Multicenter Study of Pipeline Flex for Intracranial Aneurysms

Leonardo B.C. Brasiliense, Pedro Aguilar-Salinas, Demetrius K. Lopes, Danilo Nogueira, Keith DeSousa, Peter K. Nelson, Christopher J. Moran, Marcus D. Mazur, Philipp Taussky, Min S. Park, Guilherme Dabus, Italo Linfante, Imran Chaudry, Ray D. Turner, Alex M. Spiotta, Aquilla S. Turk, Adnan H. Siddiqui, Elad I. Levy, L. Nelson Hopkins, Adam Arthur & 4 others Christopher Nickele, Douglas Gonsales, Eric Sauvageau, Ricardo A. Hanel

Research output: Contribution to journalArticle

Abstract

BACKGROUND: The Pipeline Flex (PED Flex; Medtronic, Dublin, Ireland) was designed to facilitate deployment and navigation compared to its previous iteration to reduce the rate of technical events and complications. OBJECTIVE: To assess the neurological morbidity and mortality rates of the PED Flex at 30 d. METHODS: Information from 9 neurovascular centers was retrospectively obtained between July 2014 and March 2016. Data included patient/aneurysm characteristics, periprocedural events, clinical, and angiographic outcomes. Multivariate logistic regression was performed to determine predictors of unfavorable clinical outcome (modified Rankin Scale [mRS] > 2). RESULTS: A total of 205 patients harboring 223 aneurysms were analyzed. The 30-d neurological morbidity and mortality rates were 1.9% (4/205) and 0.5% (1/205), respectively. The rate of intraprocedural events without neurological morbidity was 6.8% (14/205), consisting of intraprocedural ischemic events in 9 patients (4.5%) and hemorrhage in 5 (2.4%). Other technical events included difficulty capturing the delivery wire in 1 case (0.5%) and device migration after deployment in another case (0.5%). Favorable clinical outcome (mRS 0-2) was achieved in 186 patients (94.4%) at discharge and in 140 patients (94.5%) at 30 d. We did not find predictors of clinical outcomes on multivariate analysis. CONCLUSION: The 30-d rates of neurological morbidity and mortality in this multicenter cohort using the PED Flex for the treatment of intracranial aneurysms were low, 1.9% (4/205) and 0.5% (1/205), respectively. In addition, technical events related to device deployment were also low, most likely due to the latest modifications in the delivery system.

Original languageEnglish (US)
Pages (from-to)E402-E409
JournalNeurosurgery
Volume84
Issue number6
DOIs
StatePublished - Jun 1 2019

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Intracranial Aneurysm
Multicenter Studies
Morbidity
Aneurysm
Mortality
Equipment and Supplies
Ireland
Multivariate Analysis
Logistic Models
Hemorrhage

All Science Journal Classification (ASJC) codes

  • Surgery
  • Clinical Neurology

Cite this

Brasiliense, L. B. C., Aguilar-Salinas, P., Lopes, D. K., Nogueira, D., DeSousa, K., Nelson, P. K., ... Hanel, R. A. (2019). Multicenter Study of Pipeline Flex for Intracranial Aneurysms. Neurosurgery, 84(6), E402-E409. https://doi.org/10.1093/neuros/nyy422

Multicenter Study of Pipeline Flex for Intracranial Aneurysms. / Brasiliense, Leonardo B.C.; Aguilar-Salinas, Pedro; Lopes, Demetrius K.; Nogueira, Danilo; DeSousa, Keith; Nelson, Peter K.; Moran, Christopher J.; Mazur, Marcus D.; Taussky, Philipp; Park, Min S.; Dabus, Guilherme; Linfante, Italo; Chaudry, Imran; Turner, Ray D.; Spiotta, Alex M.; Turk, Aquilla S.; Siddiqui, Adnan H.; Levy, Elad I.; Hopkins, L. Nelson; Arthur, Adam; Nickele, Christopher; Gonsales, Douglas; Sauvageau, Eric; Hanel, Ricardo A.

In: Neurosurgery, Vol. 84, No. 6, 01.06.2019, p. E402-E409.

Research output: Contribution to journalArticle

Brasiliense, LBC, Aguilar-Salinas, P, Lopes, DK, Nogueira, D, DeSousa, K, Nelson, PK, Moran, CJ, Mazur, MD, Taussky, P, Park, MS, Dabus, G, Linfante, I, Chaudry, I, Turner, RD, Spiotta, AM, Turk, AS, Siddiqui, AH, Levy, EI, Hopkins, LN, Arthur, A, Nickele, C, Gonsales, D, Sauvageau, E & Hanel, RA 2019, 'Multicenter Study of Pipeline Flex for Intracranial Aneurysms', Neurosurgery, vol. 84, no. 6, pp. E402-E409. https://doi.org/10.1093/neuros/nyy422
Brasiliense LBC, Aguilar-Salinas P, Lopes DK, Nogueira D, DeSousa K, Nelson PK et al. Multicenter Study of Pipeline Flex for Intracranial Aneurysms. Neurosurgery. 2019 Jun 1;84(6):E402-E409. https://doi.org/10.1093/neuros/nyy422
Brasiliense, Leonardo B.C. ; Aguilar-Salinas, Pedro ; Lopes, Demetrius K. ; Nogueira, Danilo ; DeSousa, Keith ; Nelson, Peter K. ; Moran, Christopher J. ; Mazur, Marcus D. ; Taussky, Philipp ; Park, Min S. ; Dabus, Guilherme ; Linfante, Italo ; Chaudry, Imran ; Turner, Ray D. ; Spiotta, Alex M. ; Turk, Aquilla S. ; Siddiqui, Adnan H. ; Levy, Elad I. ; Hopkins, L. Nelson ; Arthur, Adam ; Nickele, Christopher ; Gonsales, Douglas ; Sauvageau, Eric ; Hanel, Ricardo A. / Multicenter Study of Pipeline Flex for Intracranial Aneurysms. In: Neurosurgery. 2019 ; Vol. 84, No. 6. pp. E402-E409.
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abstract = "BACKGROUND: The Pipeline Flex (PED Flex; Medtronic, Dublin, Ireland) was designed to facilitate deployment and navigation compared to its previous iteration to reduce the rate of technical events and complications. OBJECTIVE: To assess the neurological morbidity and mortality rates of the PED Flex at 30 d. METHODS: Information from 9 neurovascular centers was retrospectively obtained between July 2014 and March 2016. Data included patient/aneurysm characteristics, periprocedural events, clinical, and angiographic outcomes. Multivariate logistic regression was performed to determine predictors of unfavorable clinical outcome (modified Rankin Scale [mRS] > 2). RESULTS: A total of 205 patients harboring 223 aneurysms were analyzed. The 30-d neurological morbidity and mortality rates were 1.9{\%} (4/205) and 0.5{\%} (1/205), respectively. The rate of intraprocedural events without neurological morbidity was 6.8{\%} (14/205), consisting of intraprocedural ischemic events in 9 patients (4.5{\%}) and hemorrhage in 5 (2.4{\%}). Other technical events included difficulty capturing the delivery wire in 1 case (0.5{\%}) and device migration after deployment in another case (0.5{\%}). Favorable clinical outcome (mRS 0-2) was achieved in 186 patients (94.4{\%}) at discharge and in 140 patients (94.5{\%}) at 30 d. We did not find predictors of clinical outcomes on multivariate analysis. CONCLUSION: The 30-d rates of neurological morbidity and mortality in this multicenter cohort using the PED Flex for the treatment of intracranial aneurysms were low, 1.9{\%} (4/205) and 0.5{\%} (1/205), respectively. In addition, technical events related to device deployment were also low, most likely due to the latest modifications in the delivery system.",
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T1 - Multicenter Study of Pipeline Flex for Intracranial Aneurysms

AU - Brasiliense, Leonardo B.C.

AU - Aguilar-Salinas, Pedro

AU - Lopes, Demetrius K.

AU - Nogueira, Danilo

AU - DeSousa, Keith

AU - Nelson, Peter K.

AU - Moran, Christopher J.

AU - Mazur, Marcus D.

AU - Taussky, Philipp

AU - Park, Min S.

AU - Dabus, Guilherme

AU - Linfante, Italo

AU - Chaudry, Imran

AU - Turner, Ray D.

AU - Spiotta, Alex M.

AU - Turk, Aquilla S.

AU - Siddiqui, Adnan H.

AU - Levy, Elad I.

AU - Hopkins, L. Nelson

AU - Arthur, Adam

AU - Nickele, Christopher

AU - Gonsales, Douglas

AU - Sauvageau, Eric

AU - Hanel, Ricardo A.

PY - 2019/6/1

Y1 - 2019/6/1

N2 - BACKGROUND: The Pipeline Flex (PED Flex; Medtronic, Dublin, Ireland) was designed to facilitate deployment and navigation compared to its previous iteration to reduce the rate of technical events and complications. OBJECTIVE: To assess the neurological morbidity and mortality rates of the PED Flex at 30 d. METHODS: Information from 9 neurovascular centers was retrospectively obtained between July 2014 and March 2016. Data included patient/aneurysm characteristics, periprocedural events, clinical, and angiographic outcomes. Multivariate logistic regression was performed to determine predictors of unfavorable clinical outcome (modified Rankin Scale [mRS] > 2). RESULTS: A total of 205 patients harboring 223 aneurysms were analyzed. The 30-d neurological morbidity and mortality rates were 1.9% (4/205) and 0.5% (1/205), respectively. The rate of intraprocedural events without neurological morbidity was 6.8% (14/205), consisting of intraprocedural ischemic events in 9 patients (4.5%) and hemorrhage in 5 (2.4%). Other technical events included difficulty capturing the delivery wire in 1 case (0.5%) and device migration after deployment in another case (0.5%). Favorable clinical outcome (mRS 0-2) was achieved in 186 patients (94.4%) at discharge and in 140 patients (94.5%) at 30 d. We did not find predictors of clinical outcomes on multivariate analysis. CONCLUSION: The 30-d rates of neurological morbidity and mortality in this multicenter cohort using the PED Flex for the treatment of intracranial aneurysms were low, 1.9% (4/205) and 0.5% (1/205), respectively. In addition, technical events related to device deployment were also low, most likely due to the latest modifications in the delivery system.

AB - BACKGROUND: The Pipeline Flex (PED Flex; Medtronic, Dublin, Ireland) was designed to facilitate deployment and navigation compared to its previous iteration to reduce the rate of technical events and complications. OBJECTIVE: To assess the neurological morbidity and mortality rates of the PED Flex at 30 d. METHODS: Information from 9 neurovascular centers was retrospectively obtained between July 2014 and March 2016. Data included patient/aneurysm characteristics, periprocedural events, clinical, and angiographic outcomes. Multivariate logistic regression was performed to determine predictors of unfavorable clinical outcome (modified Rankin Scale [mRS] > 2). RESULTS: A total of 205 patients harboring 223 aneurysms were analyzed. The 30-d neurological morbidity and mortality rates were 1.9% (4/205) and 0.5% (1/205), respectively. The rate of intraprocedural events without neurological morbidity was 6.8% (14/205), consisting of intraprocedural ischemic events in 9 patients (4.5%) and hemorrhage in 5 (2.4%). Other technical events included difficulty capturing the delivery wire in 1 case (0.5%) and device migration after deployment in another case (0.5%). Favorable clinical outcome (mRS 0-2) was achieved in 186 patients (94.4%) at discharge and in 140 patients (94.5%) at 30 d. We did not find predictors of clinical outcomes on multivariate analysis. CONCLUSION: The 30-d rates of neurological morbidity and mortality in this multicenter cohort using the PED Flex for the treatment of intracranial aneurysms were low, 1.9% (4/205) and 0.5% (1/205), respectively. In addition, technical events related to device deployment were also low, most likely due to the latest modifications in the delivery system.

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