Robotic-assisted left atrial appendage occlusion: feasibility and safety in a preclinical randomized study in a canine model

Background Left atrial appendage occlusion (LAAO) is an established alternative to oral anticoagulation for stroke prevention in atrial fibrillation. However, conventional manual LAAO exposes operators to radiation and physical strain, while being subject to operator-dependent variability. Objectives This study aimed to conduct a comprehensive preclinical evaluation of a novel robotic-assisted system for LAAO, comparing its efficacy and safety against the conventional manual approach. Methods In a prospective, randomized controlled trial, 20 canines were assigned to undergo LAAO via robotic assistance (n=10) or manual technique (n=10). The robotic system featured a bedside unit with manipulators for sheath and delivery cable control, operated remotely from a console. The primary effectiveness endpoint was procedural success, defined as successful device implantation with satisfactory position, stability, complete LAA seal (peri-device leak < 5 mm). Safety endpoints included adverse events and pathological findings. Results The final procedural success rate was 100% (10/10) in the robotic group and 90% (9/10) in the manual group (P=1.000). First-attempt success rates were 80% (8/10) and 70% (7/10), respectively (P=0.605). There were no statistically significant differences between groups in the number of anchor attempts or the degree of final residual leak. No procedure-related adverse events occurred in the robotic group, compared to two events in the manual group (0% vs. 20%, P=0.474). However, robotic procedures were associated with longer fluoroscopy times (77.5 vs. 55.5 min, P=0.028) and higher radiation exposure doses, which were attributed to the initial learning curve and a protocol emphasizing precision. Conclusion In this preclinical study, the novel robotic LAAO system demonstrated non-inferior effectiveness and a favorable safety profile compared to the manual approach. It offered enhanced procedural standardization, albeit with initial trade-offs in efficiency. These findings support the system's feasibility and justify further development and larger-scale studies to establish its clinical role.