Rationale and design of the Left Atrial Appendage Occlusion Study (LAAOS) III

Richard Whitlock1, Jeff Healey2, Jessica Vincent3

  • 1Department of Surgery, McMaster University, Hamilton, Canada ; ; Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Canada ;

Insights

Left atrial appendage occlusion (LAAO) is being studied for stroke prevention in atrial fibrillation (AF) patients undergoing cardiac surgery. The LAAOS III trial will determine its safety and efficacy in reducing stroke risk.

Area of Science:

  • Cardiology
  • Neurology
  • Surgical Innovation

Background:

  • Left atrial appendage (LAA) occlusion is a potential stroke prevention strategy for patients with atrial fibrillation (AF).
  • Current evidence regarding the efficacy and safety of LAA occlusion is limited.
  • The LAAOS III trial is designed to definitively assess LAA occlusion in cardiac surgical patients with AF.

Purpose of the Study:

  • To evaluate the efficacy of LAA occlusion in preventing stroke and systemic arterial embolism in patients with AF undergoing cardiac surgery.
  • To assess the safety and various clinical outcomes associated with LAA occlusion during cardiac surgery.

Main Methods:

  • Randomized trial involving 4,700 patients with AF scheduled for on-pump cardiac surgery.
  • Patients will be randomized to either LAA occlusion or no LAA occlusion.
  • Primary outcome: first occurrence of stroke or systemic arterial embolism over a 4-year follow-up. Secondary outcomes include mortality, operative safety, re-hospitalization for heart failure, major bleeding, and myocardial infarction.

Main Results:

  • The Left Atrial Appendage Occlusion Study (LAAOS) III is currently in its vanguard phase.
  • As of September 9, 2013, 162 patients have been recruited.
  • The study is funded by the Canadian Institutes for Health Research (CIHR), the Canadian Network and Centre for Trials Internationally, and McMaster University Surgical Associates.

Conclusions:

  • LAAOS III is poised to be the largest trial investigating the efficacy of LAA occlusion for stroke prevention in AF.
  • The study's findings are expected to enhance understanding of stroke mechanisms in AF.
  • Results will clarify the safety and efficacy of surgical LAA occlusion as a therapeutic option.
Abstract