Derivo embolization device in the treatment of unruptured intracranial aneurysms: a prospective multicenter study.

BACKGROUND

Flow diverters (FD) are used regularly for the endovascular treatment of unruptured intracranial aneurysms. We aimed to assess the safety and effectiveness of the Derivo embolization device (DED) with respect to long-term clinical and angiographic outcomes.

METHODS

A prospective multicenter trial was conducted at 12 centers. Patients presenting with modified Rankin Score (mRS) of 0-1, treated for unruptured intracranial aneurysms with DED were eligible. Primary endpoint was the mRS assessed at 18 months with major morbidity defined as mRS 3-5. Satisfactory angiographic occlusion was defined as 3+4 on the Kamran scale.

RESULTS

Between July 2014 and February 2018, 119 patients were enrolled. Twenty-three patients were excluded. Ninety-six patients, 71 (74%) female, mean age 54±12.0 years, were included in the analysis. Mean aneurysm size was 14.2±16.9 mm. The mean number of devices implanted per patient was 1.2 (range 1-3). Clinical follow-up at 18 months was available in 90 (94%) patients, resulting in a mean follow-up period of 14.8±5.2 months. At last available follow-up of 96 enrolled patients, 91 (95%) remained mRS 0-1. The major morbidity rate (mRS 3-5) was 3.1% (3/96), major stroke rate was 4.2% (4/96), and mortality was 0%. Follow-up angiographies were available in 89 (93%) patients at a median of 12.4±5.84 months with a core laboratory adjudicated satisfactory aneurysm occlusion in 89% (79/89).

CONCLUSION

Our results suggest that DED is a safe and effective treatment for unruptured aneurysms with high rates of satisfactory occlusion and comparably low rates of permanent neurological morbidity and mortality.

TRIAL REGISTRATION

DRKS00006103.

Informations de copyright

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: CAT reports grants, non-financial support, and personal fees from Acandis, Stryker, and Microvention during the conduct of the study. FD has consulting agreements with Phenox, Cerus, and Balt and reports personal fees from Cerenovus and Acandis. KK has a consulting agreement with Phenox and reports personal fees from Philips, Penumbra, and Stryker. JHB has consulting agreements with Acandis, Cerenovus, Microvention, and Stryker. SM has a consulting agreement with Acandis and reports personal fees and non-financial support from Microvention, and non-financial support from Balt and Stryker. MK has a consulting agreement with Acandis.