Horst Sievert1, Abdi Rasekh2, Kryzstof Bartus3, Remo L Morelli4, Qizhi Fang5, Jonas Kuropka6, Duong Le4, Sameer Gafoor6, Luisa Heuer6, Payam Safavi-Naeini2, Trisha F Hue7, Gregory M Marcus5, Nitish Badhwar5, Ali Massumi2, Randall J Lee8. 1. CardioVascular Center Frankfurt CVC, Frankfurt, Germany. Electronic address: HorstSievertMD@aol.com. 2. St. Luke's Hospital, Houston, Texas; Texas Heart Institute, Baylor College of Medicine, Houston, Texas. 3. Department of Cardiovascular Surgery and Transplantology, Jagiellonian University, John Paul II Hospital, Krakow, Poland. 4. St. Mary's Hospital, San Francisco, California. 5. Department of Medicine and Cardiovascular Research Center, University of California, San Francisco, California. 6. CardioVascular Center Frankfurt CVC, Frankfurt, Germany. 7. San Francisco Coordinating Center, Department of Epidemiology and Biostatistics, University of California, San Francisco, California. 8. Department of Medicine and Cardiovascular Research Center, University of California, San Francisco, California. Electronic address: lee@medicine.ucsf.edu.
Abstract
OBJECTIVES: This study sought to assess long-term clinical outcomes in adults with nonvalvular atrial fibrillation (AF) who are ineligible for oral anticoagulation therapy and underwent left atrial appendage (LAA) ligation with the Lariat device. BACKGROUND: LAA exclusion has been used to prevent thrombus formation within the LAA in AF patients and is believed to decrease the risk of cardioembolic events. METHODS: 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. A follow-up transesophageal echocardiography was performed at 30 to 45 days post-procedure. After the procedure, patients received aspirin only, clopidogrel only, aspirin plus clopidogrel, or no antithrombotic drugs. Patients did not receive transition oral anticoagulation therapy post-LAA ligation. Patients were followed for LAA closure and adverse events, including stroke, systemic events, and death. RESULTS: Acute closure was accomplished in 138 of 139 treated patients (99%). In 1 patient, a posterior lobe was partially closed. At the day-30 to day-45 transesophageal echocardiography (n = 127), 114 (90%) had complete LAA closure, and 13 (10%) had a 2- to 4-mm leak. There were no leaks ≥5 mm. The periprocedural adverse event rate was 11.5%, including 2 cardiac perforations and 1 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. CONCLUSIONS: The findings from this analysis of post-procedure event rates suggest 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 to oral anticoagulation therapy. However, future randomized clinical trials are needed to verify these results and to determine device and procedural safety.
OBJECTIVES: This study sought to assess long-term clinical outcomes in adults with nonvalvular atrial fibrillation (AF) who are ineligible for oral anticoagulation therapy and underwent left atrial appendage (LAA) ligation with the Lariat device. BACKGROUND: LAA exclusion has been used to prevent thrombus formation within the LAA in AFpatients and is believed to decrease the risk of cardioembolic events. METHODS: 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. A follow-up transesophageal echocardiography was performed at 30 to 45 days post-procedure. After the procedure, patients received aspirin only, clopidogrel only, aspirin plus clopidogrel, or no antithrombotic drugs. Patients did not receive transition oral anticoagulation therapy post-LAA ligation. Patients were followed for LAA closure and adverse events, including stroke, systemic events, and death. RESULTS: Acute closure was accomplished in 138 of 139 treated patients (99%). In 1 patient, a posterior lobe was partially closed. At the day-30 to day-45 transesophageal echocardiography (n = 127), 114 (90%) had complete LAA closure, and 13 (10%) had a 2- to 4-mm leak. There were no leaks ≥5 mm. The periprocedural adverse event rate was 11.5%, including 2 cardiac perforations and 1 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. CONCLUSIONS: The findings from this analysis of post-procedure event rates suggest 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 AFpatients ineligible to oral anticoagulation therapy. However, future randomized clinical trials are needed to verify these results and to determine device and procedural safety.
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