Clinical Considerations for Implanted Neurological Devices in Patients Undergoing Hyperbaric Oxygen Therapy: A Case Report and Review of Manufacturer Guidelines
Abstract
:1. Introduction
2. Detailed Case Description
3. Discussion
“It is possible to damage the pump due to deformation of the bottom shield of the pump if it is exposed to pressures greater than 2.0 ATA for a single treatment, or at pressures less than or equal to 2 ATA with multiple treatments if the reservoir is not kept close to full; a full reservoir helps to support the bottom shield of the pump. [While the functioning of the pump is not affected by HBOT] a collapsed bottom shield may significantly reduce the pump’s drug capacity and would require pump replacement surgery. [Therefore, the suggested management of the pump would be to] keep the reservoir volume within 2 mL of the recommended [maximum] capacity of the [20 mL Medtronic SynchroMed] pump, and it should be refilled during the hyperbaric treatment period to keep it at or above these volumes”.
4. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Indications for Hyperbaric Oxygen Therapy |
---|
Air or gas embolisms |
Carbon monoxide poisoning |
Clostridial Myositis and Myonecrosis |
Crush injury, Compartment Syndrome and other acute traumatic ischemia |
Decompression sickness |
Arterial insufficiencies (Central Retinal Artery Occlusion, Enhancement of healing in selected problem wounds) |
Severe Anemia |
Intracranial abscess |
Necrotizing soft tissue infections |
Refractory osteomyelitis |
Delayed radiation injury (Soft Tissue and Bony Necrosis) |
Acute Thermal Burn Injury |
Idiopathic Sudden Sensorineural Hearing Loss |
Side Effects of Hyperbaric Oxygen Therapy |
Middle ear barotrauma, Sinus squeeze, Claustrophobia, Progressive myopia, Pulmonary barotrauma, Seizures |
| |||
Manufacturer | Device (Models) | HBOT Feasibility and Maximum ATA Exposure | Notes |
Abbott (ex St. Jude Medical) | SCS: All models (Proclaim, Prodigy, Eon, EonC, EonMini, Protégé, Genesis, GenesisXP, GenesisRC) | 4.0 ATA [29] | Turn devices OFF during HBOT |
DBS: All models (Infinity, Libra, LibraXP, Brio) | |||
SCS-DRG: All models (Proclaim DRG, Axium DRG) | 1.5 ATA [29] | ||
Medtronic | Stimulators: All models including SCS (Intellis, PrimeAdvance), SNS (InterStim), PNS, DBS (Activa, Restore), | 2.0 ATA [30] | These devices can be left ON during HBOT |
IDD pump (SynchroMed II) | IDD pump must be refilled during HBOT in case of multiple sessions | ||
Boston Scientific | All models | No recommendations | No tests performed in humans, device functioning not guaranteed [31,32,33] |
Stimwave technologies | SCS (Freedom) | 1.5 ATA [34] | Instructions for use recommends 1.5 ATA, but also 13 m (45 feet) for diving, which would correspond to 2.3 ATA; no clarifications received by manufacturer [35] |
Flowonix | IDD pump (Prometra II) | 2.0 ATA [36] | Instructions for use states “an increase in environmental pressure of approximately 1 ATA or greater may cause the pump to temporarily stop delivering drug; when normal atmospheric pressure is returned, the pump will resume its programmed delivery rate” [37] |
Nevro | SCS: All models (Senza, Senza II, Senza Omnia) | 4.5 ATA [38] | Turn devices OFF during HBOT [39] |
Saluda Medical | SCS (Evoke) | 1.5 ATA [40] | No response from vendor |
Nalu | SCS/PNS (Nalu) | 1.48 ATA [41] | Instructions for use recommends 1.48 ATA, but also 13 m (45 feet) for diving, which would correspond to 2.3 ATA; no clarifications received by manufacturer Do not dive/hyperbaric the external Therapy Disc |
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Schiavo, S.; Brenna, C.T.A.; Bhatia, A.; Middleton, W.J.; Katznelson, R. Clinical Considerations for Implanted Neurological Devices in Patients Undergoing Hyperbaric Oxygen Therapy: A Case Report and Review of Manufacturer Guidelines. Int. J. Environ. Res. Public Health 2023, 20, 5693. https://doi.org/10.3390/ijerph20095693
Schiavo S, Brenna CTA, Bhatia A, Middleton WJ, Katznelson R. Clinical Considerations for Implanted Neurological Devices in Patients Undergoing Hyperbaric Oxygen Therapy: A Case Report and Review of Manufacturer Guidelines. International Journal of Environmental Research and Public Health. 2023; 20(9):5693. https://doi.org/10.3390/ijerph20095693
Chicago/Turabian StyleSchiavo, Simone, Connor T. A. Brenna, Anuj Bhatia, William J. Middleton, and Rita Katznelson. 2023. "Clinical Considerations for Implanted Neurological Devices in Patients Undergoing Hyperbaric Oxygen Therapy: A Case Report and Review of Manufacturer Guidelines" International Journal of Environmental Research and Public Health 20, no. 9: 5693. https://doi.org/10.3390/ijerph20095693