1. Endovascular treatment of brain arteriovenous malformations: clinical outcomes of patients included in the registry of a pragmatic randomized trial
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Jean Raymond, Jean-Christophe Gentric, Elsa Magro, Lorena Nico, Emma Bacchus, Ruby Klink, Christophe Cognard, Anne-Christine Januel, Jean-François Sabatier, Daniela Iancu, Alain Weill, Daniel Roy, Michel W. Bojanowski, Chiraz Chaalala, Xavier Barreau, Vincent Jecko, Chrysanthi Papagiannaki, Stéphane Derrey, Eimad Shotar, Philippe Cornu, Omer F. Eker, Isabelle Pelissou-Guyotat, Michel Piotin, Sorin Aldea, Rémy Beaujeux, François Proust, René Anxionnat, Vincent Costalat, Marine Le Corre, Jean-Yves Gauvrit, Xavier Morandi, Hervé Brunel, Pierre-Hugues Roche, Thomas Graillon, Emmanuel Chabert, Denis Herbreteau, Hubert Desal, Denis Trystram, Charlotte Barbier, Thomas Gaberel, Thanh N. Nguyen, Geraldine Viard, Guylaine Gevry, Tim E. Darsaut, Cian J. O’Kelly, Michael M. C. Chow, J. Max Findlay, Jeremy L. Rempel, Robert Fahed, Howard Lesiuk, Brian Drake, Marlene dos Santos, Michel Nonent, Julien Ognard, Mourad Cheddad El-Aouni, Romuald Seizeur, Serge Timsit, Olivier Pradier, Romain Boursier, François Thillays, Vincent Roualdes, Raphael Blanc, Lionel Calviere, Jean Yves Gauvrit, Hélène Raoult, François Eugene, Anthony Le Bras, Jean-Christophe Ferre, Christophe Paya, Isabelle Lecouillard, Elodie Nouhaud, Thomas Ronziere, Olivier Naggara, Christine Rodriguez-Regent, Basile Kerleroux, Evelyne Emery, Emmanuel Touze, Roberto Riva, Isabelle Pellisou-Guyotat, Jacques Guyotat, Monsef Berhouma, Chloé Dumot, Alessandra Biondi, Laurent Thines, Nassim Bougaci, Guillaume Charbonnier, Serge Bracard, Benjamin Gory, Thierry Civit, Valérie Bernier-Chastagner, Gaultier Marnat, Guillaume Penchet, Edouard Gimbert, Aymeri Huchet, Grégoire Boulouis, Richard Bibi, Héloïse Ifergan, Kévin Janot, Stéphane Velut, Hadrien Peyriere, Jean-Marc Kaya, Adamou Touta, Lucas Troude, Sébastien Boissonneau, Frédéric Clarençon, Nader Sourour, Stéphanie Lenck, Kévin Premat, Anne-Laure Boch, Aurélien Nouet, Alain Bonafe, Cyril Dargazanli, Gregory Gascou, Pierre-Henri Lefevre, Carlos Riquelme, Raoul Pop, Hélène Cebula, Irène Ollivier, Giorgio Spatola, Laurent Spell, Vanessa Chalumeau, Sophie Gallas, Léon Ikka, Cristian Mihalea, Augustin Ozanne, Jildaz Caroff, Charbel Mounayer, Aymeric Rouchaud, François Caire, Frédéric Ricolfi, Pierre Thouant, Catherine Cao, Klaus-Luc Mourier, Walid Farah, Mohamad Abdalkader, Thien Huynh, Rabih G. Tawk, Andrew P. Carlson, Luciana Alves Oliveira Silva, Nayara de Lima Froio, Gisele Sampaio Silva, Francisco J. A. Mont’Alverne, Jose Luri Martins, George Nunes Mendes, and Rodrigo Rivera Miranda
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General Medicine - 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.
- Published
- 2022