This section covers LAA occlusion devices and examines the guideline recommendations on their use
Left atrial appendage occlusion devices
AtriClip™, a LAA occlusion device, was approved in the US in 2010 for use in patients who are undergoing open heart surgery and also have AF or a strong risk of developing AF. The phase II trial, EXCLUDE, met the study endpoints for both safety (including bleeding) and efficacy (i.e. the ability of the device to cause complete occlusion of the LAA).
A percutaneous LAA occlusion device, WATCHMAN™, was studied in the PROTECT AF trial, which assessed whether the device was non-inferior to warfarin for the prevention of stroke, systemic embolism, cardiovascular or unexplained death in patients with NVAF and a CHADS2 score of ≥1.1 It is approved in both Europe and the US.2,3
- Although the device was non-inferior in this regard, it was also associated with a higher risk of adverse events, which were mainly procedure related (e.g. pericardial effusion)
- The Continued Access Protocol (CAP; a non-randomized registry of patients undergoing WATCHMAN™ implantation) showed an improved safety profile and both the CAP registry and the PREVAIL trial showed lower incidences of procedure-related adverse events, compared with the PROTECT AF trial4,5
According to the most recent updated ESC 2012 guidelines the use of percutaneous LAA occlusion devices may be considered only in patients with a high stroke risk and contraindications for long-term oral anticoagulation.6
Next section: Patients with Valvular Atrial Fibrillation