Krzysztof Bartus1, Sameer Gafoor2, David Tschopp3, John P Foran4, Roland Tilz5, Tom Wong4, Dhanunjaya Lakkireddy6, Horst Sievert2, Randall J Lee7. 1. Department of Cardiovascular Surgery and Transplantology, Jagiellonian University, John Paul II Hospital, Krakow, Poland. 2. CardioVascular Center Frankfurt CVC, Frankfurt, Germany. 3. Austin Heart PLLC, Austin, TX, USA. 4. Heart Rhythm Centre, Royal Brompton and Harefield NHS Foundation Trust, UK. 5. Department of Cardiology, Asklepios Klinik St. Georg, Lohmuehlenstr 5, 20099 Hamburg, Germany; Department of Cardiology, University Hospital Lübeck, Ratzeburger Allee 160, 23538 Lübeck, Germany. 6. Division of Cardiology, University of Kansas Medical Center, Kansas City, KS, USA. 7. Division of Cardiology and the Cardiovascular Research Institute, University of California, San Francisco, San Francisco, CA, USA. Electronic address: lee@medicine.ucsf.edu.
Abstract
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.
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.
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