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Percutaneous Left Atrial Appendage Suture Ligation Using the LARIAT Device in Patients With Atrial Fibrillation: Initial Clinical Experience
Study Questions:
What is the efficacy and safety of left atrial appendage (LAA) closure via a percutaneous LAA ligation approach?
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 three access-related complications (during pericardial access, n = 2; and transseptal catheterization, n = 1). Adverse events included severe pericarditis postoperatively (n = 2), late pericardial effusion (n =1), unexplained sudden death (n = 2), and late strokes thought to be nonembolic (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:
The authors concluded that LAA closure with the LARIAT device can be performed effectively with acceptably low access complications and periprocedural adverse events.
Perspective:
This study reports that the percutaneous LAA ligation approach produced immediate complete closure of the LAA in over 95% of patients, with the long-term follow-up suggesting that the closure is permanent. Overall, this observational study provides evidence of the reliability of LAA exclusion with acceptably low access complications and adverse events, enabling this percutaneous LAA ligation procedure to be used in future randomized clinical trials. A noninferiority trial comparing the LARIAT device to oral anticoagulation and the Watchman device may provide atrial fibrillation patients with alternative therapy options for thromboembolic event risk reduction.
Keywords: Fluoroscopy, Follow-Up Studies, Atrial Appendage, Cardiac Catheterization, Pericarditis, Pericardial Effusion, Echocardiography
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