Department of Otolaryngology-Head and Neck Surgery, Mackay Memorial Hospital, Taipei, Taiwan.
Department of Audiology and Speech Language Pathology, Mackay Medical College, Taipei, Taiwan.
Laryngoscope. 2022 Aug;132(8):1622-1629. doi: 10.1002/lary.29958. Epub 2021 Nov 24.
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.
Prospective case series study at single tertiary referral center.
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).
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 = 2.7, R = 2.6, B = 2.6, A = 2.2, and S = 2.0 to G = 0.3, R = 0.3, B = 0.2, A = 0.2, and S = 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).
APrevent® VOIS-Implantation is a safe procedure with good voice outcomes. Postoperative adjustments can be performed smoothly to optimize voice quality and glottal closure.
3 Laryngoscope, 132:1622-1629, 2022.
目的/假设：评估新型可调节植入物 APrevent® Vocal-Implant-System（VOIS）与声带内移术（MT）联合治疗单侧声带麻痹患者 6 个月后的临床疗效。
单中心前瞻性病例系列研究。
术前及术后 1 周、7 周和 6 个月，测量并分析最大发音时间（MPT）、嗓音质量（包括 GRBAS 评分和声学参数）和自我感知嗓音障碍（嗓音障碍指数[VHI-30]），并通过基于 Södersten 和 Lindestad 分类的软性喉镜检查评估和确定声带闭合类型（Wilcoxon 符号秩检验）。
13 例患者在局部麻醉下接受 MT 和 VOIS。术后 6 个月，VHI-30 和 MPT 分别从术前的 75.0±22.9 和 2.7±2.1 s 改善至术后的 20.6±19.7 和 6.3±4.0 s。GRBAS 评分从术前的 G=2.7、R=2.6、B=2.6、A=2.2、S=2.0 改善至术后 6 个月的 G=0.3、R=0.3、B=0.2、A=0.2、S=0.3。所有患者（n=13）均获得改善的声门闭合。5 例患者接受术后调整以优化嗓音质量和声门闭合。未观察到术中或术后并发症。术后 MT 也可显著改善声学参数，包括微扰百分比、振幅微扰比和信噪比。所有结果均具有统计学意义（P<0.05，Cohen's d>0.8）。
APrevent® VOIS 植入术是一种安全的手术，具有良好的嗓音效果。可以顺利进行术后调整以优化嗓音质量和声门闭合。
3 Laryngoscope, 132:1622-1629, 2022.
