Why the study?
Does a lead-salvage protocol safely and effectively manage vagal nerve stimulator infections in children without requiring complete hardware removal?
Does a lead-salvage protocol safely and effectively manage vagal nerve stimulator infections in children without requiring complete hardware removal?
A lead-salvage protocol involving generator removal and antibiotics without lead removal may be a safe and successful strategy for managing VNS-related infections in children, avoiding the morbidity of repeat surgical dissections.
Supports lead salvage in select pediatric VNS infections; leaves open need for prospective trials before changing practice.
OBJECT: Vagal nerve stimulator (VNS) hardware infections are fraught with difficult management decisions. As with most implanted medical device-related infections, standard practice traditionally involves complete hardware removal, systemic antibiotic therapy, and subsequent reimplantation of the device. To avoid the potential morbidity of 2 repeat left carotid sheath surgical dissections, the authors have implemented a clinical protocol for managing VNS infections that involves generator removal and antibiotic therapy without lead removal. METHODS: A prospective, single-surgeon database was compared with hospital billing records to identify patients who underwent primary implantation or reimplantation of a VNS lead, generator, or both, from January 2001 to May 2010, at Oregon Health & Science University. From these records, the authors identified patients with VNS hardware infections and characterized their management, using a lead salvage protocol. RESULTS: In their review, the authors found a matching cohort of 206 children (age 3 months-17 years) who met the inclusion criteria. These children underwent 258 operations (including, in some children, multiple operations for generator end of life and/or lead malfunction). Six children experienced a single postimplantation infection (2.3% of the 258 operative cases), and no child experienced repeated infection. A lead-salvage protocol was used in 4 of 6 infected patients and was successful in 3 (75%), with clinical follow-up ranging from 10 months to 7.5 years. The fourth patient subsequently underwent lead removal and later reimplantation in standard fashion, with no adverse sequelae. CONCLUSIONS: Vagal nerve stimulator lead salvage is a safe and potentially advantageous strategy in the management of VNS-related infection. Further study is necessary to validate appropriate patient selection, success rates, and risks of this approach.
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Wozniak et al. (2011) studied this question.
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