Safety and Effectiveness of the Pipeline Flex Embolization Device With Shield Technology for the Treatment of Intracranial Aneurysms: Midterm Results From a Multicenter Study

Abstract

BACKGROUND The safety and efficacy of the first generation of the Pipeline Embolization Device (PED; Medtronic Inc) have been proven in large case series. Ischemic events are one of the most common complications following treatment of aneurysms with flow diverters. The new PED Flex with Shield technology (PED Shield; Medtronic Inc) was introduced to minimize the rate of complications. OBJECTIVE To evaluate the outcomes of patients harboring aneurysms treated with the PED Shield. METHODS This was an observational, prospective, single-arm multicenter study of patients treated with the PED Shield. The primary safety endpoint was the absence of major neurological complications and death. The secondary effectiveness endpoint was angiographic occlusion at 6 and 12 mo. Technical complications were also reported. RESULTS Between November 2017 and December 2018, 151 patients from 7 centers with 182 aneurysms were enrolled. The mean aneurysm size was 7.0 mm; 27 (14.8%) aneurysms were large, and 7 (3.8%) were giant. In 141 of 151 patients (93.4%), the primary endpoint was reached. The overall rate of periprocedural complications was 7.3%. Of the aneurysms, 79.7% met the study's secondary endpoint of complete occlusion at 6 mo and 85.3% at 12 mo. CONCLUSION The PED Shield is a safe and effective treatment for intracranial aneurysms. The results regarding total occlusion and ischemic complications did not differ from those obtained in case series using previous versions of the PED. Long-term follow-up and comparative studies are required to provide stronger conclusions regarding the reduced thrombogenicity of this device.

Pipeline Flex embolisation device with Shield Technology for the treatment of patients with intracranial aneurysms: periprocedural and 6 month outcomes

“…At 6 months of follow-up we report no significant in-stent stenosis or intraluminal hyperplasia, with all cases having less than 25% reduction in the intraluminal diameter. This low rate of stenosis is comparable to previous multicentre studies using the Pipeline Flex with Shield Technology, which reported significant stenosis in 19.4% (7/36) 10 and 2.9% (2/69) of cases 11 and correlates with a recent porcine study which found reduced in-stent stenosis when comparing Pipeline Shield with Pipeline Flex. 27 Clinical studies on previous generations of the Pipeline device showed that 8% of cases had at least moderate (>50%) stenosis in comparison to none of the cases in this series.…”

“…This study contributes further data to the growing body of evidence that the Pipeline Shield is an effective and safe treatment option for unruptured intracranial aneurysms. A multicentre study has previously shown that use of this device has led to no major strokes or deaths at one year follow-up in a cohort of 50 patients, 10 while a larger study of 151 patients reported two major strokes, one haemorrhage and one death 11 – an acceptable complication rate of 2.6% comparable with meta-analyses of studies involving the second generation Pipeline. 20 This study corroborates these positive findings with observational 6-month follow-up results from a separate tertiary centre for interventional neuroradiology not involved in previous trials.…”

“…8 , 9 Prospective, single-arm, multicentre studies have demonstrated that at one year of follow-up it has comparable or improved rates of complete aneurysm occlusion, retreatment rates and thromboembolic complication rates compared to previous Pipeline generations for unruptured aneurysms. 10 , 11 This paper contributes further evidence for the Pipeline Shield’s medium term safety and efficacy at 6 months of follow-up.…”

“…The success of the Pipeline Shield in the treatment of large and giant aneurysms reported here is encouraging and provides limited support for previously documented safety outcomes and reduced complication rates with aneurysms of this size. 10 , 11…”

Periprocedural to 1-year safety and efficacy outcomes with the Pipeline Embolization Device with Shield technology for intracranial aneurysms: a prospective, post-market, multi-center study

“…High rates of complete occlusion (70.8% and 77.2% at 6 months and 1 year, respectively) and low rate of retreatment (0.05%) among subjects treated with the PED-Shield in the present study are comparable to two previous studies of the PED-Shield: the PFLEX study, which reported complete aneurysm occlusion in 82% of subjects at 1 year and no target aneurysm recurrence or retreatment after complete occlusion, 23 and an observational study that noted complete aneurysm occlusion in 79.7% and 85.3% of cases at 6 months and 1 year, respectively. 24 Our findings are also consistent with reports evaluating previous generations of the PED, which indicated complete occlusion rates ranging from 73.6% to 78.6% at 6 months and from 78.9% to 86.8% at 1 year. 25 Additionally, studies of similar aneurysm sizes including the PREMIER 14 and IntrePED studies 15 reported target aneurysm retreatment rates at 1 year of 2.9% and 1.9%, respectively.…”