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

Abstract

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.

Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification

“…Similarly, in a follow-up series of >2 years, complete occlusion in aneurysms <10 mm progressed from 87.3% at 1 year to 93.2% at last follow-up 16. The PEDESTRIAN study encompassed 1000 aneurysms treated with the PED over 13 years, with the majority of treated aneurysms being small (64.6%; ≤10 mm) and located along the ICA (86.7%) 17. The rate of complete occlusion progressed from 75.8% at the 1 year follow-up to 92.9% and 96.4% at the intermediate (2–4 years) and long-term (>5 years) follow-up, respectively 17.…”

“…The PEDESTRIAN study encompassed 1000 aneurysms treated with the PED over 13 years, with the majority of treated aneurysms being small (64.6%; ≤10 mm) and located along the ICA (86.7%) 17. The rate of complete occlusion progressed from 75.8% at the 1 year follow-up to 92.9% and 96.4% at the intermediate (2–4 years) and long-term (>5 years) follow-up, respectively 17. Likewise, the 3-year PREMIER results emphasize that, although 1-year follow-up is a determining time point for overall therapy success, aneurysm size reduction and progression to complete occlusion can be expected in the long term.…”

Long-term outcomes of flow diversion for unruptured intracranial aneurysms: a systematic review and meta-analysis

“…Over time, clinical and angiographic outcomes improved. It was retrospective and did not have core laboratory adjudication 17. The PREMIER trial was the first prospective, independently adjudicated trial to describe 3-year follow-up after FD treatment.…”

Single-Center Experience With Endovascular Treatment for Splenic Artery Aneurysms in Long-Term Follow-Up: A Retrospective Study

“…(3) If the parent artery is located at the artery branch of segment or bifurcation of splenic hilum, the embolization of parent artery by polyvinyl alcohol or coils is preferred, or performing isolation embolization to exclude reperfusion. In addition, the pipeline embolization device may be another choice for wide-neck SAAs, which have been proven its efficacy in intracranial aneurysms (18), but the study in SAAs is poor.…”