ABSTRACT
OBJECTIVES: To evaluate the feasibility and safety of the fourth generation WATCHMAN device. BACKGROUND: The WATCHMAN left atrial appendage (LAA) closure device has been shown to be non-inferior to conventional oral anticoagulation with warfarin for stroke prevention in patients with non-valvular atrial fibrillation. A new (fourth) generation of the WATCHMAN device was designed to facilitate easier delivery and improve safety. METHODS: We conducted a prospective, non-randomized study of LAA closure with use of the 4(th) generation WATCHMAN device in 36 patients with non-valvular atrial fibrillation. Follow-up was performed at 45 days, 6 months and 12 months following implantation. RESULTS: The mean age of the population was 73 ± 6 years and 67% were male. The mean CHADS2 and CHA2 DS2-VASc Score were 2.5 and 4.5, respectively. The device was implanted successfully in 34/36 (94%). No serious hospital complications related to the device or procedure occurred. During 12 month follow-up, three ischemic strokes (8%), one hemorrhagic stroke (3%), one TIA (3%) and three deaths (9%) occurred. Device-associated thrombus formation was detected in one patient (3%) during six-month follow-up and was treated successfully with low molecular weight heparin. CONCLUSIONS: LAA closure with the 4(th) generation WATCHMAN device is feasible and safe. New technical features may contribute to a better performance of the occluder, particularly regarding the risk of pericardial effusions.
Subject(s)
Atrial Appendage , Atrial Fibrillation/therapy , Cardiac Catheterization/instrumentation , Ischemic Attack, Transient/prevention & control , Prosthesis Design , Prosthesis Implantation/instrumentation , Stroke/prevention & control , Aged , Aged, 80 and over , Atrial Appendage/diagnostic imaging , Atrial Appendage/physiopathology , Atrial Fibrillation/complications , Atrial Fibrillation/mortality , Atrial Fibrillation/physiopathology , Cardiac Catheterization/adverse effects , Cardiac Catheterization/mortality , Echocardiography, Transesophageal , Feasibility Studies , Female , Follow-Up Studies , Humans , Ischemic Attack, Transient/etiology , Ischemic Attack, Transient/mortality , Male , Middle Aged , Prospective Studies , Prosthesis Implantation/adverse effects , Prosthesis Implantation/mortality , Stroke/etiology , Stroke/mortality , Thrombosis/etiology , Time Factors , Treatment OutcomeABSTRACT
OBJECTIVES: To determine the procedural safety, safety, and efficacy of left atrial appendage (LAA) occlusion in octogenarians. BACKGROUND: Elderly patients with atrial fibrillation (AF) often do not receive appropriate anticoagulation. LAA occlusion is an option for patients with AF and contraindications to anticoagulation. Not much is known about the procedural safety and clinical efficacy of LAA occlusion in the very elderly. METHODS: A retrospective review of LAA cases at our institution between 2002 and 2013 in patients 80 years of age or older was performed. Demographic, echocardiographic, procedural, and clinical follow-up data were collected. RESULTS: Seventy-five cases were attempted in patients 80 years of age or older (average age 83.4 ± 2.8 years, 53.3% males). Hypertension, coronary artery disease, and heart failure were present in 96, 41.3, and 36%, respectively. Mean CHADS2 and CHA2DS-VASc scores were 3.3 and 5.2. Devices used included the WATCHMAN, ACP, PLAATO, Lariat, and Coherex devices, which were attempted in 34.7, 36, 17.3, 5.3, and 5.3%, respectively. Overall procedural success, safety endpoint, and 1-year device efficacy was 90.1, 3.9, and 97.4%, respectively. CONCLUSION: LAA closure is a safe and efficacious method of stroke prevention in the very elderly with AF.
