97 results on '"Papagiannaki C"'
Search Results
2. O-057 Instant study: a recent evaluation of coiling in aneurysm treatment
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Pierot, L, primary, Eker, O, additional, Berge, J, additional, Gentric, J, additional, Lévrier, O, additional, Kucps, K, additional, Barbier, C, additional, Vega, A, additional, Beaujeux, R, additional, Lopez-Martinez, J, additional, Chabert, E, additional, Rodriguez, C, additional, Valvassori, L, additional, Papagiannaki, C, additional, Ianucci, G, additional, Muto, M, additional, Costalat, V, additional, Machi, P, additional, Giweski, E, additional, White, P, additional, Herbreteau, D, additional, and Januel, A, additional
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- 2023
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3. Direct Aspiration versus Combined Technique for Distal Medium-Vessel Occlusions: Comparison on a Human Placenta Model
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Burel, J., primary, Gerardin, E., additional, Papagiannaki, C., additional, Shotar, E., additional, Sourour, N., additional, Laporte, C., additional, Hermet, P.-L., additional, Premat, K., additional, Dacher, J.-N., additional, and Clarençon, F., additional
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- 2023
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4. O02 CLEVER: clinical evaluation of WEB 0.017 device in Intracranial AneuRysms Safety results for ruptured and unruptured aneurysm at 30 days
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Szikora, I, primary, Cognard, C, additional, Costalat, V, additional, Wodarg, F, additional, Herbreteau, D, additional, Fischer, S, additional, Möhlenbruch, M, additional, Papagiannaki, C, additional, Klisch, J, additional, Rautio, R, additional, Numminen, J, additional, Berlis, A, additional, Downer, J, additional, Bester, M, additional, Velasco, S, additional, Liebig, T, additional, Byrne, J, additional, Pierot, L, additional, and Spelle, L, additional
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- 2022
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5. O-003 CLEVER: clinical evaluation of WEB 17 device in intracranial aneurysms. safety results for ruptured and unruptured aneurysm at 30 days
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Spelle, L, primary, Cognard, C, additional, Szikora, I, additional, Costalat, V, additional, Wodarg, F, additional, Herbreteau, D, additional, Fischer, S, additional, Möhlenbruch, M, additional, Papagiannaki, C, additional, Klisch, J, additional, Rautio, R, additional, Numminen, J, additional, Berlis, A, additional, Downer, J, additional, Bester, M, additional, Velasco, S, additional, Liebig, T, additional, Byrne, J, additional, and Pierot, L, additional
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- 2022
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6. Follow-up of Intracranial Aneurysms Treated by Flow Diverters: Evaluation of Parent Artery Patency Using 3D-T1 Gradient Recalled-Echo Imaging with 2-Point Dixon in Combination with 3D-TOF-MRA with Compressed Sensing
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Burel, J., primary, Gerardin, E., additional, Vannier, M., additional, Curado, A., additional, Verdalle-Cazes, M, additional, Magne, N., additional, Lefebvre, M., additional, and Papagiannaki, C., additional
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- 2022
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7. Retreatment of previously treated intracranial aneurysm: Procedural complications and risk factors for complications
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Metayer, T., primary, Lechanoine, F., additional, Bougaci, N., additional, de Schlichting, E., additional, Terrier, L., additional, Derrey, S., additional, Barbier, C., additional, Papagiannaki, C., additional, Ashraf, A., additional, Tahon, F., additional, Leplus, A., additional, Gay, E., additional, Emery, E., additional, Briant, A.R., additional, Vivien, D., additional, and Gaberel, T., additional
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- 2022
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8. Time to treatment with bridging intravenous alteplase before endovascular treatment: subanalysis of the randomized controlled SWIFT-DIRECT trial
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Meinel, TR, Kaesmacher, J, Buetikofer, L, Strbian, D, Eker, OF, Cognard, C, Mordasini, P, Deppeler, S, Pereira, VM, Albucher, JF, Darcourt, J, Bourcier, R, Guillon, B, Papagiannaki, C, Costentin, G, Sibolt, G, Raty, S, Gory, B, Richard, S, Liman, J, Ernst, M, Boulanger, M, Barbier, C, Mechtouff, L, Zhang, LQ, Marnat, G, Sibon, I, Nikoubashman, O, Reich, A, Consoli, A, Weisenburger, D, Requena, M, Garcia-Tornel, A, Saleme, S, Moulin, S, Pagano, P, Saliou, G, Carrera, E, Janot, K, Boix, M, Pop, R, Della Schiava, L, Luft, A, Piotin, M, Gentric, JC, Pikula, A, Pfeilschifter, W, Arnold, M, Siddiqui, A, Froehler, MT, Furlan, AJ, Chapot, R, Wiesmann, M, Machi, P, Diener, HC, Kulcsar, Z, Bonati, L, Bassetti, C, Escalard, S, Liebeskind, D, Saver, JL, Fischer, U, and Gralla, J
- Abstract
Background We hypothesized that treatment delays might be an effect modifier regarding risks and benefits of intravenous thrombolysis (IVT) before mechanical thrombectomy (MT). Methods We used the dataset of the SWIFT-DIRECT trial, which randomized 408 patients to IVT+MT or MT alone. Potential interactions between assignment to IVT+MT and expected time from onset-to-needle (OTN) as well as expected time from door-to-needle (DTN) were included in regression models. The primary outcome was functional independence (modified Rankin Scale (mRS) 0-2) at 3 months. Secondary outcomes included mRS shift, mortality, recanalization rates, and (symptomatic) intracranial hemorrhage at 24 hours. Results We included 408 patients (IVT+MT 207, MT 201, median age 72 years (IQR 64-81), 209 (51.2%) female). The expected median OTN and DTN were 142 min and 54 min in the IVT+MT group and 129 min and 51 min in the MT alone group. Overall there was no significant interaction between OTN and bridging IVT assignment regarding either the functional (adjusted OR (aOR) 0.76, 95% CI 0.45 to 1.30) and safety outcomes or the recanalization rates. Analysis of in-hospital delays showed no significant interaction between DTN and bridging IVT assignment regarding the dichotomized functional outcome (aOR 0.48, 95% CI 0.14 to 1.62), but the shift and mortality analyses suggested a greater benefit of IVT when in-hospital delays were short. Conclusions We found no evidence that the effect of bridging IVT on functional independence is modified by overall or in-hospital treatment delays. Considering its low power, this subgroup analysis could have missed a clinically important effect, and exploratory analysis of secondary clinical outcomes indicated a potentially favorable effect of IVT with shorter in-hospital delays. Heterogeneity of the IVT effect size before MT should be further analyzed in individual patient meta-analysis of comparable trials.
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- 2022
9. Mechanical thrombectomy practices in France: Exhaustive survey of centers and individual operators
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Forestier, Géraud, primary, Kerleroux, Basile, additional, Janot, Kévin, additional, Zhu, François, additional, Dumas, Victor, additional, Hak, Jean-François, additional, Shotar, Eimad, additional, Ben Hassen, Wagih, additional, Bourcier, Romain, additional, Soize, Sébastien, additional, Berge, Jérome, additional, Naggara, Olivier, additional, Desal, Hubert, additional, Boulouis, Grégoire, additional, Rouchaud, Aymeric, additional, Hanafi, R., additional, L’Allinec, V., additional, Girot, J.-B., additional, Charbonnier, G., additional, Biondi, A., additional, Gariel, F., additional, Marnat, G., additional, Ognard, J., additional, Gentric, J.-C., additional, Barbier, C., additional, Chabert, E., additional, Lebedinsky, P., additional, Tuilier, T., additional, Thouant, P., additional, Comby, P.-O., additional, Mejdoubi, M., additional, Heck, O., additional, Kastler, A., additional, Chalumeau, V., additional, Caroff, J., additional, Personnic, T., additional, Marchal, A., additional, Bogey, C., additional, Eker, O., additional, Carle, X., additional, Dargazanli, C., additional, Derraz, I., additional, Gory, B., additional, Detraz, L., additional, Sedat, J., additional, Zurlinden, O., additional, Escalard, S., additional, Fahed, R., additional, Guedon, A., additional, Civelli, V., additional, Premat, K., additional, Clarençon, F., additional, Ducouret, E., additional, Raynaud, N., additional, Velasco, S., additional, Manceau, P.-F., additional, Paya, C., additional, Eugene, F., additional, Le Moa, J., additional, Papagiannaki, C., additional, Aggour, M., additional, Bintner, M., additional, Veyrieres, J.-B., additional, Richter, J.S., additional, Pop, R., additional, Consoli, A., additional, Di-Maria, F., additional, Arteaga, C., additional, Darcourt, J., additional, Michelozzi, C., additional, Guedin, P., additional, Herbreteau, D., additional, and Le Bras, A., additional
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- 2020
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10. La modification de forme du dispositif WEB influence-t-elle l’évolution de l’occlusion anévrismale ? Suivi à long terme de 50 patients
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Herbreteau, D., primary, Janot, K., additional, Boustia, F., additional, Narata, A.P., additional, Papagiannaki, C., additional, and Bibi, R., additional
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- 2018
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11. La thérapie combinée par fibrinolyse intraveineuse et thrombectomie est-elle requise en cas d’occlusion de la terminaison carotidienne ?
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Alexandre, P.-L., primary, Bourcier, R., additional, Eugène, F., additional, Delasalle-Guyomarch, B., additional, Guillon, B., additional, Kerleroux, B., additional, Saleme, S., additional, Marnat, G., additional, Boucebci, S., additional, Mirza, M., additional, Ferré, J.-C., additional, Papagiannaki, C., additional, and Desal, H., additional
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- 2018
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12. Are Anatomic Results Influenced by WEB Shape Modification? Analysis in a Prospective, Single-Center Series of 39 Patients with Aneurysms Treated with the WEB
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Herbreteau, D., primary, Bibi, R., additional, Narata, A.P., additional, Janot, K., additional, Papagiannaki, C., additional, Soize, S., additional, and Pierot, L., additional
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- 2016
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13. Quadruple Spontaneous Cervical Artery Dissection Following Aneurysm Embolization: A Rare Posttreatment Complication
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Papagiannaki, C., Cottier, J.P., Barbier, C., Bibi, R., and Herbreteau, D.
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Adult ,Radiography ,Vertebral Artery Dissection ,Cervical Vertebrae ,Humans ,Female ,Intracranial Aneurysm ,cardiovascular diseases ,Case Reports ,Aneurysm, Ruptured ,Embolization, Therapeutic - Abstract
We present a unique case of multiple sCADs occurring after a ruptured intracranial aneurysm embolization. We discuss the impact of head extension during embolization as the prevailing factor in multiple artery dissections in this case and point out another cause of new-onset neurologic deficit in patients with aneurysmal SAH.
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- 2011
14. Susceptibility Vessel Sign on MRI Predicts Favorable Clinical Outcome in Patients with Anterior Circulation Acute Stroke Treated with Mechanical Thrombectomy
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Bourcier, R., primary, Volpi, S., additional, Guyomarch, B., additional, Daumas-Duport, B., additional, Lintia-Gaultier, A., additional, Papagiannaki, C., additional, Serfaty, J.M., additional, and Desal, H., additional
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- 2015
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15. WEB Intrasaccular Flow Disruptor—Prospective, Multicenter Experience in 83 Patients with 85 Aneurysms
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Papagiannaki, C., primary, Spelle, L., additional, Januel, A.-C., additional, Benaissa, A., additional, Gauvrit, J.-Y., additional, Costalat, V., additional, Desal, H., additional, Turjman, F., additional, Velasco, S., additional, Barreau, X., additional, Courtheoux, P., additional, Cognard, C., additional, Herbreteau, D., additional, Moret, J., additional, and Pierot, L., additional
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- 2014
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16. Nouvelle approche dans le traitement endovasculaire des anévrismes intracrâniens : étude multicentrique française. À propos de 83 anévrismes traités par WEB
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Herbreteau, D., primary, Papagiannaki, C., additional, Januel, A.-C., additional, Spelle, L., additional, Raoult, H., additional, Desal, H., additional, Barreau, X., additional, Courtheoux, P., additional, Costalat, V., additional, Turjman, F., additional, Kadziolka, K., additional, Gauvrit, J.-Y., additional, Bibi, R., additional, Moret, J., additional, Cognard, C., additional, and Pierot, L., additional
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- 2014
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17. O-013 Intra-aneurysmal Flow Disruption: a New Approach for the Endovascular Treatment of Intracranial Aneurysms. French Clinical Experience
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Pierot, L, primary, Januel, A, additional, Raoult, H, additional, Spelle, L, additional, Papagiannaki, C, additional, Desal, H, additional, Courtheoux, P, additional, Kadziolka, K. Krzysztof, additional, Gauvrit, J, additional, Moret, J, additional, Herbreteau, D, additional, and Cognard, C, additional
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- 2013
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18. Intracranial dissection: Incidence and long term endovascular treatment results of a not so rare disease
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Bourcier, R., primary, Papagiannaki, C., additional, Bibi, R., additional, Cottier, J.P., additional, and Herbreteau, D., additional
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- 2012
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19. Suivi à très long terme de 20 stents carotidiens type Carotid Wallstent
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Lauvin, M.-A., primary, Cazals, X., additional, Papagiannaki, C., additional, Bibi, R., additional, Bleuzen, A., additional, and Herbreteau, D., additional
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- 2012
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20. Quadruple Spontaneous Cervical Artery Dissection Following Aneurysm Embolization: A Rare Posttreatment Complication: Fig 1.
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Papagiannaki, C., primary, Cottier, J.P., additional, Barbier, C., additional, Bibi, R., additional, and Herbreteau, D., additional
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- 2010
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21. Embolization of Brain Arteriovenous Malformations for Cure: Because We Could and Because We Should
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Katsaridis, V., primary, Papagiannaki, C., additional, and Aimar, E., additional
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- 2009
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22. Local Intra-Arterial Eptifibatide for Intraoperative Vessel Thrombosis during Aneurysm Coiling
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Katsaridis, V., primary, Papagiannaki, C., additional, Skoulios, N., additional, Achoulias, I., additional, and Peios, D., additional
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- 2008
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23. Retreatment of previously treated intracranial aneurysm: Procedural complications and risk factors for complications
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Metayer, T., Lechanoine, F., Bougaci, N., de Schlichting, E., Terrier, L., Derrey, S., Barbier, C., Papagiannaki, C., Ashraf, A., Tahon, F., Leplus, A., Gay, E., Emery, E., Briant, A.R., Vivien, D., and Gaberel, T.
- Abstract
Intracranial aneurysm (IA) is a frequent vascular malformation that can be managed by endovascular treatment (EVT) or microsurgery. A previously treated IA can recanalize, which may require further treatment. The aim of our study was to evaluate procedural complications related to IA retreatment and their risk factors.
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- 2021
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24. Bridging therapy or IV thrombolysis in minor stroke with large vessel occlusion
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Gioia Mione, Pierre Seners, Isabelle Girard Buttaz, Claire Perrin, Guillaume Turc, Ruben Tamazyan, Jean-Claude Baron, Hilde Hénon, Denis Sablot, Bertrand Lapergue, Cécile Preterre, Nadia Laksiri, Ludovic Lucas, Séverine Debiais, Caroline Arquizan, Institut de psychiatrie et neurosciences de Paris (IPNP - U1266 Inserm), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP), Hôpital Foch [Suresnes], Département de neurologie[Lille], Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Centre Hospitalier Saint Jean de Perpignan, Neurologie - Centre Hospitalier de Valenciennes (CHV), Centre hospitalier Saint-Joseph [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de neurologie [Nantes], Université de Nantes (UN)-Centre hospitalier universitaire de Nantes (CHU Nantes)-Hôpital Guillaume-et-René-Laennec [Saint-Herblain], Neurologie, maladies neuro-musculaires [Hôpital de la Timone - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Service de neurologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Département de neurologie [Montpellier], Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Gui de Chauliac [Montpellier]-Université de Montpellier (UM), Hôpital Pellegrin, CHU Bordeaux [Bordeaux]-Groupe hospitalier Pellegrin, MINOR-STROKE collaborators : Achard S, Agius P, Alamowitch S, Arteaga C, Bennani O, Ben Hassen W, Ben Maacha M, Berthezene Y, Boulanger M, Boutet C, Bracard S, Bricout N, Brunel H, Cakmak S, Charron S, Charron V, Chassin O, Clarençon F, Chbicheb M, Consoli A, Cottier JP, Courselle-Arnoux A, Dargazanli C, Denier C, Dereeper O, Derex L, Desal H, Detante O, Duong DL, Fraticelli L, Gazzola S, Garnier P, Grigoras V, Gouttard S, Guedon A, Hattinguais J, Henri C, Klapczynski F, Lamy C, Ledure S, Leys D, Lopez D, Lun F, Lyoubi A, Malbranque A, Marcel S, Louis Mas J, Masson M, Mechtouff L, Mounier-Vehier F, Niclot P, Nighoghossian N, Obadia A, Oppenheim C, Papagiannaki C, Papassin J, Philippeau F, Pico F, Piotin M, Pires C, Rosso C, Samson Y, Serre I, Sibon I, Soize S, Smadja P, Spelle L, Suissa L, Triquenot A, Tuffal A, Vallet AE, Yger M, Zuber M., Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Département de neurologie [Lille], Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Gui de Chauliac [CHU Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Université de Montpellier (UM), Hôpital Gui de Chauliac [Montpellier]-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Université Montpellier 1 (UM1)-Université de Montpellier (UM), Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), and Martinez Rico, Clara
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0301 basic medicine ,Male ,medicine.medical_specialty ,Bridging (networking) ,medicine.medical_treatment ,[SDV]Life Sciences [q-bio] ,Brain Ischemia ,03 medical and health sciences ,0302 clinical medicine ,Fibrinolytic Agents ,Internal medicine ,Occlusion ,Medicine ,Humans ,Thrombolytic Therapy ,[SDV.NEU] Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC] ,Aged ,Retrospective Studies ,Thrombectomy ,Aged, 80 and over ,business.industry ,Endovascular Procedures ,Minor stroke ,Retrospective cohort study ,Odds ratio ,Thrombolysis ,Middle Aged ,Combined Modality Therapy ,Confidence interval ,3. Good health ,[SDV] Life Sciences [q-bio] ,Stroke ,030104 developmental biology ,Treatment Outcome ,Neurology ,Cardiology ,Female ,[SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC] ,Neurology (clinical) ,business ,030217 neurology & neurosurgery ,Large vessel occlusion - Abstract
OBJECTIVE Whether bridging therapy (intravenous thrombolysis [IVT] followed by endovascular treatment) is superior to IVT alone in minor stroke with large vessel occlusion (LVO) is unknown. METHODS Multicentric retrospective observational study including, in intention-to-treat, consecutive IVT-treated minor strokes (National Institutes of Health Stroke Scale [NIHSS] ≤ 5) with LVO, with or without additional mechanical thrombectomy. Propensity-score (inverse probability of treatment weighting) was used to reduce baseline between-groups differences. The primary outcome was excellent outcome, that is, modified Rankin score 0 to 1 at 3 months follow-up. RESULTS Overall, 598 patients were included (214 and 384 in the bridging therapy and IVT groups, respectively). Following propensity-score weighting, the distribution of baseline clinical and radiological variables was similar across the two patient groups. Compared with IVT alone, bridging therapy was not associated with excellent outcome (odds ratio [OR] = 0.96; 95% confidence interval [CI] = 0.75-1.24; p = 0.76), but was associated with symptomatic intracranial hemorrhage (OR = 3.01; 95% CI = 1.77-5.11; p
- Published
- 2020
25. CLinical EValuation of WEB 17 device in intracranial aneuRysms (CLEVER): 1-year effectiveness results for ruptured and unruptured aneurysms.
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Spelle L, Costalat V, Caroff J, Wodarg F, Fischer S, Herbreteau D, Möhlenbruch MA, Januel AC, Papagiannaki C, Klisch J, Numminen J, Rautio R, Berlis A, Mihalea C, Chalumeau V, Downer J, Cortese J, Ikka L, Gallas S, Bester M, Liebig T, Velasco S, Grimaldi L, Byrne J, Szikora I, Pierot L, and Cognard C
- Abstract
Background: The Woven EndoBridge (WEB) device is designed to treat wide-necked bifurcation aneurysms. The WEB 17 is the latest iteration and can be delivered through a 0.017″ microcatheter. The CLEVER study demonstrated that WEB 17 is safe and effective for providing protection against bleeding or rebleeding at 1 month and 1 year., Objective: To evaluate angiographic stability at 1 year., Methods: The CLEVER study was a prospective multicenter study conducted in 17 European centers, involved 163 subjects, comprising 60 ruptured and 103 unruptured aneurysms. Independent assessment of 1-year follow-up imaging was incorporated into the study design., Results: Aneurysm diameters ranged from 2.0 to 9.2 mm, with 95.7% being broad-based (dome-to-neck ratio <2). Follow-up imaging at 1 year was completed for 146 out of 163 subjects (89.6%) and evaluated by an independent core laboratory. The primary efficacy endpoint of adequate occlusion without re-treatment at 1 year was achieved for 120 (82.2%) of all subjects. At 1 year, the adequate occlusion rate was 86.5% for ruptured aneurysms (73.1% complete occlusion) and 82.4% for unruptured aneurysms (57.1% complete occlusion). The overall re-treatment rate at 1 year was 2.6% (4/152), with 3.1% (3/97) for unruptured aneurysms and 1.8% (1/55) for ruptured aneurysms CONCLUSION: Delivery of the WEB 17 via 0.017 inch catheters represents a significant evolution of the WEB design. The results of CLEVER presented here demonstrate that it maintains the same efficacy as previous generations of WEB., Competing Interests: Competing interests: JCa acts as associate editor for Journal of NeuroInterventional Surgery, Neuroradiology, and Journal of Neuroradiology; MAM acts as associate editor for Neuroradiology. RR acts as associate editor for Journal of Neuroradiology., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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26. Trial of Thrombectomy for Stroke with a Large Infarct of Unrestricted Size.
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Costalat V, Jovin TG, Albucher JF, Cognard C, Henon H, Nouri N, Gory B, Richard S, Marnat G, Sibon I, Di Maria F, Annan M, Boulouis G, Cardona P, Obadia M, Piotin M, Bourcier R, Guillon B, Godard S, Pasco-Papon A, Eker OF, Cho TH, Turc G, Naggara O, Velasco S, Lamy M, Clarençon F, Alamowitch S, Renu A, Suissa L, Brunel H, Gentric JC, Timsit S, Lamy C, Chivot C, Macian-Montoro F, Mounayer C, Ozkul-Wermester O, Papagiannaki C, Wolff V, Pop R, Ferrier A, Chabert E, Ricolfi F, Béjot Y, Lopez-Cancio E, Vega P, Spelle L, Denier C, Millán M, Arenillas JF, Mazighi M, Houdart E, Del Mar Freijo M, Duhamel A, Sanossian N, Liebeskind DS, Labreuche J, Lapergue B, and Arquizan C
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- Aged, Aged, 80 and over, Female, Humans, Male, Cerebral Hemorrhage etiology, Combined Modality Therapy, Endovascular Procedures, Magnetic Resonance Imaging, Tomography, X-Ray Computed, Brain Infarction diagnostic imaging, Brain Infarction etiology, Brain Infarction therapy, Acute Disease, Cerebral Arteries diagnostic imaging, Cerebral Arteries surgery, Cerebral Arterial Diseases complications, Cerebral Arterial Diseases diagnostic imaging, Cerebral Arterial Diseases pathology, Cerebral Arterial Diseases surgery, Stroke diagnostic imaging, Stroke etiology, Stroke therapy, Thrombectomy, Thrombolytic Therapy adverse effects, Thrombolytic Therapy methods, Infarction, Anterior Cerebral Artery diagnostic imaging, Infarction, Anterior Cerebral Artery pathology, Infarction, Anterior Cerebral Artery surgery
- Abstract
Background: The use of thrombectomy in patients with acute stroke and a large infarct of unrestricted size has not been well studied., Methods: We assigned, in a 1:1 ratio, patients with proximal cerebral vessel occlusion in the anterior circulation and a large infarct (as defined by an Alberta Stroke Program Early Computed Tomographic Score of ≤5; values range from 0 to 10) detected on magnetic resonance imaging or computed tomography within 6.5 hours after symptom onset to undergo endovascular thrombectomy and receive medical care (thrombectomy group) or to receive medical care alone (control group). The primary outcome was the score on the modified Rankin scale at 90 days (scores range from 0 to 6, with higher scores indicating greater disability). The primary safety outcome was death from any cause at 90 days, and an ancillary safety outcome was symptomatic intracerebral hemorrhage., Results: A total of 333 patients were assigned to either the thrombectomy group (166 patients) or the control group (167 patients); 9 were excluded from the analysis because of consent withdrawal or legal reasons. The trial was stopped early because results of similar trials favored thrombectomy. Approximately 35% of the patients received thrombolysis therapy. The median modified Rankin scale score at 90 days was 4 in the thrombectomy group and 6 in the control group (generalized odds ratio, 1.63; 95% confidence interval [CI], 1.29 to 2.06; P<0.001). Death from any cause at 90 days occurred in 36.1% of the patients in the thrombectomy group and in 55.5% of those in the control group (adjusted relative risk, 0.65; 95% CI, 0.50 to 0.84), and the percentage of patients with symptomatic intracerebral hemorrhage was 9.6% and 5.7%, respectively (adjusted relative risk, 1.73; 95% CI, 0.78 to 4.68). Eleven procedure-related complications occurred in the thrombectomy group., Conclusions: In patients with acute stroke and a large infarct of unrestricted size, thrombectomy plus medical care resulted in better functional outcomes and lower mortality than medical care alone but led to a higher incidence of symptomatic intracerebral hemorrhage. (Funded by Montpellier University Hospital; LASTE ClinicalTrials.gov number, NCT03811769.)., (Copyright © 2024 Massachusetts Medical Society.)
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- 2024
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27. Impact of Day 1 carotid patency on outcome in dissection-related tandem occlusions treated with mechanical thrombectomy.
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Perrin G, Molinier E, Gory B, Kyheng M, Labreuche J, Pasi M, Janot K, Bourcier R, Sibon I, Consoli A, Desilles JP, Olivot JM, Papagiannaki C, Soize S, Gentric JC, Dargazanli C, Caroff J, Pop R, Naggara O, Moulin S, Eker O, Alias Q, Clarençon F, Lapergue B, and Marnat G
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- Humans, Prospective Studies, Treatment Outcome, Thrombectomy methods, Carotid Artery, Internal diagnostic imaging, Carotid Artery, Internal surgery, Retrospective Studies, Stents adverse effects, Endovascular Procedures methods, Stroke diagnostic imaging, Stroke surgery, Stroke etiology
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Background: The clinical benefit of mechanical thrombectomy(MT) for stroke patients with tandem occlusion is similar to that of isolated intracranial occlusions. However, the management of cervical internal carotid artery(ICA) occlusion during the MT, particularly in the setting of carotid dissection, remains controversial. We aimed to investigate the clinical impact of cervical ICA patency at day 1 on 3-month functional outcome., Methods: We collected data from the Endovascular Treatment in Ischemic Stroke, a prospective national registry in 30 French centers performing MT between January 2015 and January 2022. Inclusion criteria were consecutive tandem occlusions related to cervical ICA dissection treated with MT. Tandem occlusions of other etiology, isolated cervical ICA occlusions without intracranial thrombus and patients without day-1 ICA imaging were excluded. Primary endpoint was the 3-month functional outcome. Secondary endpoints included intracranial hemorrhage(ICH), excellent outcome, mortality and early neurological improvement. A sensitivity analysis was performed in patients with intracranial favorable recanalization after MT., Results: During the study period, 137 patients were included of which 89(65%) presented ICA patency at day 1. The odds of favorable outcome did not significantly differ between patients with patent and occluded ICA at day 1(68.7 vs 59.1%;aOR=1.30;95%CI 0.56-3.00,p=0.54). Excellent outcome, early neurological improvement, mortality and ICH were also comparable between groups. Sensitivity analysis showed similar results., Conclusion: ICA patency at day 1 in patients with tandem occlusions related to dissection did not seem to influence functional outcome. Endovascular recanalization of the cervical ICA including stenting might not be systematically required in this setting., Competing Interests: Declaration of competing interest The authors have no disclosure related to the present publication., (Copyright © 2024 The Author(s). Published by Elsevier Masson SAS.. All rights reserved.)
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- 2024
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28. MRI vs CT for Baseline Imaging Evaluation in Acute Large Artery Ischemic Stroke: A Subanalysis of the SWIFT-DIRECT Trial
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Fladt J, Kaesmacher J, Meinel TR, Bütikofer L, Strbian D, Eker OF, Albucher JF, Desal H, Marnat G, Papagiannaki C, Richard S, Requena M, Lapergue B, Pagano P, Ernst M, Wiesmann M, Boulanger M, Liebeskind DS, Gralla J, and Fischer U
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- Humans, Arteries, Computed Tomography Angiography, Magnetic Resonance Imaging, Ischemic Stroke, Stroke diagnostic imaging, Stroke drug therapy, Stroke surgery
- Abstract
Background and Objectives: Whether MRI or CT is preferable for the evaluation of patients with suspected stroke remains a matter of debate, given that the imaging modality acquired at baseline may be a relevant determinant of workflow delays and outcomes with it, in patients with stroke undergoing acute reperfusion therapies., Methods: In this post hoc analysis of the SWIFT-DIRECT trial that investigated noninferiority of thrombectomy alone vs IV thrombolysis (IVT) + thrombectomy in patients with an acute ischemic anterior circulation large vessel occlusive stroke eligible to receive IVT within 4.5 hours after last seen well, we tested for a potential interaction between baseline imaging modality (MRI/MR-angiography [MRA] vs CT/CT-angiography [CTA]) and the effect of acute treatment (thrombectomy vs IVT + thrombectomy) on clinical and safety outcomes and procedural metrics (primary analysis). Moreover, we examined the association between baseline imaging modality and these outcomes using regression models adjusted for age, sex, baseline NIH Stroke Scale (NIHSS), occlusion location, and Alberta Stroke Program Early CT Score (ASPECTS) (secondary analysis). Endpoints included workflow times, the modified Rankin scale (mRS) score at 90 days, the rate of successful reperfusion, the odds for early neurologic deterioration within 24 hours, and the risk of symptomatic intracranial hemorrhage. The imaging modality acquired was chosen at the discretion of the treating physicians and commonly reflects center-specific standard procedures., Results: Four hundred five of 408 patients enrolled in the SWIFT-DIRECT trial were included in this substudy. Two hundred (49.4%) patients underwent MRI/MRA, and 205 (50.6%) underwent CT/CTA. Patients with MRI/MRA had lower NIHSS scores (16 [interquartile range (IQR) 12-20] vs 18 [IQR 14-20], p = 0.012) and lower ASPECTS (8 [IQR 6-9] vs 8 [IQR 7-9], p = 0.021) compared with those with CT/CTA. In terms of the primary analysis, we found no evidence for an interaction between baseline imaging modality and the effect of IVT + thrombectomy vs thrombectomy alone. Regarding the secondary analysis, MRI/MRA acquisition was associated with workflow delays of approximately 20 minutes, higher odds of functional independence at 90 days (adjusted odds ratio [aOR] 1.65, 95% CI 1.07-2.56), and similar mortality rates (aOR 0.73, 95% CI 0.36-1.47) compared with CT/CTA., Discussion: This post hoc analysis does not suggest treatment effect heterogeneity of IVT + thrombectomy vs thrombectomy alone in large artery stroke patients with different imaging modalities. There was no evidence that functional outcome at 90 days was less favorable following MRI/MRA at baseline compared with CT/CTA, despite significant workflow delays., Trial Registration Information: ClinicalTrials.gov Identifier: NCT03192332.
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- 2024
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29. Comparison of three antithrombotic strategies for emergent carotid stenting during stroke thrombectomy: a multicenter study.
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Pop R, Burel J, Finitsis SN, Papagiannaki C, Severac F, Mangin PH, Mihoc D, Leonard-Lorant I, Gheoca R, Wolff V, Chibbaro S, Sibon I, Richard S, Beaujeux R, Marnat G, and Gory B
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- Humans, Fibrinolytic Agents, Stents adverse effects, Treatment Outcome, Thrombectomy adverse effects, Aspirin therapeutic use, Heparin, Retrospective Studies, Carotid Stenosis diagnostic imaging, Carotid Stenosis drug therapy, Carotid Stenosis surgery, Stroke diagnostic imaging, Stroke drug therapy, Stroke surgery, Thrombosis etiology, Endovascular Procedures adverse effects
- Abstract
Background: Periprocedural antithrombotic treatment is a key determinant for the risk-benefit balance of emergent carotid artery stenting (eCAS) during stroke thrombectomy. We aimed to assess the safety and efficacy of three types of antithrombotic treatment., Methods: Retrospective review of prospectively collected endovascular databases in four comprehensive stroke centers, including consecutive cases of eCAS for tandem lesion strokes between January 2019 and July 2021. During this period, each center prospectively applied one of three periprocedural protocols: (a) two centers administered aspirin (250 mg IV); (b) one center administered aspirin and heparin (bolus+24 hours infusion); and (c) one center applied an aggressive antiplatelet strategy consisting of aspirin and clopidogrel (loading doses), with added intravenous tirofiban if in-stent thrombosis was observed during thrombectomy. Dichotomized comparisons of outcomes were performed between aggressive versus non-aggressive strategy (aspirin±heparin) and aspirin+heparin versus aspirin-alone groups., Results: Among 161 included patients, 62 received aspirin monotherapy, 38 aspirin+heparin, and 61 an aggressive treatment. Aggressive antiplatelet treatment was associated with an increased rate of excellent (modified Thrombolysis in Cerebral Infarction (mTICI) 2c-3) recanalization and reduced carotid stent thrombosis at day 1 (3.5% vs 16.3%), compared with non-aggressive strategy. There were no significant differences in hemorrhagic transformation or 90-day mortality. There was a tendency towards better clinical outcome with aggressive treatment, without reaching statistical significance. Addition of heparin to aspirin was not associated with an increased rate of carotid stent patency., Conclusions: Aggressive antiplatelet treatment was associated with improved intracranial recanalization and carotid stent patency, without safety concerns. These findings have implications for randomized trials and may be of utility for clinicians when making antithrombotic treatment choices., Competing Interests: Competing interests: SNF: patents planned, issued or pending: US11166738B2. IS: consulting fees from Sanofi Synthé-Labo, Servier, Boheringer Ingelheim, Astra-Zeneca, Novonordisk, Medtronic. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Sanofi Synthé-Labo, Medtronic, Boheringer Ingelheim, Astra-Zeneca, BMS-Pfizer. GM: consulting fees from Stryker Neurovascular, Microvention Europe, Balt. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Medtronic, Johnson and Johnson., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2023
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30. Balloon Pressure Technique with the Scepter Mini Balloon as Part of the Endovascular Strategy for Brain Arteriovenous Malformations Embolization : Preliminary Multicenter Experience.
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Clarençon F, Papagiannaki C, Saleme S, Rouchaud A, Shotar E, Rius E, Burel J, Boch AL, Sourour NA, and Mounayer C
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- Female, Humans, Adult, Retrospective Studies, Treatment Outcome, Brain, Polyvinyls, Balloon Occlusion methods, Embolization, Therapeutic methods, Arteriovenous Malformations therapy, Intracranial Arteriovenous Malformations diagnostic imaging, Intracranial Arteriovenous Malformations therapy
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Background: The balloon pressure technique (BPT) is an alternative to the pressure cooker technique. A dual lumen balloon (DLB) is used to inject the liquid embolic agent through the working lumen while the balloon is inflated. The purpose of our study was to report our early experience using the Scepter Mini dual lumen balloons for BPT in brain arteriovenous malformation (bAVM) embolization., Material and Methods: Consecutive patients treated from July 2020 to July 2021 in 3 tertiary centers using the BPT with low-profile dual lumen balloons (Scepter Mini, Microvention, Tustin, CA, USA) by endovascular means for bAVMs were retrospectively reviewed. Patient demographics and bAVM angio-architectural features were collected. The feasibility of Scepter Mini balloon navigation close to the nidus was evaluated. Technical as well as clinical (ischemic and/or hemorrhagic) complications were also systematically assessed. The occlusion rate was evaluated on follow-up DSA., Results: A total of 19 patients (10 females; mean age = 38.2 years) consecutively treated for a bAVM (8 ruptured/11 unruptured) using the BPT with a Scepter Mini through 23 embolization sessions were included in our series. Navigation of the Scepter Mini was feasible in all cases. Of the patients 3 (16%) had procedure-related ischemic stroke and 2 patients (10.5%) had late hemorrhages. None of these complications led to severe permanent sequela. Complete occlusion of bAVM embolized with intention to cure was recorded in 11/13 cases (84.6%)., Conclusion: The BPT using low-profile dual lumen balloons is feasible and seems safe for embolization of bAVMs. It may help to reach high occlusion rates, especially when performed in the intent to cure by embolization only., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)
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- 2023
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31. CLinical EValuation of WEB 17 device in intracranial aneuRysms (CLEVER): procedural, 30-day and 1-year safety results for ruptured and unruptured aneurysms.
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Spelle L, Costalat V, Caroff J, Wodarg F, Fischer S, Herbreteau D, Möhlenbruch MA, Januel AC, Papagiannaki C, Klisch J, Numminen J, Rautio R, Berlis A, Mihalea C, Chalumeau V, Downer J, Cortese J, Ikka L, Gallas S, Bester M, Liebig T, Velasco S, Grimaldi L, Byrne J, Szikora I, Pierot L, and Cognard C
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Background: Intrasaccular flow disruption is an endovascular approach for the treatment of wide-neck aneurysms and, more specifically, wide-neck bifurcation aneurysms, which are challenging to treat with previously developed technologies. The Woven EndoBridge (WEB) device has demonstrated its efficacy and safety, for both unruptured and ruptured aneurysms., Methods: The CLEVER study was an observational, multicenter, prospective study conducted in 17 European investigational sites using the WEB 17 device, for the treatment of ruptured and unruptured aneurysms. The study objective was to provide safety and efficacy data on the WEB 17 device in the treatment of wide-neck bifurcation aneurysms. Imaging results were assessed independently by a Corelab and adverse events adjudicated by a Clinical Event Adjudicator. This analysis reports procedural results and safety at 30 days and 12 months., Results: A total of 163 patients (mean age 58.1 years; 68.1% women) with 103 unruptured aneurysms and 60 ruptured aneurysms were enrolled. Most aneurysms were located on the anterior communicating artery (ACom) (37.4%) or the middle cerebral artery (MCA) bifurcation (30.1%). Aneurysm widths ranged from 2.0-9.2 mm, and the mean sac width was 5.0 mm. The WEB procedure was successfully completed in 163 patients (100%). At the 12-month follow-up, major stroke events occurred in 3 of 163 patients (1.8%), and no device-related mortality was observed., Conclusion: Endovascular treatment of ruptured and unruptured wide-neck bifurcation aneurysms using WEB 17 is safe, with a low complication rate and no device-related mortality. In particular, none of the ruptured aneurysms bled again up to 1 year of follow-up., Trial Registration Number: NCT03844334., Competing Interests: Competing interests: JC acts as associate editor for Journal of NeuroInterventional Surgery, Neuroradiology and Journal of Neuroradiology; MAM acts as associate editor for Neuroradiology. RR acts as associate editor for Journal of Neuroradiology., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2023
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32. Aspirin versus aggressive antiplatelet therapy for acute carotid stenting plus thrombectomy in tandem occlusions: ETIS Registry results.
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Marnat G, Finistis S, Moreno R, Sibon I, Pop R, Mazighi M, Clarençon F, Rosso C, Dargazanli C, Darcourt J, Olivot JM, Boulouis G, Janot K, Moulin S, Bourcier R, Consoli A, Richard S, Arquizan C, Vannier S, Richter S, Gentric JC, Papagiannaki C, Naggara O, Eker OF, Lapergue B, Caroff J, and Gory B
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- Humans, Platelet Aggregation Inhibitors therapeutic use, Aspirin, Treatment Outcome, Thrombectomy methods, Stents adverse effects, Registries, Retrospective Studies, Stroke diagnostic imaging, Stroke drug therapy, Stroke surgery, Endovascular Procedures methods, Ischemic Stroke etiology, Carotid Stenosis complications
- Abstract
Background: Patients treated with acute carotid stenting (CAS) may have higher odds of a favorable outcome than those treated without CAS during thrombectomy in tandem occlusions. Antiplatelet therapy is associated with CAS to avoid stent thrombosis, which occurs in around 20% of patients and negatively impacts outcomes. In this study we compared two antiplatelet strategies in tandem occlusion strokes treated with CAS and intracranial thrombectomy in clinical practice., Methods: The Endovascular Treatment in Ischemic Stroke Registry is an ongoing prospective observational study involving 21 comprehensive stroke centers performing thrombectomy in France. We analyzed patients with atherosclerotic tandem occlusions treated with acute CAS and intracranial thrombectomy who received at least one antiplatelet agent. Aggressive antiplatelet therapy included oral or intravenous glycoprotein (GP) IIb/IIIa or P2Y12 inhibitors. The primary outcome was cervical carotid artery patency at day 1 imaging follow-up., Results: Among the 187 included patients, 124 (66.3%) received aspirin alone and 63 (33.7%) received aggressive antiplatelet therapy. There was no significant difference regarding safety outcomes, especially in symptomatic intracerebral hemorrhage, parenchymal hematoma, and procedural complications. There was a significantly higher rate of carotid stent patency at day 1 in the aggressive antiplatelet therapy group (81.7% vs 97.1%, aOR 17.49, 95% CI 1.10 to 277.2, p=0.042). Odds of favorable functional outcome (90-day modified Rankin Scale score 0-2) were similar between the groups (OR 3.04, 95% CI 0.64 to 14.25, p=0.158)., Conclusions: In tandem occlusions treated with CAS plus thrombectomy, an aggressive antiplatelet regimen was associated with an increased rate of carotid stent patency at day 1 without safety concerns. Randomized trials are warranted to confirm these findings., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2023
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33. Location specific rupture risk of intracranial aneurysms: case of ophthalmic aneurysms.
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Chiaroni PM, Guerra X, Cortese J, Burel J, Courret T, Constant Dit Beaufils P, Agripnidis T, Leonard-Lorant I, Fauché C, Bankole NDA, Forestier G, L'allinec V, Sporns PB, Gueton G, Lorena N, Psychogios MN, Girot JB, Rouchaud A, Janot K, Raynaud N, Pop R, Hak JF, Kerleroux B, Bourcier R, Marnat G, Papagiannaki C, Sourour NA, Clarençon F, and Shotar E
- Abstract
Background: Aneurysm location is a key element in predicting the rupture risk of an intracranial aneurysm. A common impression suggests that pure ophthalmic aneurysms are under-represented in ruptured intracranial aneurysms (RIAs). The purpose of this study was to specifically evaluate the risk of rupture of ophthalmic aneurysms compared with other aneurysm locations., Methods: This multicenter study compared the frequency of ophthalmic aneurysms in a prospective cohort of RIAs admitted to 13 neuroradiology centers between January 2021 and March 2021, with a retrospective cohort of patients with unruptured intracranial aneurysms (UIAs) who underwent cerebral angiography at the same neuroradiology centers during the same time period., Results: 604 intracranial aneurysms were included in this study (355 UIAs and 249 RIAs; mean age 57 years (IQR 49-65); women 309/486, 64%). Mean aneurysm size was 6.0 mm (5.3 mm for UIAs, 7.0 mm for RIAs; P<0.0001). Aneurysm shape was irregular for 37% UIAs and 73% RIAs (P<0.0001). Ophthalmic aneurysms frequency was 14.9% of UIAs (second most common aneurysm location) and 1.2% of RIAs (second least common aneurysm location; OR 0.07 (95% CI 0.02 to 0.23), P<0.0001)., Conclusions: Ophthalmic aneurysms seem to have a low risk of rupture compared with other intracranial aneurysm locations. This calls for a re-evaluation of the benefit-risk balance when considering preventive treatment for ophthalmic aneurysms., Competing Interests: Competing interests: FC is a consultant for Medtronic, Balt Extrusion, Penumbra, Microvention, and Stryker; board member of Artedrone, and has stock options with Intradys and Collavidence. GM is a consultant for Stryker Neurovascular, Balt, Microvention Europe, and Sim and Cure, and has done paid lectures for Medtronic, Phenox, Johnson & Johnson, and Bracco. KJ is a consultant for Balt. AR is a consultant for Balt, Medtronic, Microvention, and Stryker. N-AS is a consultant for Balt, Medtronic Extrusion, and Microvention., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2023
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34. ASPECTS evolution after endovascular successful reperfusion in the early and extended time window.
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Anadani M, Finitsis S, Pop R, Darcourt J, Clarençon F, Richard S, de Havenon A, Liebeskind D, Marnat G, Bourcier R, Sibon I, Dargazanli C, Arquizan C, Blanc R, Lapergue B, Consoli A, Eugène F, Vannier S, Caroff J, Denier C, Boulanger M, Gauberti M, Saleme S, Macian F, Rosso C, Turc G, Ozkul-Wermester O, Papagiannaki C, Olivot JM, Le Bras A, Evain S, Wolff V, Timsit S, Gentric JC, Bourdain F, Veunac L, Maïer B, Ben Hassen W, and Gory B
- Abstract
Background: The Alberta Stroke Program Early CT scan Score (ASPECTS) is a reliable imaging biomarker of infarct extent on admission but the value of 24-hour ASPECTS evolution in day-to-day practice is not well studied, especially after successful reperfusion. We aimed to assess the association between ASPECTS evolution after successful reperfusion with functional and safety outcomes, as well as to identify the predictors of ASPECTS evolution., Methods: We used data from an ongoing prospective multicenter registry. Stroke patients with anterior circulation large vessel occlusion treated with endovascular therapy (EVT) and achieved successful reperfusion (modified thrombolysis in cerebral ischemia (mTICI) 2b-3) were included. ASPECTS evolution was defined as one or more point decrease in ASPECTS at 24 hours., Results: A total of 2366 patients were enrolled. In a fully adjusted model, ASPECTS evolution was associated with lower odds of favorable outcome (modified Rankin Scale (mRS) score 0-2) at 90 days (adjusted odds ratio (aOR) = 0.46; 95% confidence interval (CI) = 0.37-0.57). In addition, ASPECTS evolution was a predictor of excellent outcome (90-day mRS 0-1) (aOR = 0.52; 95% CI = 0.49-0.57), early neurological improvement (aOR = 0.42; 95% CI = 0.35-0.51), and parenchymal hemorrhage (aOR = 2.64; 95% CI, 2.03-3.44). Stroke severity, admission ASPECTS, total number of passes, complete reperfusion (mTICI 3 vs. mTICI 2b-2c) and good collaterals emerged as predictors of ASPECTS evolution., Conclusion: ASPECTS evolution is a strong predictor of functional and safety outcomes after successful endovascular therapy. Higher number of EVT attempts and incomplete reperfusion are associated with ASPECTS evolution at day 1.
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- 2023
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35. Time to treatment with bridging intravenous alteplase before endovascular treatment:subanalysis of the randomized controlled SWIFT-DIRECT trial.
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Meinel TR, Kaesmacher J, Buetikofer L, Strbian D, Eker OF, Cognard C, Mordasini P, Deppeler S, Mendes Pereira V, Albucher JF, Darcourt J, Bourcier R, Guillon B, Papagiannaki C, Costentin G, Sibolt G, Räty S, Gory B, Richard S, Liman J, Ernst M, Boulanger M, Barbier C, Mechtouff L, Zhang L, Marnat G, Sibon I, Nikoubashman O, Reich A, Consoli A, Weisenburger D, Requena M, Garcia-Tornel A, Saleme S, Moulin S, Pagano P, Saliou G, Carrera E, Janot K, Boix M, Pop R, Della Schiava L, Luft A, Piotin M, Gentric JC, Pikula A, Pfeilschifter W, Arnold M, Siddiqui A, Froehler MT, Furlan AJ, Chapot R, Wiesmann M, Machi P, Diener HC, Kulcsar Z, Bonati L, Bassetti C, Escalard S, Liebeskind D, Saver JL, Fischer U, and Gralla J
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- Humans, Female, Aged, Male, Tissue Plasminogen Activator, Time-to-Treatment, Thrombolytic Therapy, Thrombectomy, Treatment Outcome, Fibrinolytic Agents, Stroke drug therapy, Stroke complications, Brain Ischemia therapy
- Abstract
Background: We hypothesized that treatment delays might be an effect modifier regarding risks and benefits of intravenous thrombolysis (IVT) before mechanical thrombectomy (MT)., Methods: We used the dataset of the SWIFT-DIRECT trial, which randomized 408 patients to IVT+MT or MT alone. Potential interactions between assignment to IVT+MT and expected time from onset-to-needle (OTN) as well as expected time from door-to-needle (DTN) were included in regression models. The primary outcome was functional independence (modified Rankin Scale (mRS) 0-2) at 3 months. Secondary outcomes included mRS shift, mortality, recanalization rates, and (symptomatic) intracranial hemorrhage at 24 hours., Results: We included 408 patients (IVT+MT 207, MT 201, median age 72 years (IQR 64-81), 209 (51.2%) female). The expected median OTN and DTN were 142 min and 54 min in the IVT+MT group and 129 min and 51 min in the MT alone group. Overall, there was no significant interaction between OTN and bridging IVT assignment regarding either the functional (adjusted OR (aOR) 0.76, 95% CI 0.45 to 1.30) and safety outcomes or the recanalization rates. Analysis of in-hospital delays showed no significant interaction between DTN and bridging IVT assignment regarding the dichotomized functional outcome (aOR 0.48, 95% CI 0.14 to 1.62), but the shift and mortality analyses suggested a greater benefit of IVT when in-hospital delays were short., Conclusions: We found no evidence that the effect of bridging IVT on functional independence is modified by overall or in-hospital treatment delays. Considering its low power, this subgroup analysis could have missed a clinically important effect, and exploratory analysis of secondary clinical outcomes indicated a potentially favorable effect of IVT with shorter in-hospital delays. Heterogeneity of the IVT effect size before MT should be further analyzed in individual patient meta-analysis of comparable trials., Trial Registration Number: URL: https://www., Clinicaltrials: gov ; Unique identifier: NCT03192332., Competing Interests: Competing interests: MA reports honoraria for lectures from AstraZeneca, Bayer, Covidien, Medtronic and Sanofi; Participation on Scientific Advisory Boards of Amgen, Bayer, BMS, Daiichi Sankyo, Medtronic, and Pfizer. CC reports consulting fees from Medtronic (payment made to CC). EC reports grants from the Swiss Heart Foundation and Swiss National Science Foundation, not related to present study. HCD reports that in the last 3 years, he received honoraria for participation in clinical trials, contribution to advisory boards or oral presentations from: Abbott, BMS, Boehringer Ingelheim, Daiichi Sankyo, Novo-Nordisk, Pfizer, Portola and WebMD Global. Boehringer Ingelheim provided financial support for research projects. HCD also received research grants from the German Research Council (DFG) and German Ministry of Education and Research (BMBF). HCD serves as editor of Neurologie up2date, Info Neurologie & Psychiatrie, Arzneimitteltherapie, as co-editor of Cephalalgia and on the editorial board of Lancet Neurology and Drugs. MTF reports research grants from Medtronic, Siemens, Genentech, Idorsia, and Vesalio; consulting fees from Genentech, Balt USA, Cerenovus, and Oculus Imaging; participation on a Data Safety Monitoring Board or Advisory Board for Balt USA, Jacobs Institute, and Imperative Care. UF reports financial support for the present study from Medtronic. SWIFT DIRECT is an investigator-initiated trial. The sponsor was not involved in the final study design, protocol, conduct, evaluation of results or preparation of the manuscript. UF also reports research grants from Medtronic BEYOND SWIFT registry, Swiss National Science Foundation, Swiss Heart Foundation; consulting fees from Medtronic, Stryker and CSL Behring (fees paid to institution); membership of a Data Safety Monitoring Board for the IN EXTREMIS trial and TITAN trial and Portola (Alexion) Advisory board (fees paid to institution); and Vice Presidency of the Swiss Neurological Society. UF is a member of the editorial board of JNIS. JG reports a Swiss National Funds (SNF) grant for MRI in stroke. JK reports financial support of Medtronic for the BEYOND SWIFT Registry (fees paid to institution); research grant from the Swiss National Science Foundation supporting the TECNO trial (fees paid to institution); Swiss Academy of Medical Sciences research grant supporting MRI research (fees paid to institution); Swiss Heart Foundation research grant supporting cardiac MRI in the etiological workup of stroke patients (fees paid to institution). AL reports grants from the University of Zurich, the LOOP Zurich, and P&K Pühringer Foundation; consulting fees from Bayer AG; and a lecture honorarium from Moleac Pte, Singapore. DSL reports consulting fees from Cerenovus, Genentech, Medtronic, Stryker, Rapid Medical as imaging core lab. GM reports consulting fees from Stryker Neurovascular; paid lectures for Medtronic and Microvention Europe. PM reports research funding (fees paid to institution) from the Swiss National Science Foundation, Swiss Heart Foundation and Medtronic Research Grant. PM reports grants from the Swiss National Science Foundation; Consulting fees Medtronic, Stryker; payment or honoraria from Medtronic, Stryker; participation on a Data Safety Monitoring Board or Advisory Board of MicroVention. ON reports funding from a Stryker Research grant; payment or honoraria for Phenox lecture and Stryker lecture. WP reports grants from the German Research Foundation, LOEWE (research funding of the federal state of Hesse); royalties or licenses STROKE TEAM-Training (LAERDAL medical); payment or honoraria from LAERDAL medical, Alexion, Pfizer-BMS, Stryker Neurovascular; support for attending meetings and/or travel from LAERDAL medical, Alexion, Pfizer-BMS and Stryker Neurovascular. MR reports consulting fees from Medtronic, Stryker, Cerenovus, Philips and Apta Targets; payment or honoraria from Ischemia View; participation on a Data Safety Monitoring Board or Advisory Board of Sensome; stock or stock options in Anaconda Biomed, CVAid and Methinks. AHS reports being a co-investigator for NIH - 1R01EB030092-01, Project Title: High Speed Angiography at 1000 frames per second; Mentor for Brain Aneurysm Foundation Carol W. Harvey Chair of Research, Sharon Epperson Chair of Research, Project Title: A Whole Blood RNA Diagnostic for Unruptured Brain Aneurysm: Risk Assessment Prototype Development and Testing; receipt of consulting fees from Amnis Therapeutics, Apellis Pharmaceuticals, Inc, Boston Scientific, Canon Medical Systems USA, Inc, Cardinal Health 200, LLC, Cerebrotech Medical Systems, Inc, Cerenovus, Cerevatech Medical, Inc, Cordis, Corindus, Inc, Endostream Medical, Ltd, Imperative Care, InspireMD, Ltd, Integra, IRRAS AB, Medtronic, MicroVention, Minnetronix Neuro, Inc, Peijia Medical, Penumbra, Q’Apel Medical, Inc, Rapid Medical, Serenity Medical, Inc, Silk Road Medical, StimMed, LLC, Stryker Neurovascular, Three Rivers Medical, Inc, VasSol, Viz.ai, Inc (payments made to AHS); Secretary – Board of the Society of NeuroInterventional Surgery 2020-2021 (unpaid) Chair – Cerebrovascular Section of the AANS/CNS 2020-2021 (unpaid); stock or stock options Adona Medical, Inc, Amnis Therapeutics, Bend IT Technologies, Ltd, BlinkTBI, Inc, Cerebrotech Medical Systems, Inc, Cerevatech Medical, Inc, Cognition Medical, CVAID Ltd, E8, Inc, Endostream Medical, Ltd, Galaxy Therapeutics, Inc, Imperative Care, Inc, InspireMD, Ltd, Instylla, Inc, International Medical Distribution Partners, Launch NY, Inc, NeuroRadial Technologies, Inc, NeuroTechnology Investors, Neurovascular Diagnostics, Inc, Peijia Medical, PerFlow Medical, Ltd, Q’Apel Medical, Inc, QAS.ai, Inc, Radical Catheter Technologies, Inc, Rebound Therapeutics Corp (purchased 2019 by Integra Lifesciences, Corp), Rist Neurovascular, Inc (Purchased 2020 by Medtronic), Sense Diagnostics, Inc, Serenity Medical, Inc, Silk Road Medical, Sim & Cure, SongBird Therapy, Spinnaker Medical, Inc, StimMed, LLC, Synchron, Inc, Three Rivers Medical, Inc, Truvic Medical, Inc, Tulavi Therapeutics, Inc, Vastrax, LLC, VICIS, Inc, Viseon, Inc (payments made to AHS); Other financial or non-financial interests: National PI/Steering Committees: Cerenovus EXCELLENT and ARISE II Trial; Medtronic SWIFT PRIME, VANTAGE, EMBOLISE and SWIFT DIRECT Trials; MicroVention FRED Trial & CONFIDENCE Study; MUSC POSITIVE Trial; Penumbra 3D Separator Trial, COMPASS Trial, INVEST Trial, MIVI neuroscience EVAQ Trial; Rapid Medical SUCCESS Trial; InspireMD C-GUARDIANS IDE Pivotal Trial (payments made to AHS). IS reports consulting fees (paid to IS) from Sanofi Synthé-Labo, Servier, Boheringer Ingelheim, AstraZeneca, Novonordisk and Medtronic; payment or honoraria (paid to IS) from Sanofi Synthé-Labo, Medtronic, Boheringer Ingelheim, AstraZeneca and BMS-Pfizer. JS reports funding for the present manuscript from Medtronic (paid to JS); consulting fees from Cerenovus (paid to JS); participation on a Data Safety Monitoring Board or Advisory Board – MIVI (paid to JS), Phillips (paid to JS); stock or stock options in Rapid Medical (paid to JS). MW reports a grant from Stryker Neurovascular; consulting fees from Stryker Neurovascular (payments to MW); payment or honoraria from Stryker Neurovascular, Bracco Imaging (payments to MW); German Society of Neuroradiology (DGNR) Board member (no payments); receipt of equipment, materials, drugs, medical writing, gifts or other services from ab medica, Acandis, Bracco Imaging, Cerenovus, Kaneka Pharmaceuticals, Medtronic, Mentice AB, Phenox, Stryker Neurovascular (support to institution). All other authors report no competing interests., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)
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- 2023
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36. Persistent flow inside the Woven EndoBridge at angiographic follow-up: A multicenter study.
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Janot K, Charbonnier G, Marnat G, Sporns P, Burel J, Papagiannaki C, Forestier G, Hak JF, Agripnidis T, Bolognini F, Lebedinsky PA, Ifergan H, Bibi R, Herbreteau D, Adeniran Bankole ND, Biondi A, Barreau X, Guédon A, Shotar E, Clarençon F, Kerleroux B, Boulouis G, Bala F, and Rouchaud A
- Abstract
Background: The occurrence of persistent intra-device filling (BOSS 1, using the Bicêtre Occlusion Scale Score (BOSS)) in aneurysms treated with a Woven Endobridge (WEB) device is infrequent based on angiographic follow-up. To date, three monocentric case series were published studying BOSS 1 cases. Through a multicenter retrospective study, we aimed to report the incidence, and risk factors of intra-WEB persistent filling., Methods: We reached out to European academic centers that treat patients using WEB devices and requested de-identified data of patients treated with a WEB device and underwent angiographic follow-up, at least 3 months after embolization, to assess the BOSS 1 occlusion score. We compared baseline characteristics, treatment modalities, and aneurysm data of the included BOSS 1 patients with those of a control group consisting of non-BOSS 1 patients ( n = 116) who had an available angiographic follow-up. Univariable and multivariable models were employed for analysis., Results: Among the pooled sample of 591 aneurysms treated with WEB, the rate of persistent flow (BOSS 1) at angiographic follow-up was 5.2% ( n = 31 out of 591), performed after an average of 8.7 ± 6.3 months. In the multivariable-adjusted analysis, dual antiplatelet therapy in the postoperative period (adjusted odds ratio [aOR] 4.3 [95% CI 1.3-14.2]), and WEB undersizing (aOR 10.8 [95% CI 2.9-40]) were independently associated with a BOSS 1 persistent flow result., Conclusion: Persistent blood flow within the WEB device during angiographic follow-up (BOSS 1) is an uncommon occurrence. Our findings indicate that post-procedural dual antiplatelet therapy and undersizing of the WEB device are independently associated with the presence of BOSS 1 at follow-up.
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- 2023
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37. Poor clinical outcome despite successful basilar occlusion recanalization in the early time window: incidence and predictors.
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Pop R, Finitsis SN, Arquizan C, Elhorany M, Naggara O, Darcourt J, Clarençon F, Richard S, Marnat G, Bourcier R, Sibon I, Dargazanli C, Blanc R, Lapergue B, Consoli A, Eugene F, Vannier S, Caroff J, Denier C, Boulanger M, Gauberti M, Rouchaud A, Macian F, Rosso C, Turc G, Ozkul-Wermester O, Albucher JF, Le Bras A, Evain S, Wolff V, Timsit S, Gentric JC, Bourdain F, Veunac L, Papagiannaki C, and Gory B
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- Humans, Prospective Studies, Thrombectomy methods, Incidence, Treatment Outcome, Basilar Artery diagnostic imaging, Retrospective Studies, Stroke therapy, Arterial Occlusive Diseases etiology, Endovascular Procedures methods
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Background: Endovascular treatment (EVT) for basilar artery occlusions (BAO) is associated with a higher rate of futile recanalization compared with anterior circulation procedures. We aimed to identify the incidence and predictors of poor clinical outcome despite successful reperfusion in current clinical practice., Methods: We used data from the ETIS (Endovascular Treatment in Ischemic Stroke) registry, a prospective multicenter observational registry of stroke treated with EVT in France. Patients undergoing EVT for acute BAO from January 2014 to May 2019 successfully treated within 8 hours from onset were included. Predictors of 90-day poor outcome (modified Rankin Scale (mRS) 4-6) were researched within patients with successful (modified Thrombolysis In Cerebral Infarction (mTICI 2b-3)) and excellent (mTICI 2c-3) reperfusion., Results: Among 242 patients treated within 8 hours, successful reperfusion was achieved in 195 (80.5%) and excellent reperfusion in 120 (49.5%). Poor outcome was observed in 107 (54.8%) and 60 (50%) patients, respectively. In patients with successful early reperfusion, age, higher initial National Institutes of Health Stroke Scale (NIHSS) score, lower posterior circulation Alberta Stroke Programme Early CT Score (pc-ASPECTS), and absence of prior intravenous thrombolysis were independent predictors of poor outcome. The only treatment factor with an independent predictive value was first-pass mTICI 2b-3 reperfusion (adjusted OR 0.13, 95% CI 0.05 to 0.37, p<0.001). In patients with excellent early reperfusion, independent predictors were age, initial NIHSS score, first-pass mTICI 2c-3 reperfusion, and hemorrhagic transformation on post-interventional imaging., Conclusions: Early successful reperfusion with EVT occurred in 80.5% of patients, and the only treatment-related factor predictive of clinical outcome was first pass mTICI 2b-3 reperfusion. Further research is warranted to identify the optimal techniques and devices associated with first pass reperfusion in the posterior circulation., Competing Interests: Competing interests: FC: Consulting fees from Medtronic, Stryker, Balt. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Penumbra, Balt, Medtronic. Participation on a Data Safety Monitoring Board or Advisory Board – Clinsearch. J-CG: Consulting fees from Medtronic, Stryker, Balt. Support for attending meetings and/or travel from Balt. Participation on a Data Safety Monitoring Board or Advisory Board – Intradys. AR: Consulting fees from Balt. IS: Consulting fees from Sanofi Synthé-Labo, Servier, Boheringer Ingelheim, Astra-Zeneca, Novonordisk, Medtronic. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Sanofi Synthé-Labo, Medtronic, Boheringer Ingelheim, Astra-Zeneca, BMS-Pfizer. GM: Consulting fees from Stryker. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Medtronic, Microvention., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2023
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38. Thrombectomy in basilar artery occlusions: impact of number of passes and futile reperfusion.
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de Havenon A, Elhorany M, Boulouis G, Naggara O, Darcourt J, Clarençon F, Richard S, Marnat G, Bourcier R, Sibon I, Arquizan C, Dargazanli C, Maïer B, Seners P, Lapergue B, Consoli A, Eugene F, Vannier S, Caroff J, Denier C, Boulanger M, Gauberti M, Rouchaud A, Macian F, Rosso C, Turc G, Ozkul-Wermester O, Papagiannaki C, Albucher JF, Le Bras A, Evain S, Wolff V, Pop R, Timsit S, Gentric JC, Bourdain F, Veunac L, Fahed R, Finitsis SN, and Gory B
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- Humans, Basilar Artery diagnostic imaging, Basilar Artery surgery, Prospective Studies, Treatment Outcome, Thrombectomy methods, Cerebral Infarction etiology, Reperfusion, Retrospective Studies, Stroke diagnostic imaging, Stroke surgery, Arterial Occlusive Diseases diagnostic imaging, Arterial Occlusive Diseases surgery, Ischemic Stroke etiology, Endovascular Procedures methods
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Background: The number of mechanical thrombectomy (MT) passes is strongly associated with angiographic reperfusion as well as clinical outcomes in patients with anterior circulation ischemic stroke. However, these associations have not been analyzed in patients with basilar artery occlusion (BAO). We investigated the influence of the number of MT passes on the degree of reperfusion and clinical outcomes, and compared outcome after ≤3 passes versus >3 passes., Methods: We used data from the prospective multicentric Endovascular Treatment in Ischemic Stroke (ETIS) Registry at 18 sites in France. Patients with BAO treated with MT were included. The primary outcome was a favorable outcome, defined as a modified Rankin Scale score of 0-3 at 90 days. We fit mixed multiple regression models, with center as a random effect., Results: We included 275 patients. Successful recanalization (modified Thrombolysis In Cerebral Infarction (mTICI) 2b-3) was achieved in 88.4%, and 41.8% had a favorable outcome. The odds ratio for favorable outcome with each pass above 1 was 0.41 (95% CI 0.23 to 0.73) and for recanalization (mTICI 2b-3) it was 0.70 (95% CI 0.57 to 0.87). In patients with ≤3 passes, the rate of favorable outcome in recanalized versus non-recanalized patients was 50.5% versus 10.0% (p=0.001), while in those with >3 passes it was 16.7% versus 15.2% (p=0.901)., Conclusions: We found that BAO patients had a significant relationship between the number of MT passes and both recanalization and favorable functional outcome. We further found that the benefit of recanalization in BAO patients was significant only when recanalization was achieved within three passes, encouraging at least three passes before stopping the procedure., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2023
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39. Direct Aspiration versus Combined Technique for Distal Medium-Vessel Occlusions: Comparison on a Human Placenta Model.
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Burel J, Gerardin E, Papagiannaki C, Shotar E, Sourour N, Laporte C, Hermet PL, Premat K, Dacher JN, and Clarençon F
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- Humans, Thrombectomy methods, Treatment Outcome, Arteries, Stents, Retrospective Studies, Stroke, Thrombosis
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Background and Purpose: Mechanical thrombectomy appears to be a promising option for distal medium-vessel occlusions, for which intravenous thrombolysis is effective but may be insufficient when used alone. This study aimed to determine the optimal technique for these distal mechanical thrombectomies using the human placenta model., Materials and Methods: Twenty-four procedures were performed, allowing comparison of direct aspiration ( n = 12) versus the combined technique ( n = 12). Two positions of the aspiration catheter were tested for each of these techniques: in direct contact with the clot and at a distance from it (5-10 mm). Two types of clots were tested: red blood cell-rich clots and fibrin-rich clots. First-pass recanalization and induced arterial collapse and traction were assessed., Results: The first-pass recanalization was less frequent for direct aspiration than for the combined technique, without reaching statistical significance (41.7% versus 75.0%, P = .098). Full collapse ( P < .001) and extended arterial traction ( P = .001) were significantly less frequent for direct aspiration. For direct aspiration with the aspiration catheter not in direct contact with the clot, there was not a single first-pass recanalization and there was systematic arterial collapse, resulting in a no-flow in the aspiration syringe., Conclusions: The combined technique appears to be more harmful, and although direct aspiration has a lower rate of first-pass recanalization, it seems appropriate to try direct aspiration as a first-line procedure. However, if the aspiration catheter cannot reach the clot, it is not useful or even risky to try aspiration alone. These results need to be confirmed by clinical studies., (© 2023 by American Journal of Neuroradiology.)
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- 2023
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40. Patient Selection in a Pragmatic Study on the Management of Patients with Brain Arteriovenous Malformations.
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Raymond J, Benomar A, Gentric JC, Magro E, Nico L, Bacchus E, Klink R, Iancu D, Weill A, Roy D, Bojanowski MW, Chaalala C, Eker O, Pelissou-Guyotat I, Piotin M, Aldea S, Barbier C, Gaberel T, Papagiannaki C, Derrey S, Nguyen TN, Abdalkader M, Cognard C, Januel AC, Sabatier JF, Jecko V, Barreau X, Costalat V, Le Corre M, Gauvrit JY, Morandi X, Biondi A, Thines L, Desal H, Bourcier R, Beaujeux R, Proust F, Viard G, Gevry G, and Darsaut TE
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- Humans, Patient Selection, Treatment Outcome, Brain, Retrospective Studies, Intracranial Arteriovenous Malformations surgery, Embolization, Therapeutic, Radiosurgery methods
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Background: The Treatment of Brain Arteriovenous Malformations Study (TOBAS) is an all-inclusive pragmatic study comprising 2 randomized clinical trials (RCTs). Patients excluded from the RCTs are followed in parallel treatment and observation registries, allowing a comparison between RCT and registry patients., Methods: The first randomized clinical trial (RCT-1) offers 1:1 randomized allocation of intervention versus conservative management for patients with arteriovenous malformation (AVM). The second randomized clinical trial (RCT-2) allocates 1:1 pre-embolization or no pre-embolization to surgery or radiosurgery patients judged treatable with or without embolization. Characteristics of RCT patients are reported and compared to registry patients., Results: From June 2014 to May 2021, 1010 patients with AVM were recruited; 498 patients were observed and 373 were included in the treatment registries. Randomized allocation in RCT-1 was applied to 139 (26%) of the 512 patients (including 127 of 222 [57%] with unruptured AVMs) considered for curative treatment. RCT-1 AVM patients differed (in rupture status, Spetzler-Martin grade and baseline modified Rankin Score) from those in the observation or treatment registries (P < 0.001). Most patients had small (<3 cm; 71%) low-grade (Spetzler-Martin I-II; 64%) unruptured (91%) AVMs. The allocated management was conservative (n = 71) or curative (n = 68), using surgery (n = 39), embolization (n = 16), or stereotactic radiosurgery (n = 13). Pre-embolization was considered for 179/309 (58%) patients allocated/assigned to surgery or stereotactic radiosurgery; 87/179 (49%) were included in RCT-2. RCT-2 patient AVMs differed in size, eloquence and grade from patients of the pre-embolization registry (P < 0.01). Most had small (<3 cm in 82%) low-grade (83%) AVMs in non-eloquent brain (64%)., Conclusions: Patients included in the RCTs differ significantly from registry patients. Meaningful results can be obtained if multiple centers actively participate in the TOBAS RCTs., (Copyright © 2023 Elsevier Inc. All rights reserved.)
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- 2023
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41. Endovascular treatment as first-line therapy in Spetzler-Martin grade III brain arteriovenous malformations: a multicenter retrospective study.
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Burel J, Papagiannaki C, Sourour N, Talbi A, Garnier M, Hermary C, Talaat M, Boch AL, Nouet A, Lenck S, Premat K, Shotar E, and Clarençon F
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- Humans, Adult, Middle Aged, Retrospective Studies, Treatment Outcome, Microsurgery, Brain surgery, Intracranial Arteriovenous Malformations therapy, Intracranial Arteriovenous Malformations surgery, Embolization, Therapeutic adverse effects, Embolization, Therapeutic methods, Radiosurgery
- Abstract
Objective: The management of Spetzler-Martin grade (SMG) III brain arteriovenous malformations (bAVMs) may be challenging, whatever the exclusion treatment modality chosen. The purpose of this study was to evaluate the safety and effectiveness of endovascular treatment (EVT) as a first-line treatment of SMG III bAVMs., Methods: The authors performed a retrospective, two-center, observational cohort study. Cases recorded in institutional databases between January 1998 and June 2021 were reviewed. Patients who were ≥ 18 years of age, had ruptured or unruptured SMG III bAVMs, and received EVT as first-line therapy were included. Baseline characteristics of patients and bAVMs, procedure-related complications, clinical outcome according to the modified Rankin Scale, and angiographic follow-up were assessed. The independent risk factors of procedure-related complications and poor clinical outcome were assessed using binary logistic regression., Results: One hundred sixteen patients with 116 SMG III bAVMs were included. The mean age of the patients was 41.9 ± 14.0 years. The most common presentation was hemorrhage (66.4%). Forty-nine (42.2%) bAVMs were found to be completely obliterated by EVT alone at follow-up. Complications occurred in 39 patients (33.6%), including 5 (4.3%) major procedure-related complications. There was no independent predictor of procedure-related complication. Age > 40 years and poor preoperative modified Rankin Scale score were the independent predictors of poor clinical outcome., Conclusions: EVT of SMG III bAVMs provides encouraging results but needs further improvement. When the embolization procedure performed with intent to cure appears difficult and/or risky, a combined technique (with microsurgery or radiosurgery) may be a safer and more effective strategy. In terms of safety and effectiveness, the benefit of EVT (alone or included in a multimodal management strategy) for SMG III bAVMs needs to be confirmed by randomized controlled trials.
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- 2023
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42. Effect of intravenous thrombolysis before endovascular therapy on outcome according to collateral status: insight from the ETIS Registry.
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Anadani M, Januel AC, Finitsis S, Clarençon F, Richard S, Marnat G, Bourcier R, Sibon I, Dargazanli C, Arquizan C, Blanc R, Lapergue B, Consoli A, Eugene F, Vannier S, Caroff J, Denier C, Boulanger M, Gauberti M, Rouchaud A, Macian Montoro F, Rosso C, Ben Hassen W, Turc G, Ozkul-Wermester O, Papagiannaki C, Albucher JF, Le Bras A, Evain S, Wolff V, Pop R, Timsit S, Gentric JC, Bourdain F, Veunac L, de Havenon A, Liebeskind DS, Maier B, and Gory B
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- Humans, Thrombolytic Therapy methods, Prospective Studies, Treatment Outcome, Thrombectomy adverse effects, Registries, Fibrinolytic Agents, Brain Ischemia diagnosis, Stroke drug therapy, Stroke diagnosis, Endovascular Procedures methods, Ischemic Stroke etiology
- Abstract
Background: It is unknown whether collateral status modifies the effect of pretreatment intravenous thrombolysis (IVT) on the outcomes of patients with large vessel occlusions treated with endovascular therapy (EVT). We aimed to assess whether collateral status modifies the effect of IVT on the outcomes of EVT in clinical practice., Methods: We used data from the ongoing prospective multicentric Endovascular Treatment in Ischemic Stroke (ETIS) Registry in France. Patients with anterior circulation proximal large vessel occlusions treated with EVT within 6 hours of symptom onset were enrolled. Patients were divided into two groups based on pretreatment with IVT. The two groups were matched based on baseline characteristics. We tested the interaction between collateral status and IVT in unadjusted and adjusted models., Results: A total of 1589 patients were enrolled in the study, of whom 55% received IVT. Using a propensity score matching method, 724 no IVT patients were matched to 549 IVT patients. In propensity score weighted analysis, IVT was associated with higher odds of early neurological improvement (OR 1.74; 95% CI 1.33 to 2.26), favorable functional outcome (OR 1.66; 95% CI 1.23 to 2.24), excellent functional outcome (OR 2.04; 95% CI 1.47 to 2.83), and successful reperfusion (OR 2.18; 95% CI 1.51 to 3.16). IVT was not associated with mortality or hemorrhagic complications. There was no interaction between collateral status and IVT association with any of the outcomes., Conclusions: Collateral status does not modify the effect of pretreatment IVT on the efficacy and safety outcomes of EVT., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2023
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43. Carotid artery direct access for mechanical thrombectomy: the Carotid Artery Puncture Evaluation (CARE) study.
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Dumas V, Kaesmacher J, Ognard J, Forestier G, Dargazanli C, Janot K, Behme D, Shotar E, Chabert E, Velasco S, Bricout N, Ben Hassen W, Veunac L, Geismar M, Eugene F, Detraz L, Darcourt J, L'Allinec V, Eker OF, Consoli A, Maus V, Gariel F, Marnat G, Papanagiotou P, Papagiannaki C, Escalard S, Meyer L, Lobsien D, Abdullayev N, Chalumeau V, Neau JP, Guillevin R, Boulouis G, Rouchaud A, Styczen H, and Fauché C
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- Humans, Thrombectomy methods, Retrospective Studies, Treatment Outcome, Carotid Arteries, Punctures adverse effects, Stroke diagnostic imaging, Stroke surgery, Ischemic Stroke, Brain Ischemia diagnostic imaging, Brain Ischemia surgery, Brain Ischemia complications
- Abstract
Background: In acute ischemic stroke due to anterior large vessel occlusion (AIS-LVO), accessing the target occluded vessel for mechanical thrombectomy (MT) is sometimes impossible through the femoral approach. We aimed to evaluate the safety and efficacy of direct carotid artery puncture (DCP) for MT in patients with failed alternative vascular access., Methods: We retrospectively analyzed data from 45 stroke centers in France, Switzerland and Germany through two research networks from January 2015 to July 2019. We collected physician-centered data on DCP practices and baseline characteristics, procedural variables and clinical outcome after DCP. Uni- and multivariable models were conducted to assess risk factors for complications., Results: From January 2015 to July 2019, 28 149 MT were performed, of which 108 (0.39%) resulted in DCP due to unsuccessful vascular access. After DCP, 77 patients (71.3%) had successful reperfusion (modified Thrombolysis In Cerebral Infarction (mTICI) score ≥2b) and 28 (25.9%) were independent (modified Rankin Scale (mRS) score 0-2) at 3 months. 20 complications (18.5%) attributed to DCP occurred, all of them during or within 1 hour of the procedure. Complications led to extension of the intubation time in the intensive care unit in 7 patients (6.4%) and resulted in death in 3 (2.8%). The absence of use of a hemostatic closure device was associated with a higher complication risk (OR 3.04, 95% CI 1.03 to 8.97; p=0043)., Conclusion: In this large multicentric study, DCP was scantly performed for vascular access to perform MT (0.39%) in patients with AIS-LVO and had a high rate of complications (18.5%). Our results provide arguments for not closing the cervical access by manual compression after MT., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2022
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44. Clinical Impact and Predictors of Diffusion Weighted Imaging (DWI) Reversal in Stroke Patients with Diffusion Weighted Imaging Alberta Stroke Program Early CT Score 0-5 Treated by Thrombectomy : Diffusion Weighted Imaging Reversal in Large Volume Stroke.
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Panni P, Lapergue B, Maïer B, Finitsis S, Clarençon F, Richard S, Marnat G, Bourcier R, Sibon I, Dargazanli C, Blanc R, Consoli A, Eugène F, Vannier S, Spelle L, Denier C, Boulanger M, Gauberti M, Saleme S, Macian F, Rosso C, Naggara O, Turc G, Ozkul-Wermester O, Papagiannaki C, Albucher JF, Darcourt J, Le Bras A, Evain S, Wolff V, Pop R, Timsit S, Gentric JC, Bourdain F, Veunac L, Arquizan C, and Gory B
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- Humans, Prospective Studies, Thrombectomy, Diffusion Magnetic Resonance Imaging methods, Tomography, X-Ray Computed, Treatment Outcome, Retrospective Studies, Ischemic Stroke, Stroke diagnostic imaging, Stroke surgery, Brain Ischemia diagnostic imaging, Brain Ischemia surgery
- Abstract
Purpose: To determine whether reversal of DWI lesions (DWIr) on the DWI-ASPECTS (diffusion weighted imaging Alberta Stroke Program CT Score) template should serve as a predictor of 90-day clinical outcome in acute ischemic stroke (AIS) patients with pretreatment diffusion-weighted imaging (DWI)-ASPECTS 0-5 treated with thrombectomy, and to determine its predictors in current practice., Methods: We analyzed data of all consecutive patients included in the prospective multicenter national Endovascular Treatment in Ischemic Stroke Registry between 1 January 2015 and 31 December 2020 with a premorbid mRS ≤ 2, who presented with a pretreatment DWI-ASPECTS 0-5 score, underwent thrombectomy and had an available 24 h post-interventional MRI follow-up. Multivariable analyses were performed to evaluate the clinical impact of DWIr on early neurological improvement (ENI), 3‑month modified Rankin scale (mRS) score distribution (shift analysis) and to define independent predictors of DWIr., Results: Early neurological improvement was detected in 82/211 (41.7%) of patients while 3‑month functional independence was achieved by 75 (35.5%) patients. The DWI reversal (39/211, 18.9%) resulted an independent predictor of both ENI (aOR 3.6, 95% CI 1.2-7.7; p 0.018) and 3‑month clinical outcome (aOR for mRS shift: 2.2, 95% CI 1-4.6; p 0.030). Only successful recanalization (mTICI 2c-3) independently predicted DWIr in the studied population (aOR 3.3, 95% CI 1.3-7.9; p 0.009)., Conclusion: The DWI reversal occurs in a non-negligible proportion of DWI-ASPECTS 0-5 patients subjected to thrombectomy and significantly influences clinical outcome. The mTICI 2c-3 recanalization emerged as an independent DWIr predictor., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)
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- 2022
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45. Patient and aneurysm factors associated with aneurysm recanalization after coiling.
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Pierot L, Barbe C, Thierry A, Bala F, Eugene F, Cognard C, Herbreteau D, Velasco S, Chabert E, Desal H, Aggour M, Rodriguez-Regent C, Gallas S, Sedat J, Marnat G, Sourour N, Consoli A, Papagiannaki C, Spelle L, and White P
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- Cohort Studies, Follow-Up Studies, Humans, Prospective Studies, Retrospective Studies, Stents, Treatment Outcome, Aneurysm, Ruptured complications, Aneurysm, Ruptured diagnostic imaging, Aneurysm, Ruptured therapy, Embolization, Therapeutic adverse effects, Embolization, Therapeutic methods, Endovascular Procedures adverse effects, Endovascular Procedures methods, Intracranial Aneurysm complications, Intracranial Aneurysm diagnostic imaging, Intracranial Aneurysm therapy, Vascular Diseases therapy
- Abstract
Background: One limitation of the endovascular treatment of intracranial aneurysms is aneurysm recanalization. The Analysis of Recanalization after Endovascular Treatment of intracranial Aneurysm (ARETA) study is a prospective multicenter cohort study evaluating the factors associated with recanalization after endovascular treatment., Methods: The current analysis is focused on patients treated by coiling or balloon-assisted coiling (BAC). Postoperative, mid-term vascular imaging, and evolution of aneurysm occlusion were independently evaluated by two neuroradiologists. A 3-grade scale was used for aneurysm occlusion (complete occlusion, neck remnant, and aneurysm remnant) and for occlusion evolution (improved, stable, and worsened). Recanalization was defined as any worsening of aneurysm occlusion., Results: Between December 2013 and May 2015, 16 French neurointerventional departments enrolled 1289 patients. A total of 945 aneurysms in 908 patients were treated with coiling or BAC. The overall rate of aneurysm recanalization at mid-term follow-up was 29.5% (95% CI 26.6% to 32.4%): 28.9% and 30.3% in the coiling and BAC groups, respectively. In multivariate analyses factors independently associated with recanalization were current smoking (36.6% in current smokers vs 24.5% in current non-smokers (OR 1.8 (95% CI 1.3 to 2.4); p=0.0001), ruptured status (31.9% in ruptured aneurysms vs 25.1% in unruptured (OR 1.5 (95% CI 1.1 to 2.1); p=0.006), aneurysm size ≥10 mm (48.8% vs 26.5% in aneurysms <10 mm (OR 2.6 (95% CI 1.8 to 3.9); p<0.0001), wide neck (32.1% vs 25.8% in narrow neck (OR 1.5 (95% CI 1.1 to 2.1); p=0.02), and MCA location (34.3% vs 28.3% in other locations (OR 1.5 (95% CI 1.0 to 2.1); p=0.04)., Conclusions: Several factors are identified by the ARETA study as playing a role in aneurysm recanalization after coiling: current smoking, aneurysm status (ruptured), aneurysm size (≥10 mm), neck size (wide neck), and aneurysm location (middle cerebral artery). This finding has important consequences in clinical practice., Trial Registration Number: URL: http://www., Clinicaltrials: gov; Unique Identifier: NCT01942512., Competing Interests: Competing interests: LP: Support for the present manuscript from the French Ministry of Health (institutional); Consulting fees from Balt, Microvention, Perflow, Phenox, Vesalio; Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Balt, Microvention, Perflow, Phenox; Support for attending meetings and/or travel from Balt, Microvention, Phenox. CC: Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Medtronic, Microvention, MIVI, Stryker. MA: Grants or contracts from Medtronic, Cerenovus, Balt, Cerus, Stryker; Consulting fees from Medtronic, Cerenovus, Balt, Cerus, Stryker; Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Medtronic, Cerenovus, Balt, Cerus, Stryker; Payment for expert testimony from Cerenovus; Support for attending meetings and/or travel from Medtronic, Cerenovus, Balt, Cerus, Stryker; Participation to DSMB or AB from Cerenovus. GM: Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Medtronic, Microvention. NS: Consulting fees from Medtronic, Balt; Support for attending meetings and/or travel from Balt, Cerus, Stryker. CP: payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Microvention. LS: Grants or contracts from Philips (institutional); Consulting fees from Balt, Medtronic, Phenox, Microvention, Stryker; Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Medtronic, Balt, Microvention, Stryker; Support for attending meetings and/or travel from Balt, Medtronic, Microvention, Stryker. PW: Support for the present manuscript from the French Ministry of Health (institutional); Grants or contracts from Medtronic, Stryker, Penumbra (institutional); Consulting fees from Microvention-Terumo; Participation to DSMB or AB from Mr-Clean Direct, TENSION, Protect-U. PW is a chairperson for UK Neurointerventional group and JNIS associate editor., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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46. Endovascular treatment of brain arteriovenous malformations: clinical outcomes of patients included in the registry of a pragmatic randomized trial.
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Raymond J, Gentric JC, Magro E, Nico L, Bacchus E, Klink R, Cognard C, Januel AC, Sabatier JF, Iancu D, Weill A, Roy D, Bojanowski MW, Chaalala C, Barreau X, Jecko V, Papagiannaki C, Derrey S, Shotar E, Cornu P, Eker OF, Pelissou-Guyotat I, Piotin M, Aldea S, Beaujeux R, Proust F, Anxionnat R, Costalat V, Corre ML, Gauvrit JY, Morandi X, Brunel H, Roche PH, Graillon T, Chabert E, Herbreteau D, Desal H, Trystram D, Barbier C, Gaberel T, Nguyen TN, Viard G, Gevry G, and Darsaut TE
- Subjects
- Humans, Treatment Outcome, Registries, Brain, Retrospective Studies, Intracranial Arteriovenous Malformations diagnostic imaging, Intracranial Arteriovenous Malformations therapy, Intracranial Arteriovenous Malformations etiology, Embolization, Therapeutic adverse effects, Embolization, Therapeutic methods, Radiosurgery methods
- Abstract
Objective: The role of endovascular treatment in the management of patients with brain arteriovenous malformations (AVMs) remains uncertain. AVM embolization can be offered as stand-alone curative therapy or prior to surgery or stereotactic radiosurgery (SRS) (pre-embolization). The Treatment of Brain AVMs Study (TOBAS) is an all-inclusive pragmatic study that comprises two randomized trials and multiple registries., Methods: Results from the TOBAS curative and pre-embolization registries are reported. The primary outcome for this report is death or dependency (modified Rankin Scale [mRS] score > 2) at last follow-up. Secondary outcomes include angiographic results, perioperative serious adverse events (SAEs), and permanent treatment-related complications leading to an mRS score > 2., Results: From June 2014 to May 2021, 1010 patients were recruited in TOBAS. Embolization was chosen as the primary curative treatment for 116 patients and pre-embolization prior to surgery or SRS for 92 patients. Clinical and angiographic outcomes were available in 106 (91%) of 116 and 77 (84%) of 92 patients, respectively. In the curative embolization registry, 70% of AVMs were ruptured, and 62% were low-grade AVMs (Spetzler-Martin grade I or II), while the pre-embolization registry had 70% ruptured AVMs and 58% low-grade AVMs. The primary outcome of death or disability (mRS score > 2) occurred in 15 (14%, 95% CI 8%-22%) of the 106 patients in the curative embolization registry (4 [12%, 95% CI 5%-28%] of 32 unruptured AVMs and 11 [15%, 95% CI 8%-25%] of 74 ruptured AVMs) and 9 (12%, 95% CI 6%-21%) of the 77 patients in the pre-embolization registry (4 [17%, 95% CI 7%-37%] of 23 unruptured AVMs and 5 [9%, 95% CI 4%-20%] of 54 ruptured AVMs) at 2 years. Embolization alone was confirmed to occlude the AVM in 32 (30%, 95% CI 21%-40%) of the 106 curative attempts and in 9 (12%, 95% CI 6%-21%) of 77 patients in the pre-embolization registry. SAEs occurred in 28 of the 106 attempted curative patients (26%, 95% CI 18%-35%, including 21 new symptomatic hemorrhages [20%, 95% CI 13%-29%]). Five of the new hemorrhages were in previously unruptured AVMs (n = 32; 16%, 95% CI 5%-33%). Of the 77 pre-embolization patients, 18 had SAEs (23%, 95% CI 15%-34%), including 12 new symptomatic hemorrhages [16%, 95% CI 9%-26%]). Three of the hemorrhages were in previously unruptured AVMs (3/23; 13%, 95% CI 3%-34%)., Conclusions: Embolization as a curative treatment for brain AVMs was often incomplete. Hemorrhagic complications were frequent, even when the specified intent was pre-embolization before surgery or SRS. Because the role of endovascular treatment remains uncertain, it should preferably, when possible, be offered in the context of a randomized trial.
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47. The human placenta as a model for training and research in mechanical thrombectomy: Clarifications and use of the chorionic plate veins.
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Burel J, Cornacchini J, Garnier M, Patrier S, Guigné A, Gerardin E, Papagiannaki C, Sourour N, Shotar E, Premat K, Laporte C, and Clarençon F
- Abstract
Indications for mechanical thrombectomy in acute ischemic stroke are increasing, resulting in the continuous development of new devices and techniques. Therefore, there is a need for a realistic testing and training environment that offers the opportunity to practice different procedures and test the latest devices. Some authors have described the use of the human placenta as a model for neurointerventional surgery, with striking similarities to real-life conditions. This model has many advantages, including its relatively low cost and minimal infrastructure requirements, with fewer ethical concerns compared to animal models. So far, some preparation and set-up details were missing, and only arteries from the chorionic plate were used. This article provides the necessary clarifications and a mapping of the chorionic plate veins, so that the use of this model, which is particularly well suited for mechanical thrombectomy, can be as easy and wide as possible. A video explaining how to prepare the model is provided., Competing Interests: Author NS reports a conflict of interest with Medtronic, Balt Extrusion, Microvention (consultant), and Stock/Stock Options: Medina. Author FC reports a conflict of interest with Medtronic, Guerbet, Balt Extrusion (payment for readings), and Codman Neurovascular (core lab). The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Burel, Cornacchini, Garnier, Patrier, Guigné, Gerardin, Papagiannaki, Sourour, Shotar, Premat, Laporte and Clarençon.)
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48. Surgical treatment of brain arteriovenous malformations: clinical outcomes of patients included in the registry of a pragmatic randomized trial.
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Darsaut TE, Magro E, Bojanowski MW, Chaalala C, Nico L, Bacchus E, Klink R, Iancu D, Weill A, Roy D, Sabatier JF, Cognard C, Januel AC, Pelissou-Guyotat I, Eker O, Roche PH, Graillon T, Brunel H, Proust F, Beaujeux R, Aldea S, Piotin M, Cornu P, Shotar E, Gaberel T, Barbier C, Corre ML, Costalat V, Jecko V, Barreau X, Morandi X, Gauvrit JY, Derrey S, Papagiannaki C, Nguyen TN, Abdalkader M, Tawk RG, Huynh T, Viard G, Gevry G, Gentric JC, and Raymond J
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- Humans, Treatment Outcome, Prospective Studies, Registries, Brain, Retrospective Studies, Intracranial Arteriovenous Malformations diagnostic imaging, Intracranial Arteriovenous Malformations surgery, Embolization, Therapeutic methods, Radiosurgery methods
- Abstract
Objective: The Treatment of Brain Arteriovenous Malformations Study (TOBAS) is a pragmatic study that includes 2 randomized trials and registries of treated or conservatively managed patients. The authors report the results of the surgical registry., Methods: TOBAS patients are managed according to an algorithm that combines clinical judgment and randomized allocation. For patients considered for curative treatment, clinicians selected from surgery, endovascular therapy, or radiation therapy as the primary curative method, and whether observation was a reasonable alternative. When surgery was selected and observation was deemed unreasonable, the patient was not included in the randomized controlled trial but placed in the surgical registry. The primary outcome of the trial was mRS score > 2 at 10 years (at last follow-up for the current report). Secondary outcomes include angiographic results, perioperative serious adverse events, and permanent treatment-related complications leading to mRS score > 2., Results: From June 2014 to May 2021, 1010 patients were recruited at 30 TOBAS centers. Surgery was selected for 229/512 patients (44%) considered for curative treatment; 77 (34%) were included in the surgery versus observation randomized trial and 152 (66%) were placed in the surgical registry. Surgical registry patients had 124/152 (82%) ruptured and 28/152 (18%) unruptured arteriovenous malformations (AVMs), with the majority categorized as low-grade Spetzler-Martin grade I-II AVM (118/152 [78%]). Thirteen patients were excluded, leaving 139 patients for analysis. Embolization was performed prior to surgery in 78/139 (56%) patients. Surgical angiographic cure was obtained in 123/139 all-grade (89%, 95% CI 82%-93%) and 105/110 low-grade (95%, 95% CI 90%-98%) AVM patients. At the mean follow-up of 18.1 months, 16 patients (12%, 95% CI 7%-18%) had reached the primary safety outcome of mRS score > 2, including 11/16 who had a baseline mRS score ≥ 3 due to previous AVM rupture. Serious adverse events occurred in 29 patients (21%, 95% CI 15%-28%). Permanent treatment-related complications leading to mRS score > 2 occurred in 6/139 patients (4%, 95% CI 2%-9%), 5 (83%) of whom had complications due to preoperative embolization., Conclusions: The surgical treatment of brain AVMs in the TOBAS registry was curative in 88% of patients. The participation of more patients, surgeons, and centers in randomized trials is needed to definitively establish the role of surgery in the treatment of unruptured brain AVMs. Clinical trial registration no.: NCT02098252 (ClinicalTrials.gov).
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49. Thrombectomy alone versus intravenous alteplase plus thrombectomy in patients with stroke: an open-label, blinded-outcome, randomised non-inferiority trial.
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Fischer U, Kaesmacher J, Strbian D, Eker O, Cognard C, Plattner PS, Bütikofer L, Mordasini P, Deppeler S, Pereira VM, Albucher JF, Darcourt J, Bourcier R, Benoit G, Papagiannaki C, Ozkul-Wermester O, Sibolt G, Tiainen M, Gory B, Richard S, Liman J, Ernst MS, Boulanger M, Barbier C, Mechtouff L, Zhang L, Marnat G, Sibon I, Nikoubashman O, Reich A, Consoli A, Lapergue B, Ribo M, Tomasello A, Saleme S, Macian F, Moulin S, Pagano P, Saliou G, Carrera E, Janot K, Hernández-Pérez M, Pop R, Schiava LD, Luft AR, Piotin M, Gentric JC, Pikula A, Pfeilschifter W, Arnold M, Siddiqui AH, Froehler MT, Furlan AJ, Chapot R, Wiesmann M, Machi P, Diener HC, Kulcsar Z, Bonati LH, Bassetti CL, Mazighi M, Liebeskind DS, Saver JL, and Gralla J
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- Fibrinolytic Agents adverse effects, Humans, Intracranial Hemorrhages etiology, Treatment Outcome, Stroke drug therapy, Stroke surgery, Thrombectomy, Tissue Plasminogen Activator adverse effects
- Abstract
Background: Whether thrombectomy alone is equally as effective as intravenous alteplase plus thrombectomy remains controversial. We aimed to determine whether thrombectomy alone would be non-inferior to intravenous alteplase plus thrombectomy in patients presenting with acute ischaemic stroke., Methods: In this multicentre, randomised, open-label, blinded-outcome trial in Europe and Canada, we recruited patients with stroke due to large vessel occlusion confirmed with CT or magnetic resonance angiography admitted to endovascular centres. Patients were randomly assigned (1:1) via a centralised web server using a deterministic minimisation method to receive stent-retriever thrombectomy alone or intravenous alteplase plus stent-retriever thrombectomy. In both groups, thrombectomy was initiated as fast as possible with any commercially available Solitaire stent-retriever revascularisation device (Medtronic, Irvine, CA, USA). In the combined treatment group, intravenous alteplase (0·9 mg/kg bodyweight, maximum dose 90 mg per patient) was administered as early as possible after randomisation for 60 min with 10% of the calculated dose given as an initial bolus. Personnel assessing the primary outcome were masked to group allocation; patients and treating physicians were not. The primary binary outcome was a score of 2 or less on the modified Rankin scale at 90 days. We assessed the non-inferiority of thrombectomy alone versus intravenous alteplase plus thrombectomy in all randomly assigned and consenting patients using the one-sided lower 95% confidence limit of the Mantel-Haenszel risk difference, with a prespecified non-inferiority margin of 12%. The main safety endpoint was symptomatic intracranial haemorrhage assessed in all randomly assigned and consenting participants. This trial is registered with ClinicalTrials.gov, NCT03192332, and is closed to new participants., Findings: Between Nov 29, 2017, and May 7, 2021, 5215 patients were screened and 423 were randomly assigned, of whom 408 (201 thrombectomy alone, 207 intravenous alteplase plus thrombectomy) were included in the primary efficacy analysis. A modified Rankin scale score of 0-2 at 90 days was reached by 114 (57%) of 201 patients assigned to thrombectomy alone and 135 (65%) of 207 patients assigned to intravenous alteplase plus thrombectomy (adjusted risk difference -7·3%, 95% CI -16·6 to 2·1, lower limit of one-sided 95% CI -15·1%, crossing the non-inferiority margin of -12%). Symptomatic intracranial haemorrhage occurred in five (2%) of 201 patients undergoing thrombectomy alone and seven (3%) of 202 patients receiving intravenous alteplase plus thrombectomy (risk difference -1·0%, 95% CI -4·8 to 2·7). Successful reperfusion was less common in patients assigned to thrombectomy alone (182 [91%] of 201 vs 199 [96%] of 207, risk difference -5·1%, 95% CI -10·2 to 0·0, p=0·047)., Interpretation: Thrombectomy alone was not shown to be non-inferior to intravenous alteplase plus thrombectomy and resulted in decreased reperfusion rates. These results do not support omitting intravenous alteplase before thrombectomy in eligible patients., Funding: Medtronic and University Hospital Bern., Competing Interests: Declaration of interests UF reports financial support for the present study from Medtronic; research grants from Medtronic BEYOND SWIFT registry, the Swiss National Science Foundation, and the Swiss Heart Foundation; consulting fees from Medtronic, Stryker, and CSL Behring (fees paid to institution); has membership of a data safety monitoring board for the IN EXTREMIS trial and the TITAN trial; was on the advisory board for Portola (Alexion; fees paid to institution); and is Vice President of the Swiss Neurological Society. JK reports financial support from Medtronic for the BEYOND SWIFT registry (fees paid to institution); and research grants from the Swiss National Science Foundation supporting the TECNO trial (fees paid to institution), Swiss Academy of Medical Sciences supporting MRI research (fees paid to institution), and Swiss Heart Foundation supporting cardiac MRI in the aetiological work-up of stroke patients (fees paid to institution). CC reports consulting fees from Medtronic. PMo reports research funding (fees paid to institution) from the Swiss National Science Foundation, the Swiss Heart Foundation, and Medtronic. GM reports consulting fees from Stryker Neurovascular; and was paid for lectures for Medtronic and Microvention Europe. IS reports consulting fees from Sanofi Synthé-Labo, Servier, Boheringer Ingelheim, AstraZeneca, Novonordisk, and Medtronic; and payment or honoraria from Sanofi Synthé-Labo, Medtronic, Boheringer Ingelheim, AstraZeneca, and BMS—Pfizer. ON reports funding from a Stryker Research grant; and payment or honoraria for lectures for Phenox and Stryker. MR reports consulting fees from Medtronic, Stryker, Cerenovus, Philips, and Apta Targets; payment or honoraria from Ischemia View; participates on a data safety monitoring board or advisory board of Sensome; and has stock or stock options in Anaconda Biomed, CVAid, and Methinks. EC reports grants from the Swiss Heart Foundation and Swiss National Science Foundation, not related to the present study. ARL reports grants from the University of Zurich, the LOOP Zurich, and P&K Pühringer Foundation; consulting fees from Bayer; and a lecture honorarium from Moleac Pte, Singapore. WP reports grants from the German Research Foundation, LOEWE (research funding of the federal state of Hesse); royalties or licenses from the Stroke Team Training (Laerdal Medical); payment or honoraria from Laerdal Medical, Alexion, Pfizer—BMS, and Stryker Neurovascular; and support for attending meetings or travel from Laerdal Medical, Alexion, Pfizer—BMS, and Stryker Neurovascular. MA reports honoraria for lectures from AstraZeneca, Bayer, Covidien, Medtronic, and Sanofi; and participates on scientific advisory boards of Amgen, Bayer, BMS, Daiichi Sankyo, Medtronic, and Pfizer. AHS reports being a coinvestigator for the US National Institutes of Health (1R01EB030092-01); is mentor for the Carol W Harvey Chair of Research and Sharon Epperson Chair of Research at the Brain Aneurysm Foundation; receipt of consulting fees from Amnis Therapeutics, Apellis Pharmaceuticals, Boston Scientific, Canon Medical Systems USA, Cardinal Health 200, Cerebrotech Medical Systems, Cerenovus, Cerevatech Medical, Cordis, Corindus, Endostream Medical, Imperative Care, InspireMD, Integra, IRRAS AB, Medtronic, MicroVention, Minnetronix Neuro, Peijia Medical, Penumbra, Q’Apel Medical, Rapid Medical, Serenity Medical, Silk Road Medical, StimMed, Stryker Neurovascular, Three Rivers Medical, VasSol, and Viz.ai; is Secretary of the Board of the Society of NeuroInterventional Surgery 2020–2021 (unpaid); is Chair of the Cerebrovascular Section of the AANS/CNS 2020–2021 (unpaid); has stock or stock options in Adona Medical, Amnis Therapeutics, Bend IT Technologies, BlinkTBI, Cerebrotech Medical Systems, Cerevatech Medical, Cognition Medical, CVAID, E8, Endostream Medical, Galaxy Therapeutics, Imperative Care, InspireMD, Instylla, International Medical Distribution Partners, Launch NY, NeuroRadial Technologies, NeuroTechnology Investors, Neurovascular Diagnostics, Peijia Medical, PerFlow Medical, Q’Apel Medical, QAS.ai, Radical Catheter Technologies, Rebound Therapeutics (purchased 2019 by Integra Lifesciences), Rist Neurovascular, (purchased 2020 by Medtronic), Sense Diagnostics, Serenity Medical, Silk Road Medical, Sim & Cure, SongBird Therapy, Spinnaker Medical, StimMed, Synchron, Three Rivers Medical, Truvic Medical, Tulavi Therapeutics, Vastrax, VICIS, and Viseon; and other financial or non-financial interests: national principal investigator or steering committees for Cerenovus EXCELLENT and ARISE II Trial; Medtronic SWIFT PRIME, VANTAGE, EMBOLISE and SWIFT DIRECT Trials; MicroVention FRED Trial and CONFIDENCE Study; MUSC POSITIVE Trial; Penumbra 3D Separator Trial, COMPASS Trial, INVEST Trial, MIVI neuroscience EVAQ Trial; Rapid Medical SUCCESS Trial; and InspireMD C-GUARDIANS IDE Pivotal Trial. MTF reports research grants from Medtronic, Siemens, Genentech, Idorsia, and Vesalio; consulting fees from Genentech, Balt USA, CereNovus, and Oculus Imaging; and participates on a data safety monitoring board or advisory board for Balt USA, Jacobs Institute, and Imperative Care. MW reports a grant from Stryker Neurovascular; consulting fees from Stryker Neurovascular; payment or honoraria from Stryker Neurovascular and Bracco Imaging; is board member for the German Society of Neuroradiology (no payments); and receipt of equipment, materials, drugs, medical writing, gifts, or other services from Ab medica, Acandis, Bracco Imaging, Cerenovus, Kaneka Pharmaceuticals, Medtronic, Mentice, Phenox, and Stryker Neurovascular (support to institution). PMa reports grants from the Swiss National Science Foundation; consulting fees from Medtronic and Stryker; payment or honoraria from Medtronic and Stryker; and participated on a data safety monitoring board or advisory board of MicroVention. H-CD reports honoraria for participation in clinical trials, contribution to advisory boards, or oral presentations from Abbott, BMS, Boehringer Ingelheim, Daiichi-Sankyo, Novo-Nordisk, Pfizer, Portola, and WebMD Global; financial support for research projects from Boehringer Ingelheim; received research grants from the German Research Council and German Ministry of Education and Research; serves as Editor of Neurologie up2date, InFo Neurologie & Psychiatrie, Arzneimitteltherapie, and coeditor of Cephalalgia; and is on the editorial board of The Lancet Neurology and Drugs. MM reports payment or honoraria from Boehringer Ingelheim. DSL reports consulting fees from Cerenovus, Genentech, Medtronic, Stryker, and Rapid Medical as imaging core laboratory. JLS reports funding for the present study from Medtronic; consulting fees from Cerenovus; participates on a data safety monitoring board or advisory board for MIVI and Phillips; and has stock or stock options in Rapid Medical. JG reports a Swiss National Funds grant for MRI in stroke. All other authors declare no competing interests., (Copyright © 2022 Elsevier Ltd. All rights reserved.)
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50. Benefit of mechanical thrombectomy in acute ischemic stroke related to calcified cerebral embolus.
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Grand T, Dargazanli C, Papagiannaki C, Bruggeman A, Maurer C, Gascou G, Fauche C, Bourcier R, Tessier G, Blanc R, Machaa MB, Marnat G, Barreau X, Ognard J, Gentric JC, Barbier C, Gory B, Rodriguez C, Boulouis G, Eugène F, Thouant P, Ricolfi F, Janot K, Herbreteau D, Eker OF, Cappucci M, Dobrocky T, Möhlenbruch M, Demerath T, Psychogios M, Fischer S, Cianfoni A, Majoie C, Emmer B, Marquering H, Valter R, Lenck S, Premat K, Cortese J, Dormont D, Sourour NA, Shotar E, Samson Y, and Clarençon F
- Subjects
- Adult, Humans, Retrospective Studies, Treatment Outcome, Network Meta-Analysis, Brain Ischemia diagnostic imaging, Brain Ischemia surgery, Intracranial Embolism complications, Intracranial Embolism diagnostic imaging, Intracranial Embolism surgery, Ischemic Stroke diagnostic imaging, Ischemic Stroke etiology, Ischemic Stroke surgery, Thrombectomy
- Abstract
Purpose: Mechanical thrombectomies (MT) in patients with large vessel occlusion (LVO) related to calcified cerebral embolus (CCE) have been reported, through small case series, being associated with low reperfusion rate and worse outcome, compared to regular MT. The purpose of the MASC (Mechanical Thrombectomy in Acute Ischemic Stroke Related to Calcified Cerebral Embolus) study was to evaluate the incidence of CCEs treated by MT and the effectiveness of MT in this indication., Methods: The MASC study is a retrospective multicentric (n = 37) national study gathering the cases of adult patients who underwent MT for acute ischemic stroke with LVO related to a CCE in France from January 2015 to November 2019. Reperfusion rate (mTICI ≥ 2B), complication rate and 90-day mRS were systematically collected. We then conducted a systematic review by searching for articles in PubMed, Cochrane Library, Embase and Google Scholar from January 2015 to March 2020. A meta-analysis was performed to estimate clinical outcome at 90 days, reperfusion rate and complications., Results: We gathered data from 35 patients. Reperfusion was obtained in 57% of the cases. Good clinical outcome was observed in 28% of the patients. The meta-analysis retrieved 136 patients. Reperfusion and good clinical outcome were obtained in 50% and 29% of the cases, respectively., Conclusion: The MASC study found worse angiographic and clinical outcomes compared to regular thrombectomies. Individual patient-based meta-analysis including the MASC findings shows a 50% reperfusion rate and a 29% of good clinical outcome., Competing Interests: Declaration of Competing Interest Pr F. Clarençon is consultant for Medtronic, Guerbet, Balt Extrusion, Penumbra, Stryker (paid lectures), Artedrone (advisory board), Biomodex (consultant) and Microvention (core lab). Dr N. Sourour is consultant for Medtronic, Balt Extrusion, Microvention Dr F. Eugene is consultant for Biomodex SA Pr. JC. Gentric is consultant pour Medtronic, Stryker, Balt, Penumbra (paid lectures) /Advisory Board and stock options: Intradys Pr A. Biondi is consultant for Balt Extrusion, Medtronic, Microvention, Penumbra, Phenox, Stryker Neurovascular, (Copyright © 2022 Elsevier Masson SAS. All rights reserved.)
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