Left atrial appendage closure device implantation in patients at very high risk for stroke.

Background: Little is known about the role of left atrial appendage closure using the Watchman device (Boston Scientific) in patients who are at very high risk for stroke.

Objective: The purpose of this study was to assess the role of Watchman in patients with CHADS-VASc ≥5.

Methods: All patients undergoing procedures for Watchman implant at our institution were enrolled in a prospective registry. All 104 consecutive recipients with CHADS-VASc ≥5 were included.

Results: Median patient age was 78.5 ± 6.4 years, 56% were male, mean CHADS-VASc was 5.7 ± 0.9, and mean HASBLED was 4.0 ± 1.0. Indications for implantation were significant prior bleeding (73%), unacceptable bleeding risk (21%), and unacceptable stroke and bleeding risk (6%). Watchman implantation was successful in all patients. All but 2 patients completed 45 days of postprocedural anticoagulation; 56% used warfarin and 44% used a novel oral anticoagulant. Transesophageal echocardiogram at 45 days revealed no significant peridevice leak. One patient was found to have a small mobile, filamentous echodensity attached on the medial aspect of the Watchman device. This resolved with longer anticoagulation with dabigatran and did not result in adverse outcome. At 1-year follow up, ischemic stroke had occurred in 3 patients (2.8%) at 96, 119, and 276 days after the procedure.

Conclusion: In a population of patients with mean CHADS-VASc of 5.7, Watchman implantation seemed to be safe and efficacious, with a residual annual ischemic stroke risk of 2.8%. In an atrial fibrillation population with a similar CHADS-VASc score, the estimated annual risk of stroke is ≈12% off anticoagulation and >4% on warfarin.