Abstract MP8: Long Term Angiographic and Clinical Outcomes From 1,000 Aneurysms Treated With the Pipeline Embolization Device

Abstract

Background and Purpose: Prospective studies have established the safety and efficacy of the Pipeline TM Embolization Device (PED) for the treatment of intracranial aneurysms (IA). Here, we report long-term outcomes from The Pipeline Embolization Devices for the Treatment of Intracranial Aneurysms (PEDESTRIAN) Registry. Methods: This was a retrospective review of prospectively collected data from the PEDESTRIAN registry. Between March 2006 and July 2019, consecutive patients with complex IA were treated with PED at one center in Argentina. Patients with unfavorable anatomy and/or recurrence following previous treatment were included, and those with acute subarachnoid hemorrhage (SAH) were excluded. The primary angiographic endpoint was complete occlusion and long-term stability. Clinical and angiographic 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% [671/835] female) with 1,000 aneurysms were included. The majority (64.6%) of aneurysms were small (≤10mm), 25.6% were large (11-24mm), and 9.8% were giant (≥25mm). A total of 1,214 PEDs were deployed, with a single device deployed in 84.2% of aneurysms. Follow-up angiography was available for 85.1% of patients with 776 aneurysms at mean 24.6±25.0 months. Complete Raymond Roy I occlusion was demonstrated in 75.8% (588/776) of aneurysms at 12-months, 92.9% (300/323) at 2-4 years, and 96.4% (159/165) 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 in the longer term. The overall major morbidity and neurological mortality rate was 5.8% (44/835), and the all-cause mortality rate was 4.6% (38/835). Conclusions: Endovascular treatment of IA with PED is safe and effective, with rates of complete occlusion, complications, and mortality comparable to previous prospective studies. Serial angiographic follow-up showed high and increasing occlusion rates, with stable occlusion of all cases at 13 years.