The DERIVO 2 Heal Embolization Device in the Treatment of Ruptured and Unruptured Intracranial Aneurysms: a Retrospective Multicenter Study.

SAH cerebral aneurysm endovascular treatment flow diverter hemorrhage

Journal

Clinical neuroradiology
ISSN: 1869-1447
Titre abrégé: Clin Neuroradiol
Pays: Germany
ID NLM: 101526693

Informations de publication

Date de publication:
22 Aug 2024
Historique:
received: 08 06 2024
accepted: 11 07 2024
medline: 22 8 2024
pubmed: 22 8 2024
entrez: 22 8 2024
Statut: aheadofprint

Résumé

The use of flow diverting stents in the treatment of intracranial aneurysms is associated with a risk of neurological morbidity due to their thrombogenicity. To reduce this risk different surface modifications have been developed. The Derivo 2 Embolization Device (Acandis, Pforzheim, Germany) has proven to be a safe and effective flow diverter. To overcome the risk of thrombo-embolism, the device was modified by adding an anti-thrombogenic fibrin-heparin coating. We aimed to assess the safety and effectiveness of the Derivo 2 heal Embolization Device. Retrospective multicenter data from nine German neurovascular centers between February 2022 until December 2023 were used. Patients treated with the Derivo 2 heal Embolization Device for unruptured or ruptured intracranial aneurysms were included. Peri- and postprocedural adverse events, clinical outcomes, and angiographic follow-up results were evaluated. 84 patients (73.8% female; mean age 58.7 years) with 89 aneurysms (mean size 9.8 mm) were included. 87.6% were located in the anterior circulation. Most of them were sidewall aneurysms (88.8%). 96 flow diverters were used. 99.0% were successfully implanted. An in-stent balloon angioplasty was performed in 6.0% of the cases. An additional coiling was performed in 28.6%. Technical difficulties were present in 12.0% of the cases. Thrombotic events occurred in 4.8% with no neurological sequelae. Mortality and morbidity were 0 and 1.2% respectively. Adequate aneurysm occlusion was achieved in 80.7% with a mean follow-up time of 6.6 months. The Derivo 2 heal Embolization Device showed a satisfying aneurysm occlusion and safety with a low rate of neurological morbidity.

Identifiants

pubmed: 39172220
doi: 10.1007/s00062-024-01446-8
pii: 10.1007/s00062-024-01446-8
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© 2024. The Author(s).

Références

Brinjikji W, Murad MH, Lanzino G, Cloft HJ, Kallmes DF. Endovascular Treatment of Intracranial Aneurysms With Flow Diverters: A Meta-Analysis. Stroke. 2013;44:442–7. https://doi.org/10.1161/STROKEAHA.112.678151 .
doi: 10.1161/STROKEAHA.112.678151 pubmed: 23321438
Lv X, Yang H, Liu P, Li Y. Flow-diverter devices in the treatment of intracranial aneurysms: A meta-analysis and systematic review. Neuroradiol J. 2016;29:66–71. https://doi.org/10.1177/1971400915621321 .
doi: 10.1177/1971400915621321 pubmed: 26838174 pmcid: 4978339
Yan Y, Zhu D, Tang H, Huang Q. Safety and Efficacy of Flow Diverter Treatment for Aneurysm in Small Cerebral Vessels: A Systematic Review and Meta-Analysis. World Neurosurg. 2018;115:54–64. https://doi.org/10.1016/j.wneu.2018.04.009 .
doi: 10.1016/j.wneu.2018.04.009 pubmed: 29653275
Arrese I, Sarabia R, Pintado R, Delgado-Rodriguez M. Flow-Diverter Devices for Intracranial Aneurysms: Systematic Review and Meta-analysis. Neurosurgery. 2013;73:193–200. https://doi.org/10.1227/01.neu.0000430297.17961.f1 .
doi: 10.1227/01.neu.0000430297.17961.f1 pubmed: 23624409
Hellstern V, Aguilar PM, Henkes E, Donauer E, Wendl C, Bäzner H, et al. Use of a p64 MW Flow Diverter with Hydrophilic Polymer Coating (HPC) and Prasugrel Single Antiplatelet Therapy for the Treatment of Unruptured Anterior Circulation Aneurysms: Safety Data and Short-term Occlusion Rates. Cardiovasc Intervent Radiol. 2022;45:1364–74. https://doi.org/10.1007/s00270-022-03153-8 .
doi: 10.1007/s00270-022-03153-8 pubmed: 35562486 pmcid: 9458553
Mohammaden MH, English SW, Stapleton CJ, Khedr E, Shoyb A, Hegazy A, et al. Safety and efficacy of ticagrelor as single antiplatelet therapy in prevention of thromboembolic complications associated with the Pipeline Embolization Device (PED): multicenter experience. J Neurointerventional Surg. 2020;12:1113–6. https://doi.org/10.1136/neurintsurg-2020-015978 .
doi: 10.1136/neurintsurg-2020-015978
White TG, Santhumayor BA, Turpin J, Shah K, Toscano D, Teron I, et al. Flow diverter surface modifications for aneurysm treatment: A review of the mechanisms and data behind existing technologies. Interv Neuroradiol. 2023. https://doi.org/10.1177/15910199231207550 . 15910199231207550.
doi: 10.1177/15910199231207550
Riedelová-Reicheltová Z, Brynda E, Riedel T. Fibrin Nanostructures for Biomedical Applications. Physiol Res. 2016; https://doi.org/10.33549/physiolres.933428 .
doi: 10.33549/physiolres.933428 pubmed: 27762592
Mühl-Benninghaus R, Fries F, Kießling M, Tomori T, Krajewski S, Simgen A, et al. Vascular Response on a Novel Fibrin-Based Coated Flow Diverter. Cardiovasc Intervent Radiol. 2022;45:236–43. https://doi.org/10.1007/s00270-021-03007-9 .
doi: 10.1007/s00270-021-03007-9 pubmed: 34913987
Trivelato FP, Abud DG, Ulhôa AC, Waihrich ES, Abud TG, Castro ALH, et al. Derivo Embolization Device for the Treatment of Intracranial Aneurysms: A Multicenter Study of 183 Aneurysms. Stroke. 2019;50:2351–8. https://doi.org/10.1161/STROKEAHA.119.025407 .
doi: 10.1161/STROKEAHA.119.025407 pubmed: 31288675
Taschner CA, Stracke CP, Dorn F, Kadziolka KB, Kreiser K, Solymosi L, et al. Derivo embolization device in the treatment of unruptured intracranial aneurysms: a prospective multicenter study. J Neurointerventional Surg. 2021;13:541–6. https://doi.org/10.1136/neurintsurg-2020-016303 .
doi: 10.1136/neurintsurg-2020-016303
van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJA, van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. https://www.ahajournals.org/doi/10.1161/01.STR.19.5.604
Brott T, Adams HP, Olinger CP, Marler JR, Barsan WG, Biller J, et al. Measurements of acute cerebral infarction: a clinical examination scale. Stroke. 1989;20:864–70. https://doi.org/10.1161/01.STR.20.7.864 .
doi: 10.1161/01.STR.20.7.864 pubmed: 2749846
O’Kelly CJ, Krings T, Fiorella D, Marotta TR. A Novel Grading Scale for the Angiographic Assessment of Intracranial Aneurysms Treated Using Flow Diverting Stents. Interv Neuroradiol. 2010;16:133–7.  https://journals.sagepub.com/doi/10.1177/159101991001600204
doi: 10.1177/159101991001600204 pubmed: 20642887 pmcid: 3277972
Kraus B, Goertz L, Turowski B, Borggrefe J, Schlamann M, Dorn F, et al. Safety and efficacy of the Derivo Embolization Device for the treatment of unruptured intracranial aneurysms: a multicentric study. J Neurointerventional Surg. 2019;11:68–73. https://doi.org/10.1136/neurintsurg-2018-013963 .
doi: 10.1136/neurintsurg-2018-013963
on behalf of the Italian DERIVO® Registry Group, Piano M, Lozupone E, Sgoifo A, Nuzzi NP, Asteggiano F, et al. Long-term follow-up of the Derivo® Embolization Device (DED®) for intracranial aneurysms: the Italian Multicentric Registry. J Neurosurg Sci. 2021; https://doi.org/10.23736/S0390-5616.21.05300-5 .
doi: 10.23736/S0390-5616.21.05300-5
Chagas Lourenço G, Dantas F. Silva E Carvalho T, Firmino RUR, Quesado Filgueiras Filho M, Tosello RT, et al. Endovascular treatment of intracranial aneurysms using the Derivo Embolization Device: a multicenter experience. J Neurointerventional Surg. 2023;15:776–80. https://doi.org/10.1136/neurintsurg-2022-018648 .
doi: 10.1136/neurintsurg-2022-018648
Thormann M, Sillis N, Thoma T, Altenbernd J, Berger B, Cioltan A, et al. The DERIVO®2 Embolization Device in the treatment of ruptured and unruptured intracranial aneurysms: A multicenter analysis. Interv Neuroradiol. 2022; https://doi.org/10.1177/15910199221142643 .
doi: 10.1177/15910199221142643 pubmed: 36567499
Meyer L, Stracke CP, Bester M, Kallmes KM, Zeleňák K, Rouchaud A, et al. Predictors of aneurysm occlusion after treatment with flow diverters: a systematic literature review. J Neurointerventional Surg. 2023; https://doi.org/10.1136/jnis-2022-019993 .
doi: 10.1136/jnis-2022-019993
Hohenstatt S, Ulfert C, Herweh C, Hilgenfeld T, Schmitt N, Schönenberger S, et al. Long-term Follow-up After Aneurysm Treatment with the Flow Redirection Endoluminal Device (FRED) Flow Diverter. Clin Neuroradiol. 2023; https://doi.org/10.1007/s00062-023-01346-3 .
doi: 10.1007/s00062-023-01346-3 pubmed: 37833546 pmcid: 10881684
Bonafe A, Perez MA, Henkes H, Lylyk P, Bleise C, Gascou G, et al. Diversion-p64: results from an international, prospective, multicenter, single-arm post-market study to assess the safety and effectiveness of the p64 flow modulation device. J Neurointerventional Surg. 2022;14:898–903. https://doi.org/10.1136/neurintsurg-2021-017809 .
doi: 10.1136/neurintsurg-2021-017809
Aguilar Pérez M, Bhogal P, Henkes E, Ganslandt O, Bäzner H, Henkes H. In-stent Stenosis after p64 Flow Diverter Treatment. Clin Neuroradiol. 2018;28:563–8. https://doi.org/10.1007/s00062-017-0591-y .
doi: 10.1007/s00062-017-0591-y pubmed: 28488025
Inoue T, Croce K, Morooka T, Sakuma M, Node K, Simon DI. Vascular Inflammation and Repair. JACC Cardiovasc Interv. 2011;4:1057–66. https://doi.org/10.1016/j.jcin.2011.05.025 .
doi: 10.1016/j.jcin.2011.05.025 pubmed: 22017929 pmcid: 3341937
Mitra AK. In stent restenosis: bane of the stent era. J Clin Pathol. 2006;59:232–9. https://doi.org/10.1136/jcp.2005.025742 .
doi: 10.1136/jcp.2005.025742 pubmed: 16505271 pmcid: 1860348
Grewe PH, Deneke T, Machraoui A, Barmeyer J, Müller K‑M. Acute and chronic tissue response to coronary stent implantation: pathologic findings in human specimen. J Am Coll Cardiol. 2000;35:157–63. https://doi.org/10.1016/S0735-1097(99)00486-6 .
doi: 10.1016/S0735-1097(99)00486-6 pubmed: 10636274
Ravindran K, Salem MM, Alturki AY, Thomas AJ, Ogilvy CS, Moore JM. Endothelialization following Flow Diversion for Intracranial Aneurysms: A Systematic Review. Ajnr Am J Neuroradiol. 2019;40:295–301. https://doi.org/10.3174/ajnr.A5955 .
doi: 10.3174/ajnr.A5955 pubmed: 30679207 pmcid: 7028638
Bender MT, Jiang B, Campos JK, Lin L‑M, Beaty N, Vo CD, et al. Single-stage flow diversion with adjunctive coiling for cerebral aneurysm: outcomes and technical considerations in 72 cases. J Neurointerventional Surg. 2018;10:843–50. https://doi.org/10.1136/neurintsurg-2017-013739 .
doi: 10.1136/neurintsurg-2017-013739
Vollherbst DF, Lücking H, DuPlessis J, Sonnberger M, Maurer C, Kocer N, et al. The FRESH Study: Treatment of Intracranial Aneurysms with the New FRED X Flow Diverter with Antithrombotic Surface Treatment Technology—First Multicenter Experience in 161 Patients. Am J Neuroradiol. 2023;44:474–80. https://doi.org/10.3174/ajnr.A7834 .
doi: 10.3174/ajnr.A7834 pubmed: 36997283 pmcid: 10084892
De Villiers L, Carraro DNV, Domitrovic L, Dhillon PS, Vanguard Study RH. Initial experience with the new fourth generation Pipeline Vantage Flow Diverter (PVFD): 6‑month results, technical and clinical considerations. J Neurointerventional Surg. 2024; https://doi.org/10.1136/jnis-2023-021182 .
doi: 10.1136/jnis-2023-021182
Ernst M, Jamous A, Bartl M, Riedel C, Holtmannspötter M, Voit-Höhne H, et al. Multicenter study of the safety and effectiveness of intracranial aneurysm treatment with the p64MW-HPC flow modulation device. Interv Neuroradiol. 2023; https://doi.org/10.1177/15910199231220964 .
doi: 10.1177/15910199231220964 pubmed: 38105527
Petrov A, Rentsenkhuu G, Nota B, Ganzorig E, Regzengombo B, Jagusch S, et al. Initial experience with the novel p64MW HPC flow diverter from a cohort study in unruptured anterior circulation aneurysms under dual antiplatelet medication. Interv Neuroradiol. 2021;27:42–50. https://doi.org/10.1177/1591019920939845 .
doi: 10.1177/1591019920939845 pubmed: 32640858
Sciacca S, Bassiouny A, Mansoor N, Minett T, Balasundaram P, Siddiqui J, et al. Early Outcomes of the Pipeline Vantage Flow Diverter: A Multicentre Study. Clin Neuroradiol. 2023;33:887–96. https://doi.org/10.1007/s00062-023-01314-x .
doi: 10.1007/s00062-023-01314-x pubmed: 37378843
Guimaraens L, Saldaña J, Vivas E, Cifuentes S, Balaguer E, Mon D, et al. Flow diverter stents for endovascular treatment of aneurysms: a comparative study of efficacy and safety between FREDX and FRED. J Neurointerventional Surg. 2024; https://doi.org/10.1136/jnis-2023-021103 .
doi: 10.1136/jnis-2023-021103
Manning NW, Cheung A, Phillips TJ, Wenderoth JD. Pipeline shield with single antiplatelet therapy in aneurysmal subarachnoid haemorrhage: multicentre experience. J Neurointerventional Surg. 2019;11:694–8. https://doi.org/10.1136/neurintsurg-2018-014363 .
doi: 10.1136/neurintsurg-2018-014363
Pierot L, Lamin S, Barreau X, Berlis A, Ciceri E, Cohen JE, et al. Coating (Coating to Optimize Aneurysm Treatment in the New Flow Diverter Generation) study. The first randomized controlled trial evaluating a coated flow diverter (p64 MW HPC): study design. J Neurointerventional Surg. 2023;15:684–8. https://doi.org/10.1136/neurintsurg-2022-018969 .
doi: 10.1136/neurintsurg-2022-018969
Caroff J, King RM, Ughi GJ, Marosfoi M, Langan ET, Raskett C, et al. Longitudinal Monitoring of Flow-Diverting Stent Tissue Coverage After Implant in a Bifurcation Model Using Neurovascular High-Frequency Optical Coherence Tomography. Neurosurgery. 2020;87:1311–9. https://doi.org/10.1093/neuros/nyaa208 .
doi: 10.1093/neuros/nyaa208 pubmed: 32463884 pmcid: 7666887
Monteiro A, Lopes DK, Aghaebrahim A, Hanel R. Optical coherence tomography for elucidation of flow-diversion phenomena: The concept of endothelized mural thrombus behind reversible in-stent stenosis in flow-diverters. Interv Neuroradiol. 2021;27:774–80. https://doi.org/10.1177/15910199211003432 .
doi: 10.1177/15910199211003432 pubmed: 33752477 pmcid: 8673897
Anagnostakou V, Ughi GJ, Puri AS, Gounis MJ. Optical Coherence Tomography for Neurovascular Disorders. Neuroscience. 2021;474:134–44. https://doi.org/10.1016/j.neuroscience.2021.06.008 .
doi: 10.1016/j.neuroscience.2021.06.008 pubmed: 34126186
Ughi GJ, Marosfoi MG, King RM, Caroff J, Peterson LM, Duncan BH, et al. A neurovascular high-frequency optical coherence tomography system enables in situ cerebrovascular volumetric microscopy. Nat Commun. 2020;11:3851. https://doi.org/10.1038/s41467-020-17702-7 .
doi: 10.1038/s41467-020-17702-7 pubmed: 32737314 pmcid: 7395105
Becske T, Kallmes DF, Saatci I, McDougall CG, Szikora I, Lanzino G, et al. Pipeline for Uncoilable or Failed Aneurysms: Results from a Multicenter Clinical Trial. Radiology. 2013;267:858–68. https://doi.org/10.1148/radiol.13120099 .
doi: 10.1148/radiol.13120099 pubmed: 23418004
Becske T, Potts MB, Shapiro M, Kallmes DF, Brinjikji W, Saatci I, et al. Pipeline for uncoilable or failed aneurysms: 3‑year follow-up results. J Neurosurg. 2017;127:81–8. https://doi.org/10.3171/2015.6.JNS15311 .
doi: 10.3171/2015.6.JNS15311 pubmed: 27739944
Nordmeyer H, Schwab R. Behme D P078/182 The derivo 2 heal embolization device in the treatment of ruptured and unruptured intracranial aneurysms: a retrospective multicenter analysis. J NeuroIntervent Surg. 2023;15:A47. https://jnis.bmj.com/content/15/Suppl_2/A47.2

Auteurs

Roland Schwab (R)

University Clinic for Neuroradiology, Medical Faculty and University Hospital, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany. Schwab.Roland@outlook.de.
Research Campus STIMULATE, Otto-von-Guericke University Magdeburg, Magdeburg, Germany. Schwab.Roland@outlook.de.

Christoph Kabbasch (C)

Department of Radiology and Neuroradiology, Faculty of Medicine and University Hospital, University of Cologne, Cologne, Germany.

Lukas Goertz (L)

Department of Radiology and Neuroradiology, Faculty of Medicine and University Hospital, University of Cologne, Cologne, Germany.

Marius Kaschner (M)

Department of Diagnostic and Interventional Radiology, Medical Faculty, University Düsseldorf, Düsseldorf, Germany.

Daniel Weiss (D)

Department of Diagnostic and Interventional Radiology, Medical Faculty, University Düsseldorf, Düsseldorf, Germany.

Christian Loehr (C)

Department of Radiology and Neuroradiology, Klinikum Vest, Recklinghausen, Germany.

Hauke Wensing (H)

Department of Radiology and Neuroradiology, Klinikum Vest, Recklinghausen, Germany.

Maxim Bester (M)

Department of Diagnostic and Interventional Neuroradiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Andreas Simgen (A)

Department for Neuroradiology, Westpfalz-Klinikum Kaiserslautern, Kaiserslautern, Germany.

André Kemmling (A)

Department of Neuroradiology, University Marburg, Marburg, Germany.

Christina Wendl (C)

University Hospital Regensburg, Institute of Radiology, Regensburg, Germany.

Erelle Fuchs (E)

University Clinic for Neuroradiology, Medical Faculty and University Hospital, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany.

Maximilian Thormann (M)

University Clinic for Neuroradiology, Medical Faculty and University Hospital, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany.

Daniel Behme (D)

University Clinic for Neuroradiology, Medical Faculty and University Hospital, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany.
Research Campus STIMULATE, Otto-von-Guericke University Magdeburg, Magdeburg, Germany.

Hannes Nordmeyer (H)

Department of Neuroradiology Städtisches Klinikum Solingen, Solingen, Germany.
Medical School, Department of Health, Witten/Herdecke University, Witten, Germany.

Classifications MeSH