Pre-clinical evaluation of a minimally invasive laryngeal pacemaker system in mini-pig.
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.
Department Otorhinolaryngology, SRH Wald-Klinikum Gera, 07548, Gera, Germany. gerhard.foerster@wkg.srh.de.
Gerhard
G
Foerster
Section for Motor Research, Pathophysiology and Biomechanics of University Hospital for Trauma-, Hand- and Reconstructive Surgery, Friedrich-Schiller-University Jena, Jena, Germany.
Dirk
D
Arnold
Institute for Laboratory Animal Sciences and Welfare of Friedrich-Schiller-University Jena, Jena, Germany.
Sabine
S
Bischoff
Department of Pathology, SRH Wald-Klinikum Gera, Gera, Germany.
Karsten
K
Boltze
Section for Motor Research, Pathophysiology and Biomechanics of University Hospital for Trauma-, Hand- and Reconstructive Surgery, Friedrich-Schiller-University Jena, Jena, Germany.
Hans-Christoph
HC
Scholle
Institute for Laboratory Animal Sciences and Welfare of Friedrich-Schiller-University Jena, Jena, Germany.
Harald
H
Schubert
Department Otorhinolaryngology, SRH Wald-Klinikum Gera, 07548, Gera, Germany.
Andreas H
AH
Mueller
D000818:Animals; D004558:Electric Stimulation / Q000295:instrumentation*; D007821:Laryngeal Muscles / Q000503:physiopathology; D007828:Laryngoscopy; D023421:Models, Animal; D019736:Prostheses and Implants; D013552:Swine; D013556:Swine, Miniature; D014826:Vocal Cord Paralysis / Q000601:surgery*
Laryngeal pacemaker; Larynx; Middle term; Mini-pig; Neurostimulation; Posterior cricoarytenoid (PCA) muscle