N-butyl cyanoacrylate embolization of cerebral arteriovenous malformations: Results of a prospective, randomized, multi-center trial

摘要: BACKGROUND AND PURPOSE Liquid N-butyl cyanoacrylate (n-BCA) use for the treatment of arteriovenous malformations (AVM) in brain has become part medical practice. However, no study led to Food and Drug Administration's approval n-BCA intravascular use. The purpose this was verify effectiveness safety an n-BCA/Tantalum Powder/Ethiodized Oil mixture, compared with conventional (Trufill polyvinyl alcohol [PVA]) preoperative embolization cerebral AVM. METHODS Between October 15, 1996, March 24, 1999, 104 patients at 13 centers were prospectively randomized undergo using Powder/Ethiodol mixture or Trufill PVA. pre-embolization therapy goals determined terms number pedicles be embolized percent nidus reduction expected. Embolization results evaluated by a central laboratory. Subsequent surgical resection data recorded. Safety evaluation included recording device complications, procedure intracranial events/overall neurologic outcomes, which could either device-related, procedure-related, both. RESULTS AVM dimensions (79.4% group 86.9% PVA group) mean vessels (2.2 2.1 similar two groups. Coils used more commonly (P<.0001). No differences detected time, who required transfusion, volume transfusion units, type fluid replacement. Glasgow Outcome Scale scores not significantly different between groups before treatment, after embolization, resection. Two 42 underwent had been treated experienced post-resection hematoma, eight 45 (P<.05). CONCLUSION This prospective, trial showed that is equivalent as embolic agent feeding embolized.