title: Two-year clinical outcome from the Iberian registry patients after left atrial appendage closure.
abstract: OBJECTIVE
  The aim of this study was to observe the percentage of thromboembolic and haemorrhagic events over a 2-year follow-up in patients with non-valvular atrial fibrillation (NVAF) undergoing closure of the left atrial appendage (LAA) with an occlusion device. Observed events and CHADS2 (congestive heart failure, hypertension, age, diabetes, stroke history), CHA2DS2-VASc (also adding: vascular disease and sex) and HAS-BLED (hypertension, abnormal liver/renal function, stroke history, bleeding predisposition, labile international normalised ratios, elderly, drugs/alcohol use)-predicted events were compared.
  
  
  METHODS
  LAA closure with an occlusion device was performed in 167 NVAF patients contraindicated for oral anticoagulants and recruited from 12 hospitals between 2009 and 2013. At least two transoesophageal echocardiograms were performed in the first 6 months postimplantation. Antithrombotics included clopidogrel and aspirin. Patients were monitored for death, stroke, major and relevant bleeding and hospitalisation for concomitant conditions. Mean age was 74.68±8.58, median follow-up was 24 months, 5.38% had intraoperative complications and implantation was successful in 94.6% of subjects. Mortality during follow-up was 10.8%, mostly (9.5%) non-cardiac related. Bleeding occurred in 10.1% of subjects, 5.7% major and 4.4% minor though relevant, and 4.4% suffered stroke. Major bleeding and stroke/transient ischaemic attack events within 2 years (annual event rates, 290 patients/year) were less frequent than expected from CHADS2 (2.4% vs 9.6%), CHA2DS2-VASc (2.4% vs 8.3%) and HAS-BLED (3.1% vs 6.6%) risk scores (p<0.001, p=0.003, p=0.047, respectively).
  
  
  CONCLUSIONS
  LAA closure with an occlusion device in patients contraindicated for oral anticoagulants is a therapeutic option associated with fewer thromboembolic and haemorrhagic events than expected from risk scores, particularly in the second year postimplantation.
authors.affiliation: Hospital Universitario Infanta Cristina, Badajoz, Spain.
authors.forename: José Ramón
authors.initials: JR
authors.lastname: López Mínguez
authors.affiliation: Hospital Universitario Infanta Cristina, Badajoz, Spain.
authors.forename: Juan Manuel Nogales
authors.initials: JM
authors.lastname: Asensio
authors.affiliation: Hospital Universitario Infanta Cristina, Badajoz, Spain.
authors.forename: Javier Elduayen
authors.initials: JE
authors.lastname: Gragera
authors.affiliation: Hospital de Coimbra, Coimbra, Portugal.
authors.forename: Marco
authors.initials: M
authors.lastname: Costa
authors.affiliation: Hospital Universitario de Salamanca, Salamanca, Spain.
authors.forename: Ignacio Cruz
authors.initials: IC
authors.lastname: González
authors.affiliation: Hospital Clínico Universitario de Valladolid, Valladolid, Spain.
authors.forename: Federico Gimeno
authors.initials: FG
authors.lastname: de Carlos
authors.affiliation: Hospital Puerta de Hierro, Majadahonda, Spain.
authors.forename: José Antonio Fernández
authors.initials: JA
authors.lastname: Díaz
authors.affiliation: Hospital Clínic de Barcelona, Barcelona, Spain.
authors.forename: Victoria
authors.initials: V
authors.lastname: Martín Yuste
authors.affiliation: Hospital Universitario La Paz, Madrid, Spain.
authors.forename: Raúl Moreno
authors.initials: RM
authors.lastname: González
authors.affiliation: Hospital Virgen de la Victoria, Málaga, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Domínguez-Franco
authors.affiliation: Hospital de La Princesa, Madrid, Spain.
authors.forename: Amparo Benedicto
authors.initials: AB
authors.lastname: Buendía
authors.affiliation: Hospital de Burgos, Burgos, Spain.
authors.forename: Jesús Herrero
authors.initials: JH
authors.lastname: Garibi
authors.affiliation: Hospital 12 de Octubre, Madrid, Spain.
authors.forename: Felipe Hernández
authors.initials: FH
authors.lastname: Hernández
authors.affiliation: Hospital de Oporto, Oporto, Portugal.
authors.forename: Vasco Gama
authors.initials: VG
authors.lastname: Ribeiro
mesh_terms: D000368:Aged; D020517:Atrial Appendage; D001281:Atrial Fibrillation / Q000628:therapy*; D005260:Female; D005767:Gastrointestinal Diseases / Q000209:etiology; D006325:Heart Atria; D006470:Hemorrhage / Q000209:etiology; D006801:Humans; D008297:Male; D011474:Prosthesis Design; D019919:Prosthesis Implantation / Q000379:methods; D012042:Registries; D055989:Septal Occluder Device; D020521:Stroke / Q000209:etiology; D060205:Therapeutic Occlusion / Q000009:adverse effects / Q000379:methods*; D013923:Thromboembolism / Q000209:etiology; D016896:Treatment Outcome