title: Percutaneous left atrial appendage occlusion in patients with non-valvular atrial fibrillation: implantation and up to four years follow-up of the AMPLATZER Cardiac Plug.
abstract: OBJECTIVE
  Percutaneous left atrial appendage occlusion (LAAO) may be considered for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF). Data on device implantation safety and feasibility and long-term follow-up are limited.
  
  
  RESULTS
  LAAO was performed using the AMPLATZER Cardiac Plug (ACP) device in 134 NVAF patients with long-term OAC contraindication, with median (interquartile range) CHA2DS2-VASc and HAS-BLED scores of four (3-5) and three (2-3.75), respectively. Follow-up data were collected over a mean follow-up period of 680 days (range: 42 days to 4.3 years) comprising a total implant experience of 238 patient-years. Device implantation was successful in 95.5% of the procedures and associated with a rate of major procedural complications of 2.2%. At the most recent follow-up, almost all patients were receiving antiplatelet therapy. Ischaemic stroke was observed at an annual rate of 0.8% and the annual rate of any thromboembolic (TE) event was 2.5%. Major bleeding during follow-up occurred at an annual rate of 1.3%.
  
  
  CONCLUSIONS
  LAAO is a safe and effective stroke prevention therapy in a high-risk NVAF cohort, both at implantation and over longer follow-up periods. The long-term assessed ischaemic stroke rate in patients treated with LAAO is markedly reduced compared to the expected rate based on the patients' risk scores.
authors.affiliation: Interventional Cardiology Unit, Careggi Hospital, Florence, Italy.
authors.forename: Gennaro
authors.initials: G
authors.lastname: Santoro
authors.forename: Francesco
authors.initials: F
authors.lastname: Meucci
authors.forename: Miroslava
authors.initials: M
authors.lastname: Stolcova
authors.forename: Marco
authors.initials: M
authors.lastname: Rezzaghi
authors.forename: Fabio
authors.initials: F
authors.lastname: Mori
authors.forename: Cataldo
authors.initials: C
authors.lastname: Palmieri
authors.forename: Umberto
authors.initials: U
authors.lastname: Paradossi
authors.forename: Luigi Emilio
authors.initials: LE
authors.lastname: Pastormerlo
authors.forename: Gabriele
authors.initials: G
authors.lastname: Rosso
authors.forename: Sergio
authors.initials: S
authors.lastname: Berti
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D020517:Atrial Appendage / Q000503:physiopathology / Q000601:surgery*; D001281:Atrial Fibrillation / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000209:etiology; D006801:Humans; D008297:Male; D055989:Septal Occluder Device / Q000009:adverse effects; D020521:Stroke / Q000209:etiology; D013923:Thromboembolism / Q000209:etiology; D016896:Treatment Outcome