Valay Parikh1, Krzysztof Bartus2, Radoslaw Litwinowicz2, Mohit K Turagam3, Jerzy Sadowski2, Boguslaw Kapelak2, Magdalena Bartus4, Jakub Podolec2, Maciej Brzezinski5, Dan Musat6, Abdi Rasekh7, Suneet Mittal6, Jie Cheng8, Nitish Badhwar9, Randall Lee9,10, Dhanunjaya Lakkireddy11. 1. Department of Electrophysiology, Baptist Health System, San Antonio, Texas. 2. Department of Cardiovascular Surgery and Transplantology, John Paul II Hospital, Jagiellonian University, Krakow, Poland. 3. Section of Electrophysiology, Icahn School of Medicine at Mount Sinai, New York. 4. Department of Pharmacology, Jagiellonian University, Krakow, Poland. 5. Department of Physiology, Medical University of Gdansk, Gdansk, Poland. 6. Section of Electrophysiology, Valley Health System, Ridgewood, New Jersey. 7. Section of Electrophysiology, Texas Heart Institute, Houston, Texas. 8. Section of Electrophysiology, Baylor Medical Center, University of Texas, Houston, Texas. 9. Department of Medicine, Division of Cardiac Electrophysiology, University of California San Francisco, San Francisco, California. 10. Cardiovascular Research Institute, Institute for Regeneration Medicine, University of California San Francisco, San Francisco, California. 11. The Kansas City Heart Rhythm Institute & Research Foundation, Overland Park, Kansas.
Abstract
BACKGROUND: Left atrial appendage closure (LAAC) with LARIAT has emerged as one of the alternatives to oral anticoagulation (OAC) in patients with nonvalvular atrial fibrillation (AF). Our aim was to study long-term outcomes in patients undergoing LARIAT procedure. METHODS: We analyzed patients screened for LARIAT device in four centers between December 2009 and June 2012. Out of these, patients who didn't undergo LAAC with the LARIAT device due to unfavorable LAA morphology and other preprocedural contraindications were included in control group. We analyzed thromboembolism, bleeding events, and mortality between LAA and control group. RESULTS: About 153 patients were screened. Out of these, 108 (70.6%) patients underwent LARIAT placement (LAA arm) and 45 (29.4%) excluded patients were included in control arm. There were no differences in CHADS2 and CHA2 DS2 -VASc score. Mean HAS-BLED score was significantly higher in the LARIAT group (3.5 ± 1.06 vs 3.09 ± 1.22, P = .04). Mean follow-up time (in years) was 6.56 ± 0.84 in LAA and 6.5 ± 1.26 in control arm. During follow-up period, the LARIAT group was associated with significantly less thromboembolic events (1.9% vs 24%, P < .001), bleeding events (9.2% vs 24.4%, P = .03), and mortality (5.6% vs 20%, P = .01) as compared with the control group. CONCLUSIONS: Long-term data from routine clinical practice from our study suggests that LAA exclusion with LARIAT device is an effective treatment in management of nonvalvular AF patients with high risk of stroke, bleeding, and mortality. Further randomized trials, such as aMAZE, will provide more insight in this expanding field.
BACKGROUND: Left atrial appendage closure (LAAC) with LARIAT has emerged as one of the alternatives to oral anticoagulation (OAC) in patients with nonvalvular atrial fibrillation (AF). Our aim was to study long-term outcomes in patients undergoing LARIAT procedure. METHODS: We analyzed patients screened for LARIAT device in four centers between December 2009 and June 2012. Out of these, patients who didn't undergo LAAC with the LARIAT device due to unfavorable LAA morphology and other preprocedural contraindications were included in control group. We analyzed thromboembolism, bleeding events, and mortality between LAA and control group. RESULTS: About 153 patients were screened. Out of these, 108 (70.6%) patients underwent LARIAT placement (LAA arm) and 45 (29.4%) excluded patients were included in control arm. There were no differences in CHADS2 and CHA2 DS2 -VASc score. Mean HAS-BLED score was significantly higher in the LARIAT group (3.5 ± 1.06 vs 3.09 ± 1.22, P = .04). Mean follow-up time (in years) was 6.56 ± 0.84 in LAA and 6.5 ± 1.26 in control arm. During follow-up period, the LARIAT group was associated with significantly less thromboembolic events (1.9% vs 24%, P < .001), bleeding events (9.2% vs 24.4%, P = .03), and mortality (5.6% vs 20%, P = .01) as compared with the control group. CONCLUSIONS: Long-term data from routine clinical practice from our study suggests that LAA exclusion with LARIAT device is an effective treatment in management of nonvalvular AFpatients with high risk of stroke, bleeding, and mortality. Further randomized trials, such as aMAZE, will provide more insight in this expanding field.