Percutaneous left atrial appendage occlusion for patients in atrial fibrillation suboptimal for warfarin therapy: 5-year results of the PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) Study.

  • Burstein S
  • Casale P
  • Kramer P
 et al. 
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Abstract

OBJECTIVES: The aim of this study was to determine 5-year clinical status for patients treated with percutaneous left atrial appendage transcatheter occlusion with the PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) system., BACKGROUND: Anticoagulation reduces thromboembolism among patients with nonvalvular atrial fibrillation (AF). However, warfarin is a challenging medication due to risks of inadequate anticoagulation and bleeding. Thus, PLAATO was evaluated as a treatment strategy for nonwarfarin candidate patients with AF at high risk for stroke., METHODS: Sixty-four patients with permanent or paroxysmal AF participated in this observational, multicenter prospective study. Primary end points were: new major or minor stroke, cardiac or neurological death, myocardial infarction, or requirement for cardiovascular surgery related to the procedure within 1 month of the index procedure. Patients were followed for up to 5 years., RESULTS: Thirty-day freedom from major adverse events rate was 98.4% (95% confidence interval: 90.89% to >99.99%). One patient, who did not receive a PLAATO implant, experienced 2 events within 30 days (cardiovascular surgery, death). Treatment success was 100% 1 month after device implantation. At 5-year follow-up, there were 7 deaths, 5 major strokes, 3 minor strokes, 1 cardiac tamponade requiring surgery, 1 probable cerebral hemorrhage/death, and 1 myocardial infarction. Only 1 event (cardiac tamponade) was adjudicated as related to the implant procedure. After up to 5 years of follow-up, the annualized stroke/transient ischemic attack (TIA) rate was 3.8%. The anticipated stroke/TIA rate (with the CHADS(2) scoring method) was 6.6%/year., CONCLUSIONS: The PLAATO system is safe and effective. At 5-year follow-up the annualized stroke/TIA rate in our patients was 3.8%/year, less than predicted by the CHADS(2) scoring system.

Author-supplied keywords

  • *Anticoagulants/tu [Therapeutic Use]
  • *Atrial Fibrillation/th [Therapy]
  • *Cardiac Catheterization/mt [Methods]
  • *Stroke/pc [Prevention & Control]
  • *Thromboembolism/pc [Prevention & Control]
  • *Warfarin/tu [Therapeutic Use]
  • Adult
  • Aged
  • Aged, 80 and over
  • Atrial Appendage
  • Atrial Fibrillation/co [Complications]
  • Atrial Fibrillation/dt [Drug Therapy]
  • Atrial Fibrillation/mo [Mortality]
  • Canada/ep [Epidemiology]
  • Cardiac Catheterization/ae [Adverse Effects]
  • Cardiac Catheterization/is [Instrumentation]
  • Cardiac Catheterization/mo [Mortality]
  • Cardiac Surgical Procedures
  • Cineangiography
  • Echocardiography, Doppler, Color
  • Echocardiography, Transesophageal
  • Equipment Design
  • Feasibility Studies
  • Female
  • Humans
  • Male
  • Middle Aged
  • Myocardial Infarction/et [Etiology]
  • Prospective Studies
  • Risk Assessment
  • Stroke/et [Etiology]
  • Stroke/mo [Mortality]
  • Thromboembolism/et [Etiology]
  • Thromboembolism/mo [Mortality]
  • Time Factors
  • Treatment Failure
  • United States/ep [Epidemiology]

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Authors

  • Steven Burstein

  • Paul N Casale

  • Paul H Kramer

  • Paul Teirstein

  • David O Williams

  • Mark Reisman

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