The device’s characteristics and visibility might provide “comfort benefit” to neurointerventionalists, lead author says.
Endovascular treatment of unruptured intracranial aneurysms using a second-generation flow diverter known as the Derivo Embolization Device (DED; Acandis) imparts a high rate of procedural safety and adequate occlusion rates, according to a retrospective but multicenter study.
Thromboembolic complications and morbidity rates seen with the DED were in line with its competitors, according to Lukas Goertz, MD (University Hospital of Cologne, Germany), who led the study along with Bastian Kraus, MD (University Hospital of Duesseldorf, Germany). Their results were published online recently in the Journal of NeuroInterventional Surgery.
“Since the introduction of the first available flow diverters, they have been used for the treatment of complex aneurysms, especially at the internal carotid artery that are not suitable or very challenging to treat by conventional coiling or microsurgical clipping,” Goertz told Neurovascular Exchange. “Moreover, studies have shown higher aneurysms occlusion rates and similar morbidity rates when compared to coiling and stent-coiling.”
To analyze the DED, Goertz and colleagues conducted a retrospective analysis of all patients with unruptured intracranial aneurysms who were treated with the device between November 2015 and December 2017 at three German centers.
DED implantation was attempted in 42 patients with 42 aneurysms, and all procedures had technical success. Most patients (90.5%) had internal carotid artery aneurysms. Multiple devices were required in 7.2% of patients, and 26.2% required adjunctive coiling due to large aneurysm size.
Procedure-related complications occurred in 9.5% of cases, all during the hospital stay. These complications included three thromboembolic events and one aneurysm perforation. There were no deaths.
Ischemic stroke with persistent aphasia at 30-day follow-up occurred in one patient and was caused by a thromboembolic infarct, resulting in a morbidity rate of 2.4% (with morbidity defined as any increase in the mRS score ≤ 30 days). Among the three-quarters of patients available for angiographic follow-up, which occurred at a mean of 177.2 days, complete aneurysm occlusion was seen in 72.7% and favorable aneurysm occlusion in 87.9%.
The DED has several unique properties, according to Goertz. It consists of radiopaque composite nitinol wires and three additional radiopaque markers at both ends. Therefore, the DED provides favorable visibility under fluoroscopy, he said.
“Moreover, the DED is provided with a thin surface layer of oxides and oxynitrides, which is supposed to reduce the friction during delivery and may lead to lower thrombogenicity of this device,” Goertz told NVX. Finally, the DED is equipped with a flexible structure and an improved delivery system, which allows subtotal resheathing of the device in case of misplacement.
“These properties simplify delivery of the DED when compared to first-generation [devices],” Goertz said. “Moreover, our study indicates that the number of devices per aneurysms can be kept low, and that the rate of thromboembolic events compares favorably to other flow-diverter types. These properties might represent a safety benefit for the patients.”
Goertz noted that this was not a comparative study, but said that the safety profile seen with DED was similar to that of other flow diverters, with the most frequent complications being thromboembolic and hemorrhagic events.
“The results of our small study indicate an acceptable low risk of thromboembolic events and a favorable morbidity rate when compared to previous studies on first-generation flow-diverters,” Goertz said. “Moreover, the favorable visibility and improved delivery system of the DED might represent a comfort benefit for the performing neurointerventionalist.”
Kraus B, Goertz L, Turowski B, et al. Safety and efficacy of the Derivo Embolization Device for the treatment of unruptured intracranial aneurysms: a multicentric study. J NeuroIntervent Surg. 2018;Epub ahead of print.
Goertz and Kraus report no relevant conflicts of interest.