• Journal of neurosurgery · Oct 2024

    Conservative management of brain arteriovenous malformations: results of the prospective observation registry of a pragmatic trial.

    • Tim E Darsaut, Jean-Christophe Gentric, Jonathan Heppner, Camille Lopez, Roland Jabre, Daniela Iancu, Daniel Roy, Alain Weill, Michel W Bojanowski, Chiraz Chaalala, Pierre-Olivier Comby, David Roberge, Christophe Cognard, Anne-Christine Januel, Jean-Francois Sabatier, Hubert Desal, Vincent Roualdes, Jean-Christophe Ferre, Quentin Alias, Chrysanthi Papagiannaki, Stéphane Derrey, Stanislas Smajda, Sorin Aldea, Thomas Gaberel, Charlotte Barbier, Xavier Barreau, Gaultier Marnat, Vincent Jecko, Rene Anxionnat, Isabelle Merlot, Thanh N Nguyen, Mohamad Abdalkader, Chloe Dumot, Roberto Riva, Thomas Graillon, Lucas Troude, Basile Kerleroux, Irene Ollivier, Remy Beaujeux, Grégoire Boulouis, Alexia Planty-Bonjour, Laurent Spelle, Vanessa Chalumeau, Olivier Naggara, Pierre-Henri Lefevre, Marine Le Corre, Eimad Shotar, Andrew P Carlson, Alessandra Biondi, Laurent Thines, Rabih G Tawk, Thien Huynh, Robert Fahed, J Max Findlay, Emmanuel Chabert, Justine Zehr, Guylaine Gevry, Ruby Klink, Geraldine Viard, Elsa Magro, Jean Raymond, and and the TOBAS Collaborative Group.
    • 1Department of Surgery, Division of Neurosurgery, University of Alberta Hospital, Edmonton, Alberta, Canada.
    • J. Neurosurg. 2024 Oct 11: 1101-10.

    ObjectiveMany patients recruited in the Treatment of Brain Arteriovenous Malformations Study (TOBAS) are managed conservatively. The aim of this study was to monitor what happened to those patients.MethodsTOBAS comprises two randomized controlled trials and multiple prospective registries. All patients with brain arteriovenous malformations (AVMs) can participate. This report concerns patients selected for conservative management. The primary trial outcome measure is related death or dependency (modified Rankin Scale [mRS] score > 2) at 10 years. Secondary outcomes include intracranial hemorrhages, nonhemorrhagic neurological events, and serious adverse events (SAEs). For this report, outcome results are presented using patient-years, Kaplan-Meier survival curves, and Cox log-rank tests. There was no blinding.ResultsFrom June 2014 to May 2021, 1010 patients were recruited, of whom 498 (49%) were proposed the prospective observation registry. After exclusions, 434 (87%) patients remained for analysis. The majority of patients had unruptured AVMs (378/434 [87%]), of which 195 (52%) were low grade (Spetzler-Martin grade I or II). During a mean follow-up period of 3.2 years (total 1368 patient-years), the primary outcome occurred in 23 of 434 (5%) patients, corresponding to an incidence of 1.7 (95% CI 1.1-2.5) per 100 patient-years. For unruptured AVMs the incidence was 1.1 (95% CI 0.7-1.9) per 100 patient-years, and for low-grade unruptured AVMs it was 0.6 (95% CI 0.2-1.7) per 100 patient-years. Poor outcomes were more frequent in patients with a history of rupture (HR 5.6 [95% CI 2.4-13.0], p < 0.001), infratentorial AVMs (HR 2.9 [95% CI 1.1-7.3], p = 0.027), and age ≥ 55 years (HR 3.2 [95% CI 1.4-7.6], p = 0.007). Major intracranial hemorrhage occurred in 35 of 434 (8%) patients (incidence of 2.6 [95% CI 1.9-3.6] per 100 patient-years; 2.0 [95% CI 1.3-2.9] per 100 patient-years for unruptured AVMs and 1.3 [95% CI 0.6-2.6] per 100 patient-years for low-grade unruptured AVMs). Major AVM hemorrhages were more frequent in ruptured (HR 4.4 [95% CI 2.1-8.9], p < 0.001), large (HR 2.6 [95% CI 1.1-6.6], p = 0.039), and high-grade (HR 2.5 [95% CI 1.2-5.3], p = 0.013) AVMs and those with deep venous drainage (HR 2.1 [95% CI 1.1-4.2], p = 0.032). SAEs occurred in 48 of 434 (11%) patients (incidence of 3.6 [95% CI 2.7-4.8] per 100 patient-years). For unruptured AVMs the incidence was 2.8 (95% CI 2.0-4.0) per 100 patient-years, and for low-grade unruptured AVMs it was 1.8 (95% CI 1.0-3.2) per 100 patient-years.ConclusionsNearly half of TOBAS participants were observed. Rates of untoward neurological events were within expected boundaries.

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