Outcome study of the Pipeline Vantage Embolization Device (second version) in unruptured (and ruptured) aneurysms (PEDVU(R) study).

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.
Competing Interests: Competing interests: Microvention core laboratory for neurointerventional study: payment to TCB. Siemens Healthineers Speakers Bureau Educational lecture on brain tumours, not related to aneurysms: payment to TCB. Medtronic Speakers Bureau Educational lecture on an independent non-industry-sponsored study published in AJNR 2019 on Pipeline Flow Diverter device: payment to TCB. Bayer Speakers Bureau Educational lecture on Explainability in AI, not related to aneurysms: payment to TCB. Consulting and proctoring agreement with Medtronic, Stryker, Balt, and Cerenovus: payment to TP. Microvention, Balt, and Medtronic support to attend meetings: payment to TM.
(© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)