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

Laryngoscope. 2022 Aug;132(8):1622-1629. doi: 10.1002/lary.29958. Epub 2021 Nov 24.

Authors

Li-Chun Hsieh^{1

2}, Chin-Kuo Chen³, Chin-Wen Chang^{1

2}, Yi-Shing Leu¹, Guan-Min Ho^{1

4}

Affiliations

¹ Department of Otolaryngology-Head and Neck Surgery, Mackay Memorial Hospital, Taipei, Taiwan.
² Department of Audiology and Speech Language Pathology, Mackay Medical College, Taipei, Taiwan.
³ Communication Enhancement Center and Department of Otolaryngology-Head and Neck Surgery, Chang Gung Memorial Hospital, Taoyuan, Taiwan.
⁴ Yomin ENT and Pediatric Clinic, APrevent Medical, Taipei, Taiwan.

PMID: 34817072
DOI: 10.1002/lary.29958

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.

Keywords: Medialization thyroplasty; adjustable VOIS-Implant; glottic insufficiency; unilateral vocal fold paralysis.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Glottis
Humans
Laryngoplasty*
Treatment Outcome
Vocal Cord Paralysis* / surgery
Vocal Cords / surgery
Voice Quality