Hypoglossal Nerve Stimulator Implantable Pulse Generator Exchange for Battery Depletion

Goates, Andrew J.; Louis, Erik K. St.; Olson, Michael D.

doi:10.1177/0194599820925767

Cited by 2 publications

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References 4 publications

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“…If the leads are not deep into the IPG, the risk of damage during the extraction is much higher. Therefore, as previously posited by Goates, a preoperative chest radiograph in both the anteroposterior and lateral views should be obtained 6 . Based on this evaluation, the surgeon may use either the prior incision or employ a new incision in order to be positioned away from the leads.…”

Section: Discussionmentioning

confidence: 99%

“…Therefore, as previously posited by Goates, a preoperative chest radiograph in both the anteroposterior and lateral views should be obtained. 6 Based on this evaluation, the surgeon may use either the prior incision or employ a new incision in order to be positioned away from the leads. Preoperative imaging is not always entirely predictive of lead positioning and does not obviate the risk of potential damage to the leads, especially if the stimulation lead is superficial to the generator.…”

Section: Discussionmentioning

confidence: 99%

“…The first cohort of implanted patients is currently entering the anticipated longevity window during which batteries may reach depletion. The first case study of an IPG exchange for battery depletion was reported in 2020 6 . The number of patients requiring generator replacements will continue to grow in the coming years.…”

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confidence: 99%

“…The first case study of an IPG exchange for battery depletion was reported in 2020. 6 The number of patients requiring generator replacements will continue to grow in the coming years. With this in mind, our study sought to examine the surgical experience with IPG replacements and examine long-term outcomes related to disease burden in this unique cohort of patients.…”

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confidence: 99%

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Long‐Term Generator Replacement Experience in Hypoglossal Nerve Stimulator Therapy Recipients With CPAP‐Intolerant Obstructive Sleep Apnea

Magaña

Strollo

Steffen

et al. 2023

Otolaryngol.--head neck surg.

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ObjectiveIn the last decade, hypoglossal nerve stimulation (HNS) has emerged as a therapeutic alternative for patients with obstructive sleep apnea. The original clinical trial cohorts are entering the phase of expected battery depletion (8‐12 years). This study aimed to examine the surgical experience with implantable pulse generator (IPG) replacements and the associated long‐term therapy outcomes.Study DesignRetrospective analysis of patients from the original clinical trial databases (STAR, German post‐market) who were followed in the ongoing ADHERE registry.SettingInternational multicenter HNS registry.MethodsThe ADHERE registry and clinical trial databases were cross‐referenced to identify the serial numbers of IPGs that were replaced. Data collection included demographics, apnea‐hypopnea index (AHI), therapy use, operative times, and adverse events.ResultsFourteen patients underwent IPG replacement 8.3 ± 1.1 years after their initial implantation. Body mass index was unchanged between the original implant and IPG replacement (29 ± 4 vs 28 ± 2 kg/m2, p = .50). The mean IPG replacement operative time was shorter than the original implant (63 ± 50 vs 154 ± 58 minutes, p < .002); however, 2 patients required stimulation lead replacement which significantly increased operative time. For patients with available AHI and adherence data, the mean change in AHI from baseline to latest follow‐up (8.7 ± 1.1 years after de novo implant) was −50.06%, and the mean therapy use was 7.2 hours/night.ConclusionIPG replacement surgery was associated with low complications and shorter operative time. For patients with available outcomes data, adherence and efficacy remained stable after 9 years of follow‐up.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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confidence: 99%

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confidence: 99%

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