Neuroophthalmological outcomes associated with use of the Pipeline Embolization Device: Analysis of the PUFS trial results

Daniel H. Sahlein, Mohammad Fouladvand, Tibor Becske, Isil Saatci, Cameron McDougall, István Szikora, Giuseppe Lanzino, Christopher J. Moran, Henry H. Woo, Demetrius K. Lopes, Aaron L. Berez, Daniel J. Cher, Adnan H. Siddiqui, Elad I. Levy, Felipe C. Albuquerque, David J. Fiorella, Zsolt Berentei, Miklos Marosfoi, Saruhan H. Cekirge, David F. KallmesPeter K. Nelson

Research output: Contribution to journalArticle

Abstract

Object Neuroophthalmological morbidity is commonly associated with large and giant cavernous and supraclinoid internal carotid artery (ICA) aneurysms. The authors sought to evaluate the neuroophthalmological outcomes after treatment of these aneurysms with the Pipeline Embolization Device (PED). Methods The Pipeline for Uncoilable or Failed Aneurysms (PUFS) trial was an international, multicenter prospective trial evaluating the safety and efficacy of the PED. All patients underwent complete neuroophthalmological examinations both before the PED procedure and at a 6-month follow-up. All examinations were performed for the purpose of this study and according to study criteria. Results In total, 108 patients were treated in the PUFS trial, 98 of whom had complete neuroophthalmological follow-up. Of the patients with complete follow-up, 39 (40%) presented with a neuroophthalmological baseline deficit that was presumed to be attributable to the aneurysm, and patients with these baseline deficits had significantly larger aneurysms. In 25 of these patients (64%), the baseline deficit showed at least some improvement 6 months after PED treatment, whereas in 1 patient (2.6%), the deficits only worsened. In 5 patients (5%), new deficits had developed at the 6-month follow-up, while in another 6 patients (6%), deficits that were not originally assumed to be related to the aneurysm had improved by that time. A history of diabetes was associated with failure of the baseline deficits to improve after the treatment. The aneurysm maximum diameter was significantly larger in patients with a new deficit or a worse baseline deficit at 6 months postprocedure. Conclusions Patients treated with the PED for large and giant ICA aneurysms had excellent neuroophthalmological outcomes 6 months after the procedure, with deficits improving in most of the patients, very few deficits worsening, and few new deficits developing.

Original languageEnglish (US)
Pages (from-to)897-905
Number of pages9
JournalJournal of Neurosurgery
Volume123
Issue number4
DOIs
StatePublished - Oct 1 2015
Externally publishedYes

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Aneurysm
Equipment and Supplies
Internal Carotid Artery
Multicenter Studies
Morbidity
Safety
Therapeutics

Keywords

  • Aneurysm
  • Aneurysm embolization
  • Flow diversion
  • Neuroophthalmology
  • Pipeline Embolization Device
  • Vascular disorders

ASJC Scopus subject areas

  • Surgery
  • Clinical Neurology

Cite this

Neuroophthalmological outcomes associated with use of the Pipeline Embolization Device : Analysis of the PUFS trial results. / Sahlein, Daniel H.; Fouladvand, Mohammad; Becske, Tibor; Saatci, Isil; McDougall, Cameron; Szikora, István; Lanzino, Giuseppe; Moran, Christopher J.; Woo, Henry H.; Lopes, Demetrius K.; Berez, Aaron L.; Cher, Daniel J.; Siddiqui, Adnan H.; Levy, Elad I.; Albuquerque, Felipe C.; Fiorella, David J.; Berentei, Zsolt; Marosfoi, Miklos; Cekirge, Saruhan H.; Kallmes, David F.; Nelson, Peter K.

In: Journal of Neurosurgery, Vol. 123, No. 4, 01.10.2015, p. 897-905.

Research output: Contribution to journalArticle

Sahlein, DH, Fouladvand, M, Becske, T, Saatci, I, McDougall, C, Szikora, I, Lanzino, G, Moran, CJ, Woo, HH, Lopes, DK, Berez, AL, Cher, DJ, Siddiqui, AH, Levy, EI, Albuquerque, FC, Fiorella, DJ, Berentei, Z, Marosfoi, M, Cekirge, SH, Kallmes, DF & Nelson, PK 2015, 'Neuroophthalmological outcomes associated with use of the Pipeline Embolization Device: Analysis of the PUFS trial results', Journal of Neurosurgery, vol. 123, no. 4, pp. 897-905. https://doi.org/10.3171/2014.12.JNS141777
Sahlein, Daniel H. ; Fouladvand, Mohammad ; Becske, Tibor ; Saatci, Isil ; McDougall, Cameron ; Szikora, István ; Lanzino, Giuseppe ; Moran, Christopher J. ; Woo, Henry H. ; Lopes, Demetrius K. ; Berez, Aaron L. ; Cher, Daniel J. ; Siddiqui, Adnan H. ; Levy, Elad I. ; Albuquerque, Felipe C. ; Fiorella, David J. ; Berentei, Zsolt ; Marosfoi, Miklos ; Cekirge, Saruhan H. ; Kallmes, David F. ; Nelson, Peter K. / Neuroophthalmological outcomes associated with use of the Pipeline Embolization Device : Analysis of the PUFS trial results. In: Journal of Neurosurgery. 2015 ; Vol. 123, No. 4. pp. 897-905.
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abstract = "Object Neuroophthalmological morbidity is commonly associated with large and giant cavernous and supraclinoid internal carotid artery (ICA) aneurysms. The authors sought to evaluate the neuroophthalmological outcomes after treatment of these aneurysms with the Pipeline Embolization Device (PED). Methods The Pipeline for Uncoilable or Failed Aneurysms (PUFS) trial was an international, multicenter prospective trial evaluating the safety and efficacy of the PED. All patients underwent complete neuroophthalmological examinations both before the PED procedure and at a 6-month follow-up. All examinations were performed for the purpose of this study and according to study criteria. Results In total, 108 patients were treated in the PUFS trial, 98 of whom had complete neuroophthalmological follow-up. Of the patients with complete follow-up, 39 (40{\%}) presented with a neuroophthalmological baseline deficit that was presumed to be attributable to the aneurysm, and patients with these baseline deficits had significantly larger aneurysms. In 25 of these patients (64{\%}), the baseline deficit showed at least some improvement 6 months after PED treatment, whereas in 1 patient (2.6{\%}), the deficits only worsened. In 5 patients (5{\%}), new deficits had developed at the 6-month follow-up, while in another 6 patients (6{\%}), deficits that were not originally assumed to be related to the aneurysm had improved by that time. A history of diabetes was associated with failure of the baseline deficits to improve after the treatment. The aneurysm maximum diameter was significantly larger in patients with a new deficit or a worse baseline deficit at 6 months postprocedure. Conclusions Patients treated with the PED for large and giant ICA aneurysms had excellent neuroophthalmological outcomes 6 months after the procedure, with deficits improving in most of the patients, very few deficits worsening, and few new deficits developing.",
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TY - JOUR

T1 - Neuroophthalmological outcomes associated with use of the Pipeline Embolization Device

T2 - Analysis of the PUFS trial results

AU - Sahlein, Daniel H.

AU - Fouladvand, Mohammad

AU - Becske, Tibor

AU - Saatci, Isil

AU - McDougall, Cameron

AU - Szikora, István

AU - Lanzino, Giuseppe

AU - Moran, Christopher J.

AU - Woo, Henry H.

AU - Lopes, Demetrius K.

AU - Berez, Aaron L.

AU - Cher, Daniel J.

AU - Siddiqui, Adnan H.

AU - Levy, Elad I.

AU - Albuquerque, Felipe C.

AU - Fiorella, David J.

AU - Berentei, Zsolt

AU - Marosfoi, Miklos

AU - Cekirge, Saruhan H.

AU - Kallmes, David F.

AU - Nelson, Peter K.

PY - 2015/10/1

Y1 - 2015/10/1

N2 - Object Neuroophthalmological morbidity is commonly associated with large and giant cavernous and supraclinoid internal carotid artery (ICA) aneurysms. The authors sought to evaluate the neuroophthalmological outcomes after treatment of these aneurysms with the Pipeline Embolization Device (PED). Methods The Pipeline for Uncoilable or Failed Aneurysms (PUFS) trial was an international, multicenter prospective trial evaluating the safety and efficacy of the PED. All patients underwent complete neuroophthalmological examinations both before the PED procedure and at a 6-month follow-up. All examinations were performed for the purpose of this study and according to study criteria. Results In total, 108 patients were treated in the PUFS trial, 98 of whom had complete neuroophthalmological follow-up. Of the patients with complete follow-up, 39 (40%) presented with a neuroophthalmological baseline deficit that was presumed to be attributable to the aneurysm, and patients with these baseline deficits had significantly larger aneurysms. In 25 of these patients (64%), the baseline deficit showed at least some improvement 6 months after PED treatment, whereas in 1 patient (2.6%), the deficits only worsened. In 5 patients (5%), new deficits had developed at the 6-month follow-up, while in another 6 patients (6%), deficits that were not originally assumed to be related to the aneurysm had improved by that time. A history of diabetes was associated with failure of the baseline deficits to improve after the treatment. The aneurysm maximum diameter was significantly larger in patients with a new deficit or a worse baseline deficit at 6 months postprocedure. Conclusions Patients treated with the PED for large and giant ICA aneurysms had excellent neuroophthalmological outcomes 6 months after the procedure, with deficits improving in most of the patients, very few deficits worsening, and few new deficits developing.

AB - Object Neuroophthalmological morbidity is commonly associated with large and giant cavernous and supraclinoid internal carotid artery (ICA) aneurysms. The authors sought to evaluate the neuroophthalmological outcomes after treatment of these aneurysms with the Pipeline Embolization Device (PED). Methods The Pipeline for Uncoilable or Failed Aneurysms (PUFS) trial was an international, multicenter prospective trial evaluating the safety and efficacy of the PED. All patients underwent complete neuroophthalmological examinations both before the PED procedure and at a 6-month follow-up. All examinations were performed for the purpose of this study and according to study criteria. Results In total, 108 patients were treated in the PUFS trial, 98 of whom had complete neuroophthalmological follow-up. Of the patients with complete follow-up, 39 (40%) presented with a neuroophthalmological baseline deficit that was presumed to be attributable to the aneurysm, and patients with these baseline deficits had significantly larger aneurysms. In 25 of these patients (64%), the baseline deficit showed at least some improvement 6 months after PED treatment, whereas in 1 patient (2.6%), the deficits only worsened. In 5 patients (5%), new deficits had developed at the 6-month follow-up, while in another 6 patients (6%), deficits that were not originally assumed to be related to the aneurysm had improved by that time. A history of diabetes was associated with failure of the baseline deficits to improve after the treatment. The aneurysm maximum diameter was significantly larger in patients with a new deficit or a worse baseline deficit at 6 months postprocedure. Conclusions Patients treated with the PED for large and giant ICA aneurysms had excellent neuroophthalmological outcomes 6 months after the procedure, with deficits improving in most of the patients, very few deficits worsening, and few new deficits developing.

KW - Aneurysm

KW - Aneurysm embolization

KW - Flow diversion

KW - Neuroophthalmology

KW - Pipeline Embolization Device

KW - Vascular disorders

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