Preliminary results of intracranial aneurysm treatment with derivo2heal embolization device

Abstract

Introduction: The Derivo 2 Heal Embolization Device (D2HED) is a novel flow diverter (FD) providing a fibrin-/heparin-based surface coating aiming at lower thrombogenicity. We evaluate periprocedural aspects and preliminary aneurysm occlusion efficacy for intracranial aneurysm treatment.

Methods: Thirty-four D2HEDs deployments (34 aneurysms, 32 patients) between 04/2021 and 10/2023 were analyzed. All patients were under dual antiplatelet therapy (dAPT). Periprocedural details, adverse events, and follow-up (FU) imaging were reviewed by consultant-level neuroradiologists. Complication rates and aneurysm occlusion efficacy are compared with performance data of other FDs based on literature research.

Results: Each intervention succeeded in the deployment of one D2HED. Significant and/or increased intraaneurysmal contrast stagnation immediately after D2HED deployment was seen in 73.5% of cases according to O'Kelly-Marotta (OKM) grading scale. Clinically relevant early adverse events occurred in three patients: Among them two cases with fusiform aneurysms in the posterior circulation (ischemic events, early in-stent-thrombosis) and one patient (ischemic event) out of the majority of 31 treated internal carotid artery aneurysms (3,2%). Regarding mid-term FU (> 165 days), one aneurysm did not show progressive occlusion presumably caused by a prominent A1 segment arising from the terminal ICA aneurysm itself. Apart from that, mid-term complete / partial occlusion rates of 80% / 20% could be demonstrated.

Conclusion: Our case series - although suffering from restricted sample size - suggests a potential effectiveness of D2HED in managing intracranial aneurysms. Further studies with larger samples are warranted to quantify long-term occlusion efficacy and the impact of antithrombogenic surface coating on the necessary (d)APT.

Keywords: Derivo 2heal; Flow diversion; Intracranial aneurysm.

Fig. 1

Device Visibility & Fish Mouthing Example. (A1/2): Postinterventional control after FD deployment with incomplete apposition of the proximal FD to the parental vessel curvature (A1) with FD retraction and complete vessel wall adaptation based on follow-up DSA 257 days after intervention (A2). (B1-4) Progressive proximal fish mouthing: Initial post-deployment projection (B1), compared with a control projection the following day (B2) after initial suspicion was noticed by a CT at the first postinterventional day; followed by the decision for a second FD deployment with FPCTA before the second FD deployment (B3) and control angiogram after second FD deployment (B4). FD, flow diverter; DSA, digital subtraction angiography

Fig. 2

Case Illustration with Intimal Hyperplasia & Missing Aneurysm Occlusion. (A1-A3): Baseline illustration of the terminal ICA aneurysm extending to the vascular outlets of A1/M1 segments. (B1): Control angiogram after FD deployment with contrast media stasis within the aneurysm and slightly delayed perfusion of the A1 segment. (C1-C3): Missing / pending aneurysm occlusion 189 days after FD deployment (C1) supposedly caused by a prominent A1 segment connected to the aneurysm basis (FPCTA C2), furthermore a non-stenosing intimal hyperplasia (FPCTA C3). ICA – internal carotid artery; FD, flow diverter; DSA, digital subtraction angiography; FPCTA, flat panel computed tomography angiography

Fig. 3

Case Illustration with Ischemic Events in the AchA Territory. (A1-A3, aneurysm characteristics before FD deployment): Baseline imaging with a terminal ICA aneurysm and the AchA (arrows) arising from the aneurysm sac. (B1/2, DSA and FPCTA images immediately after FD deployment): Control angiogram and control FPCTA after flow diverter deployment with the AchA (arrows) proven to be patent. (C1/C2, 133 days after FD treatment): Ischemic areas in the AchA territory (MRI DWI) 133 days after FD treatment and shortly after reduction to sAPT, supposed to be caused by a AchA arising from the progressively thrombosed, initially fusiform-dysplastic aneurysm. Nevertheless, the AchA was proven to be still patent in the subsequent follow-up DSA (C2). AchA, anterior choroidal artery; ICA – internal carotid artery; FD, flow diverter; MRI, magnetic resonance imaging; DWI, diffusion weighted imaging; DSA, digital subtraction angiography; FPCTA, flat panel computed tomography; APT, antiplatelet therapy