Virtual implantation of Derivo Embolization Devices using PreSize Neurovascular software: Accuracy evaluation and size selection comparison study.

BACKGROUND

Evaluating the deployed length of flow diverting stents (FDs) to select the optimal device size remains a challenging, yet crucial, task in aneurysm treatment. This study reports on the accuracy of PreSize Neurovascular (Oxford Heartbeat Ltd), a visualization and simulation software for FD intervention planning, in predicting FD deployed length, and on its impact on device size selection.

METHODS

Imaging data from consecutive patients treated with Derivo Embolization Device (Acandis GmbH) were collected from University Medical Center Hamburg-Eppendorf and retrospectively analyzed. Accuracy evaluation: prediction accuracy was calculated by comparing deployed FD lengths measured from imaging data and simulated by PreSize. Size selection comparison: two Interventional Neuroradiologists (INR1, INR2), blinded to the devices deployed, used PreSize to select the optimal device size (diameter and length). Their choices were compared against the deployed devices selected by conventional planning.

RESULTS

Among 98 implanted devices, PreSize predicted deployed FD length with a mean accuracy of 94.54% (95% confidence interval [93.72%, 95.35%]). Among 98 aneurysm cases, PreSize-informed device lengths were significantly shorter (Wilcoxon signed-rank test, INR1: W = 394, P < .001, INR2: W = 305, P < .001) by 4.13 and 4.18 mm on average, and up to 20 and 25 mm, for INR1 and INR2, respectively, than the conventionally selected FDs. In 32% of cases, PreSize-informed devices resulted in fewer vessel bends covered by the FD while achieving sufficient aneurysm coverage.

CONCLUSIONS

PreSize retrospectively predicted deployed FD lengths with high accuracy. Moreover, INRs in this study were more inclined to select shorter stent length in the simulation than they would have done conventionally.

Déclaration de conflit d'intérêts

Declaration of conflicting interestsThe authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr. Flottmann reports personal fees from Eppdata. Dr. Iori, Dr. Bonfanti and Dr. Mandaltsi are employees of Oxford Heartbeat Ltd. Dr. Fiehler reports research support from German Ministry of Science and Education (BMBF), German Ministry of Economy and Innovation (BMWi), German Research Foundation (DFG), European Union (EU), Hamburgische Investitions- und Förderbank (IFB), Medtronic, Microvention, Route92, Stryker; grants and personal fee from Acandis, Bayer, Boehringer Ingelheim, Cerenovus, Evasc Neurovascular, MD Clinicals, Medtronic, Microvention, Penumbra, Phenox, Stryker, Transverse Medical outside the submitted work and stock holdings for Tegus Medical. Dr. Fiehler also serves as the CEO of Eppdata. Dr. Bester reports personal fee from Acandis for as consulter/proctor outside the submitted work. No other disclosures were reported.