APrevent^® Vocal Implant System (VOIS) for External Vocal Fold Medialization with Re-Adjustability – an open-label, non-randomized pilot study

Background Permanent unilateral recurrent laryngeal nerve paralysis with glottic insufficiency often requires external medialization thyroplasty type I (MT). However current implants do not allow subsequent adjustment in case of vocal fold position alteration, therefore always making revision surgeries necessary. The objective of this study is to evaluate the novel APrevent® VOIS-Implant (VOIS), which in the long-term can be re-adjusted with a balloon-system.

Methods Since 2018 the VOIS was for the first time intraoperatively inserted in 8 patients scheduled for routine MT, prior to the implantation of the conventional Titanium Vocal Fold Medialization Implant (TVFMI). The operative handling and the voice outcome-parameters were assessed. Voice sound analysis, measurement of maximum phonation time (MPT), and assessment of glottal closure were performed in all patients intraoperatively before and after implantation of VOIS and TVFMI. Data were statistically analyzed (paired t test).

Results All patients showed significant improvement of the voice and in glottal closure after VOIS as well as after TVFMI implantation. RBH-value improved from preoperative (R)2.1, (B)2.3, (H)2.5 to postoperative (R)0.6, (B)0.3, (H)0.8 after VOIS implantation. The MPT improved from pre-operative 7.9 sec to post-operative 14.6 sec after VOIS. The results were comparable with those of TVFMI. Regarding operative handling, the implantation of VOIS was without any problems and complications.

Conclusions The newly developed VOIS implant, compared to conventionally used TVFMI implant, showed comparable results in improvement of voice quality and glottal closure. A long-term study with VOIS is being planned.

Poster-PDF A-1365.PDF

Publication History

Article published online:
10 June 2020