Abstract
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. 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 κ. The significance of the difference was analyzed with the Wilcoxon signed rank test. The agreement index between manual selection and computed optimal dimensions was low (κ for diameter = 0.219; κ for length = 0.149, P < .01). Computed optimal device lengths were significantly shorter (median, 14 versus 16 mm, T = 402, r = -0.28, P < .01). No significant difference was observed for device diameters. 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.
Highlights
BACKGROUND AND PURPOSEThe 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
Low agreement between manually determined and computed optimal device dimensions is not proof, per se, that virtual simulation performs better than manual selection. It reflects the potential for optimization of the device-sizing process, and use of the Sim&Size software reduces, in particular, device length
The Pipeline Embolization Device (PED) was initially approved in the United States by the FDA in 2011 for endovascular treatment of adults with large or giant wide-neck intracranial aneurysms of the internal carotid artery from the petrous to the superior hypophyseal segment,[6] but indications for its use have subsequently been expanded to a wide range of aneurysm locations and morphologies.[7,8,9,10,11,12]
Summary
The purpose of the present study was only to evaluate whether the use of a computer-based simulation model results in the selection of different PED dimensions, and we certainly acknowledge a lack of study design and statistical power for any meaningful outcome analysis
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