First U.S. Experience Using the Pipeline Flex Embolization Device with Shield Technology for Treatment of Intracranial Aneurysms

Justin M Cappuzzo; Andre Monteiro; Maritza N Taylor; Muhammad Waqas; Ammad A Baig; Faisal Almayman; Jason M Davies; Kenneth V Snyder; Adnan H Siddiqui; Elad I Levy

doi:10.1016/j.wneu.2021.12.031

First U.S. Experience Using the Pipeline Flex Embolization Device with Shield Technology for Treatment of Intracranial Aneurysms

World Neurosurg. 2022 Mar:159:e184-e191. doi: 10.1016/j.wneu.2021.12.031. Epub 2021 Dec 14.

Authors

Affiliations

¹ Department of Neurosurgery, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA; Department of Neurosurgery, Gates Vascular Institute at Kaleida Health, Buffalo, New York, USA.
² Jacobs School of Medicine, University at Buffalo, Buffalo, New York, USA.
³ Department of Neurosurgery, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA; Department of Bioinformatics, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA; Canon Stroke and Vascular Research Center, University at Buffalo, Buffalo, New York, USA; Department of Neurosurgery, Gates Vascular Institute at Kaleida Health, Buffalo, New York, USA; Jacobs Institute, Buffalo, New York, USA.
⁴ Department of Neurosurgery, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA; Canon Stroke and Vascular Research Center, University at Buffalo, Buffalo, New York, USA; Department of Neurosurgery, Gates Vascular Institute at Kaleida Health, Buffalo, New York, USA; Jacobs Institute, Buffalo, New York, USA.
⁵ Department of Neurosurgery, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA; Department of Bioinformatics, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA; Department of Radiology, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA; Canon Stroke and Vascular Research Center, University at Buffalo, Buffalo, New York, USA; Department of Neurosurgery, Gates Vascular Institute at Kaleida Health, Buffalo, New York, USA.
⁶ Department of Neurosurgery, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA; Department of Radiology, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA; Canon Stroke and Vascular Research Center, University at Buffalo, Buffalo, New York, USA; Department of Neurosurgery, Gates Vascular Institute at Kaleida Health, Buffalo, New York, USA; Jacobs Institute, Buffalo, New York, USA. Electronic address: elevy@ubns.com.

PMID: 34920157
DOI: 10.1016/j.wneu.2021.12.031

Abstract

Background: The Pipeline Flex Embolization Device with Shield technology (PED-Shield [Medtronic, Dublin, Ireland]) is a third-generation flow diverter. Surface modification of the mesh with phosphorylcholine covalently bound to the metal struts aims to reduce thrombogenicity. In the present study, we report the results from the first U.S. series of patients with intracranial aneurysms treated with the PED-Shield and a comprehensive systematic literature review.

Methods: We retrospectively collected the patient demographics, aneurysm characteristics, procedural details, and periprocedural complications from our prospectively maintained endovascular database (April 2021 to July 2021). Our literature review encompassed 3 databases (PubMed, Embase, and MEDLINE).

Results: Ten patients with 11 anterior circulation unruptured wide-necked aneurysms (10 saccular, 1 fusiform) were included. The average patient age was 64.7 years (range, 45-86 years), and 9 were women. One device demonstrated insufficient distal opening. No other technical issues or intraprocedural complications had occurred. After the procedure, 1 patient had developed a groin hematoma and 1 had experienced a small intracranial hemorrhage, with no clinical repercussions. All patients were discharged with dual-antiplatelet therapy. In the review, we identified 15 studies. Most had been conducted in Europe and South America and 3 were U.S. case reports of compassionate use of the device.

Conclusions: In our initial periprocedural experience with the PED-Shield for intracranial aneurysm treatment, the device demonstrated an excellent performance and no major complications. Further studies are required to evaluate the long-term follow-up results and the safety of different antiplatelet regimens.

Keywords: Aneurysm; Flow diversion; Pipeline embolization device; Shield technology.

Publication types

Systematic Review

MeSH terms

Aged
Aged, 80 and over
Embolization, Therapeutic* / methods
Female
Humans
Intracranial Aneurysm* / diagnostic imaging
Intracranial Aneurysm* / etiology
Intracranial Aneurysm* / therapy
Male
Middle Aged
Retrospective Studies
Technology
Treatment Outcome