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Multicenter Study
Multicenter Study of Pipeline Flex for Intracranial Aneurysms.
- Brasiliense Leonardo B C LBC Division of Neurosurgery, University of Arizona, Tucson, Arizona., 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 S Arthur, Christopher Nickele, Douglas Gonsales, Eric Sauvageau, and Ricardo A Hanel.
- Division of Neurosurgery, University of Arizona, Tucson, Arizona.
- Neurosurgery. 2019 Jun 1; 84 (6): E402-E409.
BackgroundThe 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.ObjectiveTo assess the neurological morbidity and mortality rates of the PED Flex at 30 d.MethodsInformation 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).ResultsA 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.ConclusionThe 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.Copyright © 2018 by the Congress of Neurological Surgeons.
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