Introduction PED-Shield was introduced to minimize thromboembolic complications. In this study, we investigated the safety and effectiveness of PED-Shield among all patients treated for intracranial aneurysms at our center.
Aim of Study Investigate the safety and effectiveness of PED-Shield 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 PED-Shield 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 PED-Shield. We also observed low rates of mortality and morbidity consistent with fewer thromboembolic complications with PED-Shield.
Disclosure of Interest Dr Pedro Lylyk is proctor and consultant for Medtronic.
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