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

Thomas A. Tomsick, Phillip Purdy, Michael Horowitz, Thomas Kopitnik, Duke Samson, Jacques Dion, Gregory Joseph, Robert Dawson, David Owens, Danial Barrow, John Barr, Stephen Powers, Kevin Cockroft, Brian Holmes, Maria Sumas, Robert Wallace, Thomas Masaryk, John Perl, Douglas Chyatte, John M. TewHarry Van Loveren, Mario Zuccarello, Michael Marks, Alexander Norbash, Gary Steinberg, Van Halbach, Randall Higashida, Christopher Dowd, Michael Lawton, Charles Wilson, Cameron McDougall, Robert Spetzler, Gary Nesbit, Stanley Barnwell, Douglas Nichols, Kent Thielen, John Atkinson, Fredric Meyer, David Piepgras, In Sup Choi, John D. Day, Alejandro Berenstein, Avi Setton, Johnny Pryor, Yasunari Niimi, Eugene Flamm, Andrew DeNardo, John Scott, F. Reed Murtagh

Research output: Contribution to journalArticle

138 Citations (Scopus)

Abstract

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 tranfusion, 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.

Original languageEnglish (US)
Pages (from-to)748-755
Number of pages8
JournalAmerican Journal of Neuroradiology
Volume23
Issue number5
StatePublished - 2002

Fingerprint

Enbucrilate
Intracranial Arteriovenous Malformations
Polyvinyl Alcohol
Tantalum
Ethiodized Oil
Arteriovenous Malformations
Powders
Glasgow Outcome Scale
Therapeutics
Drug Approval
Safety
Equipment and Supplies
United States Food and Drug Administration
Hematoma
Nervous System

ASJC Scopus subject areas

  • Clinical Neurology
  • Radiology Nuclear Medicine and imaging
  • Radiological and Ultrasound Technology

Cite this

Tomsick, T. A., Purdy, P., Horowitz, M., Kopitnik, T., Samson, D., Dion, J., ... Murtagh, F. R. (2002). N-butyl cyanoacrylate embolization of cerebral arteriovenous malformations: Results of a prospective, randomized, multi-center trial. American Journal of Neuroradiology, 23(5), 748-755.

N-butyl cyanoacrylate embolization of cerebral arteriovenous malformations : Results of a prospective, randomized, multi-center trial. / Tomsick, Thomas A.; Purdy, Phillip; Horowitz, Michael; Kopitnik, Thomas; Samson, Duke; Dion, Jacques; Joseph, Gregory; Dawson, Robert; Owens, David; Barrow, Danial; Barr, John; Powers, Stephen; Cockroft, Kevin; Holmes, Brian; Sumas, Maria; Wallace, Robert; Masaryk, Thomas; Perl, John; Chyatte, Douglas; Tew, John M.; Van Loveren, Harry; Zuccarello, Mario; Marks, Michael; Norbash, Alexander; Steinberg, Gary; Halbach, Van; Higashida, Randall; Dowd, Christopher; Lawton, Michael; Wilson, Charles; McDougall, Cameron; Spetzler, Robert; Nesbit, Gary; Barnwell, Stanley; Nichols, Douglas; Thielen, Kent; Atkinson, John; Meyer, Fredric; Piepgras, David; Choi, In Sup; Day, John D.; Berenstein, Alejandro; Setton, Avi; Pryor, Johnny; Niimi, Yasunari; Flamm, Eugene; DeNardo, Andrew; Scott, John; Murtagh, F. Reed.

In: American Journal of Neuroradiology, Vol. 23, No. 5, 2002, p. 748-755.

Research output: Contribution to journalArticle

Tomsick, TA, Purdy, P, Horowitz, M, Kopitnik, T, Samson, D, Dion, J, Joseph, G, Dawson, R, Owens, D, Barrow, D, Barr, J, Powers, S, Cockroft, K, Holmes, B, Sumas, M, Wallace, R, Masaryk, T, Perl, J, Chyatte, D, Tew, JM, Van Loveren, H, Zuccarello, M, Marks, M, Norbash, A, Steinberg, G, Halbach, V, Higashida, R, Dowd, C, Lawton, M, Wilson, C, McDougall, C, Spetzler, R, Nesbit, G, Barnwell, S, Nichols, D, Thielen, K, Atkinson, J, Meyer, F, Piepgras, D, Choi, IS, Day, JD, Berenstein, A, Setton, A, Pryor, J, Niimi, Y, Flamm, E, DeNardo, A, Scott, J & Murtagh, FR 2002, 'N-butyl cyanoacrylate embolization of cerebral arteriovenous malformations: Results of a prospective, randomized, multi-center trial', American Journal of Neuroradiology, vol. 23, no. 5, pp. 748-755.
Tomsick, Thomas A. ; Purdy, Phillip ; Horowitz, Michael ; Kopitnik, Thomas ; Samson, Duke ; Dion, Jacques ; Joseph, Gregory ; Dawson, Robert ; Owens, David ; Barrow, Danial ; Barr, John ; Powers, Stephen ; Cockroft, Kevin ; Holmes, Brian ; Sumas, Maria ; Wallace, Robert ; Masaryk, Thomas ; Perl, John ; Chyatte, Douglas ; Tew, John M. ; Van Loveren, Harry ; Zuccarello, Mario ; Marks, Michael ; Norbash, Alexander ; Steinberg, Gary ; Halbach, Van ; Higashida, Randall ; Dowd, Christopher ; Lawton, Michael ; Wilson, Charles ; McDougall, Cameron ; Spetzler, Robert ; Nesbit, Gary ; Barnwell, Stanley ; Nichols, Douglas ; Thielen, Kent ; Atkinson, John ; Meyer, Fredric ; Piepgras, David ; Choi, In Sup ; Day, John D. ; Berenstein, Alejandro ; Setton, Avi ; Pryor, Johnny ; Niimi, Yasunari ; Flamm, Eugene ; DeNardo, Andrew ; Scott, John ; Murtagh, F. Reed. / N-butyl cyanoacrylate embolization of cerebral arteriovenous malformations : Results of a prospective, randomized, multi-center trial. In: American Journal of Neuroradiology. 2002 ; Vol. 23, No. 5. pp. 748-755.
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title = "N-butyl cyanoacrylate embolization of cerebral arteriovenous malformations: Results of a prospective, randomized, multi-center trial",
abstract = "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 tranfusion, 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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TY - JOUR

T1 - N-butyl cyanoacrylate embolization of cerebral arteriovenous malformations

T2 - Results of a prospective, randomized, multi-center trial

AU - Tomsick, Thomas A.

AU - Purdy, Phillip

AU - Horowitz, Michael

AU - Kopitnik, Thomas

AU - Samson, Duke

AU - Dion, Jacques

AU - Joseph, Gregory

AU - Dawson, Robert

AU - Owens, David

AU - Barrow, Danial

AU - Barr, John

AU - Powers, Stephen

AU - Cockroft, Kevin

AU - Holmes, Brian

AU - Sumas, Maria

AU - Wallace, Robert

AU - Masaryk, Thomas

AU - Perl, John

AU - Chyatte, Douglas

AU - Tew, John M.

AU - Van Loveren, Harry

AU - Zuccarello, Mario

AU - Marks, Michael

AU - Norbash, Alexander

AU - Steinberg, Gary

AU - Halbach, Van

AU - Higashida, Randall

AU - Dowd, Christopher

AU - Lawton, Michael

AU - Wilson, Charles

AU - McDougall, Cameron

AU - Spetzler, Robert

AU - Nesbit, Gary

AU - Barnwell, Stanley

AU - Nichols, Douglas

AU - Thielen, Kent

AU - Atkinson, John

AU - Meyer, Fredric

AU - Piepgras, David

AU - Choi, In Sup

AU - Day, John D.

AU - Berenstein, Alejandro

AU - Setton, Avi

AU - Pryor, Johnny

AU - Niimi, Yasunari

AU - Flamm, Eugene

AU - DeNardo, Andrew

AU - Scott, John

AU - Murtagh, F. Reed

PY - 2002

Y1 - 2002

N2 - 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 tranfusion, 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.

AB - 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 tranfusion, 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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