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

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

doi:10.1002/lary.29958

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

Li Chun Hsieh, Chin Kuo Chen, Chin Wen Chang, Yi Shing Leu, Guan Min Ho^*

^*Corresponding author for this work

School of Traditional Chinese Medicine

Research output: Contribution to journal › Journal Article › peer-review

6 Scopus citations

Abstract

Objectives/Hypothesis: Evaluation of the clinical outcomes after 6 months of treatment with a novel adjustable implant, the APrevent® Vocal-Implant-System (VOIS), in conjunction with medialization thyroplasty (MT) in patients with unilateral vocal fold paralysis. Study Design: Prospective case series study at single tertiary referral center. Methods: Preoperative and 1 week, 7 weeks, and 6 months postoperative glottal efficiency (maximum phonation time [MPT]), voice quality (including GRBAS-scores and acoustic parameters) and self-perceived voice-related handicap (voice handicap index [VHI-30]) were measured and analyzed, whereas type of vocal fold closure was evaluated and determined by flexible videolaryngoscopy based on Södersten and Lindestad classification (Wilcoxon signed-rank test). Results: Thirteen patients underwent MT with VOIS under local anesthesia. Six months after surgery, the VHI-30 and MPT had improved from a preoperative mean of 75.0 ± 22.9 and 2.7 ± 2.1 s to a postoperative mean of 20.6 ± 19.7 and 6.3 ± 4.0 s, respectively. The mean GRBAS score improved from preoperative scores of G_preop = 2.7, R_preop = 2.6, B_preop = 2.6, A_preop = 2.2, and S_preop = 2.0 to G_postop = 0.3, R_postop = 0.3, B_postop = 0.2, A_postop = 0.2, and S_postop = 0.3 at 6 months postoperatively. Improved glottal closure was achieved in all patients (n = 13). Five patients received postoperative adjustment for the optimization of voice quality and glottal closure. No intra- or postoperative complications were observed. Significant improvements in acoustic parameters, including percentage jitter, percentage shimmer, and signal-to-noise ratio, were also observed after MT. All results were statistically significant (P <.05, Cohen's d >.8). Conclusions: APrevent® VOIS-Implantation is a safe procedure with good voice outcomes. Postoperative adjustments can be performed smoothly to optimize voice quality and glottal closure. Level of Evidence: 3 Laryngoscope, 132:1622–1629, 2022.

Original language	English
Pages (from-to)	1622-1629
Number of pages	8
Journal	Laryngoscope
Volume	132
Issue number	8
DOIs	https://doi.org/10.1002/lary.29958
State	Published - 08 2022

Bibliographical note

Publisher Copyright:
© 2021 The American Laryngological, Rhinological and Otological Society, Inc.

Keywords

Medialization thyroplasty
adjustable VOIS-Implant
glottic insufficiency
unilateral vocal fold paralysis

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10.1002/lary.29958

Cite this

@article{16170485c55b416f905e340475144f6b,

title = "Preliminary Clinical Outcomes of VOIS-Implant in Patients With Unilateral Vocal Fold Paralysis",

abstract = "Objectives/Hypothesis: Evaluation of the clinical outcomes after 6 months of treatment with a novel adjustable implant, the APrevent{\textregistered} Vocal-Implant-System (VOIS), in conjunction with medialization thyroplasty (MT) in patients with unilateral vocal fold paralysis. Study Design: Prospective case series study at single tertiary referral center. Methods: Preoperative and 1 week, 7 weeks, and 6 months postoperative glottal efficiency (maximum phonation time [MPT]), voice quality (including GRBAS-scores and acoustic parameters) and self-perceived voice-related handicap (voice handicap index [VHI-30]) were measured and analyzed, whereas type of vocal fold closure was evaluated and determined by flexible videolaryngoscopy based on S{\"o}dersten and Lindestad classification (Wilcoxon signed-rank test). Results: Thirteen patients underwent MT with VOIS under local anesthesia. Six months after surgery, the VHI-30 and MPT had improved from a preoperative mean of 75.0 ± 22.9 and 2.7 ± 2.1 s to a postoperative mean of 20.6 ± 19.7 and 6.3 ± 4.0 s, respectively. The mean GRBAS score improved from preoperative scores of Gpreop = 2.7, Rpreop = 2.6, Bpreop = 2.6, Apreop = 2.2, and Spreop = 2.0 to Gpostop = 0.3, Rpostop = 0.3, Bpostop = 0.2, Apostop = 0.2, and Spostop = 0.3 at 6 months postoperatively. Improved glottal closure was achieved in all patients (n = 13). Five patients received postoperative adjustment for the optimization of voice quality and glottal closure. No intra- or postoperative complications were observed. Significant improvements in acoustic parameters, including percentage jitter, percentage shimmer, and signal-to-noise ratio, were also observed after MT. All results were statistically significant (P <.05, Cohen's d >.8). Conclusions: APrevent{\textregistered} VOIS-Implantation is a safe procedure with good voice outcomes. Postoperative adjustments can be performed smoothly to optimize voice quality and glottal closure. Level of Evidence: 3 Laryngoscope, 132:1622–1629, 2022.",

keywords = "Medialization thyroplasty, adjustable VOIS-Implant, glottic insufficiency, unilateral vocal fold paralysis",

author = "Hsieh, {Li Chun} and Chen, {Chin Kuo} and Chang, {Chin Wen} and Leu, {Yi Shing} and Ho, {Guan Min}",

note = "Publisher Copyright: {\textcopyright} 2021 The American Laryngological, Rhinological and Otological Society, Inc.",

year = "2022",

month = aug,

doi = "10.1002/lary.29958",

language = "英语",

volume = "132",

pages = "1622--1629",

journal = "Laryngoscope",

issn = "0023-852X",

publisher = "Wiley-Blackwell",

number = "8",

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TY - JOUR

T1 - Preliminary Clinical Outcomes of VOIS-Implant in Patients With Unilateral Vocal Fold Paralysis

AU - Hsieh, Li Chun

AU - Chen, Chin Kuo

AU - Chang, Chin Wen

AU - Leu, Yi Shing

AU - Ho, Guan Min

PY - 2022/8

Y1 - 2022/8

N2 - Objectives/Hypothesis: Evaluation of the clinical outcomes after 6 months of treatment with a novel adjustable implant, the APrevent® Vocal-Implant-System (VOIS), in conjunction with medialization thyroplasty (MT) in patients with unilateral vocal fold paralysis. Study Design: Prospective case series study at single tertiary referral center. Methods: Preoperative and 1 week, 7 weeks, and 6 months postoperative glottal efficiency (maximum phonation time [MPT]), voice quality (including GRBAS-scores and acoustic parameters) and self-perceived voice-related handicap (voice handicap index [VHI-30]) were measured and analyzed, whereas type of vocal fold closure was evaluated and determined by flexible videolaryngoscopy based on Södersten and Lindestad classification (Wilcoxon signed-rank test). Results: Thirteen patients underwent MT with VOIS under local anesthesia. Six months after surgery, the VHI-30 and MPT had improved from a preoperative mean of 75.0 ± 22.9 and 2.7 ± 2.1 s to a postoperative mean of 20.6 ± 19.7 and 6.3 ± 4.0 s, respectively. The mean GRBAS score improved from preoperative scores of Gpreop = 2.7, Rpreop = 2.6, Bpreop = 2.6, Apreop = 2.2, and Spreop = 2.0 to Gpostop = 0.3, Rpostop = 0.3, Bpostop = 0.2, Apostop = 0.2, and Spostop = 0.3 at 6 months postoperatively. Improved glottal closure was achieved in all patients (n = 13). Five patients received postoperative adjustment for the optimization of voice quality and glottal closure. No intra- or postoperative complications were observed. Significant improvements in acoustic parameters, including percentage jitter, percentage shimmer, and signal-to-noise ratio, were also observed after MT. All results were statistically significant (P <.05, Cohen's d >.8). Conclusions: APrevent® VOIS-Implantation is a safe procedure with good voice outcomes. Postoperative adjustments can be performed smoothly to optimize voice quality and glottal closure. Level of Evidence: 3 Laryngoscope, 132:1622–1629, 2022.

AB - Objectives/Hypothesis: Evaluation of the clinical outcomes after 6 months of treatment with a novel adjustable implant, the APrevent® Vocal-Implant-System (VOIS), in conjunction with medialization thyroplasty (MT) in patients with unilateral vocal fold paralysis. Study Design: Prospective case series study at single tertiary referral center. Methods: Preoperative and 1 week, 7 weeks, and 6 months postoperative glottal efficiency (maximum phonation time [MPT]), voice quality (including GRBAS-scores and acoustic parameters) and self-perceived voice-related handicap (voice handicap index [VHI-30]) were measured and analyzed, whereas type of vocal fold closure was evaluated and determined by flexible videolaryngoscopy based on Södersten and Lindestad classification (Wilcoxon signed-rank test). Results: Thirteen patients underwent MT with VOIS under local anesthesia. Six months after surgery, the VHI-30 and MPT had improved from a preoperative mean of 75.0 ± 22.9 and 2.7 ± 2.1 s to a postoperative mean of 20.6 ± 19.7 and 6.3 ± 4.0 s, respectively. The mean GRBAS score improved from preoperative scores of Gpreop = 2.7, Rpreop = 2.6, Bpreop = 2.6, Apreop = 2.2, and Spreop = 2.0 to Gpostop = 0.3, Rpostop = 0.3, Bpostop = 0.2, Apostop = 0.2, and Spostop = 0.3 at 6 months postoperatively. Improved glottal closure was achieved in all patients (n = 13). Five patients received postoperative adjustment for the optimization of voice quality and glottal closure. No intra- or postoperative complications were observed. Significant improvements in acoustic parameters, including percentage jitter, percentage shimmer, and signal-to-noise ratio, were also observed after MT. All results were statistically significant (P <.05, Cohen's d >.8). Conclusions: APrevent® VOIS-Implantation is a safe procedure with good voice outcomes. Postoperative adjustments can be performed smoothly to optimize voice quality and glottal closure. Level of Evidence: 3 Laryngoscope, 132:1622–1629, 2022.

KW - Medialization thyroplasty

KW - adjustable VOIS-Implant

KW - glottic insufficiency

KW - unilateral vocal fold paralysis

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DO - 10.1002/lary.29958

M3 - 文章

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AN - SCOPUS:85119863696

SN - 0023-852X

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SP - 1622

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JO - Laryngoscope

JF - Laryngoscope

IS - 8

ER -

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

Abstract

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Keywords

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