Left Atrial Appendage Ligation in Nonvalvular Atrial Fibrillation
What are the long-term clinical outcomes in adults with nonvalvular atrial fibrillation (AF) who are ineligible for oral anticoagulation (OAC) therapy and underwent left atrial appendage (LAA) ligation with the LARIAT device?
LAA ligation with the LARIAT device was performed in 139 patients with nonvalvular AF. LAA closure was verified during the procedure by LA angiography and transesophageal echocardiography (TEE). A follow-up TEE was performed at 30-45 days postprocedure. After the procedure, patients received aspirin (ASA) only, clopidogrel only, ASA plus clopidogrel, or no antithrombotic drugs. Patients did not receive transition OAC therapy post-LAA ligation. Patients were followed for LAA closure and adverse events, including stroke, systemic events, and death.
Acute closure was accomplished in 138 of 139 (99%) treated patients. In one patient, a posterior lobe was partially closed. At the day 30-45 TEE (n = 127), 114 (90%) had complete LAA closure, and 13 (10%) had a 2-4 mm leak. There were no leaks ≥5 mm. The periprocedural adverse event rate was 11.5%, including two cardiac perforations and one death due to pulmonary embolus. Over a mean follow-up of 2.9 ± 1.1 years, the event rate for the composite endpoint of stroke and systemic embolism was 1.0% per year (n = 4). The combined stroke, embolism, and death of any cause event rate was 2.8% (n = 11) per year.
The authors concluded that LAA ligation with the LARIAT device effectively closes the LAA and may be a beneficial approach to reduce the risk of embolic events in AF patients ineligible for OAC therapy.
This study reports that the initial experience of LAA ligation with the LARIAT device suggests that this device may be an option for patients with AF and high risk of cardioembolic stroke who cannot tolerate long-term anticoagulation therapy. However, the device has been associated with adverse events requiring corrective interventions, and prospective randomized studies are needed to confirm the efficacy and safety following percutaneous LAA ligation with the LARIAT device. The FDA released a Safety Communication in July 2015 stating that the safety and effectiveness of the LARIAT Suture Delivery Device to close the LAA and prevent stroke in patients with AF has not been established, further emphasizing the need for prospective randomized studies.
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