Abstract Number ‐ 33: Patients Treated with The Pipeline Shield Flow Diverter Enrolled Within the INSPIRE Study: Primary analysis

Abstract

Introduction The INSPIRE study collects post‐market data on multiple devices from more than 40 centers world‐wide. One of these devices is the PipelineTM Flex flow diverter with Shield TechnologyTM (Pipeline Shield) for the treatment of intracranial aneurysms. The Shield surface modification is designed to enhance endothelization of the device with low thromboembolic risks. We analyze the efficacy and safety outcomes after Pipeline Shield therapy at the 1‐year follow‐up in a large prospective study. Methods INSPIRE is a prospective, multicenter, single arm study. Patients are followed for 1‐year post‐procedure and results are adjudicated by an independent Clinical Events Committee and Imaging Core Laboratory. All patients were treated per their hospital’s standard of care. The primary safety endpoint was neurological death or major stroke in the treated vascular area. The primary efficacy endpoint was complete aneurysm occlusion without significant parent artery stenosis (>50%) or retreatment. For this analysis, the last‐available observation was carried forward to overcome differences between centers’ imaging schedules. Results A total of 537 patients were enrolled, with 504 patients with 488 aneurysms included in the analysis (mean age 53.8±12.2, 77.0% [388/504] female). The majority of aneurysms were located in the ICA (74.2%, 362/488). Of the remaining aneurysms, 16.0% (78/488) were in the anterior circulation and 9.8% (48/488) were in the posterior circulation. The majority of aneurysms were saccular (89.3% [436/488]). A total of 47.1% of aneurysms were small ( = 25 mm, 25/488). Adjunctive devices were used in 20.9% (102/488) of cases, including balloon (42.2% [19/43]), coil (63.7%, [65/102]), stent (5.9% [6/102]), or flow diverter (9.8% [10/102]). At 1‐year post‐procedure, complete occlusion (Raymond Roy Class I) was achieved in 74.9% (326/435) aneurysms. The primary safety endpoint occurred in 2.2% (11/504) patients. The primary endpoint was achieved in 73.2% (290/396) cases; reasons for primary endpoint failure included residual neck (5.8% [23/396]), residual aneurysm (19.4% [77/396]), stenosis >50% (1.0% [4/396]), and re‐treatment (1.5% [6/396]). Among ICA aneurysms, complete occlusion was achieved in 78.1% (249/319). The primary safety endpoint occurred in 2.0% (7/356) patients. The primary endpoint was achieved in 77.1% (225/292) cases; reasons for primary endpoint failure among ICA aneurysms included residual neck (5.5% [16/292]), residual aneurysm (16.4% [48/292]), stenosis >50% (0.7% [2/292]), and re‐treatment (1.4% [67/292]). Conclusions INSPIRE data suggests good rates of complete occlusion, efficacy, and safety among a large cohort of patients with aneurysms in a variety of challenging locations and sizes treated with the Pipeline Shield device, with adjudication by CEC and Imaging Core Lab ensuring high quality of these data.