title: Transcatheter left atrial appendage occlusion in patients with atrial fibrillation and a high bleeding risk using aspirin alone for post-implant antithrombotic therapy.
abstract: OBJECTIVE
  The aim of the study was to evaluate the safety and efficacy of left atrial appendage occlusion (LAAO) with the AMPLATZER Cardiac Plug (ACP) or Amulet using aspirin alone (ASA) as post-implantation antithrombotic treatment.
  
  
  RESULTS
  This was a single-centre, prospective, non-randomised study on LAAO with the ACP or Amulet in a consecutive cohort (n=110) treated by ASA alone post implantation. The primary outcome was device-related thrombosis, while secondary outcomes were ischaemic stroke or major bleeding. Clinical follow-up was conducted after six weeks and 12 months with TEE and cardiac CT. One hundred and seven patients were included in the analysis. Three patients were excluded due to a mechanical valve prosthesis. CHA2DS2-VASc score was 4.4±1.6 and HAS-BLED 4.1±1.1. Successful implantation was obtained in all patients with a periprocedural complication rate of 4.6%. Median follow-up was 2.3 years, with a total of 265 patient-years. Device-related thrombosis was detected in 2/107 (1.9%) cases. Stroke occurred in 6/107 patients, with an annualised rate of 2.3%, which is a 61% risk reduction compared to the predicted rate. Annual risk of major bleeding was reduced by 57%.
  
  
  CONCLUSIONS
  LAAO with the ACP or Amulet was safely performed with ASA monotherapy after implantation without an increased risk of device-related thrombosis or stroke.
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Kasper
authors.initials: K
authors.lastname: Korsholm
authors.forename: Kirsten Melgaard
authors.initials: KM
authors.lastname: Nielsen
authors.forename: Jesper Møller
authors.initials: JM
authors.lastname: Jensen
authors.forename: Henrik Kjærulf
authors.initials: HK
authors.lastname: Jensen
authors.forename: Grethe
authors.initials: G
authors.lastname: Andersen
authors.forename: Jens Erik
authors.initials: JE
authors.lastname: Nielsen-Kudsk
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001241:Aspirin / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000628:therapy*; D006348:Cardiac Surgical Procedures / Q000295:instrumentation*; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation; D005260:Female; D006325:Heart Atria; D006801:Humans; D008297:Male; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000209:etiology / Q000517:prevention & control*; D011446:Prospective Studies; D055989:Septal Occluder Device / Q000009:adverse effects; D013927:Thrombosis / Q000209:etiology / Q000517:prevention & control*
chemical_list: D010975:Platelet Aggregation Inhibitors; D001241:Aspirin