Results of the ANSWER Trial Using the PulseRider for the Treatment of Broad-Necked, Bifurcation Aneurysms

Alejandro M. Spiotta, Colin P. Derdeyn, Satoshi Tateshima, Jay Mocco, R. Webster Crowley, Kenneth Liu, Lee Jensen, Koji Ebersole, Alan Reeves, Demetrius K. Lopes, Ricardo A. Hanel, Eric Sauvageau, Gary Duckwiler, Adnan Siddiqui, Elad Levy, Ajit Puri, Lee Pride, Roberta Novakovic, M. Imran Chaudry, Raymond D. TurnerAquilla S. Turk

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

BACKGROUND: The safety and probable benefit of the PulseRider (Pulsar Vascular, Los Gatos, California) for the treatment of broad-necked, bifurcation aneurysms was studied in the context of the prospective, nonrandomized, single arm clinical trial - the Adjunctive Neurovascular Support of Wide-neck aneurysm Embolization and Reconstruction (ANSWER) Trial. OBJECTIVE: To present the results of the United States cases employing the PulseRider device as part of the ANSWER clinical trial. METHODS: Aneurysms treated with the PulseRider device among sites enrolling in the ANSWER trial were prospectively studied and the results are summarized. Aneurysms arising at either the carotid terminus or basilar apex that were relatively broad necked were considered candidates for inclusion into the ANSWER study. RESULTS: Thirty-four patients were enrolled (29 female and 5 male) with a mean age of 60.9 years (27 basilar apex and 7 carotid terminus). Mean aneurysm height ranged from 2.4 to 15.9 mm with a mean neck size of 5.2 mm (range 2.3-11.6 mm). In all patients, the device was delivered and deployed. Immediate Raymond I or II occlusion was achieved in 82.4% and progressed to 87.9% at 6-month follow-up. A modified Rankin Score of 2 or less was seen in 94% of patients at 6 months. CONCLUSION: The results from the ANSWER trial demonstrate that the PulseRider device is safe and offers probable benefit as for the treatment of bifurcation aneurysms arising at the basilar apex or carotid terminus. As such, it represents a useful addition to the armamentarium of the neuroendovascular specialist.

Original languageEnglish (US)
Pages (from-to)56-65
Number of pages10
JournalNeurosurgery
Volume81
Issue number1
DOIs
StatePublished - Jul 1 2017

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Aneurysm
Neck
Therapeutics
Equipment and Supplies
Clinical Trials
DEAE-Dextran
Blood Vessels
Arm
Safety

All Science Journal Classification (ASJC) codes

  • Surgery
  • Clinical Neurology

Cite this

Spiotta, A. M., Derdeyn, C. P., Tateshima, S., Mocco, J., Crowley, R. W., Liu, K., ... Turk, A. S. (2017). Results of the ANSWER Trial Using the PulseRider for the Treatment of Broad-Necked, Bifurcation Aneurysms. Neurosurgery, 81(1), 56-65. https://doi.org/10.1093/neuros/nyx085
Spiotta, Alejandro M. ; Derdeyn, Colin P. ; Tateshima, Satoshi ; Mocco, Jay ; Crowley, R. Webster ; Liu, Kenneth ; Jensen, Lee ; Ebersole, Koji ; Reeves, Alan ; Lopes, Demetrius K. ; Hanel, Ricardo A. ; Sauvageau, Eric ; Duckwiler, Gary ; Siddiqui, Adnan ; Levy, Elad ; Puri, Ajit ; Pride, Lee ; Novakovic, Roberta ; Chaudry, M. Imran ; Turner, Raymond D. ; Turk, Aquilla S. / Results of the ANSWER Trial Using the PulseRider for the Treatment of Broad-Necked, Bifurcation Aneurysms. In: Neurosurgery. 2017 ; Vol. 81, No. 1. pp. 56-65.
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abstract = "BACKGROUND: The safety and probable benefit of the PulseRider (Pulsar Vascular, Los Gatos, California) for the treatment of broad-necked, bifurcation aneurysms was studied in the context of the prospective, nonrandomized, single arm clinical trial - the Adjunctive Neurovascular Support of Wide-neck aneurysm Embolization and Reconstruction (ANSWER) Trial. OBJECTIVE: To present the results of the United States cases employing the PulseRider device as part of the ANSWER clinical trial. METHODS: Aneurysms treated with the PulseRider device among sites enrolling in the ANSWER trial were prospectively studied and the results are summarized. Aneurysms arising at either the carotid terminus or basilar apex that were relatively broad necked were considered candidates for inclusion into the ANSWER study. RESULTS: Thirty-four patients were enrolled (29 female and 5 male) with a mean age of 60.9 years (27 basilar apex and 7 carotid terminus). Mean aneurysm height ranged from 2.4 to 15.9 mm with a mean neck size of 5.2 mm (range 2.3-11.6 mm). In all patients, the device was delivered and deployed. Immediate Raymond I or II occlusion was achieved in 82.4{\%} and progressed to 87.9{\%} at 6-month follow-up. A modified Rankin Score of 2 or less was seen in 94{\%} of patients at 6 months. CONCLUSION: The results from the ANSWER trial demonstrate that the PulseRider device is safe and offers probable benefit as for the treatment of bifurcation aneurysms arising at the basilar apex or carotid terminus. As such, it represents a useful addition to the armamentarium of the neuroendovascular specialist.",
author = "Spiotta, {Alejandro M.} and Derdeyn, {Colin P.} and Satoshi Tateshima and Jay Mocco and Crowley, {R. Webster} and Kenneth Liu and Lee Jensen and Koji Ebersole and Alan Reeves and Lopes, {Demetrius K.} and Hanel, {Ricardo A.} and Eric Sauvageau and Gary Duckwiler and Adnan Siddiqui and Elad Levy and Ajit Puri and Lee Pride and Roberta Novakovic and Chaudry, {M. Imran} and Turner, {Raymond D.} and Turk, {Aquilla S.}",
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Spiotta, AM, Derdeyn, CP, Tateshima, S, Mocco, J, Crowley, RW, Liu, K, Jensen, L, Ebersole, K, Reeves, A, Lopes, DK, Hanel, RA, Sauvageau, E, Duckwiler, G, Siddiqui, A, Levy, E, Puri, A, Pride, L, Novakovic, R, Chaudry, MI, Turner, RD & Turk, AS 2017, 'Results of the ANSWER Trial Using the PulseRider for the Treatment of Broad-Necked, Bifurcation Aneurysms', Neurosurgery, vol. 81, no. 1, pp. 56-65. https://doi.org/10.1093/neuros/nyx085

Results of the ANSWER Trial Using the PulseRider for the Treatment of Broad-Necked, Bifurcation Aneurysms. / Spiotta, Alejandro M.; Derdeyn, Colin P.; Tateshima, Satoshi; Mocco, Jay; Crowley, R. Webster; Liu, Kenneth; Jensen, Lee; Ebersole, Koji; Reeves, Alan; Lopes, Demetrius K.; Hanel, Ricardo A.; Sauvageau, Eric; Duckwiler, Gary; Siddiqui, Adnan; Levy, Elad; Puri, Ajit; Pride, Lee; Novakovic, Roberta; Chaudry, M. Imran; Turner, Raymond D.; Turk, Aquilla S.

In: Neurosurgery, Vol. 81, No. 1, 01.07.2017, p. 56-65.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Results of the ANSWER Trial Using the PulseRider for the Treatment of Broad-Necked, Bifurcation Aneurysms

AU - Spiotta, Alejandro M.

AU - Derdeyn, Colin P.

AU - Tateshima, Satoshi

AU - Mocco, Jay

AU - Crowley, R. Webster

AU - Liu, Kenneth

AU - Jensen, Lee

AU - Ebersole, Koji

AU - Reeves, Alan

AU - Lopes, Demetrius K.

AU - Hanel, Ricardo A.

AU - Sauvageau, Eric

AU - Duckwiler, Gary

AU - Siddiqui, Adnan

AU - Levy, Elad

AU - Puri, Ajit

AU - Pride, Lee

AU - Novakovic, Roberta

AU - Chaudry, M. Imran

AU - Turner, Raymond D.

AU - Turk, Aquilla S.

PY - 2017/7/1

Y1 - 2017/7/1

N2 - BACKGROUND: The safety and probable benefit of the PulseRider (Pulsar Vascular, Los Gatos, California) for the treatment of broad-necked, bifurcation aneurysms was studied in the context of the prospective, nonrandomized, single arm clinical trial - the Adjunctive Neurovascular Support of Wide-neck aneurysm Embolization and Reconstruction (ANSWER) Trial. OBJECTIVE: To present the results of the United States cases employing the PulseRider device as part of the ANSWER clinical trial. METHODS: Aneurysms treated with the PulseRider device among sites enrolling in the ANSWER trial were prospectively studied and the results are summarized. Aneurysms arising at either the carotid terminus or basilar apex that were relatively broad necked were considered candidates for inclusion into the ANSWER study. RESULTS: Thirty-four patients were enrolled (29 female and 5 male) with a mean age of 60.9 years (27 basilar apex and 7 carotid terminus). Mean aneurysm height ranged from 2.4 to 15.9 mm with a mean neck size of 5.2 mm (range 2.3-11.6 mm). In all patients, the device was delivered and deployed. Immediate Raymond I or II occlusion was achieved in 82.4% and progressed to 87.9% at 6-month follow-up. A modified Rankin Score of 2 or less was seen in 94% of patients at 6 months. CONCLUSION: The results from the ANSWER trial demonstrate that the PulseRider device is safe and offers probable benefit as for the treatment of bifurcation aneurysms arising at the basilar apex or carotid terminus. As such, it represents a useful addition to the armamentarium of the neuroendovascular specialist.

AB - BACKGROUND: The safety and probable benefit of the PulseRider (Pulsar Vascular, Los Gatos, California) for the treatment of broad-necked, bifurcation aneurysms was studied in the context of the prospective, nonrandomized, single arm clinical trial - the Adjunctive Neurovascular Support of Wide-neck aneurysm Embolization and Reconstruction (ANSWER) Trial. OBJECTIVE: To present the results of the United States cases employing the PulseRider device as part of the ANSWER clinical trial. METHODS: Aneurysms treated with the PulseRider device among sites enrolling in the ANSWER trial were prospectively studied and the results are summarized. Aneurysms arising at either the carotid terminus or basilar apex that were relatively broad necked were considered candidates for inclusion into the ANSWER study. RESULTS: Thirty-four patients were enrolled (29 female and 5 male) with a mean age of 60.9 years (27 basilar apex and 7 carotid terminus). Mean aneurysm height ranged from 2.4 to 15.9 mm with a mean neck size of 5.2 mm (range 2.3-11.6 mm). In all patients, the device was delivered and deployed. Immediate Raymond I or II occlusion was achieved in 82.4% and progressed to 87.9% at 6-month follow-up. A modified Rankin Score of 2 or less was seen in 94% of patients at 6 months. CONCLUSION: The results from the ANSWER trial demonstrate that the PulseRider device is safe and offers probable benefit as for the treatment of bifurcation aneurysms arising at the basilar apex or carotid terminus. As such, it represents a useful addition to the armamentarium of the neuroendovascular specialist.

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U2 - 10.1093/neuros/nyx085

DO - 10.1093/neuros/nyx085

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JF - Neurosurgery

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