Long-term Event Reduction After Left Atrial Appendage Closure. Results of the Iberian Registry II

Rev Esp Cardiol (Engl Ed). 2019 Jun;72(6):449-455. doi: 10.1016/j.rec.2018.03.017. Epub 2018 May 10.
[Article in English, Spanish]

Abstract

Introduction and objectives: Many patients with nonvalvular atrial fibrillation are still left without protection due to a contraindication for anticoagulants. This study aimed to establish the occurrence of stroke and major bleeding events in patients with nonvalvular atrial fibrillation and left atrial appendage closure with long-term follow-up and to explore the factors associated with higher long-term mortality.

Methods: Analysis of a multicenter single cohort prospectively recruited from 2009 to 2015. Thromboembolic and bleeding events were compared with those expected from CHA2DS2-VASc and HAS-BLED scores. Multivariate analysis examined variables associated with mortality during follow-up.

Results: A total of 598 patients (1093 patient-years) with a contraindication for anticoagulants were recruited (median 75.4 years). The success rate of left atrial appendage closure device implantation was 95.8%. Thirty patients (5%) experienced periprocedural complications. The rate of events (per 100 patient-years) during follow-up (mean 22.9 months; median 16.1 months) was as follows: death 7.0%; ischemic stroke 1.6% (vs 8.5% expected according to CHA2DS2-VASc; P < .001); intracranial hemorrhage 0.8%; gastrointestinal bleeding 3.2%; severe bleeding 3.9% (vs 6.3% expected by HAS-BLED, P = .002). These results were improved in the subgroup of 176 patients with follow-up > 24 months (mean follow-up 46.6 months, 683 patient-years) for severe bleeding 2.6% (vs 6.3% expected by HAS-BLED, P < .033). The factors significantly associated with higher mortality were age (HR, 1.1), intracranial hemorrhage (HR, 6.8), and stroke during follow-up (HR, 2.7).

Conclusions: Left atrial appendage closure significantly reduced the incidence of stroke and bleeding events and the benefit was maintained. Intracranial hemorrhage, age and stroke were associated with higher mortality.

Keywords: Bleeding; Cierre de orejuela izquierda; Fibrilación auricular no valvular; Hemorragia; Ictus; Left atrial appendage closure; Mortalidad; Mortality; Nonvalvular atrial fibrillation; Stroke.

Publication types

  • Multicenter Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Atrial Appendage / diagnostic imaging
  • Atrial Appendage / surgery*
  • Atrial Fibrillation / complications
  • Atrial Fibrillation / diagnosis
  • Atrial Fibrillation / surgery*
  • Cardiac Surgical Procedures / methods*
  • Echocardiography, Transesophageal
  • Female
  • Follow-Up Studies
  • Humans
  • Incidence
  • Male
  • Portugal / epidemiology
  • Prospective Studies
  • Registries*
  • Septal Occluder Device*
  • Spain / epidemiology
  • Stroke / epidemiology
  • Stroke / etiology
  • Stroke / prevention & control*
  • Time Factors
  • Treatment Outcome