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Pre-clinical evaluation of a minimally invasive laryngeal pacemaker system in mini-pig

  • Laryngology
  • Published:
European Archives of Oto-Rhino-Laryngology Aims and scope Submit manuscript

Abstract

Microlaryngoscopic enlargement techniques have been the standard treatment for bilateral vocal fold paralysis (BVFP) for decades. Laryngeal pacing is a promising alternative treatment based on the electrostimulation of the posterior cricoarytenoid (PCA) muscle. This paper reports on the results of a pre-clinical study aiming to evaluate this method. Eight Göttingen mini-pigs were implanted with a laryngeal pacemaker (LP) implant prototype and with two LP electrodes, one in each PCA muscle. The 6-week follow-up included endoscopic stimulation controls in general anaesthesia and radiographic controls of electrode integrity and position stability. Stimulation parameters for optimal glottal opening were evaluated via videolaryngoscopy. Histopathology was performed upon conclusion of the study. 7/8 (87.5 %) animals were successfully implanted with the LP implant prototype and two LP electrodes. In general, stimulation was effectively delivered and correlated with the expected PCA muscle activation. 2/14 (14.3 %) electrodes dislocated and 1/14 (7.1 %) electrode tip broke. The LP system used in this experiment to induce vocal fold abduction by means of selective functional electrical stimulation of the PCA showed promising results. It may be a valid alternative to the current golden standard for BVFP treatment. Clinical studies are needed to confirm the medical relevance of the LP.

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Acknowledgments

We thank Michael Todd for language editing, and the staff of the Institute for Laboratory Animal Sciences and Welfare of the University of Jena for supporting and hosting this trial. We thank the Department for Pathology of SRH Wald-Klinikum Gera for the offer of facilities and scientific support.

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Authors and Affiliations

  1. Department Otorhinolaryngology, SRH Wald-Klinikum Gera, 07548, Gera, Germany

    Gerhard Foerster & Andreas H. Mueller

  2. Section for Motor Research, Pathophysiology and Biomechanics of University Hospital for Trauma-, Hand- and Reconstructive Surgery, Friedrich-Schiller-University Jena, Jena, Germany

    Dirk Arnold & Hans-Christoph Scholle

  3. Institute for Laboratory Animal Sciences and Welfare of Friedrich-Schiller-University Jena, Jena, Germany

    Sabine Bischoff & Harald Schubert

  4. Department of Pathology, SRH Wald-Klinikum Gera, Gera, Germany

    Karsten Boltze

Authors
  1. Gerhard Foerster
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  2. Dirk Arnold
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  3. Sabine Bischoff
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  4. Karsten Boltze
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  5. Hans-Christoph Scholle
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  6. Harald Schubert
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  7. Andreas H. Mueller
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Corresponding author

Correspondence to Gerhard Foerster.

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Conflict of interest

This work was financially supported by MED-EL (Medical Electronics) Innsbruck, Austria. The animal trials were sponsored by MED-EL Medical Electronics, Innsbruck. The authors declare no conflicts of interest.

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Foerster, G., Arnold, D., Bischoff, S. et al. Pre-clinical evaluation of a minimally invasive laryngeal pacemaker system in mini-pig. Eur Arch Otorhinolaryngol 273, 151–158 (2016). https://doi.org/10.1007/s00405-015-3735-1

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  • DOI: https://doi.org/10.1007/s00405-015-3735-1

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