Percutaneous Left Atrial Appendage Suture Ligation Using the LARIAT Device in Patients With Atrial Fibrillation Initial Clinical Experience

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. (C) 2012 by the American College of Cardiology Foundation