ABSTRACT
BACKGROUND: In neurovascular treatment planning, endovascular devices to manage complex intracranial aneurysms requiring intervention are often selected based on conventional measurements and interventional neuroradiologist experience. A recently developed technology allows a patient-specific 3D-printed model to mimic the navigation experience. The goal of this study was to assess the effect of pre-procedure 3D simulation on procedural and clinical outcomes for wide-neck aneurysm embolization. MATERIALS & METHODS: In this unblinded, non-randomized, prospective, multicenter study conducted from November 18 through December 20, patients with complex intracranial aneurysms (neck > 4 mm or ratio < 21) were treated by WEB or flow diverter stents (FDS). The primary endpoint was concordance between simulation and procedure, 3D-printed model accuracy as well as embolization outcomes including complications, procedure times, and radiation dose were also assessed. Secondary endpoint was to compare versus a retrospective WEB cohort. RESULTS: Twenty-one patients were treated, 76% of cases by WEB and 24% by FDS. Concordance between post-simulation and real procedure efficiency was 0.85 [0.69 - 1.00] for size device selection and 0.93 [0.79 - 1.00] for wall-apposition/aneurysm neck closure. Geometrical accuracy of the 3D-printed model showed a mean absolute shift of 0.11 mm. Two complications without major clinical impact were reported with a post-operative mRS similar to pre-procedure mRS for all patients. CONCLUSIONS: Rehearsal using accurate 3D-printed patient-specific aneurysm models enabled optimization of embolization strategy, resulting in reduced procedure duration and cumulative fluoroscopy time which translated to reduced radiation exposure compared to procedures performed without simulation.
