Rationale: U.S. FDA-approved implantable neuromodulation therapy options for treating medically intractable epilepsy now include Vagus Nerve Stimulation (VNS; LivaNova), Responsive Neurostimulation System (RNS; NeuroPace) and Deep Brain Stimulation (DBS; Medtronic). These treatment options require intermittent physical presence ‘on-site’ interrogations and adjustments of the implantable pulse generator (IPG) for optimizing stimulation settings. Such a clinical workflow requiring multiple patient visits with a provider often poses challenges for a large proportion of both providers and individuals implanted with these devices. Such challenges can include traveling great distances to qualified providers. The COVID-19 pandemic has accelerated the need for alternative solutions to 'virtually' interrogate and program these IPGs from outside of healthcare settings to maintain patient safety without compromising the integrity of the programming workflow.
The goal of this proof-of-concept study is to demonstrate the feasibility of deploying a secure, remotely accessible strategy for ‘off-site’ interrogation and programming of children and adults implanted with all models of the VNS IPG. This strategy was incorporated into virtual audio-video telehealth visit workflow. Methods: An ethernet-compatible Keyboard-Video-Mouse (KVM) switch was installed at a remote rural clinic originating site, where the patient is based, in Northern Illinois (EHM). The KVM switch was successfully connected to the LivaNova HP-programming tablet and Bluetooth-enabled wireless wand. Five patients (ages 9-48) implanted with a VNS IPG and living in the same rural community visited this rural telehealth-friendly site. A VPN-based firewall and HIPAA-compliant security features maintained cyber-security of the system at this site. The distant site, where the provider was based, was located 80-miles away at an urban tertiary care institution (RUMC). Results: Successful HIPAA-compliant remote interrogation and programming of each of the sentinel five patients was performed where the patient remained at the rural originating site. The provider-programmers (RC & MAR) were located at the distant site. A screen capture of stimulation parameters, stimulation therapy statistics, and magnet swipes were captured from the distant site’s telehealth display using standard screen capture software and uploaded to the respective patient’s medical record (EPIC). Billing codes 95970 for device analysis, and 95834 for programming were used for all patients in addition to 99215 for a virtual audio-video telehealth return visit lasting 40+ minutes. Conclusions: This proof-of-concept study demonstrated the first known successful remote interrogation and programming of VNS IPGs implanted in children and adults. Moreover, the relevance of this strategy during the COVID-19 pandemic is critical. All of these individuals remained self-isolated in their geographically distant rural community while linked to the urban-based provider during a telehealth encounter. This strategy offers a powerful tool to providers for remotely analyzing and adjusting VNS stimulation parameters without requiring a physically present on-site patient-provider visit. As a result, virtual remote VNS interrogations and programming can now complement the telehealth workflow as permitted by federal, state, and medical board regulations. Funding: Please list any funding that was received in support of this abstract.: Adelaide Cervantes Pediatric Epilepsy Fund Foglia Family Foundation