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Abstract
Introduction Prospective studies have established the safety and efficacy of the PipelineTM Embolization Device (PED) for treatment of intracranial aneurysms (IA)
Objective/Aim To investigate long-term outcomes from the Pipeline Embolization Devices for the Treatment of Intracranial Aneurysms (PEDESTRIAN) Registry.
Methods The PEDESTRIAN registry data was retrospectively reviewed, which included patients (March 2006–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 3–6 months, 12 months, and yearly thereafter.
Results A total of 835 patients (mean age 55.9±14.7 years; 80.0% female) with 1,000 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 1,214 PEDs were deployed. Follow-up angiography was available for 85.1% of patients with 776 aneurysms at 24.6±25.0 months (mean). Complete occlusion was demonstrated in 75.8% of aneurysms at 12-months, 92.9% at 2–4 years, and 96.4% at >5 years. During the post-procedural period, mRs remained stable or improved in 96.2% of patients, with stability or improvement in 99.1% of patients >5 years. 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 endovascular treatment of IA with PED is safe and effective.
Reference
Nelson PK, Lylyk P, Szikora I, Wetzel SG, Wanke I, Fiorella D. The pipeline embolization device for the intracranial treatment of aneurysms trial. AJNR Am J Neuroradiol 2011;32(1):34–40.
Disclosure Dr Scrivano is a proctor in the use of the PED for Medtronic. Dr Lundquist is a proctor in the use of the PED for Medtronic. Dr Pedro Lylyk serves as a consultant/proctor for Medtronic and he received fees from Medtronic for lectures and for development of educational presentations. This project was supported by Medtronic through an unrestricted research grant.