Objectives: The purpose of the study was to determine the efficacy and safety of left atrial appendage (LAA) closure via a percutaneous LAA ligation approach.
Background: Embolic stroke is the most devastating consequence of atrial fibrillation. Exclusion of the LAA is believed to decrease the risk of embolic stroke.
Methods: Eighty-nine patients with atrial fibrillation were enrolled to undergo percutaneous ligation of the LAA with the LARIAT device. The catheter-based LARIAT device consists of a snare with a pre-tied suture that is guided epicardially over the LAA. LAA closure was confirmed with transesophageal echocardiography (TEE) and contrast fluoroscopy immediately, then with TEE at 1 day, 30 days, 90 days, and 1 year post-LAA ligation.
Results: Eighty-five (96%) of 89 patients underwent successful LAA ligation. Eighty-one of 85 patients had complete closure immediately. Three of 85 patients had a ≤ 2-mm residual LAA leak by TEE color Doppler evaluation. One of 85 patients had a ≤ 3-mm jet by TEE. There were no complications due to the device. There were 3 access-related complications (during pericardial access, n = 2; and transseptal catheterization, n = 1). Adverse events included severe pericarditis post-operatively (n = 2), late pericardial effusion (n = 1), unexplained sudden death (n = 2), and late strokes thought to be non-embolic (n = 2). At 1 month (81 of 85) and 3 months (77 of 81) post-ligation, 95% of the patients had complete LAA closure by TEE. Of the patients undergoing 1-year TEE (n = 65), there was 98% complete LAA closure, including the patients with previous leaks.
Conclusions: LAA closure with the LARIAT device can be performed effectively with acceptably low access complications and periprocedural adverse events in this observational study.
Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.