Erika Hutt1, Oussama M Wazni2, Simrat Kaur1, Walid I Saliba2, Khaldoun G Tarakji2, Samir Kapadia3, Jose Aguilera1, Amr F Barakat4, Mouin Abdallah5, Wael Jaber6, Peter Rasmussen7, Shazam Hussain7, Ken Uchino7, Dolora Wisco7, Bruce D Lindsay2, Mohamed Kanj2, Ayman A Hussein8. 1. Department of Internal Medicine, Cleveland Clinic Foundation, Cleveland, Ohio. 2. Section of Cardiac Pacing and Electrophysiology, Cleveland Clinic Foundation, Cleveland, Ohio. 3. Section Head of Invasive and Interventional Cardiology, Cleveland Clinic Foundation, Cleveland, Ohio. 4. Department of Cardiovascular Medicine, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. 5. Section of Clinical Cardiology, Cleveland Clinic Foundation, Cleveland, Ohio. 6. Section of Cardiovascular Imaging, Cleveland Clinic Foundation, Cleveland, Ohio. 7. Department of Cerebrovascular Medicine, Cleveland Clinic Foundation, Cleveland, Ohio. 8. Section of Cardiac Pacing and Electrophysiology, Cleveland Clinic Foundation, Cleveland, Ohio. Electronic address: husseia@ccf.org.
Abstract
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 CHA2DS2-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 CHA2DS2-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 CHA2DS2-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 CHA2DS2-VASc score, the estimated annual risk of stroke is ≈12% off anticoagulation and >4% on warfarin.
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 CHA2DS2-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 CHA2DS2-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 CHA2DS2-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 CHA2DS2-VASc score, the estimated annual risk of stroke is ≈12% off anticoagulation and >4% on warfarin.