title: Outcomes and costs of left atrial appendage closure from randomized controlled trial and real-world experience relative to oral anticoagulation.
abstract: The aim of this study was to analyse randomized controlled study and real-world outcomes of patients with non-valvular atrial fibrillation (NVAF) undergoing left atrial appendage closure (LAAC) with the Watchman device and to compare costs with available antithrombotic therapies.
  
  
  
  Registry data of LAAC from two centres were prospectively collected from 110 patients with NVAF at risk of stroke, suitable and unsuitable for long-term anticoagulation (age 71.3 ± 9.2 years, CHADS22.8 ± 1.2, CHA2DS2-VASc 4.5 ± 1.6, and HAS-BLED 3.8 ± 1.1). Outcomes from PROTECT AF and registry study LAAC were compared with warfarin, dabigatran, rivaroxaban, apixaban, aspirin, and no treatment using a network meta-analysis. Costs were estimated over a 10-year horizon. Uncertainty was assessed using sensitivity analyses. The procedural success rate was 92% (103/112). Follow-up was 24.1 ± 4.6 months, during which annual rates of stroke, major bleeding, and all-cause mortality were 0.9% (2/223 patient-years), 0.9% (2/223 patient-years), and 1.8% (4/223 patient-years), respectively. Anticoagulant therapy was successfully stopped in 91.2% (93/102) of implanted patients by 12 months. Registry study LAAC stroke and major bleeding rates were significantly lower than PROTECT AF results: mean absolute difference of stroke, 0.89% (P = 0.02) and major bleeding, 5.48% (P < 0.001). Left atrial appendage closure achieved cost parity between 4.9 years vs. dabigatran 110 mg and 8.4 years vs. warfarin. At 10 years, LAAC was cost-saving against all therapies (range £1162-£7194).
  
  
  
  Left atrial appendage closure in NVAF in a real-world setting may result in lower stroke and major bleeding rates than reported in LAAC clinical trials. Left atrial appendage closure in both settings achieves cost parity in a relatively short period of time and may offer substantial savings compared with current therapies. Savings are most pronounced among higher risk patients and those unsuitable for anticoagulation.
authors.affiliation: Heart Rhythm Centre, NIHR Cardiovascular Research Unit, Royal Brompton & Harefield Hospitals and National Heart and Lung Institute, Imperial College, Sydney Street, London SW3 6NP, UK.
authors.forename: Sandeep
authors.initials: S
authors.lastname: Panikker
authors.affiliation: Southampton Health Technology Assessments Centre, University of Southampton, Southampton, UK.
authors.forename: Joanne
authors.initials: J
authors.lastname: Lord
authors.affiliation: Heart Rhythm Centre, NIHR Cardiovascular Research Unit, Royal Brompton & Harefield Hospitals and National Heart and Lung Institute, Imperial College, Sydney Street, London SW3 6NP, UK.
authors.forename: Julian W E
authors.initials: JW
authors.lastname: Jarman
authors.affiliation: GfK Bridgehead, Wayland, MA, USA.
authors.forename: Shannon
authors.initials: S
authors.lastname: Armstrong
authors.affiliation: Heart Rhythm Centre, NIHR Cardiovascular Research Unit, Royal Brompton & Harefield Hospitals and National Heart and Lung Institute, Imperial College, Sydney Street, London SW3 6NP, UK.
authors.forename: David G
authors.initials: DG
authors.lastname: Jones
authors.affiliation: Heart Rhythm Centre, NIHR Cardiovascular Research Unit, Royal Brompton & Harefield Hospitals and National Heart and Lung Institute, Imperial College, Sydney Street, London SW3 6NP, UK.
authors.forename: Shouvik
authors.initials: S
authors.lastname: Haldar
authors.affiliation: Heart Rhythm Centre, NIHR Cardiovascular Research Unit, Royal Brompton & Harefield Hospitals and National Heart and Lung Institute, Imperial College, Sydney Street, London SW3 6NP, UK.
authors.forename: Charles
authors.initials: C
authors.lastname: Butcher
authors.affiliation: Heart Rhythm Centre, NIHR Cardiovascular Research Unit, Royal Brompton & Harefield Hospitals and National Heart and Lung Institute, Imperial College, Sydney Street, London SW3 6NP, UK.
authors.forename: Habib
authors.initials: H
authors.lastname: Khan
authors.affiliation: Heart Rhythm Centre, NIHR Cardiovascular Research Unit, Royal Brompton & Harefield Hospitals and National Heart and Lung Institute, Imperial College, Sydney Street, London SW3 6NP, UK.
authors.forename: Lilian
authors.initials: L
authors.lastname: Mantziari
authors.affiliation: Heart Rhythm Centre, NIHR Cardiovascular Research Unit, Royal Brompton & Harefield Hospitals and National Heart and Lung Institute, Imperial College, Sydney Street, London SW3 6NP, UK.
authors.forename: Edward
authors.initials: E
authors.lastname: Nicol
authors.affiliation: Heart Rhythm Centre, NIHR Cardiovascular Research Unit, Royal Brompton & Harefield Hospitals and National Heart and Lung Institute, Imperial College, Sydney Street, London SW3 6NP, UK.
authors.forename: Wajid
authors.initials: W
authors.lastname: Hussain
authors.affiliation: Heart Rhythm Centre, NIHR Cardiovascular Research Unit, Royal Brompton & Harefield Hospitals and National Heart and Lung Institute, Imperial College, Sydney Street, London SW3 6NP, UK.
authors.forename: Jonathan R
authors.initials: JR
authors.lastname: Clague
authors.affiliation: Heart Rhythm Centre, NIHR Cardiovascular Research Unit, Royal Brompton & Harefield Hospitals and National Heart and Lung Institute, Imperial College, Sydney Street, London SW3 6NP, UK.
authors.forename: John P
authors.initials: JP
authors.lastname: Foran
authors.affiliation: Heart Rhythm Centre, NIHR Cardiovascular Research Unit, Royal Brompton & Harefield Hospitals and National Heart and Lung Institute, Imperial College, Sydney Street, London SW3 6NP, UK.
authors.forename: Vias
authors.initials: V
authors.lastname: Markides
authors.affiliation: Heart Rhythm Centre, NIHR Cardiovascular Research Unit, Royal Brompton & Harefield Hospitals and National Heart and Lung Institute, Imperial College, Sydney Street, London SW3 6NP, UK tom.wong@imperial.ac.uk.
authors.forename: Tom
authors.initials: T
authors.lastname: Wong
mesh_terms: D000925:Anticoagulants; D020517:Atrial Appendage; D001281:Atrial Fibrillation; D006801:Humans; D020521:Stroke; D016896:Treatment Outcome; D014859:Warfarin
chemical_list: D000925:Anticoagulants; D014859:Warfarin
keywords: Anticoagulation; Atrial fibrillation; Health economics; Left atrial appendage; Stroke prevention