UMBRELAA: DESIGN OF A VARIABLE-SIZED LEFT ATRIAL APPENDAGE OCCLUSION DEVICE FOR STROKE PREVENTION

Abstract

Blood clots originating in the left atrial appendage (LAA) are the leading cause of ischemic stroke in patients with nonvalvular atrial fibrillation (AF). Complications from and contraindications to oral anticoagulants (OACs), in addition to the recent successes of endocardial LAA closure devices, have driven increased interest in mechanical LAA occlusion. However, current devices are limited in their abilities to accommodate diverse LAA anatomies, motivating the development of a novel endocardial LAA occluder that supports more anatomical variability. We present the design of an in-situ expandable plug as well as an accompanying pacifier module for LAA occlusion. The final design accommodates LAA diameter ranges of 14 millimeters for each device size (10-24mm and 24-38mm), double that of any approved device. This adaptability can help to overcome imperfect pre-procedural imaging and suboptimal device fit. Benchtop tug and leak tests demonstrate the stability and sealing capacities of the design.