Left atrial appendage ligation with the next generation LARIAT(+) suture delivery device: Early clinical experience.

Background: The purpose of the study was to determine the efficacy and safety of left atrial appendage (LAA) closure with a micropuncture pericardial access approach and the new LARIAT(+) suture delivery device.

Methods: Seventy-two patients with atrial fibrillation were enrolled to undergo telescopic micropuncture pericardial access and percutaneous ligation of the LAA with the LARIAT(+) device. LAA closure was confirmed with transesophageal echocardiography (TEE) and contrast fluoroscopy immediately, then with TEE at 30days and 90days post-LAA ligation. Patients were monitored for 12months by an independent clinical research organization for adverse events, stroke, embolic events and death of any cause.

Results: 72 patients were screened for the LARIAT(+) procedure. Fourteen patients were screened failures (7 patients due to unfavorable anatomy and 7 patients with LAA thrombus). Fifty-eight patients underwent successful LAA ligation. All 58 patients had complete acute closure of the LAA. At 1month 52 of 54 patients (96.3%) had LAA closure, while at 3months 48 of 52 patients (92.3%) had LAA closure. There were no leaks greater than 3mm at both 1 and 3months. There were no device or procedural related complications, and only 1 30day adverse event involving late pericardial effusion. There were no strokes, embolic events or deaths after 12months.

Conclusions: LAA closure with the micropuncture pericardial access approach and the LARIAT(+) device can be performed effectively with acceptably low periprocedural adverse events.