Burk Fabian, Förster Gerhard, Klinge Kathleen, Müller Andreas H
Klinik für HNO-Heilkunde und plastische Operationen, SRH Wald-Klinikum Gera, Str. des Friedens 122, 07548, Gera, Deutschland.
HNO. 2025 May 20. doi: 10.1007/s00106-025-01640-1.
Unilateral vocal fold paralysis (UVFP) often leads to considerable limitations in voice quality and voice-related quality of life. Medialization thyroplasty (MT) is an established procedure for voice rehabilitation in cases of glottic insufficiency. Since December 2019, the APrevent® Vocal Implant System (VOIS, APrevent Biotech, Vienna, Austria) has been available in Germany as the first secondarily adjustable implant.
A retrospective evaluation included 12 patients who received MT with the VOIS implant. Voice quality was analyzed multidimensionally at timepoints T0 (preoperative), T1 (2-3 months postoperatively), and T2 (6 months postoperatively).
Significant improvements were observed in all examined parameters. The mean maximum phonation time (MPT) increased from 5.79 s (T0) to 10.07 s at T1 (p < 0.001) and to 13.22 s at T2 (p = 0.001). Maximum sound pressure level (SPLmax) increased from 77.08 to 86.09 dB at T1 (p = 0.004) and to 86.17 dB at T2 (p = 0.005). Perceptual voice quality, particularly breathiness, improved significantly from 2.29 to 0.73 at T1 (p = 0.004) and to 0.67 at T2 (p = 0.002). Additionally, there was a reduction in the VHI-12 score from 30.73 preoperatively to 11.29 at T1 (p = 0.016) and to 15.22 at T2 (p = 0.008). No significant changes were noted between T1 and T2.
Medialization thyroplasty with the VOIS implant resulted in significant improvements in voice quality and voice-related quality of life. The unique feature of the VOIS system, i.e., its secondary adjustability without a second surgery, offers potential for further optimization. Further studies are needed on the value of volume correction and the differential indications between MT and reinnervation techniques in UVFP.
单侧声带麻痹（UVFP）常导致嗓音质量和与嗓音相关的生活质量受到相当大的限制。甲状软骨内移成形术（MT）是声门闭合不全病例中一种成熟的嗓音康复手术。自2019年12月起，APrevent® 嗓音植入系统（VOIS，APrevent Biotech，维也纳，奥地利）作为首款可二次调节的植入物在德国上市。
一项回顾性评估纳入了12例接受VOIS植入物甲状软骨内移成形术的患者。在时间点T0（术前）、T1（术后2 - 3个月）和T2（术后6个月）对嗓音质量进行多维度分析。
所有检查参数均有显著改善。平均最大发声时间（MPT）从T0时的5.79秒增加到T1时的10.07秒（p < 0.001），T2时增加到13.22秒（p = 0.001）。最大声压级（SPLmax）从T0时的77.08分贝增加到T1时的86.09分贝（p = 0.004），T2时增加到86.17分贝（p = 0.005）。嗓音的感知质量，尤其是气息声，从T0时的2.29显著改善到T1时的0.73（p = 0.004），T2时改善到0.67（p = 0.002）。此外，嗓音障碍指数 - 12（VHI - 12）评分从术前的30.73降低到T1时的11.29（p = 0.016），T2时降低到15.22（p = 0.008）。T1和T2之间未观察到显著变化。
使用VOIS植入物的甲状软骨内移成形术使嗓音质量和与嗓音相关的生活质量得到显著改善。VOIS系统的独特之处，即无需二次手术即可进行二次调节，为进一步优化提供了潜力。需要进一步研究UVFP中容量校正的价值以及MT与神经再支配技术之间的不同适应证。
