Affiliations 

  • 1 Department of Cardiology, GenesisCare, Greenslopes Private Hospital, Suite 212 Ramsay Specialist Centre, Newdegate Street, Greenslopes, Brisbane 4120, Australia
  • 2 Department of Cardiology, E. Meshalkin National Medical Research Center of the Ministry of Health, Novosibirsk, Russian Federation
  • 3 Department of Cardiology, Medical Centre Leeuwarden, Leeuwarden, Netherlands
  • 4 Department of Cardiology, Erasmus MC, Rotterdam, Netherlands
  • 5 Department of Cardiology, Ospedale Civile, Cirie, Italy
  • 6 Boston Scientific Corp, St. Paul, USA
  • 7 Department of Cardiology, National Heart Institute, Kuala Lumpur, Malaysia
  • 8 Department of Cardiology, St. Antonius Hospital, Nieuwegein, Netherlands
Europace, 2020 02 01;22(2):225-231.
PMID: 31665276 DOI: 10.1093/europace/euz286

Abstract

AIMS: Clinical practice guidelines do not recommend discontinuation of long-term oral anticoagulation in patients with a high stroke risk after catheter ablation for atrial fibrillation (AF). Left atrial appendage closure (LAAC) with Watchman has emerged as an alternative to long-term anticoagulation for patients accepting of the procedural risks. We report on the long-term outcomes of combining catheter ablation procedures for AF and LAAC from multicentre registries.

METHODS AND RESULTS: Data were pooled from two prospective, real-world Watchman LAAC registries running in parallel in Europe/Middle-East/Russia (EWOLUTION) and Asia/Australia (WASP) between 2013 and 2015. Of the 1140 patients, 142 subjects at 11 centres underwent a concomitant AF ablation and LAAC procedure. The mean CHA2DS2-VASc score was 3.4 ± 1.4 and HAS-BLED score 1.5 ± 0.9. Successful LAAC was achieved in 99.3% of patients. The 30-day device and/or procedure-related serious adverse event rate was 2.1%. After a mean follow-up time of 726 ± 91 days, 92% of patients remained off oral anticoagulation. The rates of the composite endpoint of ischaemic stroke/transient ischaemic attack/systemic thromboembolism were 1.09 per 100 patient-years (100-PY); and for non-procedural major bleeding were 1.09 per 100-PY. These represent relative reductions of 84% and 70% vs. expected rates per risk scores.

CONCLUSION: The long-term outcomes from these international, multicentre registries show efficacy for all-cause stroke prevention and a significant reduction in late bleeding events in a population of high stroke risk post-ablation patients who have been withdrawn from oral anticoagulation.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.