data from an analysis of 97,185 Watchman FLX implants found a 97.5 percent successful implantation rate and a low rate of serious safety events, extending the evidence into routine clinical practice. Stroke protection must also be considered alongside rhythm management. Emerging evidence from the OCEAN and ALONE-AF studies suggests select atrial fibrillation patients with a lower risk of stroke, defined as a CHA₂DS₂-VASc stroke risk score of 0 to 2, who maintain sinus rhythm following cardiac ablation may do well without long-term anticoagulation. However, these findings should not be extrapolated to moderate- or higher-risk patients with a CHA₂DS₂-VASc score of 3 or greater, who may remain at risk despite successful ablation. Two large meta-analyses published in 2026 reported a significant increase in thromboembolic events and a lower incidence of major bleeding events among patients who discontinued oral anticoagulants after atrial fibrillation ablation, suggesting persistent stroke risk.