title: Left Atrial Appendage Electrical Isolation and Concomitant Device Occlusion to Treat Persistent Atrial Fibrillation: A First-in-Human Safety, Feasibility, and Efficacy Study.
abstract: Left atrial appendage (LAA) electric isolation is reported to improve persistent atrial fibrillation (AF) ablation outcomes. However, loss of LAA mechanical function may increase thromboembolic risk. Concomitant LAA electric isolation and occlusion as part of conventional AF ablation has never been tested in humans. We therefore evaluated the feasibility, safety, and efficacy of LAA electric isolation and occlusion in patients undergoing long-standing persistent AF ablation.
  
  
  
  Patients with long-standing persistent AF (age, 68±7 years; left atrium diameter, 46±3 mm; and AF duration, 25±15 months) underwent AF ablation, LAA electric isolation, and occlusion. Outcomes were compared with a balanced (1:2 ratio) control group who had AF ablation alone. Among 22 patients who underwent ablation, LAA electric isolation was possible in 20. Intraprocedural LAA reconnection occurred in 17 of 20 (85%) patients, predominantly at anterior and superior locations. All were reisolated. LAA occlusion was successful in all 20 patients. There were no major periprocedural complications. Imaging at 45 days and 9 months confirmed satisfactory device position and excluded pericardial effusion. One of twenty (5%) patients had a gap of ≥5 mm requiring anticoagulation. Nineteen of twenty (95%) patients stopped warfarin at 3 months. Without antiarrhythmic drugs, freedom from AF at 12 months after a single procedure was significantly higher in the study group (19/20, 95%) than in the control group (25/40, 63%), P=0.036. Freedom from atrial arrhythmias was demonstrated in 12 of 20 (60%) and 18 of 20 (90%) patients after 1 and ≤2 procedures (mean, 1.3), respectively.
  
  
  
  Persistent AF ablation, LAA electric isolation, and mechanical occlusion can be performed concomitantly. This technique may improve the success of persistent AF ablation while obviating the need for chronic anticoagulation.
  
  
  
  URL: https://clinicaltrials.gov. Unique identifier: NCT02028130.
authors.affiliation: From the Heart Rhythm Centre, National Institute for Health Research (NIHR) Cardiovascular Research Unit, Heart Rhythm Centre, Royal Brompton and Harefield Hospitals, National Heart and Lung Institute, Imperial College London, London, United Kingdom (S.P., J.W.E.J., S.H., C.B., H.K., L.M., E.N., J.P.F., V.M., T.W.); CV Path Institute, Gaithersburg, MD (R.V., R.K.); and Department of Cardiology, National Heart Centre Singapore, Singapore (E.L.).
authors.forename: Sandeep
authors.initials: S
authors.lastname: Panikker
authors.affiliation: From the Heart Rhythm Centre, National Institute for Health Research (NIHR) Cardiovascular Research Unit, Heart Rhythm Centre, Royal Brompton and Harefield Hospitals, National Heart and Lung Institute, Imperial College London, London, United Kingdom (S.P., J.W.E.J., S.H., C.B., H.K., L.M., E.N., J.P.F., V.M., T.W.); CV Path Institute, Gaithersburg, MD (R.V., R.K.); and Department of Cardiology, National Heart Centre Singapore, Singapore (E.L.).
authors.forename: Julian W E
authors.initials: JW
authors.lastname: Jarman
authors.affiliation: From the Heart Rhythm Centre, National Institute for Health Research (NIHR) Cardiovascular Research Unit, Heart Rhythm Centre, Royal Brompton and Harefield Hospitals, National Heart and Lung Institute, Imperial College London, London, United Kingdom (S.P., J.W.E.J., S.H., C.B., H.K., L.M., E.N., J.P.F., V.M., T.W.); CV Path Institute, Gaithersburg, MD (R.V., R.K.); and Department of Cardiology, National Heart Centre Singapore, Singapore (E.L.).
authors.forename: Renu
authors.initials: R
authors.lastname: Virmani
authors.affiliation: From the Heart Rhythm Centre, National Institute for Health Research (NIHR) Cardiovascular Research Unit, Heart Rhythm Centre, Royal Brompton and Harefield Hospitals, National Heart and Lung Institute, Imperial College London, London, United Kingdom (S.P., J.W.E.J., S.H., C.B., H.K., L.M., E.N., J.P.F., V.M., T.W.); CV Path Institute, Gaithersburg, MD (R.V., R.K.); and Department of Cardiology, National Heart Centre Singapore, Singapore (E.L.).
authors.forename: Robert
authors.initials: R
authors.lastname: Kutys
authors.affiliation: From the Heart Rhythm Centre, National Institute for Health Research (NIHR) Cardiovascular Research Unit, Heart Rhythm Centre, Royal Brompton and Harefield Hospitals, National Heart and Lung Institute, Imperial College London, London, United Kingdom (S.P., J.W.E.J., S.H., C.B., H.K., L.M., E.N., J.P.F., V.M., T.W.); CV Path Institute, Gaithersburg, MD (R.V., R.K.); and Department of Cardiology, National Heart Centre Singapore, Singapore (E.L.).
authors.forename: Shouvik
authors.initials: S
authors.lastname: Haldar
authors.affiliation: From the Heart Rhythm Centre, National Institute for Health Research (NIHR) Cardiovascular Research Unit, Heart Rhythm Centre, Royal Brompton and Harefield Hospitals, National Heart and Lung Institute, Imperial College London, London, United Kingdom (S.P., J.W.E.J., S.H., C.B., H.K., L.M., E.N., J.P.F., V.M., T.W.); CV Path Institute, Gaithersburg, MD (R.V., R.K.); and Department of Cardiology, National Heart Centre Singapore, Singapore (E.L.).
authors.forename: Eric
authors.initials: E
authors.lastname: Lim
authors.affiliation: From the Heart Rhythm Centre, National Institute for Health Research (NIHR) Cardiovascular Research Unit, Heart Rhythm Centre, Royal Brompton and Harefield Hospitals, National Heart and Lung Institute, Imperial College London, London, United Kingdom (S.P., J.W.E.J., S.H., C.B., H.K., L.M., E.N., J.P.F., V.M., T.W.); CV Path Institute, Gaithersburg, MD (R.V., R.K.); and Department of Cardiology, National Heart Centre Singapore, Singapore (E.L.).
authors.forename: Charles
authors.initials: C
authors.lastname: Butcher
authors.affiliation: From the Heart Rhythm Centre, National Institute for Health Research (NIHR) Cardiovascular Research Unit, Heart Rhythm Centre, Royal Brompton and Harefield Hospitals, National Heart and Lung Institute, Imperial College London, London, United Kingdom (S.P., J.W.E.J., S.H., C.B., H.K., L.M., E.N., J.P.F., V.M., T.W.); CV Path Institute, Gaithersburg, MD (R.V., R.K.); and Department of Cardiology, National Heart Centre Singapore, Singapore (E.L.).
authors.forename: Habib
authors.initials: H
authors.lastname: Khan
authors.affiliation: From the Heart Rhythm Centre, National Institute for Health Research (NIHR) Cardiovascular Research Unit, Heart Rhythm Centre, Royal Brompton and Harefield Hospitals, National Heart and Lung Institute, Imperial College London, London, United Kingdom (S.P., J.W.E.J., S.H., C.B., H.K., L.M., E.N., J.P.F., V.M., T.W.); CV Path Institute, Gaithersburg, MD (R.V., R.K.); and Department of Cardiology, National Heart Centre Singapore, Singapore (E.L.).
authors.forename: Lilian
authors.initials: L
authors.lastname: Mantziari
authors.affiliation: From the Heart Rhythm Centre, National Institute for Health Research (NIHR) Cardiovascular Research Unit, Heart Rhythm Centre, Royal Brompton and Harefield Hospitals, National Heart and Lung Institute, Imperial College London, London, United Kingdom (S.P., J.W.E.J., S.H., C.B., H.K., L.M., E.N., J.P.F., V.M., T.W.); CV Path Institute, Gaithersburg, MD (R.V., R.K.); and Department of Cardiology, National Heart Centre Singapore, Singapore (E.L.).
authors.forename: Edward
authors.initials: E
authors.lastname: Nicol
authors.affiliation: From the Heart Rhythm Centre, National Institute for Health Research (NIHR) Cardiovascular Research Unit, Heart Rhythm Centre, Royal Brompton and Harefield Hospitals, National Heart and Lung Institute, Imperial College London, London, United Kingdom (S.P., J.W.E.J., S.H., C.B., H.K., L.M., E.N., J.P.F., V.M., T.W.); CV Path Institute, Gaithersburg, MD (R.V., R.K.); and Department of Cardiology, National Heart Centre Singapore, Singapore (E.L.).
authors.forename: John P
authors.initials: JP
authors.lastname: Foran
authors.affiliation: From the Heart Rhythm Centre, National Institute for Health Research (NIHR) Cardiovascular Research Unit, Heart Rhythm Centre, Royal Brompton and Harefield Hospitals, National Heart and Lung Institute, Imperial College London, London, United Kingdom (S.P., J.W.E.J., S.H., C.B., H.K., L.M., E.N., J.P.F., V.M., T.W.); CV Path Institute, Gaithersburg, MD (R.V., R.K.); and Department of Cardiology, National Heart Centre Singapore, Singapore (E.L.).
authors.forename: Vias
authors.initials: V
authors.lastname: Markides
authors.affiliation: From the Heart Rhythm Centre, National Institute for Health Research (NIHR) Cardiovascular Research Unit, Heart Rhythm Centre, Royal Brompton and Harefield Hospitals, National Heart and Lung Institute, Imperial College London, London, United Kingdom (S.P., J.W.E.J., S.H., C.B., H.K., L.M., E.N., J.P.F., V.M., T.W.); CV Path Institute, Gaithersburg, MD (R.V., R.K.); and Department of Cardiology, National Heart Centre Singapore, Singapore (E.L.). tom.wong@imperial.ac.uk.
authors.forename: Tom
authors.initials: T
authors.lastname: Wong
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage; D020517:Atrial Appendage / Q000503:physiopathology / Q000601:surgery*; D001281:Atrial Fibrillation / Q000503:physiopathology / Q000601:surgery*; D017115:Catheter Ablation / Q000295:instrumentation / Q000379:methods*; D004562:Electrocardiography; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D061214:Patient Safety; D011446:Prospective Studies; D011788:Quality of Life; D013923:Thromboembolism / Q000517:prevention & control; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants
keywords: atrial appendage; atrial fibrillation; catheter ablation; thromboembolism; warfarin