Abstract TMP3: Long-term Outcomes From The Pipeline Embolization Devices For The Treatment Of Intracranial Aneurysms (PEDESTRIAN) Registry With Ped Shield Sub-analysis

Abstract

Background: Prospective studies have established the safety and efficacy of the Pipeline TM Embolization Device (PED) 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 was retrospectively reviewed, which included patients (March 2006-July2019) with complex IAs treated with PED. 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 (≤10mm), 25.6% were large (11-24mm), and 9.8% were giant (≥25mm). 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%. At multivariate analysis, age (HR 1.04; 95% CI 1.01-1.07, p=0.002) and non-saccular morphology (HR 2.91; 95% CI 1.06-7.97, p=0.038) were identified as independent predictors of mRs worsening. We found a trend towards lower rates of thromboembolic complications since the implementation of prasugrel, with 26 (4.4%) patients on clopidogrel developing stroke compared with 4 (1.6%) patients on prasugrel (OR 2.74; 95% CI 0.95-7.95, p=0.06). Trend towards less thromboembolic complications with PED Shield N= 3/213 (1,4%) OR 0.38 (95% CI o.12; 1.27), p value=0.11 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.