Bayer Pharma AG

Essence of this Article

AtriClip™, a left atrial appendage (LAA) occlusion device, was approved in the United States (US) in 2010 for use in patients who are undergoing open-heart surgery and also have atrial fibrillation (AF) or a strong risk of developing AF. In a study of the percutaneous LAA occlusion device, WATCHMAN™, the device was found to be non-inferior to warfarin for the prevention of stroke, systemic embolism, cardiovascular or unexplained death in patients with non-valvular AF and a CHADS2 score of ≥1. However, the device was also associated with a higher risk of adverse events.

Other Options

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 non-valvular AF and a CHADS2 score of ≥1.211 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). An improved safety profile has been demonstrated by results from the Continued Access Protocol (CAP) registry (a non-randomized registry of patients undergoing WATCHMAN implantation) and the PREVAIL trial, which both showed lower incidences of procedure-related adverse events compared with the PROTECT-AF trial.539, 540 Despite being available in Europe, the WATCHMAN device is not yet approved in the US, although the US Food and Drug Administration (FDA) advisory panel has recently voted in favour of the device ahead of a full FDA hearing.

According to the most recent updated European Society of Cardiology 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.187


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