Derivo Embolization Device for the Treatment of Intracranial Aneurysms

Abstract

Background and Purpose— Flow diverter technology improvements are necessary to provide safe and good results and enable the treatment of a larger variety of aneurysms. We report a nationwide experience with the Derivo Embolization Device in the treatment of intracranial aneurysms. Methods— BRAIDED (Brazilian Registry of Aneurysms Assigned to Intervention With the Derivo Embolization Device) is a multicenter, prospective, interventional, single-arm trial of the Derivo Embolization Device for the treatment of intracranial aneurysms. The primary effectiveness end point was total aneurysm occlusion at 6- and 12-month angiographies. The secondary safety end point was the absence of serious adverse events during follow-up. Univariable and multivariable logistic regression was performed to identify predictors of aneurysm persistence, periprocedural complications, and adverse events during follow-up. Results— Between December 2016 and October 2018, 146 patients harboring 183 intracranial aneurysms were treated in 151 interventions at 7 centers. Derivo Embolization Device placement was technically successful in all patients. Most aneurysms (86.9%) were located at the internal carotid artery, and the mean diameter was 6.7 mm. At 6 months, 113 of 140 (80.7%) aneurysms met the study’s primary end point, and 74 of 83 (89.2%) met the study’s primary end point at 12 months. Saccular morphology of the aneurysm (odds ratio, 5.66; 95% CI, 1.01–31.77) and the presence of a branch arising from the sac (odds ratio, 6.36; 95% CI, 2.11–22.36) predicted persistence. A long duration of follow-up (odds ratio, 0.86; 95% CI, 0.78–0.95) predicted total occlusion. Of the 146 enrolled patients, 138 (94.5%) were treated without serious adverse events during follow-up. In the multivariable analysis, aneurysms located at a sidewall were less likely to experience these events than those located at bifurcations (odds ratio, 0.07; 95% CI, 0.01–0.51). Conclusions— The Derivo Embolization Device is a safe and effective treatment for intracranial aneurysms. Clinical Trial Registration— URL: http://plataformabrasil.saude.gov.br/login.jsf . Unique identifier: CAAE 77089717.7.1001.5125.

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

“…Mean aneurysm size of 6.7±5.1 mm was smaller compared with aneurysms treated in our trial which might explain the higher rate of complete aneurysm occlusion at 12 months of 89.2%. 11 …”

Delayed rupture of intracranial aneurysms after placement of intra-luminal flow diverter

“…According to the preliminary reports, the second-generation flow diverters seem safer with regard to the issue of delayed rupture. 44 , 50–52 But, as the second-generation flow diverters were just used in a relatively short period time and a limited population, prospective and comparative study with their first-generation counterparts is needed. Besides, as a majority of the delayed ruptured aneurysms were large/giant and symptomatic ones, the decision of flow diverter treatment should be prudent and under sufficient pre-procedural evaluation.…”

Advances in endovascular aneurysm management: flow modulation techniques with braided mesh devices

“…Morbidity was 4.1% and mortality was 1.4%. 30 The literature has reported an occlusion rate of 80.7% at 6 months to 89.2% at 1 year with Derivo FD. Morbidity and mortality are comparable to other FDs.…”