Derivo embolization device for intracranial aneurysms: a Spanish multicenter retrospective study

Piñana, Carlos; Friedemann, Sebastià Remollo; Zamarro, Joaquín; Werner, Mariano; Rueda, M. Espinosa de; Vega, Pedro; Hernández, David; Murias, Eduardo; Rivera, Eila; Olier, J.; Román, Luís San; Páez-Carpio, Alfredo; Requena, Manuel; Aixut, Sònia; Lascuevas, Marta De Dios; Moreu, Manuel; Rosati, Santiago; Gramegna, Laura Ludovica; Castaño, Carlos

doi:10.1136/jnis-2022-019220

Cited by 4 publications

(1 citation statement)

References 24 publications

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“…In the present study, major ischemic stroke occurred in 2%, which is lower than reported in most studies of the PED. Similarly, major complications for Derivo were 5% in the Trivelato study, 4% in the Pinana study, 2% in the Lourenco study, and 3% in the Taschner study [14,16,33,34].…”

Section: Safetymentioning

confidence: 89%

Long-term Safety and Efficacy of the Derivo Embolization Device in a Single-center Series

Goertz,

Zopfs,

Kottlors

et al. 2024

Clin Neuroradiol

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Purpose This study analyzes the long-term clinical and angiographic outcomes of the Derivo Embolization Device (DED), an advanced flow diverter device with an electropolished surface, for the treatment of intracranial aneurysms. Methods A consecutive series of 101 patients (mean age: 58 years, 72% female) treated with the DED for 122 aneurysms at a single center between 2017 and 2023 was retrospectively analyzed for major (change in National Institutes of Health Stroke Scale [NIHSS] score ≥ 4 points) and minor (change in NIHSS score < 4 points) neurological events, procedural morbidity (increase of at least one point on the modified Rankin Scale), and angiographic results. Results There were 14 (11%) recurrent aneurysms, 15 (12%) ruptured aneurysms, 26 (21%) posterior circulation aneurysms and 16 (13%) fusiform or dissecting aneurysms. Device deployment failed in 1 case (1%). Procedure-related symptomatic procedural complications consisted of 2 (2%) major events (1 major stroke and 1 vessel perforation with intracranial hemorrhage and infarction) and 6 minor events (6 minor strokes). Procedural morbidity was 5%. There were no late ischemic or hemorrhagic events during follow-up. Complete and favorable aneurysm occlusion was achieved in 54% (40/74) and 62% (46/74) at a mean of 5 months, 71% (27/38) and 87% (33/38) at a mean of 12 months, and 76% (25/33) and 97% (32/33) at a mean of 35 months, respectively. Conclusion The results demonstrate progressive aneurysm occlusion beyond 12 months after DED implantation with an almost 100% favorable occlusion rate. Procedural morbidity was low and there were no late complications.

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Section: Safetymentioning

confidence: 89%

Long-term Safety and Efficacy of the Derivo Embolization Device in a Single-center Series

Goertz,

Zopfs,

Kottlors

et al. 2024

Clin Neuroradiol

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Preliminary results of intracranial aneurysm treatment with derivo2heal embolization device

Rueckel,

Ozpeynirci,

Trumm

et al. 2024

Neuroradiology

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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.

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

Goertz,

Zopfs,

Kottlors

et al. 2024

Interv Neuroradiol

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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.

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Derivo embolization device for intracranial aneurysms: a Spanish multicenter retrospective study

Cited by 4 publications

References 24 publications

Long-term Safety and Efficacy of the Derivo Embolization Device in a Single-center Series

Long-term Safety and Efficacy of the Derivo Embolization Device in a Single-center Series

Preliminary results of intracranial aneurysm treatment with derivo2heal embolization device

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

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