Comparison of Pipeline Embolization Device Sizing Based on Conventional 2D Measurements and Virtual Simulation Using the Sim&Size Software: An Agreement Study

Abstract

BACKGROUND AND PURPOSE: The Sim&Size software simulates case-specific intraluminal Pipeline Embolization Device behavior, wall apposition, and device length in real-time on the basis of rotational angiography DICOM data. The purpose of this multicenter study was to evaluate whether preimplantation device simulation with the Sim&Size software results in selection of different device dimensions than manual sizing. MATERIALS AND METHODS: In a multicenter cohort of 74 patients undergoing aneurysm treatment with the Pipeline Embolization Device, we compared apparent optimal device dimensions determined by neurointerventionalists with considerable Pipeline Embolization Device experience based on manual 2D measurements taken from rotational angiography with computed optimal dimensions determined by Sim&Size experts blinded to the neurointerventionalists' decision. Agreement between manually determined and computed optimal dimensions was evaluated with the Cohen. The significance of the difference was analyzed with the Wilcoxon signed rank test. RESULTS: The agreement index between manual selection and computed optimal dimensions was low (for diameter ϭ 0.219; for length ϭ 0.149, P Ͻ .01). Computed optimal device lengths were significantly shorter (median, 14 versus 16 mm, T ϭ 402, r ϭ Ϫ0.28, P Ͻ .01). No significant difference was observed for device diameters. CONCLUSIONS: Low agreement between manually determined and computed optimal device dimensions is not proof, per se, that virtual simulation performs better than manual selection. Nevertheless, it ultimately reflects the potential for optimization of the device-sizing process, and use of the Sim&Size software reduces, in particular, device length. Nevertheless, further evaluation is required to clarify the impact of device-dimension modifications on outcome.

Virtual simulation with Sim&Size software for Pipeline Flex Embolization: evaluation of the technical and clinical impact

“…Sim&Size virtual simulation software has been previously described and has been associated with shorter stent lengths compared with standard calculations on 2D/3D images, but the study was not designed to evaluate other technical outcomes and clinical events among subjects treated with and without simulation 6…”

“…The degree of wall apposition is simultaneously displayed as an interactive color-scale along the stent length. Different landing zones, device dimensions, and the amount of ‘push’ applied during device deployment can all be assayed in real time by the operator, modifying the final position and the behavior of the device 5 6…”

Software-based simulation for preprocedural assessment of Tubridge flow diverter sizing: a validation study

“…[12] Ospel et al supposed that simulated length of Pipeline calculated by software was shorter than the manually determined presumed optimal devices. [13] In our study a longer devices was calculated by software than physicians' selection. This may result from the material and structural differences between the Tubridge and the Pipeline FD.…”

A Multicenter Pilot Study on the Clinical Utility of Computational Modeling for Flow-Diverter Treatment Planning

“…10,[25][26][27] Previous retrospective studies that evaluated the application of computational modeling to FD sizing have demonstrated the potential benefits of the technology for improving FD size selection. 10,25 To date, few, if any, studies have exclusively focused on both the utility and predictive fidelity of computational device modeling in a prospective case series. Yet, evaluations under typical clinical workflows are essential for understanding the contribution of the technology to clinical practice and its potential for adoption.…”