Implantation of Large Diameter (5.5-6 mm) Derivo Embolization Devices for the Treatment of Cerebral Aneurysms

Abstract

Background: The efficacy of flow diverters is dependent upon robust wall apposition in the parent artery. Usage in large caliber cerebral vessels has therefore been limited as few implants with diameters > 5 mm exist. We present our initial experience in treating cerebral aneurysms using the 5.5 mm and 6 mm diameter implants of the Derivo embolization device (DED).

Methods: Our prospectively maintained institutional database was reviewed to identify patients in whom a > 5 mm DED was implanted between November 2016 and February 2021. The primary efficacy outcome was complete or near-complete aneurysm occlusion at 6 months (O'Kelly-Marotta, OKM, C-D, adapted for magnetic resonance angiography). Safety outcomes included 30-day major morbidity defined as modified Rankin Score (mRS) 3-5, mortality, serious adverse events and procedural complications.

Results: A total of 21 large diameter DEDs were deployed in 18 patients (age 59.5 ± 14.1 years), harboring 19 unruptured aneurysms. Of the aneurysms 14 (73.7%) were saccular in morphology (sac diameter 10.9 ± 5.5 mm, neck diameter 6.8 ± 3.1 mm), 3 (15.8%) aneurysms were dissecting, 1 (5.3%) iatrogenic pseudoaneurysm and 1 (5.3%) fusiform. Aneurysm locations were: ICA (internal carotid artery) (n = 17); (7 cavernous, 4 paraophthalmic, 2 paraclinoid, 1 petrous, 2 communicating, 1 cervical); vertebrobasilar (n = 2). Adjunct stenting to optimize proximal wall apposition was undertaken in 5 (27.8%) patients. At 6 months 75% of patients followed-up met the primary efficacy endpoint (OKM C-D). There were no serious adverse events, 30-day major morbidity (mRS 3-5) or mortality.

Conclusion: Implantation of large diameter (5.5 mm and 6 mm) DEDs into capacious cerebral vessels to treat a range of complex aneurysms is safe and technically feasible but may require adjunct stenting to optimize proximal wall apposition. Short-term efficacy of this device subset is comparable to previous DED and other flow diverter studies. Long-term follow-up and comparative studies are required for further assessment.

Keywords: Embolization; Endovascular; Flow diverter; Intracranial aneurysm; Stent.