Ankyras simulation for flow diversion of intracranial aneurysms: a standardized workflow integrated clinical validation study.

Abstract

Accurate flow diverter (FD) sizing is critical for successful intracranial aneurysm (IA) treatment. We evaluated the predictive performance of the Ankyras FD simulation platform within a standardized simulation based clinical workflow using three-dimensional (3D) DynaCTA centerline analysis as an advanced validation reference standard. A retrospective analysis of a prospectively maintained institutional database of Ankyras guided IA treatments between April 2024 and October 2025 was performed. 3D rotational angiography data generated Ankyras simulations for treatment planning, device selection, and intraoperative guidance. Simulated length (SL) and proximal landing zone (PLZ) were compared with post-deployment length (DL) from DynaCTA centerline measurements (3D Slicer). Accuracy was assessed using correlation coefficients, mean absolute error (MAE), and Bland-Altman analysis. 54 consecutive patients (48 women, mean age 54.2 years) with 63 IAs underwent 57 pipeline embolization device (PED) treatments. All achieved procedural success without intraoperative complications; two required adjunctive stent placement for malapposition. Mean SL was 21.44±3.53 mm and DL was 21.49±3.52 mm (n=46), with a strong SL-DL correlation (r=0.91), minimal bias (-0.05 mm), and 1.24 mm MAE. PLZ demonstrated a strong correlation (r=0.94), low bias (0.14 mm), and minimal MAE (1.34 mm) between Ankyras and the deployed values (n=45). Bland-Altman analysis showed narrow agreement limits without evidence of proportional error. Using a robust 3D DynaCTA centerline based validation, Ankyras demonstrated high accuracy for PED deployment length and landing zone prediction within a standardized clinical treatment workflow of pre-procedural planning, intraoperative guidance, and post-deployment assessment.