Abstract
Background: Residual peri-device leaks (PDL) post-left atrial appendage (LAA) occlusion are linked with increased stroke risk. The Zenith LAA Occlusion system enables direct intra-conduit contrast injection into the LAA, a novel method for visualizing smaller PDLs difficult to detect by TEE imaging. The device also features a two-stage deployment, an independent dynamic anchoring mechanism enabling atraumatic recapture and repositioning, and a covered self-closing conduit, ensuring no exposed metal in the atrium.
Methods: A single-arm, multi-phase preclinical study implanted Zenith devices in 17 canines (follow-up from 4 to 90 days). The study evaluated the feasibility of the implantation and intra-conduit contrast visualization for peri-device leak detection compared to TEE imaging. Seal, stability, ease of positioning, and long-term endothelialization were also assessed.
Results: Intra-conduit contrast visualization identified leaks undetectable by TEE imaging, demonstrating its potential for a more comprehensive PDL assessment. Atraumatic repositioning facilitated precise device placement, ensuring optimal sealing. By day 45, uniform full-face endothelialization was observed, with no device-related thrombus (DRT).
Conclusion: The Zenith LAAO system has the potential to improve PDL assessment. Its design allows for direct contrast visualization of the occluded LAA. This direct visualization, combined with atraumatic repositioning and a design optimized for full-face endothelization, could lead to improved sealing and reduced DRT formation. These features may improve long-term outcomes.