TY - JOUR
T1 - Treatment of intracranial aneurysms using the pipeline flex embolization device with shield technology
T2 - Angiographic and safety outcomes at 1-year follow-up
AU - Martínez-Galdámez, Mario
AU - Lamin, Saleh M.
AU - Lagios, Konstantinos G.
AU - Liebig, Thomas
AU - Ciceri, Elisa F.
AU - Chapot, Rene
AU - Stockx, Luc
AU - Chavda, Swarupsinh
AU - Kabbasch, Christoph
AU - Faragò, Giuseppe
AU - Nordmeyer, Hannes
AU - Boulanger, Thierry
AU - Piano, Mariangela
AU - Boccardi, Edoardo P.
PY - 2018/1/1
Y1 - 2018/1/1
N2 - Purpose: The Pipeline Embolization Device (PED) is a routine first-line treatment option for intracranial aneurysms (IAs). The Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield) is an updated version of the PED which has been modified to include a surface phosphorylcholine biocompatible polymer. Its early technical success and safety have been reported previously. Here, we assessed the long-term safety and efficacy of the Pipeline Shield for the treatment of IAs. Materials and methods: The Pipeline Flex Embolization Device with Shield Technology (PFLEX) study was a prospective, single-arm, multicenter study for the treatment of unruptured IAs using the Pipeline Shield. The primary endpoint was a major stroke in the territory supplied by the treated artery or neurologic death at 1-year post-procedure. Angiographic outcomes were also assessed by an independent radiology laboratory at 6 months and 1 year. Results: Fifty patients (mean age, 53 years; 82% female) with 50 unruptured IAs were treated. Mean aneurysm diameter was 8.82±6.15 mm. Of the target aneurysms, 38/50 (76%) were small (<10 mm), 11/50 (22%) were large (≥10 and<25 mm), and 1/50 (2%) was giant (≥25 mm). Forty-seven (94%) were located in the internal carotid artery and three (6%) in the vertebral artery. At 1-year post-procedure, no major strokes or neurologic deaths were reported, and complete occlusion was achieved in 27/33 (81.8%). There were no instances of aneurysm recurrence or retreatment. Conclusions: Our 1-year follow-up concerning angiographic and safety outcomes corroborate previous evidence that the Pipeline Shield is a safe and effective treatment for IAs. Trial registration number: NCT02390037
AB - Purpose: The Pipeline Embolization Device (PED) is a routine first-line treatment option for intracranial aneurysms (IAs). The Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield) is an updated version of the PED which has been modified to include a surface phosphorylcholine biocompatible polymer. Its early technical success and safety have been reported previously. Here, we assessed the long-term safety and efficacy of the Pipeline Shield for the treatment of IAs. Materials and methods: The Pipeline Flex Embolization Device with Shield Technology (PFLEX) study was a prospective, single-arm, multicenter study for the treatment of unruptured IAs using the Pipeline Shield. The primary endpoint was a major stroke in the territory supplied by the treated artery or neurologic death at 1-year post-procedure. Angiographic outcomes were also assessed by an independent radiology laboratory at 6 months and 1 year. Results: Fifty patients (mean age, 53 years; 82% female) with 50 unruptured IAs were treated. Mean aneurysm diameter was 8.82±6.15 mm. Of the target aneurysms, 38/50 (76%) were small (<10 mm), 11/50 (22%) were large (≥10 and<25 mm), and 1/50 (2%) was giant (≥25 mm). Forty-seven (94%) were located in the internal carotid artery and three (6%) in the vertebral artery. At 1-year post-procedure, no major strokes or neurologic deaths were reported, and complete occlusion was achieved in 27/33 (81.8%). There were no instances of aneurysm recurrence or retreatment. Conclusions: Our 1-year follow-up concerning angiographic and safety outcomes corroborate previous evidence that the Pipeline Shield is a safe and effective treatment for IAs. Trial registration number: NCT02390037
KW - intracranial aneurysm
KW - phosphorylcholine
KW - pipeline embolization device
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U2 - 10.1136/neurintsurg-2018-014204
DO - 10.1136/neurintsurg-2018-014204
M3 - Article
AN - SCOPUS:85054134506
JO - Journal of NeuroInterventional Surgery
JF - Journal of NeuroInterventional Surgery
SN - 1759-8478
ER -