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Journal of neurosurgery · Apr 2023
Randomized Controlled TrialSurgical treatment of brain arteriovenous malformations: clinical outcomes of patients included in the registry of a pragmatic randomized trial.
- Tim E Darsaut, Elsa Magro, Michel W Bojanowski, Chiraz Chaalala, Lorena Nico, Emma Bacchus, Ruby Klink, Daniela Iancu, Alain Weill, Daniel Roy, Jean-Francois Sabatier, Christophe Cognard, Anne-Christine Januel, Isabelle Pelissou-Guyotat, Omer Eker, Pierre-Hugues Roche, Thomas Graillon, Hervé Brunel, Francois Proust, Rémy Beaujeux, Sorin Aldea, Michel Piotin, Philippe Cornu, Eimad Shotar, Thomas Gaberel, Charlotte Barbier, CorreMarine LeMLDepartments of22Neurosurgery and., Vincent Costalat, Vincent Jecko, Xavier Barreau, Xavier Morandi, Jean-Yves Gauvrit, Stéphane Derrey, Chrysanthi Papagiannaki, Thanh N Nguyen, Mohamad Abdalkader, Rabih G Tawk, Thien Huynh, Geraldine Viard, Guylaine Gevry, Jean-Christophe Gentric, Jean Raymond, TOBAS Collaborative Group, and List of participating TOBAS centers and physicians.
- 1Division of Neurosurgery, Department of Surgery, University of Alberta Hospital, Mackenzie Health Sciences Centre, Edmonton, Alberta, Canada.
- J. Neurosurg. 2023 Apr 1; 138 (4): 891899891-899.
ObjectiveThe 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.MethodsTOBAS 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.ResultsFrom 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.ConclusionsThe 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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