Abstract
BackgroundLeft atrial appendage occlusion (LAAO) represents a treatment alternative to anticoagulation in patients with atrial fibrillation. We evaluate a novel device for epicardial LAAO in a translational canine model.MethodsNine hounds (n = 9) were used to assess usability, safety, and efficacy of the TigerPaw Pro (TPP) device for epicardial LAAO. Following baseline imaging (intra-cardiac echocardiography (ICE) and angiography) and intraoperative visual inspection, usability was tested via a ``closure/re-opening`` maneuver followed by deployment of a total of twenty TPP devices (n = 20) on the left and right atrial appendages respectively. Procedural safety was evaluated by assessing for adverse-events via direct Epicardial inspection and endocardial imaging. Efficacy evaluation included assessment of device positioning, presence of residual stumps and completeness of closure. Post-mortem evaluation was performed to confirm safety and efficacy.ResultsUsability testing of all TPP devices was successful (n = 20;100%, delivery-time range 22–120 s) without any procedural adverse-events (tissue damage or tears, bleeding, vessel-impingement, structural impact). All devices fully traversed the ostium (n = 18) or appendage body (n = 2), and conformed smoothly to adjacent cardiac anatomy. In nineteen deployments (n = 19;95%), all device connector pairs were fully engaged, while in one TPP device the most distal pair remained unengaged. ICE and post-mortem inspections revealed complete closure of all appendage ostia (n = 18;100%) and only in one case a small residual stump was detected. Intraoperative safety findings were further confirmed post-mortem. Devices created a nearly smooth line of closure via symmetric endocardial tissue-coaptation.ConclusionsIn this preclinical model, the TPP demonstrated good ease of use for ostial access, ability to re-position (after engagement) and rapid deployment, while achieving safe and effective LAAO.
Highlights
Left atrial appendage occlusion (LAAO) represents a treatment alternative to anticoagulation in patients with atrial fibrillation
No tissue injury was detectable at the site of jaw closure either immediately or 5 minutes after jaw removal (Fig. 3a-f)
Further inspection of the right atrial appendage (RAA) revealed a minimal hematoma on the RAA tip which was not considered to be device-related, but was most likely caused by surgical forceps during grasping maneuvers to expose the RAA
Summary
Left atrial appendage occlusion (LAAO) represents a treatment alternative to anticoagulation in patients with atrial fibrillation. Newer non-vitamin K dependent oral anticoagulants (NOACs) with improved safety and efficacy profiles have lately replaced VKAs as the first-line treatment option [3]. The risk of serious bleeding events inherent for all antithrombotic agents requires the development of alternative stroke prevention strategies for patients with AF. The development of percutaneous catheter-based techniques emerged as another promising alternative strategy [5, 6], with robust clinical data. The development of new epicardial surgical devices with promising initial clinical results was intended to address this void. The AtriClip (AtriCure, Inc.) LAA exclusion system was introduced in 2007 and Initial experience showed an excellent safety, efficacy and durability profile [7] which was further confirmed by imaging-controlled mid- and long-term follow-up results [8, 9]
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