Treatment of intracranial aneurysms using the pipeline flex embolization device with shield technology: Angiographic and safety outcomes at 1-year follow-up

Mario Martínez-Galdámez, Saleh M. Lamin, Konstantinos G. Lagios, Thomas Liebig, Elisa F. Ciceri, Rene Chapot, Luc Stockx, Swarupsinh Chavda, Christoph Kabbasch, Giuseppe Faragò, Hannes Nordmeyer, Thierry Boulanger, Mariangela Piano, Edoardo P. Boccardi

Research output: Contribution to journalArticlepeer-review

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. 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

Original languageEnglish
JournalJournal of NeuroInterventional Surgery
DOIs
Publication statusAccepted/In press - Jan 1 2018

Keywords

  • intracranial aneurysm
  • phosphorylcholine
  • pipeline embolization device

ASJC Scopus subject areas

  • Surgery
  • Clinical Neurology

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