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Safety and effectiveness in explantation and re-implantation of hypoglossal nerve stimulation devices

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Abstract

Purpose

Since 2001, hypoglossal nerve stimulators have been implanted in patients with obstructive sleep apnea around the world, initially in trial situations but more recently also in regular care settings. Medium term data indicate effectiveness and tolerability of treatment. However, when assessing the safety of the procedure, the safe feasibility of explantation or reimplantation must also be considered.

Patients and methods

Nine patients with an implanted respiratory-driven hypoglossal nerve stimulator. We have evaluated the feasibility and safety of explantation or re-implantation with another stimulation system.

Results

In 2012, nine patients were implanted with a respiratory-driven hypoglossal nerve stimulator as part of the Apnex Medical Pivotal Study. The study was ended in 2013. For a variety of reasons, the system was explanted from all nine patients by the year 2019. Three of these patients were re-implanted with a different system with respiratory sensing during the same session (mean incision to closure time for explantation 88.2 ± 35.01 min., mean incision to closure time for re-implantation 221.75 ± 52.73 min.). Due to extensive scar tissue formation, all procedures were technically challenging. Complication rate was significantly higher when re-implantation was performed or attempted in the same surgical session (0 of 5 patients with explantation versus 3 of 4 patients with attempted re-implantation; p = 0.018). There was no significant difference between the AHI values before and after implantation in patients with re-implantation.

Conclusion

Explantation and re-implantation are technically challenging though possible procedures. The single-staged equilateral reimplantation of another hypoglossal nerve stimulation system can, but need not, be successful.

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Funding

Apnex Medical Pivotal Study was financed by Apnex Medical Inc. Aftercare and evaluation of patient data in clinical follow-up—as presented here—was not financed.

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Authors and Affiliations

  1. Department of Otorhinolaryngology, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany

    Philipp Arens, Heidi Olze & Steffen Dommerich

  2. Department of Cardiology and Pulmonology, Center of Sleep Medicine, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany

    Thomas Penzel, Ingo Fietze, Alexander Blau & Bodo Weller

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  1. Philipp Arens
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  2. Thomas Penzel
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  4. Alexander Blau
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  6. Heidi Olze
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  7. Steffen Dommerich
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Contributions

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by PA, SD, IF, AB and BW. Supervision was done by TP. The first draft of the manuscript was written by PA. Reviewing and editing of the manuscript was done by SD, TP and HO. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Philipp Arens.

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Conflict of interest

Philipp Arens P, Thomas Penzel, Ingo Fietze, Alexander Blau, Heidi Olze and Steffen Dommerich received financial support from ImThera Inc. and Apnex Medical Inc. within the framework of research projects related to hypoglossal nerve stimulation therapy. Philipp Arens received a speaker’s fee for an invited talk on behalf of Inspire Medical Inc.

Ethical approval

Procedures performed within the Apnex Pivotal Study were in accordance with the ethical standards of the national research committee (LAGeSo Berlin, 11/0326-ZS EK 11) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Consent to participate

Informed consent was obtained from all individual participants included in the study.

Consent for publication

Informed consent was obtained from all individual participants included in the study.

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Not applicable.

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Arens, P., Penzel, T., Fietze, I. et al. Safety and effectiveness in explantation and re-implantation of hypoglossal nerve stimulation devices. Eur Arch Otorhinolaryngol 278, 477–483 (2021). https://doi.org/10.1007/s00405-020-06170-w

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  • DOI: https://doi.org/10.1007/s00405-020-06170-w

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