Comparison of Woven EndoBridge device sizing with conventional measurements and virtual simulation using the Sim&Size software: a multicenter experience

Abstract

BackgroundSelection of the appropriate device size mandatory during aneurysm treatment with a Woven EndoBridge (WEB). We aimed to investigate if virtual simulation with Sim&Size software may have an impact on technical, angiographic, and clinical outcomes after WEB treatment.MethodsData from two large-volume centers were collected and compared (January 2017–January 2020). Virtual simulation was systematically adopted in one center, while conventional sizing was used in the other one. Outcomes were the duration of intervention, the radiation dose (in milligrays, the number of corrective interventions for inappropriate WEB size, the number of WEBs not deployed, angiographic occlusion, and complications. Univariate and multivariate linear models were adopted.ResultsA total of 186 aneurysms were treated with WEB (109 with and 77 without virtual simulation). Patient characteristics and aneurysm features were comparable among virtual and conventional sizing, except for mean age (62.2±11.8 years and 56.2±10.1 years, P=0.0004) and median aspect ratio (1.6, IQR=1.2–2 and 1.2, IQR=1–1.6, P=0.0001). Years of operator experience were comparable. Virtual simulation was independently associated with shorter intervention time (45 min, IQR=33–63.5 min vs 63.5 min, IQR=41–84.7 min, P=0.0001), lower radiation dose (1051 mGy, IQR=815–1399 mGy vs 1207 mGy, IQR=898–2084 mGy, P=0.0001), and lower number of WEBs not deployed (26/77=33.7% vs 8/109=7.3%, P=0.0001). The need for additional maneuvers was significantly lower in the virtual simulation group (5/109=4.6% vs 12/77=15.6%, P=0.021). Angiographic outcomes and complications were comparable.ConclusionsIn this multicenter experience, virtual simulation with Sim&Size software seems to facilitate the selection of the appropriate WEB device for aneurysm treatment, reducing the time of intervention, the radiation dose, the number of devices not deployed, and the need for corrective interventions.Trial registration numberclinicaltrials.gov Identifier: NCT04621552.