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This section covers LAA occlusion devices and examines the guideline recommendations on their use
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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
Guideline recommendations
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
References
- Holmes DR, Reddy VY, Turi ZG et al. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet 2009;374:534–542. Return to content
- US Food and Drug Administration. WATCHMAN LAA closure technology - P130013. 2015. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm440621.htm [accessed 30 August 2018]. US Food and Drug Administration. WATCHMAN LAA closure technology - P130013. 2015. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm440621.htm [accessed 30 August 2018]. Return to content
- Boston Scientific Corporation. Boston Scientific WATCHMAN® left atrial appendage closure device receives CE mark approval for expanded use. 2012. Available at: http://news.bostonscientific.com/2012-08-26-Boston-Scientific-WATCHMAN-Left-Atrial-Appendage-Closure-Device-Receives-CE-Mark-Approval-For-Expanded-Use [accessed 30 August 2018]. Boston Scientific Corporation. Boston Scientific WATCHMAN® left atrial appendage closure device receives CE mark approval for expanded use. 2012. Available at: http://news.bostonscientific.com/2012-08-26-Boston-Scientific-WATCHMAN-Left-Atrial-Appendage-Closure-Device-Receives-CE-Mark-Approval-For-Expanded-Use [accessed 30 August 2018]. Return to content
- Reddy VY, Holmes D, Doshi SK et al. Safety of percutaneous left atrial appendage closure: results from the Watchman left atrial appendage system for embolic protection in patients with AF (PROTECT AF) clinical trial and the continued access registry. Circulation 2011;123:417–424. Return to content
- Holmes DR, Jr., Kar S, Price MJ et al. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol 2014;64:1–12. Return to content
- Kirchhof P, Benussi S, Kotecha D et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J 2016;37:2893–2962. Return to content
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