Angiographic and clinical outcomes from 396 aneurysms treated with the pipeline flex embolization device with shield technology

Abstract

Background The PEDESTRIAN registry demonstrated high rates of complete long-term occlusion and good clinical outcomes among patients with intracranial aneurysms treated with the pipeline embolization device. The pipeline flex embolization device with shield technology was introduced to minimize thromboembolic complications. In this study, we investigated the safety and effectiveness of pipeline embolization device with shield technology among all patients treated for intracranial aneurysms at our center. Methods This was a single-arm retrospective study of prospectively collected data of patients treated with pipeline embolization device with shield technology at our high-volume center between January 2018–January 2021. The primary efficacy endpoint was complete occlusion as measured by a class 1 Raymond-Roy score at 1-year and 2-year follow-up. The primary safety endpoint was major morbidity and neurological mortality up to 1 year following intervention. Results A total of 328 patients (mean age 56.1 ± 14.7 years; 81.1% female), 80 of whom were previously included in PEDESTRIAN, with 396 aneurysms, were analyzed. A total of 378 devices were deployed, with 93.9% (372/396) of aneurysms requiring only one device. Follow-up angiography was available for 90.2% (296/328) of the procedures after a mean time of 14.0 ± 8.2 months. Complete occlusion was demonstrated for 78.5% (132/168) of aneurysms at 12 months and 90.7% (98/108) at 24 months. The overall rates of major morbidity and neurological mortality after 2 years were 1.5% (5/328) and 0.6% (2/328), respectively. Conclusion Our results demonstrate high rates of complete long-term occlusion among patients treated with pipeline embolization device with shield technology. We also observed low rates of mortality and morbidity consistent with fewer thromboembolic complications with pipeline embolization devices with shield technology.