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® 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, 1321622-1629, 2022.