Flow Diverters for Intracranial Aneurysms

Author:

Gory Benjamin1,Berge Jerome2,Bonafé Alain3,Pierot Laurent4,Spelle Laurent5,Piotin Michel6,Biondi Alessandra7,Cognard Christophe8,Mounayer Charbel9,Sourour Nader10,Barbier Charlotte11,Desal Hubert12,Herbreteau Denis13,Chabert Emmanuel14,Brunel Hervé15,Ricolfi Frédéric16,Anxionnat René1,Decullier Evelyne17,Huot Laure17,Turjman Francis18,Barreau Xavier,Menegon Patrice,Marnat Gaultier,Costalat Vincent,Gascou Gregory,Dargazanli Cyril,Soize Sébastien,Metaxas Georges,Moret Jacques,Ikka Léon,Caroff Jildaz,Rouchaud Aymeric,Mihaela Christian,Benachour Nidal,Blanc Raphaël,Redjem Hocine,Pomero Elisa,Januel Anne Christine,Darcout Julien,Guenego Adrien,Tall Philippe,Bonneville Fabrice,Saleme Suzana,Clarençon Frédéric,Bourcier Romain,Narata Ana Paula,Bibi Richard,Bracard Serge,Derelle Anne-Laure,Tonnelet Romain,Liao Liang,Kulcsar Zsolt,Taschner Christian,

Affiliation:

1. From the Department of Diagnostic and Therapeutic Neuroradiology, INSERM U1254, University Hospital of Nancy, France (B.G., R.A.)

2. Department of Neuroradiology, CHU de Bordeaux, France (J.B.)

3. Department of Neuroradiology, Hôpital Gui de Chauliac, Montpellier, France (A. Bonafé)

4. Department of Neuroradiology, CHU Reims, France (L.P.)

5. Department of Interventional Neuroradiology, CHU Bicêtre, Le Kremlin Bicêtre, France (L.S.)

6. Department of Interventional Neuroradiology, Rothschild Fondation, Paris, France (M.P.)

7. Department of Neuroradiology and Endovascular Therapy, CHU Besançon, France (A. Biondi)

8. Department of Diagnostic and Therapeutic Neuroradiology, CHU Toulouse, France (C.C.)

9. Department of Interventional Neuroradiology, CHU Limoges, France (C.M.)

10. Department of Interventional Neuroradiology, Pitié-Salpêtrière Hospital, Paris, France (N.S.)

11. Department of Neuroradiology, CHU Caen, France (C.B.)

12. Department of Neuroradiology, CHU Nantes, France (H.D.)

13. Department of Neuroradiology, CHU Tours, France (D.H.)

14. Department of Neuroradiology, CHU Clermont-Ferrand, France (E.C.)

15. Department of Neuroradiology, CHU Marseille, France (H.B.)

16. Department of Neuroradiology, CHU Dijon, France (F.R.)

17. Pôle Information Médicale Evaluation Recherche, Unité de Recherche clinique (E.D., L.H.), Hospices Civils de Lyon, France.

18. Department of Interventional Neuroradiology (F.T.), Hospices Civils de Lyon, France.

Abstract

Background and Purpose— Flow diverters are used for endovascular therapy of intracranial aneurysms. We did a nationwide prospective study to investigate the safety and effectiveness of flow diversion at 12 months. Methods— DIVERSION was a national prospective cohort study including all flow diverters placement between October 2012 and February 2014 in France. The primary end point was the event-free survival rate at 12 months, defined as the occurrence of morbidity (intracranial hemorrhage, ischemic stroke, noncerebral hemorrhage, or neurological deficit due to mass effect), retreatment, or death within 12 months post-treatment. A quality control was carried out on 100% of the collected data and of at least 10% of the included patients in each center, chosen at random. All reported serious events were adjudicated by an independent Data Safety and Monitoring Board. Satisfactory occlusion was defined as 3 or 4 on Kamran scale by an independent imaging core laboratory at 12 months. Results— We enrolled 398 patients harboring 477 intracranial aneurysms. At least 1 morbidity-mortality event was noted in 95 of 408 interventions representing an event-free survival rate of 75.7% (95% CI, 71.1–79.7). The rate of permanent-related serious events and mortality was 5.9% and 1.2% at 12 months, respectively. Multivariate analysis showed that high baseline blood pressure (hazard ratio, 2.54; 95% CI, 1.35–4.79; P =0.039), diabetes mellitus (hazard ratio, 3.70; 95% CI, 1.60–8.6; P =0.0022), and larger aneurysms (hazard ratio, 1.07; 95% CI, 1.04–1.11; P <0.0001) were associated with the occurrence of a neurological deficit. The satisfactory occlusion rate at 12 months was 79.9%, and the absence of high baseline blood pressure (odds ratio, 2.01; 95% CI, 1.12–3.71; P =0.0193) and postprocedural satisfactory occlusion (odds ratio, 2.75; 95% CI, 1.49–5.09; P =0.0012) were associated with a 12-month satisfactory occlusion. Conclusions— A satisfactory occlusion was achieved in almost 80% of cases after flow diverter treatment with a permanent-related serious event and mortality rates of 5.9% and 1.2% at 12 months, respectively.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Advanced and Specialized Nursing,Cardiology and Cardiovascular Medicine,Neurology (clinical)

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