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Treatment of intracranial aneurysms using the pipeline flex embolization device with shield technology: angiographic and safety outcomes at 1-year follow-up.
- Source :
-
Journal of neurointerventional surgery [J Neurointerv Surg] 2019 Apr; Vol. 11 (4), pp. 396-399. Date of Electronic Publication: 2018 Sep 27. - Publication Year :
- 2019
-
Abstract
- 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.<br />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.<br />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.<br />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.<br />Trial Registration Number: NCT02390037.<br />Competing Interests: Competing interests: MM-G serves as a proctor and consultant for Medtronic. SML proctors and consults for Medtronic. TL previously consulted and proctored for Covidien, Stryker, and MicroVention, and currently serves as a proctor and consultant for Sequent Medical. EPB receives honoraria from Medtronic and serves as a consultant for Medtronic.<br /> (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
- Subjects :
- Adult
Aged
Blood Vessel Prosthesis adverse effects
Blood Vessel Prosthesis trends
Cerebral Angiography adverse effects
Embolization, Therapeutic adverse effects
Female
Follow-Up Studies
Humans
Male
Middle Aged
Prospective Studies
Recurrence
Retreatment trends
Time Factors
Treatment Outcome
Cerebral Angiography trends
Embolization, Therapeutic instrumentation
Embolization, Therapeutic trends
Intracranial Aneurysm diagnostic imaging
Intracranial Aneurysm therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1759-8486
- Volume :
- 11
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Journal of neurointerventional surgery
- Publication Type :
- Academic Journal
- Accession number :
- 30262655
- Full Text :
- https://doi.org/10.1136/neurintsurg-2018-014204