Epicardial left atrial appendage occlusion with a new medical device: assessment of procedural feasibility, safety and efficacy in a large animal model

Abstract

Background: Left 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. Methods: Nine 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. Results: Usability 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. Conclusions: In this preclinical model, the TPP demonstrated good ease of use for ostial access, ability to reposition (after engagement) and rapid deployment, while achieving safe and effective LAAO.

Three‐dimensional and catheter‐based intracardiac echocardiographic characterization of the interatrial septum in 2 horses with suspicion of a patent foramen ovale

“… 15 In human medicine, ICE is commonly used in interventional cardiology for adequate guidance of, for example, endocardial ablation, transseptal puncture for LA access, or percutaneous intracardiac defect closure. 15 , 16 In dogs, ICE is mainly applied in experimental settings, 17 , 18 , 19 with only a few clinical reports. 20 , 21 The use of ICE in horses remains anecdotal.…”

Percutaneous Left Atrial Appendage Occlusion: An Emerging Option in Patients with Atrial Fibrillation at High Risk of Bleeding

“…In addition to these options, percutaneous LAAO can be performed with an endo-epicardial approach, using the LARIAT ® device (SentreHeart, Inc., Redwood City, CA, USA) with good results in terms of efficacy and safety [ 45 ]. Two more devices for epicardial LAAO are still under evaluation: Sierra Ligation System (Aegis Medical, Los Angeles, CA, USA) and TigerPaw Pro (Laax, Livermore, CA, USA) (TPP) [ 46 ].…”

Ultra-high field cardiac MRI in large animals and humans for translational cardiovascular research

“…Many countries ( 2 , 3 ) aim to completely replace them long-term ( 4 ), but still they are of high relevance to provide unique information which cannot be obtained from replacement methods such as cell cultures and organoids ( 5 , 6 ), computer simulations ( 7 ) or combinations thereof ( 8 ). Moreover, they allow testing methodologies which would be considered unsafe in humans such as application of untested drugs or contrast agents ( 9 ), or medical devices ( 10 ). Other applications are studies which would be unethical in humans, e.g., the use of open chest models in research ( 11 ) or resuscitation research ( 12 , 13 ).…”