Single-center experience with the new-generation Derivo embolization device for ruptured and unruptured intracranial aneurysms.

BACKGROUND

The aim of this study is to evaluate safety and efficacy of the new-generation Derivo embolization device in complex ruptured (RIA) and unruptured (UIA) intracranial aneurysms.

METHODS

Retrospective analysis of 32 patients with complex RIAs and UIAs treated with Derivo at our hospital from November 2015 to December 2018. Clinical safety was defined as absence of death, transient attack, absence of minor and major stroke, and Derivo associated hemorrhage. Treatment efficacy was assessed angiographically (DSA) immediately after treatment and at 6-month follow-up according to the O'Kelly-Marotta (OKM) Grading Scale (from A=total filling to D=no filling; prolongation of stasis 1=arterial to 3=venous phase).

RESULTS

Thirty-two patients with 39 aneurysms were treated with 42 Derivos. In five aneurysms, additional coiling was performed. Deployment was technically successful in all cases. Two patients developed a procedure related minor stroke (one transient). In one patient bleeding due to an inflammatory aneurysmatic wall process occurred 20 days after retreatment and in one patient a stroke due to in-stent thrombosis occurred when dual platelet inhibition (PI) was switched to permanent single PI 12 month after FD treatment. No treatment related deaths were observed. Initial DSA revealed three OKM D, six OKM C, five OKM B, and 25 OKM A. Six-month follow-up for DSA and clinical evaluation was available in 20/32 patients (62.5%), 26 of 39 aneurysms (66.7%) and revealed 73.1% complete and 3.8% subtotal occlusion (OKM D: 19 of 26, OKM C3: one of 26).

CONCLUSIONS

Treatment of complex RIAs and UIAs with the new-generation Derivo appeared to be safe and effective in this single-center case series for ruptured and unruptured intracranial aneurysms. Immediate DSA revealed a significant flow modulation; and 6-month follow-up showed a high occlusion rate.