Long-Term Clinical and Angiographic Outcomes Following Pipeline Embolization Device Treatment of Complex Internal Carotid Artery Aneurysms: Five-Year Results of the Pipeline for Uncoilable or Failed Aneurysms Trial

Tibor Becske, Waleed Brinjikji, Matthew B. Potts, David F Kallmes, Maksim Shapiro, Christopher J. Moran, Elad I. Levy, Cameron G. McDougall, István Szikora, Giuseppe Lanzino, Henry H. Woo, Demetrius K. Lopes, Adnan H. Siddiqui, Felipe C. Albuquerque, David J. Fiorella, Isil Saatci, Saruhan H. Cekirge, Aaron L. Berez, Daniel J. Cher, Zsolt BerenteiMiklós Marosfoi, Peter K. Nelson

Research output: Contribution to journalArticle

94 Citations (Scopus)

Abstract

BACKGROUND: Early and mid-term safety and efficacy of aneurysm treatment with the Pipeline Embolization Device (PED) has been well demonstrated in prior studies.

OBJECTIVE: To present 5-yr follow-up for patients treated in the Pipeline for Uncoilable or Failed Aneurysms clinical trial.

METHODS: In our prospective, multicenter trial, 109 complex internal carotid artery (ICA) aneurysms in 107 subjects were treated with the PED. Patients were followed per a standardized protocol at 180 d and 1, 3, and 5 yr. Aneurysm occlusion, in-stent stenosis, modified Rankin Scale scores, and complications were recorded.

RESULTS: The primary endpoint of complete aneurysm occlusion at 180 d (73.6%) was previously reported. Aneurysm occlusion for those patients with angiographic follow-up progressively increased over time to 86.8% (79/91), 93.4% (71/76), and 95.2% (60/63) at 1, 3, and 5 yr, respectively. Six aneurysms (5.7%) were retreated. New serious device-related events at 1, 3, and 5 yr were noted in 1% (1/96), 3.5% (3/85), and 0% (0/81) of subjects. There were 4 (3.7%) reported deaths in our trial. Seventy-eight (96.3%) of 81 patients with 5-yr clinical follow-up had modified Rankin Scale scores ≤2. No delayed neurological deaths or hemorrhagic or ischemic cerebrovascular events were reported beyond 6 mo. No recanalization of a previously occluded aneurysm was observed.

CONCLUSION: Our 5-yr findings demonstrate that PED is a safe and effective treatment for large and giant wide-necked aneurysms of the intracranial ICA, with high rates of complete occlusion and low rates of delayed adverse events.

Original languageEnglish (US)
Pages (from-to)40-48
Number of pages9
JournalNeurosurgery
Volume80
Issue number1
DOIs
StatePublished - Jan 1 2017

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Internal Carotid Artery
Aneurysm
Equipment and Supplies
Therapeutics
Intracranial Aneurysm
Multicenter Studies
Stents
Pathologic Constriction
Clinical Trials
Safety

Keywords

  • Cerebral aneurysm
  • Flow diversion
  • Pipeline embolization device
  • PUFS

ASJC Scopus subject areas

  • Surgery
  • Clinical Neurology

Cite this

Long-Term Clinical and Angiographic Outcomes Following Pipeline Embolization Device Treatment of Complex Internal Carotid Artery Aneurysms : Five-Year Results of the Pipeline for Uncoilable or Failed Aneurysms Trial. / Becske, Tibor; Brinjikji, Waleed; Potts, Matthew B.; Kallmes, David F; Shapiro, Maksim; Moran, Christopher J.; Levy, Elad I.; McDougall, Cameron G.; Szikora, István; Lanzino, Giuseppe; Woo, Henry H.; Lopes, Demetrius K.; Siddiqui, Adnan H.; Albuquerque, Felipe C.; Fiorella, David J.; Saatci, Isil; Cekirge, Saruhan H.; Berez, Aaron L.; Cher, Daniel J.; Berentei, Zsolt; Marosfoi, Miklós; Nelson, Peter K.

In: Neurosurgery, Vol. 80, No. 1, 01.01.2017, p. 40-48.

Research output: Contribution to journalArticle

Becske, T, Brinjikji, W, Potts, MB, Kallmes, DF, Shapiro, M, Moran, CJ, Levy, EI, McDougall, CG, Szikora, I, Lanzino, G, Woo, HH, Lopes, DK, Siddiqui, AH, Albuquerque, FC, Fiorella, DJ, Saatci, I, Cekirge, SH, Berez, AL, Cher, DJ, Berentei, Z, Marosfoi, M & Nelson, PK 2017, 'Long-Term Clinical and Angiographic Outcomes Following Pipeline Embolization Device Treatment of Complex Internal Carotid Artery Aneurysms: Five-Year Results of the Pipeline for Uncoilable or Failed Aneurysms Trial', Neurosurgery, vol. 80, no. 1, pp. 40-48. https://doi.org/10.1093/neuros/nyw014
Becske, Tibor ; Brinjikji, Waleed ; Potts, Matthew B. ; Kallmes, David F ; Shapiro, Maksim ; Moran, Christopher J. ; Levy, Elad I. ; McDougall, Cameron G. ; Szikora, István ; Lanzino, Giuseppe ; Woo, Henry H. ; Lopes, Demetrius K. ; Siddiqui, Adnan H. ; Albuquerque, Felipe C. ; Fiorella, David J. ; Saatci, Isil ; Cekirge, Saruhan H. ; Berez, Aaron L. ; Cher, Daniel J. ; Berentei, Zsolt ; Marosfoi, Miklós ; Nelson, Peter K. / Long-Term Clinical and Angiographic Outcomes Following Pipeline Embolization Device Treatment of Complex Internal Carotid Artery Aneurysms : Five-Year Results of the Pipeline for Uncoilable or Failed Aneurysms Trial. In: Neurosurgery. 2017 ; Vol. 80, No. 1. pp. 40-48.
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abstract = "BACKGROUND: Early and mid-term safety and efficacy of aneurysm treatment with the Pipeline Embolization Device (PED) has been well demonstrated in prior studies.OBJECTIVE: To present 5-yr follow-up for patients treated in the Pipeline for Uncoilable or Failed Aneurysms clinical trial.METHODS: In our prospective, multicenter trial, 109 complex internal carotid artery (ICA) aneurysms in 107 subjects were treated with the PED. Patients were followed per a standardized protocol at 180 d and 1, 3, and 5 yr. Aneurysm occlusion, in-stent stenosis, modified Rankin Scale scores, and complications were recorded.RESULTS: The primary endpoint of complete aneurysm occlusion at 180 d (73.6{\%}) was previously reported. Aneurysm occlusion for those patients with angiographic follow-up progressively increased over time to 86.8{\%} (79/91), 93.4{\%} (71/76), and 95.2{\%} (60/63) at 1, 3, and 5 yr, respectively. Six aneurysms (5.7{\%}) were retreated. New serious device-related events at 1, 3, and 5 yr were noted in 1{\%} (1/96), 3.5{\%} (3/85), and 0{\%} (0/81) of subjects. There were 4 (3.7{\%}) reported deaths in our trial. Seventy-eight (96.3{\%}) of 81 patients with 5-yr clinical follow-up had modified Rankin Scale scores ≤2. No delayed neurological deaths or hemorrhagic or ischemic cerebrovascular events were reported beyond 6 mo. No recanalization of a previously occluded aneurysm was observed.CONCLUSION: Our 5-yr findings demonstrate that PED is a safe and effective treatment for large and giant wide-necked aneurysms of the intracranial ICA, with high rates of complete occlusion and low rates of delayed adverse events.",
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T1 - Long-Term Clinical and Angiographic Outcomes Following Pipeline Embolization Device Treatment of Complex Internal Carotid Artery Aneurysms

T2 - Five-Year Results of the Pipeline for Uncoilable or Failed Aneurysms Trial

AU - Becske, Tibor

AU - Brinjikji, Waleed

AU - Potts, Matthew B.

AU - Kallmes, David F

AU - Shapiro, Maksim

AU - Moran, Christopher J.

AU - Levy, Elad I.

AU - McDougall, Cameron G.

AU - Szikora, István

AU - Lanzino, Giuseppe

AU - Woo, Henry H.

AU - Lopes, Demetrius K.

AU - Siddiqui, Adnan H.

AU - Albuquerque, Felipe C.

AU - Fiorella, David J.

AU - Saatci, Isil

AU - Cekirge, Saruhan H.

AU - Berez, Aaron L.

AU - Cher, Daniel J.

AU - Berentei, Zsolt

AU - Marosfoi, Miklós

AU - Nelson, Peter K.

PY - 2017/1/1

Y1 - 2017/1/1

N2 - BACKGROUND: Early and mid-term safety and efficacy of aneurysm treatment with the Pipeline Embolization Device (PED) has been well demonstrated in prior studies.OBJECTIVE: To present 5-yr follow-up for patients treated in the Pipeline for Uncoilable or Failed Aneurysms clinical trial.METHODS: In our prospective, multicenter trial, 109 complex internal carotid artery (ICA) aneurysms in 107 subjects were treated with the PED. Patients were followed per a standardized protocol at 180 d and 1, 3, and 5 yr. Aneurysm occlusion, in-stent stenosis, modified Rankin Scale scores, and complications were recorded.RESULTS: The primary endpoint of complete aneurysm occlusion at 180 d (73.6%) was previously reported. Aneurysm occlusion for those patients with angiographic follow-up progressively increased over time to 86.8% (79/91), 93.4% (71/76), and 95.2% (60/63) at 1, 3, and 5 yr, respectively. Six aneurysms (5.7%) were retreated. New serious device-related events at 1, 3, and 5 yr were noted in 1% (1/96), 3.5% (3/85), and 0% (0/81) of subjects. There were 4 (3.7%) reported deaths in our trial. Seventy-eight (96.3%) of 81 patients with 5-yr clinical follow-up had modified Rankin Scale scores ≤2. No delayed neurological deaths or hemorrhagic or ischemic cerebrovascular events were reported beyond 6 mo. No recanalization of a previously occluded aneurysm was observed.CONCLUSION: Our 5-yr findings demonstrate that PED is a safe and effective treatment for large and giant wide-necked aneurysms of the intracranial ICA, with high rates of complete occlusion and low rates of delayed adverse events.

AB - BACKGROUND: Early and mid-term safety and efficacy of aneurysm treatment with the Pipeline Embolization Device (PED) has been well demonstrated in prior studies.OBJECTIVE: To present 5-yr follow-up for patients treated in the Pipeline for Uncoilable or Failed Aneurysms clinical trial.METHODS: In our prospective, multicenter trial, 109 complex internal carotid artery (ICA) aneurysms in 107 subjects were treated with the PED. Patients were followed per a standardized protocol at 180 d and 1, 3, and 5 yr. Aneurysm occlusion, in-stent stenosis, modified Rankin Scale scores, and complications were recorded.RESULTS: The primary endpoint of complete aneurysm occlusion at 180 d (73.6%) was previously reported. Aneurysm occlusion for those patients with angiographic follow-up progressively increased over time to 86.8% (79/91), 93.4% (71/76), and 95.2% (60/63) at 1, 3, and 5 yr, respectively. Six aneurysms (5.7%) were retreated. New serious device-related events at 1, 3, and 5 yr were noted in 1% (1/96), 3.5% (3/85), and 0% (0/81) of subjects. There were 4 (3.7%) reported deaths in our trial. Seventy-eight (96.3%) of 81 patients with 5-yr clinical follow-up had modified Rankin Scale scores ≤2. No delayed neurological deaths or hemorrhagic or ischemic cerebrovascular events were reported beyond 6 mo. No recanalization of a previously occluded aneurysm was observed.CONCLUSION: Our 5-yr findings demonstrate that PED is a safe and effective treatment for large and giant wide-necked aneurysms of the intracranial ICA, with high rates of complete occlusion and low rates of delayed adverse events.

KW - Cerebral aneurysm

KW - Flow diversion

KW - Pipeline embolization device

KW - PUFS

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