Safety profiles of percutaneous left atrial appendage closure devices: An analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database from 2009 to 2016

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Excerpt

Atrial fibrillation (AF) affects an estimated 2.3 to 5.1 million Americans by contemporary estimates and is known as a leading cause of stroke.1 The left atrial appendage (LAA) is thought to be the major nidus for systemic thromboembolism in AF. Oral anticoagulation (OAC) based on the CHADS2 or CHA2DS2‐VASc scores has traditionally been the mainstay of stroke prevention in AF,4 but it has been limited to a degree by factors including risk of bleeding, the need for ongoing monitoring within a relatively narrow therapeutic window, and patient adherence.5 Several new strategies for percutaneous left atrial appendage closure (LAAC) have emerged for AF patients with elevated stroke risk and contraindication or intolerance to long‐term OAC.9 Two are currently approved by the Food and Drug Administration (FDA) for use in the United States: the WATCHMAN™ device (Boston Scientific Corp., Marlborough, MA, USA), which is approved for use in stroke prevention in appropriate candidates, and the LARIAT® Suture Delivery Device (SentreHEART, Inc., Redwood City, CA, USA), which has FDA 510(k) approval for soft tissue ligation and is used in an “off label” fashion for LAAC in patients with contraindications to OAC. The objective of this study was to evaluate and compare the safety profiles of these two devices, as assessed by FDA MAUDE medical device reports (MDRs) of events associated with each device.
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