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document
N-butyl cyanoacrylate embolization of cerebral arteriovenous malformations : results of a prospective , randomized , multi-center trial . BACKGROUND AND PURPOSE Liquid N-butyl cyanoacrylate ( n-BCA ) use for the treatment of arteriovenous malformations ( AVM ) in the brain has become part of medical practice . However , no study has led to the Food and Drug Administration 's approval of n-BCA for intravascular use . The purpose of this study was to verify the effectiveness and safety of an n-BCA/Tantalum Powder/Ethiodized Oil mixture , compared with conventional treatment ( Trufill polyvinyl alcohol [ PVA ] ) for preoperative embolization of cerebral AVM . METHODS Between October 15 , 1996 , and March 24 , 1999 , 104 patients at 13 centers were prospectively randomized to undergo embolization using an n-BCA/Tantalum Powder/Ethiodol mixture or Trufill PVA . The pre-embolization therapy goals were determined in terms of the number of pedicles to be embolized and the percent of nidus reduction expected . Embolization results were evaluated by a central laboratory . Subsequent surgical resection data were recorded . Safety evaluation data included recording device complications , procedure complications , and intracranial events/overall neurologic outcomes , which could be either device-related , procedure-related , or both . RESULTS The reduction of AVM dimensions ( 79.4 % in the n-BCA group and 86.9 % in the PVA group ) and the mean number of vessels embolized ( 2.2 in the n-BCA group and 2.1 in the PVA group ) was similar in the two groups . Coils were used more commonly with PVA embolization ( P < .0001 ) . No differences were detected in surgical resection time , number of patients who required transfusion , volume and number of transfusion units , or type and volume of fluid replacement . Glasgow Outcome Scale scores were not significantly different between the two groups before treatment , after embolization , or after resection . Two of 42 patients who underwent resection and had been treated with n-BCA experienced post-resection hematoma , compared with eight of 45 patients who underwent resection and had been treated with PVA ( P < .05 ) . CONCLUSION This prospective , randomized trial showed that n-BCA is equivalent to PVA as a preoperative embolic agent for treatment of cerebral AVM as determined by percent of nidus reduction and number of feeding pedicles embolized .
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Intervention_Pharmacological
embolization using an n-BCA/Tantalum Powder/Ethiodol mixture
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Intervention_Pharmacological
Trufill PVA
9034
Outcome_Adverse-effects
device complications
9035
Outcome_Adverse-effects
procedure complications
9036
Outcome_Physical
intracranial events/overall neurologic outcomes
9037
Outcome_Physical
AVM dimensions
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Outcome_Physical
mean number of vessels embolized
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Outcome_Other
surgical resection time
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Outcome_Other
number of patients who required transfusion
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Outcome_Other
volume and number of transfusion units
9042
Outcome_Other
type and volume of fluid replacement
9043
Outcome_Physical
Glasgow Outcome Scale scores
9044
Outcome_Adverse-effects
post-resection hematoma
9045
Participant_Sample-size
104
9046
Participant_Condition
cerebral AVM