Addressing Peri-Device Leaks in Next-Generation Transcatheter Left Atrial Appendage Occluders: An Open Question

With FDA-approved devices, left atrial appendage (LAA) occlusion has emerged as a well-established and rapidly growing approach to stroke prevention in patients with non-valvular atrial fibrillation. These devices are indicated for use in patients who are at increased risk of stroke and systemic embolism, as determined by CHA2DS2-VASc scores, and are suitable for anticoagulation therapy, with an appropriate rationale for seeking a non-pharmacologic alternative. This includes patients who may be unsuitable for long-term anticoagulation due to contra-indications. These devices, generally consisting of a nitinol-framed structure with a circular cross-section, are positioned within the LAA to obstruct the ostium, effectively preventing the thrombus from embolizing the brain. The initial clinical data from pivotal trials and observational registries indicated no strong correlation between peri-device leaks (PDLs) and adverse events. However, recent studies have shown that PDLs are associated with a higher risk of thrombo-embolic events, leading to renewed interest in managing PDLs. This paper reviews the occurrence of PDLs after percutaneous LAA occlusion using current FDA-approved devices, highlighting the need for non-circular occluders to better-accommodate the inherent variability in LAA anatomy. It also compares the benefits and limitations of emerging approaches still under investigation, focusing on addressing PDLs.