Preliminary Clinical Outcomes of <scp>VOIS</scp>‐Implant in Patients With Unilateral Vocal Fold Paralysis

Hsieh, Li‐Chun; Chen, Chin‐Kuo; Chang, Chin-Wen; Leu, Yi-Shing; Ho, Guan‐Min

doi:10.1002/lary.29958

Cited by 6 publications

(1 citation statement)

References 26 publications

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“…No revision surgery would be required for under‐ or over‐corrections. As shown in our previously published preliminary clinical data 19,20 the APrevent® VOIS is a reasonable and efficient method to achieve sufficient vocal fold medialization with subsequent voice improvement, providing further supportive evidence in addition to the positive findings from the preclinical development and testing.…”

Section: Discussionsupporting

confidence: 58%

Pre‐clinical evaluation of APrevent® VOIS for unilateral vocal fold paralysis medialization

Rast²,

Hsieh

et al. 2023

Laryngoscope Investig Oto

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Objective To evaluate the concept and efficacy of an adjustable implant (Prototype SH30: porcine implant and APrevent® VOIS: human concept) for treatment of unilateral vocal fold paralysis (UVFP) via in vivo mini‐pig studies, human computed tomographic (CT) and magnetic resonance (MR) image analysis, ex‐vivo aerodynamic and acoustic analysis. Methods Feasibility testing and prototype implantation were performed using in‐vivo UVFP porcine model (n = 8), followed by a dimensional finding study using CT and MR scans of larynges (n = 75) for modification of the implant prototypes. Acoustic and aerodynamic measurements were recorded on excised canine (n = 7) larynges with simulated UVFP before and after medialization with VOIS‐Implant. Results The prototype showed in the in‐vivo UVFP porcine model an improved glottic closure from grade 6 incomplete closure to complete closure (n = 5), to grade 2 incomplete closure (n = 2) and grade 3 incomplete closure (n = 1). On human CT/MR scans the identification of the correct size was successful in 97.3% using the thyroid cartilage alar “distance S” as the only parameter, which is an important step towards procedure standardization and implant design. Results were confirmed with implantation in human laryngeal cadavers (n = 44). Measurements of the acoustic and aerodynamic effects after implantation showed a significant decreased phonation threshold pressure (p = .0187), phonation threshold flow (p = .0001) and phonation threshold power (p = .0046) on excised canine larynges with simulated UVFP. Percent jitter and percent shimmer decreased (p = .2976; p = .1771) but not significant. Conclusions Based on the preclinical results four sizes, differing in medial length, implant width and expansion direction of silicone cushions, seem to be enough to satisfy laryngeal size variations. This concept is significantly effective in medializing UVFP and improving the aerodynamic and acoustic qualities of phonation as reported in a preliminary clinical outcome study with long‐term implantation. Level of Evidence N/A

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Section: Discussionsupporting

confidence: 58%

Pre‐clinical evaluation of APrevent® VOIS for unilateral vocal fold paralysis medialization

Rast²,

Hsieh

et al. 2023

Laryngoscope Investig Oto

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Safety and Adverse Events of Medialization Thyroplasty: A Systematic Review

Valley,

Karp,

Garber

2023

The Laryngoscope

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IntroductionUnilateral vocal fold paralysis or paresis (UVFP) is a condition that causes significant morbidity due to dysphonia, dysphagia, and aspiration. Type I medialization thyroplasty (MT) is the current mainstay surgical treatment for UVFP. Though widely considered a safe procedure, concerns exist over possible airway complications which can lead to overnight observation. Herein, we report a systematic review of the safety and adverse events of MT to aid in determining the safety of same‐day discharge.Data SourcesPubMed and Embase databases.Review MethodsOur search identified studies investigating complications associated with MT. Articles were selected if published between January 1, 1989 and March 15, 2023. Abstracts were screened, and data were extracted from included studies. Only Type I MT procedures were included; case reports were excluded. Participant characteristics, intervention details, results, and adverse events were extracted.ResultsThe database query identified 751 abstracts, of which 46 studies met eligibility criteria. A total of 2426 patients underwent MT. The most common implant was Silastic (n = 898, 37.0%) followed by Gore‐Tex (n = 664, 27.4%). There were 254 (10.5%) total complications reported; 110 (4.5%) were considered major. The most common complication was nonobstructive hematoma (n = 59, 2.4%) followed by hemorrhage (n = 36, 1.5%). Implant extrusion (n = 24, 0.99%) or displacement (n = 15, 0.62%) occurred mostly in Silastic and Gore‐Tex implants. Same‐day discharge occurred with 429 patients and was not associated with adverse events.ConclusionsUVFP can be reliably improved by MT with a low risk of complications. Outpatient MT is a promising treatment with a favorable safety profile. Laryngoscope, 2023

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Long-term voice outcomes of medialization thyroplasty with adjustable implant for unilateral vocal fold paralysis

Huang,

Chen,

et al. 2023

Eur Arch Otorhinolaryngol

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Preliminary Clinical Outcomes of VOIS‐Implant in Patients With Unilateral Vocal Fold Paralysis

Cited by 6 publications

References 26 publications

Pre‐clinical evaluation of APrevent® VOIS for unilateral vocal fold paralysis medialization

Pre‐clinical evaluation of APrevent® VOIS for unilateral vocal fold paralysis medialization

Safety and Adverse Events of Medialization Thyroplasty: A Systematic Review

Long-term voice outcomes of medialization thyroplasty with adjustable implant for unilateral vocal fold paralysis

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