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Lookup NU author(s): Dr Alistair Jenkins
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© 2022 Elsevier Ltd. Objective: Vagus Nerve Stimulation (VNS) paired with rehabilitation delivered by the Vivistim® Paired VNS™ System was approved by the FDA in 2021 to improve motor deficits in chronic ischemic stroke survivors with moderate to severe arm and hand impairment. Vagus nerve stimulators have previously been implanted in over 125,000 patients for treatment-resistant epilepsy and the surgical procedure is generally well-tolerated and safe. In this report, we describe the Vivistim implantation procedure, perioperative management, and complications for chronic stroke survivors enrolled in the pivotal trial. Methods: The pivotal, multisite, randomized, triple-blind, sham-controlled trial (VNS-REHAB) enrolled 108 participants. All participants were implanted with the VNS device in an outpatient procedure. Thrombolytic agents were temporarily discontinued during the perioperative period. Participants were discharged within 48 hrs and started rehabilitation therapy approximately 10 days after the Procedure. Results: The rate of surgery-related adverse events was lower than previously reported for VNS implantation for epilepsy and depression. One participant had vocal cord paresis that eventually resolved. There were no serious adverse events related to device stimulation. Over 90% of participants were taking antiplatelet drugs (APD) or anticoagulants and no adverse events or serious adverse events were reported as a result of withholding these medications during the perioperative period. Conclusions: This study is the largest, randomized, controlled trial in which a VNS device was implanted in chronic stroke survivors. Results support the use of the Vivistim System in chronic stroke survivors, with a safety profile similar to VNS implantations for epilepsy and depression.
Author(s): Liu CY, Russin J, Adelson DP, Jenkins A, Hilmi O, Brown B, Lega B, Whitworth T, Bhattacharyya D, Schwartz TH, Krishna V, Williams Z, Uff C, Willie J, Hoffman C, Vandergrift WA, Achrol AS, Ali R, Konrad P, Edmonds J, Kim D, Bhatt P, Tarver BW, Pierce D, Jain R, Burress C, Casavant R, Prudente CN, Engineer ND
Publication type: Article
Publication status: Published
Journal: Journal of Clinical Neuroscience
Year: 2022
Volume: 105
Pages: 122-128
Print publication date: 01/11/2022
Online publication date: 28/06/2022
Acceptance date: 28/09/2022
ISSN (print): 0967-5868
ISSN (electronic): 1532-2653
Publisher: Churchill Livingstone
URL: https://doi.org/10.1016/j.jocn.2022.09.013
DOI: 10.1016/j.jocn.2022.09.013
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