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

Abstract

PurposeThe 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 methodsThe 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.ResultsFifty 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.ConclusionsOur 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 numberNCT02390037

The Evolution of Flow-Diverting Stents for Cerebral Aneurysms; Historical Review, Modern Application, Complications, and Future Direction

“…These properties have been leveraged in Shield Technology TM (Medtronic) whereby a 3 nm layer of phosphorylcholine is covalently bound to the PED weave surface. In pre-clinical studies PED shield has been associated with reduced inf lammation, reduced thrombosis, and increased early neointimal growth 44,52,77) . Finally, further data on the safety of FDS and DAPT in acutely ruptured aneurysms is needed to inform further use in this sub-population of aneu-rysm patients.…”

Flow diversion for treatment of intracranial aneurysms: Mechanism and implications

“…53,72 There were no major strokes or neurologic deaths at the 30-day or 1-year postprocedure follow-up, indicating the safety of the Pipeline Shield FD for use in intracranial aneurysm treatment. 53,72 There were no major strokes or neurologic deaths at the 30-day or 1-year postprocedure follow-up, indicating the safety of the Pipeline Shield FD for use in intracranial aneurysm treatment.…”

Endovascular Neuromodulation: Safety Profile and Future Directions

“…In addition to radial forces, another key variable in stent design is the biocompatibility of the stent material, which may influence in-stent stenosis or thrombosis rates. Novel coatings, such as the Shield TM phosphorylcholine coating utilized on pipeline embolization devices (78), may reduce thrombogenicity and instent stenosis, however animal testing and human trials would be required to affirm their efficacy in the Stentrode TM setting.…”