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 CHA(2)DS(2)-VASc >= 5. METHODS All patients undergoing procedures for Watchman implant at our institution were enrolled in a prospective registry. All 104 consecutive recipients with CHA2DS2-VASc >= 5 were included. RESULTS Median patient age was 78.5 +/- 6.4 years, 56% were male, mean CHA(2)DS(2)-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 CHA(2)DS(2)-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 CHA(2)DS(2)-VASc score, the estimated annual risk of stroke isz12% off anticoagulation and.4% on warfarin.