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 C. 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. Turner Aquilla S. Turk Show 1 others Show less

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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.

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Research output : Contribution to journal › Article › peer-review

Spiotta, AM, Derdeyn, CP, Tateshima, S, Mocco, J, Crowley, RW, Liu, KC, 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

Spiotta AM, Derdeyn CP, Tateshima S, Mocco J, Crowley RW, Liu KC et al. Results of the ANSWER Trial Using the PulseRider for the Treatment of Broad-Necked, Bifurcation Aneurysms . Neurosurgery . 2017 Jul 1;81(1):56-65. doi: 10.1093/neuros/nyx085

@articletitle = "Results of the ANSWER Trial Using the PulseRider for the Treatment of Broad-Necked, Bifurcation Aneurysms",

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.",

keywords = "Aneurysm, Device, Embolization",

author = "Spiotta, and Derdeyn, and Satoshi Tateshima and Jay Mocco and Crowley, and Liu, and Lee Jensen and Koji Ebersole and Alan Reeves and Lopes, and Hanel, and Eric Sauvageau and Gary Duckwiler and Adnan Siddiqui and Elad Levy and Ajit Puri and Lee Pride and Roberta Novakovic and Chaudry, and Turner, and Turk, ",

note = "Publisher Copyright: Copyright 2017 by the Congress of Neurological Surgeons.", year = "2017", month = jul, doi = "10.1093/neuros/nyx085", language = "English (US)", volume = "81", pages = "56--65", journal = "Neurosurgery", issn = "0148-396X", publisher = "Lippincott Williams and Wilkins Ltd.",

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 - Crowley, R. Webster

AU - Liu, Kenneth C.

AU - Ebersole, Koji

AU - Reeves, Alan

AU - Lopes, Demetrius K.

AU - Hanel, Ricardo A.

AU - Sauvageau, Eric

AU - Duckwiler, Gary

AU - Siddiqui, Adnan

AU - Novakovic, Roberta

AU - Chaudry, M. Imran

AU - Turner, Raymond D.

AU - Turk, Aquilla S.

N1 - Publisher Copyright: Copyright © 2017 by the Congress of Neurological Surgeons.

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.