Background: Flow diverters are an increasingly used treatment option for intracranial aneurysms. A recent addition to the European market is the DERIVO®2 Embolization Device (DED2), promising improved radiopacity. We aimed to assess the safety and efficacy of the DED2 regarding angiographic and clinical outcomes in ruptured and unruptured cerebral aneurysms.
Methods: We performed a multicenter trial at six interventional centers. Data were prospectively collected and all patients treated with the DED2 were included. The primary endpoint was angiographic aneurysm occlusion at 6 months as assessed by the O'Kelly Marotta (OKM) grading scale with a favorable outcome definition of OKM C + D. Clinical outcome was evaluated according to the modified Rankin scale (mRS).
Results: Between August 2020 and July 2021, 37 patients were treated with the DED2 and were included in our analysis. Five patients presented with ruptured aneurysms. Median age was 60 years, 27 patients were female, and 10 male. Median mRS was 0 (range 0-4). Mean aneurysm size was 8.9 ± 7.1 mm with a mean neck size of 6.5 ± 6.1. The DED2 fully opened at deployment in all cases. Clinical follow-up was available for 30 patients (81%). Twenty-five (83%) had an mRS of 0 or 1. Three patients with ruptured aneurysms died during the follow-up period. No treatment-related major morbidity was observed. Follow-up imaging was available in 27 (90%) patients, with 23 patients (85%) showing satisfactory aneurysm occlusion OKM grade C-D.
Conclusion: In this small cohort, the DED2 provided safe and effective treatment of ruptured and unruptured intracranial aneurysms.
Keywords: Aneurysm; angiography; flow diversion.