Sim&Size versus IFU-Based Sizing for the Artisse 2.0 Intrasaccular Device in a Multicenter Registry

BACKGROUND AND PURPOSE: Virtual simulation is increasingly promoted for intrasaccular device sizing, but whether it changes device selection or procedural outcomes for new, highly conformable devices is unknown. We compared Sim&Size simulation with instructions-for-use (IFU) chart sizing for the Artisse 2.0 in early multicenter experience. MATERIALS AND METHODS: We retrospectively analyzed data from the INSPIRE-A registry (November 2022-June 2024). Sim&Size use depended on software availability. We assessed agreement between sizing tools, technical success, first-device success, adjunctive devices, procedure and fluoroscopy times, complications, and the cause of each technical failure. RESULTS: Sim&Size was used in 88/123 cases (71.5%). When both methods were used (n=59), the same device was selected in 54 (91.5%). Technical success was 98.9% with Sim&Size and 85.7% without (p=0.007), whereas first-device success (86.4% vs 80.0%, p=0.41) and procedure and fluoroscopy times did not differ. Perioperative complications occurred in 4/123 (3.3%). Of the six technical failures, five were related to device fit, mostly in anatomies at the limits of the device range, and one resulted from a perforation before deployment. A dome-to-neck ratio <1 was associated with failure (3/7 vs 3/116, p=0.002). CONCLUSIONS: For the Artisse 2.0, Sim&Size and chart-based sizing selected the same device in most cases. Sim&Size use was associated with higher technical success, whereas first-device success and procedure and fluoroscopy times were comparable. Both approaches achieved high procedural success with a low complication rate and may be used according to operator preference, with simulation potentially most useful in anatomies at the limits of the device range.