Pipeline Embolization Devices for the Treatment of Intracranial Aneurysms, Single-Center Registry: Long-Term Angiographic and Clinical Outcomes from 1000 Aneurysms.

BACKGROUND: Prospective studies have established the safety and efficacy of the PipelineTM Embolization Device (PED; Medtronic) for treatment of intracranial aneurysms (IA).

OBJECTIVE: To investigate long-term outcomes from the Pipeline Embolization Devices for the Treatment of Intracranial Aneurysms (PEDESTRIAN) Registry.

METHODS: The PEDESTRIAN Registry data were retrospectively reviewed, which included patients (March 2006 to July 2019) with complex IAs treated with PED. Patients with unfavorable anatomy and/or recurrence following previous treatment were included and excluded those with acute subarachnoid hemorrhage. The primary angiographic endpoint was complete occlusion and long-term stability. Clinical and radiological follow-up was performed at 3 to 6 mo, 12 mo, and yearly thereafter.

RESULTS: A total of 835 patients (mean age 55.9 ± 14.7 yr; 80.0% female) with 1000 aneurysms were included. Aneurysms varied in size: 64.6% were small (≤10 mm), 25.6% were large (11-24 mm), and 9.8% were giant (≥25 mm). A total of 1214 PEDs were deployed. Follow-up angiography was available for 85.1% of patients with 776 aneurysms at 24.6 ± 25.0 mo (mean). Complete occlusion was demonstrated in 75.8% of aneurysms at 12 mo, 92.9% at 2 to 4 yr, and 96.4% at >5 yr. During the postprocedural period, modified Rankin Scale scores remained stable or improved in 96.2% of patients, with stability or improvement in 99.1% of patients >5 yr. The overall major morbidity and neurological mortality rate was 5.8%.

CONCLUSION: This study demonstrated high rates of long-term complete aneurysm occlusion, stable or improved functional outcomes, and low rates of complications and mortality. Clinical and angiographic outcomes improved over long-term follow-up, demonstrating that endovascular treatment of IA with PED is safe and effective.