Outcome Study of the Pipeline Embolization Device with Shield Technology in Unruptured Aneurysms (PEDSU)

D. Atasoy; N. Kandasamy; J. Hart; J. Lynch; S.-H. Yang; D. Walsh; C. Tolias; T.C. Booth

doi:10.3174/ajnr.A6314

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Fig 1.
Illustration of Pipeline Shield mechanism and structure. A, Before Pipeline Shield deployment, the blood flow is through both the parent artery and the aneurysm. B, However, after device deployment, the blood flow in the aneurysm is reduced or disrupted. C, A schematic showing the magnified appearance of the braided wires of the Pipeline Shield. D, A 3D illustration of the phosphorylcholine molecule, which is covalently bound onto the bare metal wires in a polymer form, resulting in physiologic imitation of the cell membrane.
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Fig 2.
Pipeline Shield case. A, CTA shows a right ICA paraophthalmic segment aneurysm measuring 17 mm in maximal sac diameter before treatment. B, Digital subtraction angiography oblique view shows the aneurysm after treatment with a 5 × 14 mm Pipeline Shield and 7 adjunctive coils. The landing zone (arrow) was selected as shown because the ICA paraophthalmic segment lumen was 5.00 mm in diameter, the ICA posterior communicating artery segment lumen was 4.75 mm in diameter (wider at the infundibulum), and the ICA terminal segment was 5.5 mm in diameter. The nominal maximum diameter of the largest Pipeline Shield is 5.0 mm with a maximum unconstrained diameter of 5.25 mm. C, Different oblique view without subtraction after treatment. The Pipeline Shield (arrows) has a flared appearance as it bulges into the infundibulum of the ICA posterior communicating artery segment. D, MR imaging at 5 months postprocedure shows that the aneurysm cross-sectional diameter had increased during the 5-month interval from 17 to 32 mm. The stent was no longer covering the entire aneurysm neck in the ICA paraophthalmic segment. E and F, The aneurysm was re-treated by telescoping a larger-diameter flow-diverter device (FRED, MicroVention; arrows show proximal and distal markers), measuring 5.5 × 14 mm, through the Pipeline Shield, across the small segment of uncovered neck, and landing the stent in the ICA terminal segment. Anesthetic equipment is superimposed over the image.

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Table 1:

Aneurysm characteristics

Characteristic	No. (%) or Mean (Range)
Aneurysm location
Anterior circulation^{^a}	46 (88.5)
ICA cavernous segment	2 (3.8)
ICA paraophthalmic segment	29 (55.7)
ICA posterior communicating segment	12 (23.1)
ICA terminal segment	2 (3.8)
M1 segment of MCA	1 (1.9)
Posterior circulation	6 (11.5)
Basilar artery	3 (5.8)
Vertebral artery	2 (3.8)
Posterior cerebral artery	1 (1.9)
Neck width (mm^{^b})	5.0 (1.0–21.0)
Maximum aneurysm sac diameter (mm^{^b})	9.0 (1.0–28.0)
<10	32 (60.8)
10–25	18 (34.6)
≥25	2 (3.8)
PED number (per aneurysm)	0.86 (45/52)
Adjunctive coils placed	15 (28.8)

↵a ICA according to the New York University classification.¹⁴
↵b Millimeter to the nearest 0.5.

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Table 2:

Clinical outcomes

Outcome	Procedure No. (%)
Periprocedural outcomes (within 30 days)
Major adverse events^{^a}
Death from subdural hemorrhage	1 (2.3)
Cranial nerve palsy^{^b}	1 (2.3)
Minor adverse events
Stroke/TIA	1 (2.3)
Headache^{^b}	1 (2.3)
Postprocedure outcomes (30 days to 1 yr)
Major adverse events^{^a}
Pulsatile tinnitus (carotid cavernous fistula)	1 (2.3)
Mass effect causing reduced visual acuity	1 (2.3)

↵a An ongoing clinical event at 7 days following the event.
↵b Same patient.

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Table 3:

Image outcome^{^a}

Outcome	Aneurysm No. (%) or Mean (Range)
Adequate occlusion/remodeling at 6 months (Raymond scale 1 and 2)	41 (78.8)
No residual neck or sac (Raymond scale 1)	36 (69.2)
Residual neck (Raymond scale 2)	5 (9.6)
Residual sac (Raymond scale 3)	11 (21.1)
Adequate occlusion/remodeling at 18 months (Raymond scale 1 and 2)	47 (90.3)
No residual neck or sac (Raymond scale 1)	43 (82.7)
Residual neck (Raymond scale 2)	4 (7.7)
Residual sac (Raymond scale 3)	5 (9.6)
Mean size of aneurysms (mm)
Residual sac (Raymond scale 3)	11.5 (4.0–22.0)
No residual neck or sac (Raymond scale 1)	8.5 (1.0–28.0)
Mean size of neck (mm)
Residual sac (Raymond scale 3)	8.0 (3.0–21.0)
No residual neck or sac (Raymond scale 1)	4.5 (1.0–16.0)