Outcome study of the Pipeline Vantage Embolization Device (second version) in unruptured (and ruptured) aneurysms (PEDVU(R) study)
Published in: Journal of NeuroInterventional Surgery
Authors: Thomas C. Booth; Ahmed Bassiouny; Jeremy Lynch; Hemant Sonwalkar; Aaron Bleakley; Ahmed Iqbal; Thais Minett; James Buwanabala; Anne Pasco Narata; Tufail Patankar; Fahad I. Islim; Nitin Kandasamy; Prem Balasundaram; Stefano Sciacca; Jawad Siddiqui; Daniel Walsh; Christos Tolias; Ahilan Kailaya-Vasan; Ahmed A. Sultan; Mohamed Abd el-Latif; Adam Mortimer; Anand Sastry
Year: 2023
Publication details: 16(11):jnis-2023-020754
DOI: 10.1136/jnis-2023-020754
Publication type: Journal article
Topic: Flow diversion, Pipeline Vantage, brain aneurysm treatment, unruptured aneurysm, ruptured aneurysm
Simple summary
This multicentre study reports outcomes for a newer flow-diverting device used in intracranial aneurysm treatment. It can support content explaining that some aneurysms are considered for endovascular treatment, while treatment choice still depends on aneurysm type, rupture status and individual risk.
Mr Kailaya-Vasan’s involvement
Mr Kailaya-Vasan, consultant neurosurgeon and neurovascular surgeon, is listed as a contributing author on this publication.
Published abstract
The following abstract is reproduced from the original publication and is provided for reference. It may include technical terminology intended for clinical or academic audiences.
Background: The Pipeline Vantage Embolization Device (PEDV) is the fourth-generation pipeline flow diverter for intracranial aneurysm treatment. There are no outcome studies for the second PEDV version. We aimed to evaluate safety and efficacy outcomes. Primary and secondary objectives were to determine outcomes for unruptured and ruptured cohorts, respectively. Methods In this multicenter retrospective and prospective study, we analyzed outcome data from eight centers using core laboratory assessments. We determined 30-day and >=3-month mortality and morbidity rates, and 6- and 18-month radiographic aneurysm occlusion rates for procedures performed during the period July 2021-March 2023. Results We included 121 consecutive patients with 131 aneurysms. The adequate occlusion rate for the unruptured cohort at short-term and medium-term follow up, and also for the ruptured cohort at short-term follow up, was >90%. Two aneurysms (1.5%) underwent retreatment. When mortality attributed to a palliative case in the unruptured cohort, or subarachnoid hemorrhage in the ruptured cohort, was excluded then the overall major adverse event rate in respective cohorts was 7.5% and 23.5%, with 0% mortality rates for each. When all event causes were included on an intention-to-treat basis, the major adverse event rates in respective cohorts were 8.3% and 40.9%, with 0.9% and 22.7% mortality rates. Conclusions For unruptured aneurysm treatment, the second PEDV version appears to have a superior efficacy and similar safety profile to previous-generation PEDs. These are acceptable outcomes in this pragmatic and non-industry-sponsored study. Analysis of ruptured aneurysm outcomes is limited by cohort size. Further prospective studies, particularly for ruptured aneurysms, are needed.
Disclaimer
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