Early postmarket results after treatment of intracranial aneurysms with the pipeline embolization device: A US multicenter experience

Peter Kan, Adnan H. Siddiqui, Erol Veznedaroglu, Kenneth M. Liebman, Mandy J. Binning, Travis M Dumont, Christopher S. Ogilvy, John R. Gaughen, J. Mocco, Gregory J. Velat, Andrew J. Ringer, Babu G. Welch, Michael B. Horowitz, Kenneth V. Snyder, L. Nelson Hopkins, Elad I. Levy

Research output: Contribution to journalArticle

111 Citations (Scopus)

Abstract

BACKGROUND: The Pipeline embolization device (PED) is the latest technology available for intracranial aneurysm treatment. OBJECTIVE: To report early postmarket results with the PED. METHODS: This study was a prospective registry of patients treated with PEDs at 7 American neurosurgical centers subsequent to Food and Drug Administration approval of this device. Data collected included clinical presentation, aneurysm characteristics, treatment details, and periprocedural events. Follow-up data included degree of aneurysm occlusion and delayed (>30 days after the procedure) complications. RESULTS: Sixty-two PED procedures were performed to treat 58 aneurysms in 56 patients. Thirty-seven of the aneurysms (64%) treated were located from the cavernous to the superior hypophyseal artery segment of the internal carotid artery; 22% were distal to that segment, and 14% were in the vertebrobasilar system. A total of 123 PEDs were deployed with an average of 2 implanted per aneurysm treated. Six devices were incompletely deployed; in these cases, rescue balloon angioplasty was required. Six periprocedural (during the procedure/within 30 days after the procedure) thromboembolic events occurred, of which 5 were in patients with vertebrobasilar aneurysms. There were 4 fatal postprocedural hemorrhages (from 2 giant basilar trunk and 2 large ophthalmic artery aneurysms). The major complication rate (permanent disability/death resulting from perioperative/delayed complication) was 8.5%. Among 19 patients with 3-month follow-up angiography, 68% (13 patients) had complete aneurysm occlusion. Two patients presented with delayed flow-limiting in-stent stenosis that was successfully treated with angioplasty. CONCLUSION: Unlike conventional coil embolization, aneurysm occlusion with PED is not immediate. Early complications include both thromboembolic and hemorrhagic events and appear to be significantly more frequent in association with treatment of vertebrobasilar aneurysms.

Original languageEnglish (US)
Pages (from-to)1080-1087
Number of pages8
JournalNeurosurgery
Volume71
Issue number6
DOIs
StatePublished - Dec 2012
Externally publishedYes

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Intracranial Aneurysm
Aneurysm
Equipment and Supplies
Therapeutics
Device Approval
Ophthalmic Artery
Balloon Angioplasty
Internal Carotid Artery
Angioplasty
Stents
Registries
Angiography
Pathologic Constriction
Arteries
Hemorrhage
Technology

Keywords

  • Endovascular treatment
  • Flow diversion
  • Intracranial aneurysm
  • Pipeline device

ASJC Scopus subject areas

  • Clinical Neurology
  • Surgery

Cite this

Early postmarket results after treatment of intracranial aneurysms with the pipeline embolization device : A US multicenter experience. / Kan, Peter; Siddiqui, Adnan H.; Veznedaroglu, Erol; Liebman, Kenneth M.; Binning, Mandy J.; Dumont, Travis M; Ogilvy, Christopher S.; Gaughen, John R.; Mocco, J.; Velat, Gregory J.; Ringer, Andrew J.; Welch, Babu G.; Horowitz, Michael B.; Snyder, Kenneth V.; Hopkins, L. Nelson; Levy, Elad I.

In: Neurosurgery, Vol. 71, No. 6, 12.2012, p. 1080-1087.

Research output: Contribution to journalArticle

Kan, P, Siddiqui, AH, Veznedaroglu, E, Liebman, KM, Binning, MJ, Dumont, TM, Ogilvy, CS, Gaughen, JR, Mocco, J, Velat, GJ, Ringer, AJ, Welch, BG, Horowitz, MB, Snyder, KV, Hopkins, LN & Levy, EI 2012, 'Early postmarket results after treatment of intracranial aneurysms with the pipeline embolization device: A US multicenter experience', Neurosurgery, vol. 71, no. 6, pp. 1080-1087. https://doi.org/10.1227/NEU.0b013e31827060d9
Kan, Peter ; Siddiqui, Adnan H. ; Veznedaroglu, Erol ; Liebman, Kenneth M. ; Binning, Mandy J. ; Dumont, Travis M ; Ogilvy, Christopher S. ; Gaughen, John R. ; Mocco, J. ; Velat, Gregory J. ; Ringer, Andrew J. ; Welch, Babu G. ; Horowitz, Michael B. ; Snyder, Kenneth V. ; Hopkins, L. Nelson ; Levy, Elad I. / Early postmarket results after treatment of intracranial aneurysms with the pipeline embolization device : A US multicenter experience. In: Neurosurgery. 2012 ; Vol. 71, No. 6. pp. 1080-1087.
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abstract = "BACKGROUND: The Pipeline embolization device (PED) is the latest technology available for intracranial aneurysm treatment. OBJECTIVE: To report early postmarket results with the PED. METHODS: This study was a prospective registry of patients treated with PEDs at 7 American neurosurgical centers subsequent to Food and Drug Administration approval of this device. Data collected included clinical presentation, aneurysm characteristics, treatment details, and periprocedural events. Follow-up data included degree of aneurysm occlusion and delayed (>30 days after the procedure) complications. RESULTS: Sixty-two PED procedures were performed to treat 58 aneurysms in 56 patients. Thirty-seven of the aneurysms (64{\%}) treated were located from the cavernous to the superior hypophyseal artery segment of the internal carotid artery; 22{\%} were distal to that segment, and 14{\%} were in the vertebrobasilar system. A total of 123 PEDs were deployed with an average of 2 implanted per aneurysm treated. Six devices were incompletely deployed; in these cases, rescue balloon angioplasty was required. Six periprocedural (during the procedure/within 30 days after the procedure) thromboembolic events occurred, of which 5 were in patients with vertebrobasilar aneurysms. There were 4 fatal postprocedural hemorrhages (from 2 giant basilar trunk and 2 large ophthalmic artery aneurysms). The major complication rate (permanent disability/death resulting from perioperative/delayed complication) was 8.5{\%}. Among 19 patients with 3-month follow-up angiography, 68{\%} (13 patients) had complete aneurysm occlusion. Two patients presented with delayed flow-limiting in-stent stenosis that was successfully treated with angioplasty. CONCLUSION: Unlike conventional coil embolization, aneurysm occlusion with PED is not immediate. Early complications include both thromboembolic and hemorrhagic events and appear to be significantly more frequent in association with treatment of vertebrobasilar aneurysms.",
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T1 - Early postmarket results after treatment of intracranial aneurysms with the pipeline embolization device

T2 - A US multicenter experience

AU - Kan, Peter

AU - Siddiqui, Adnan H.

AU - Veznedaroglu, Erol

AU - Liebman, Kenneth M.

AU - Binning, Mandy J.

AU - Dumont, Travis M

AU - Ogilvy, Christopher S.

AU - Gaughen, John R.

AU - Mocco, J.

AU - Velat, Gregory J.

AU - Ringer, Andrew J.

AU - Welch, Babu G.

AU - Horowitz, Michael B.

AU - Snyder, Kenneth V.

AU - Hopkins, L. Nelson

AU - Levy, Elad I.

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N2 - BACKGROUND: The Pipeline embolization device (PED) is the latest technology available for intracranial aneurysm treatment. OBJECTIVE: To report early postmarket results with the PED. METHODS: This study was a prospective registry of patients treated with PEDs at 7 American neurosurgical centers subsequent to Food and Drug Administration approval of this device. Data collected included clinical presentation, aneurysm characteristics, treatment details, and periprocedural events. Follow-up data included degree of aneurysm occlusion and delayed (>30 days after the procedure) complications. RESULTS: Sixty-two PED procedures were performed to treat 58 aneurysms in 56 patients. Thirty-seven of the aneurysms (64%) treated were located from the cavernous to the superior hypophyseal artery segment of the internal carotid artery; 22% were distal to that segment, and 14% were in the vertebrobasilar system. A total of 123 PEDs were deployed with an average of 2 implanted per aneurysm treated. Six devices were incompletely deployed; in these cases, rescue balloon angioplasty was required. Six periprocedural (during the procedure/within 30 days after the procedure) thromboembolic events occurred, of which 5 were in patients with vertebrobasilar aneurysms. There were 4 fatal postprocedural hemorrhages (from 2 giant basilar trunk and 2 large ophthalmic artery aneurysms). The major complication rate (permanent disability/death resulting from perioperative/delayed complication) was 8.5%. Among 19 patients with 3-month follow-up angiography, 68% (13 patients) had complete aneurysm occlusion. Two patients presented with delayed flow-limiting in-stent stenosis that was successfully treated with angioplasty. CONCLUSION: Unlike conventional coil embolization, aneurysm occlusion with PED is not immediate. Early complications include both thromboembolic and hemorrhagic events and appear to be significantly more frequent in association with treatment of vertebrobasilar aneurysms.

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KW - Endovascular treatment

KW - Flow diversion

KW - Intracranial aneurysm

KW - Pipeline device

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