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

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.