Preliminary results of intracranial aneurysm treatment with derivo2heal embolization device.

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.

Treatment of intracranial aneurysms with large-diameter (≥5.5 mm) Derivo Embolization Devices, with particular focus on 7 and 8 mm diameter devices.

OBJECTIVE: There are few studies on flow diverters with diameters >5 mm. We present our preliminary experience with the 5.5-8 mm Derivo Embolization Device (DED) implants for the treatment of cerebral aneurysms. METHODS: A consecutive series of 26 patients (median age: 60 years) treated for 32 aneurysms in 26 procedures was retrospectively analyzed for procedural characteristics, complications, and mid-term angiographic results. RESULTS: The median aneurysm size was 10.5 mm, 2 of 30 (6%) aneurysms were ruptured and 9 (28%) had a fusiform or dissecting morphology. DED implantation was performed in the internal carotid artery in 18 of 26 (69%) procedures and in the vertebrobasilar artery in 8 (31%). Device deployment failed in 1 (4%) procedure. The 7 and 8 mm implants were successfully deployed in 5 cases. Additional balloon angioplasty or stent implantation was performed in 3 (12%) cases to improve wall apposition. Complications included 1 (4%) major stroke and 2 (8%) minor strokes. Angiographic follow up at a mean of 6 months showed complete occlusion in 8 of30 (27%) aneurysms and favorable occlusion in 14 (47%). CONCLUSIONS: The use of large diameter DEDs was safe and feasible. The mid-term occlusion rates are acceptable considering the complex subset of aneurysms studied. Further studies are warranted to define the indications for large-diameter DEDs and to evaluate their long-term efficacy.

The DERIVO 2heal embolisation device: A technical report using single antiplatelet therapy for intracranial pseudoaneurysm treatment.

The novel DERIVO 2heal Embolisation Device (Acandis, Pforzheim, Germany) is a flexible, fully radiopaque flow-diverter with a fibrin-based nano-coating, which is supposed to make the device inert to the coagulation cascade. We report a case of pseudoaneurysm treatment with this device under single anti-platelet therapy (SAPT). A female patient underwent endoscopic surgery for chronic rhinosinusitis. During surgery, the lateral wall of the sphenoid wall and the adjacent internal carotid artery was injured, leading to massive hemorrhage, which was treated with compression and tamponades. Eleven days after the procedure, the patient developed a rapidly growing pseudoaneurysm at the injury site with a relevant risk of upcoming aneurysm rupture. The aneurysm was treated by implantation of a DERIVO 2heal. A SAPT regimen was chosen due to the recent massive hemorrhage and anticipating enhanced progressive aneurysm occlusion. There were no thromboembolic complications and there was no morbidity. After 5 days, the pseudoaneurysm was completely occluded. The observations of the presented case are promising and warrant further investigation of this device.

Comparative Analysis of the Pipeline and the Derivo Flow Diverters for the Treatment of Unruptured Intracranial Aneurysms-A Multicentric Study.

OBJECTIVE: Flow diversion represents a safe and efficient technique for the endovascular treatment of complex intracranial aneurysms. This study compares 2 competing flow diverters, the Pipeline embolization device (PED) and the Derivo Embolization Device (DED) regarding technical aspects, clinical outcome, and angiographic results. METHODS: A total of 111 patients with unruptured aneurysms were treated with the PED (n = 62) or the DED (n = 49) between 2011 and 2019. Procedural specifics, complication rates, functional outcome, and aneurysm occlusion were evaluated retrospectively. RESULTS: Flow-diverter implantation was technically successful in all patients. There were no significant differences regarding baseline characteristics, adjunctive coiling, and fluoroscopy time. Multiple devices were more often used in the PED group (35.6%) than in the DED group (4.1%, P < 0.001). Procedural adverse events occurred in 4 cases of each group (PED: 5.5%, DED: 8.2%, P = 0.713), including 3 thromboembolic events and 1 hemorrhagic event per group. Morbidity rates were similar between the 2 groups (PED: 2.7%, DED: 4.1%, P = 1.0). There was no procedural mortality. At 6-month follow-up, complete or near-complete occlusion (O'Kelly-Marotta scale C+D) was achieved in 79.0% (49/62) after PED implantation and 80.0% (32/40) after DED implantation (P = 0.354). CONCLUSIONS: In regard to complication rates, functional outcome, and aneurysm occlusion, no significant differences were found between the PED and DED collective.

Improved Occlusion Rate of Intracranial Aneurysms Treated with the Derivo Embolization Device: One-Year Clinical and Angiographic Follow-Up in a Multicenter Study.

OBJECTIVE: The Derivo Embolization Device (DED) is a novel flow-diverter stent consisting of a flexible structure and a surface modification that aims to reduce thrombogenicity. Here, we report 1-year clinical and angiographic follow-up results of the second-generation DED for the treatment of intracranial aneurysms. METHODS: This is a retrospective study of 59 consecutive patients (mean age: 53 years, 81% women) treated with the DED for 59 aneurysms (mean size: 8.1 mm) between November 2015 and February 2018 at 3 German tertiary care centers. We evaluated the rate of ischemic stroke, functional outcome, and angiographic results during a 1-year follow-up period. RESULTS: Deployment of the DED was successful in all cases. Adverse events were observed in 6 procedures (10.2%), of which 2 were symptomatic (3.4%). No delayed ischemic or hemorrhagic events occurred during the 1-year follow-up and there were no deaths. Permanent morbidity due to in-stent thrombosis and consecutive ischemic stroke occurred in 1 patient (1.7%). Complete (O'Kelly-Marotta grading scale D) and favorable (O'Kelly-Marotta grading scale C+D) aneurysm occlusion was obtained in 70.5% (31/44) and 88.7% (39/44) at 6 months and 82.8% (24/29) and 100% (29/29) at 12 months, respectively. CONCLUSIONS: Our results demonstrate that treatment of intracranial aneurysms with the DED is associated with low rates of ischemic complications and adequate aneurysm occlusion at 1-year follow-up.

Internal Carotid Artery Reconstruction with a "Mega Flow Diverter": First Experience with the 6×50 mm DERIVO Embolization Device.

Endoluminal reconstruction with a flow diverter device has emerged as a viable and often preferable alternative to traditional techniques for the treatment of intracranial aneurysms. Precise measurement and device selection are mandatory steps when considering flow diverters usage in order to avoid potential complications. In this sense, incomplete wall-apposition has been described as a predictive factor for immediate in-stent and delayed thrombosis after stent use. One significant usage limitation of flow diverter devices is the parent artery diameter, since the maximum opening of the sizes available are recommended for vessel diameters between 5.2-5.75 mm. Here we present the first clinical use of the largest flow diverter available, the 6×50 mm DERIVO embolization device (Acandis GmbH & Co. KG, Pforzheim, Germany), into the arterial circulation for a cervical internal carotid artery endovascular reconstruction. This is a new device for large or fusiform aneurysms requiring flow diversion, especially located in the vertebrobasilar system or extracranial segments.

The DERIVO Embolization Device in the Treatment of Intracranial Aneurysms: Short- and Midterm Results.

OBJECTIVE: The DERIVO embolization device (DED) is a new nitinol flow diverter stent manufactured for the treatment of intracranial aneurysms. In this study, we evaluated the safety and efficacy of the DED in the treatment of intracranial aneurysms and present the short- and midterm results. METHODS: We treated 34 aneurysms using 26 devices in 24 patients with wide-necked, mostly medium-sized, and fusiform aneurysms. Fourteen of the patients included in the study were women and the other 10 were men. Headache was the most frequent symptom. Although 31 (91.2%) aneurysms were in the anterior circulation, 3 (8.8%) were in the posterior. Intracranial stent medication was accomplished in all patients. All patients were evaluated 1 day later for any ischemic lesion with diffusion-weighted imaging. The first and second follow-up angiograms were planned to be performed after 3 and 9 months. RESULTS: In all patients, the treatment was successful. No hemorrhagic complication was seen on computed tomography scan performed immediately after the procedure. All patients were discharged without any neurologic deficit. Although 20 (71.4%) of 28 aneurysms in 20 patients were totally closed on the 3-month follow-up angiogram, 14 (77.8%) of 18 aneurysms in 9 patients were totally closed on the 9-month follow-up. General morbidity was 8.4%, and mortality was 4.3%. CONCLUSIONS: The DED seems effective and safe in the treatment of different kinds of intracranial aneurysms.