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Derivo Embolization Device for the Treatment of Intracranial Aneurysms

2019; Lippincott Williams & Wilkins; Volume: 50; Issue: 9 Linguagem: Inglês

10.1161/strokeaha.119.025407

1524-4628

Felipe Padovani Trivelato, Daniel Giansante Abud, Alexandre Cordeiro Ulhôa, Eduardo Waihrich, Thiago Giansante Abud, Luis Henrique Castro Afonso, Guilherme Seizem Nakiri, Guilherme Duarte de Castro, Bruno de Sousa Mendes Parente, Rodrigo dos Santos Silva, Luciano Bambini Manzato, Lucas Eduardo Bonadio, Dinark Conceição Viana, José Ricardo Vanzin, Carlos Eduardo Baccin, Marco Túlio Salles Rezende,

Cerebrovascular and Carotid Artery Diseases

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.