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The Laryngoscope
© 2021 The American Laryngological,
Rhinological and Otological Society, Inc.

Preliminary Clinical Outcomes of VOIS-Implant in Patients

With Unilateral Vocal Fold Paralysis

Li-Chun Hsieh, MD, PhD ; Chin-Kuo Chen, MD, PhD, FICS ; Chin-Wen Chang, MS, SLP;
Yi-Shing Leu, MD; Guan-Min Ho, MD, PhD

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 video-
laryngoscopy 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 postoper-
atively. 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 improve-
ments 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.
Key Words: Medialization thyroplasty, adjustable VOIS-Implant, glottic insufficiency, unilateral vocal fold paralysis.
Level of Evidence: 3
Laryngoscope, 132:1622–1629, 2022

INTRODUCTION adduction (AA), and laryngeal reinnervation. Based on a

Unilateral vocal fold paralysis (UVFP) is a common
disorder caused by recurrent laryngeal nerve injury, resulting
in incomplete glottal closure with symptoms including hoarse-
ness of the voice, breathiness, and aspiration during
swallowing.1 It may be idiopathic, iatrogenic, or caused by
head and neck tumors, or neurological or infectious disease.
Treatment of nonresolving UVFP includes injection
laryngoplasty (IL), medialization thyroplasty (MT), arytenoid
From the Department of Otolaryngology-Head and Neck Surgery
(L.-C.H., C.-W.C., Y.-S.L., G.-M.H.), Mackay Memorial Hospital, Taipei, Taiwan;
Department of Audiology and Speech Language Pathology (L.-C.H., C.-W.C.),
Mackay Medical College, Taipei, Taiwan; Communication Enhancement
Center and Department of Otolaryngology-Head and Neck Surgery (C.-K.C.),
Chang Gung Memorial Hospital, Taoyuan, Taiwan; and the Yomin ENT
and Pediatric Clinic (G.-M.H.), APrevent Medical, Taipei, Taiwan.
Editor’s Note: This Manuscript was accepted for publication on
November 15, 2021.
This article has been presented partially at East Asian Conference
on Phonosurgery 2020, on the 12th of October 2020 in Chiayi, Taiwan.
The corresponding author declares to be the inventor of the VOIS-
Implant and standardized VOIS-Implantation procedure and he is also a
paid employee of the company producing the implant. The other authors
declare that they have no conflict of interest.
The authors have no other funding, financial relationships, or
conflicts of interest to disclose.
Send to correspondence to Guan-Min Ho, MD, PhD, 92, Section 2 Chung-
Shan North Road, Taipei 10449, Taiwan. E-mail: Mdhgm@apreventmed.com
DOI: 10.1002/lary.29958
review by Siu et al., evidence suggests favorable long-term
results for MT over those of IL.2 MT was first described by
Dr. Erwin Payr in 1915 and later modified and popularized by
Dr. Nobuhiko Isshiki in 1974.3 It has been widely accepted as
the standard phonosurgical procedure in UVFP patients
because of its long-lasting effect and demonstrable improve-
ment in quality of life and vocal performance.4,5 However,
because MT cannot close the posterior glottal gap, Isshiki6
described AA in 1978 for better posterior chink closure and
improved voice quality.7,8 MT with AA is a challenging proce-
dure with a prolonged surgical time and increased overall com-
plications due to extensive laryngeal manipulation.8,9
Despite the widespread use of MT, the revision rate
ranges 8%–33%,9–11 implying the existence of a learning
curve and necessity to modify MT techniques.12 Common
revision causes include improper implant size, mismatch
in vocal fold vertical height, persistent posterior glottal
gap, implant migration, and postoperative vocal quality
deterioration due to laryngeal muscle atrophy.9,11,13
Various synthetic implant materials have been intro-
duced, including free-form silastic blocks, pre-formed silas-
tic and hydroxylapatite implants, polytetrafluoroethylene
strips, and titanium vocal fold medialization implants
(TVFMI).8 Intraoperatively, it is difficult to accurately
adjust the shape and dimensions of the implant due to

Laryngoscope 132: August 2022 Hsieh et al.: Thyroplasty for Vocal Fold Paralysis
1622

laryngeal edema. Postoperatively, gradually subsiding tis-
sue swelling and progressive laryngeal atrophy may lead to
a deterioration of voice outcomes.11 However, all existing
implants cannot be adjusted postoperatively. Hoffman et al.
introduced an adjustable balloon implant in 2011, demon-
strating adequate and effective medialization with significant
improvements in aerodynamic and acoustic parameters in an
excised canine laryngeal model, suggesting that an adjust-
able implant might improve outcomes.14
The APrevent® Vocal implant system (VOIS) is a novel
implant, consisting of a titanium housing with an integrated
port system and silicon cushion, which can be adjusted
intraoperatively and/or postoperatively as required, provid-
ing the ability to achieve both medialization of the vocal fold
and adduction of the arytenoid cartilage with a single proce-
dure, with the possibility to shorten the operation time and
lower revision and complication rates. A VOIS pilot study
has been published, showing comparable intraoperative
results to those achieved with the TVFMI™.15 In our study,
we present the 6-month clinical outcomes in Asian patients
with permanent UVFP after APrevent® VOIS implantation.
MATERIALS AND METHODS
Subjects
Ethical approval for the clinical trial was obtained from the
institutional review board of Mackay Memorial Hospital (IRB
No. 19CT037Ae). Informed consent was obtained from all
patients prior to enrollment.
The participants enrolled in this study met the following
inclusion criteria: Male and female patients aged 20–80 years,
diagnosed with UVFP for ≥6 months, and significant voice disor-
ders as measured using a perceptual rating with the GRBAS-
Scale (≥2) and subjective questionnaire with voice handicap
index-30 (VHI-30) ≥33.
Patients with structural vocal fold lesions, such as polyps or
nodules, were excluded, as were patients who had undergone pre-
vious cordectomy and laryngeal framework surgery. Patients who
received IL were included in the study if the procedure was per-
formed in a time frame, which is more than double the filler’s
maximum resorption time as stated in its approval documentation
or as supported by the literature. Finally, patients with significant
nonlaryngeal speech abnormalities and severe coagulopathy were
excluded.
Operative Procedure
The standardized implantation procedure using a specific
tool set to standardize the MT procedure with the APrevent®
VOIS-Implant, which is available in four sizes, namely, x-small,
small, medium, and large, has been described previously.16,17
The first results were reported by Ho et al. in a pilot study.15
The first step was to locate specific landmarks, followed by
determining the appropriate implant size by measuring the
anteroposterior length of the thyroid ala (Fig. 1A, Table I). The
window dimensions measuring 6  11 mm were identical for all
implant sizes. However, the distance from the midline of the thy-
roid cartilage to the anterior margin of the window are implant
size-specific, ranging 7–12 mm (Fig. 1B, Table I).
In the supine position with slight neck extension, local
anesthetic (1% lidocaine, 0.5% Bupivacaine, and 1:200,000 epi-
nephrine) was administered at the incision site in combination
with intravenous sedation (remifentanil and dexmedetomidine).
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First, we used the APrevent® tool set to locate specific landmarks
that are critical for the design of the thyroplasty window and
determination of implant size (Fig. 1A). Second, we used
Lindemann’s cutting burr to outline the rectangular window and
a diamond burr to trim the window margins. Before insertion of
the VOIS-Implant, we applied window- and implant-checking
gauges to confirm smooth implantation. Finally, the implant was
inserted and fixed using a screw. The same surgeon performed
the MT for all 13 patients (L.C.H.).
After implant insertion, transnasal flexible videolaryngoscopy
was performed to check the glottal closure and patency of the air-
way, to ensure patient safety during the implant adjustment proce-
dure by injecting 0.9% physiological saline solution using a 1 mL
syringe connected to a 24-G needle filled with the maximum filling
volume (MFV), which is specific for each implant size (Table I).
During the adjustment procedure patients were asked to phonate a
sustained vowel “I”, while saline solution was delivered or removed
from the silicone cushion of the VOIS-Implant in 0.02 mL steps.
Optimization of glottal closure and vocal quality was performed
both during and after surgery.
Outcome Measurements
Prior to MT, comprehensive preoperative examinations,
including video-laryngoscopy, functional voice assessment, and
aerodynamic tests, were performed to identify the best therapeu-
tic options. All aerodynamic and acoustic measurements were
evaluated by an experienced speech-language pathologist. Total
scores from the VHI-30 were collected from all patients. All pre-
operative examinations were repeated at all postoperative
follow-up visits (1 week, 7 weeks, and 6 months).
The functional voice assessment involved perceptual rating
with the GRBAS-Scale, which describes five perceptual parame-
ters: overall grade (G), roughness (R), breathiness (B), asthenia
(A), and strain (S). The rating was performed on a four-point
scale where 0 = normal, 1 = mild, 2 = moderate, and 3 = severe
deviance. The GRBAS scores were determined by the same oto-
laryngologist (L.C.H.) experienced in voice disorders. Glottal effi-
ciency was evaluated with maximum phonation time (MPT) by
asking patients to produce a sustained vowel /a/ three times for
as long as possible at a comfortable intensity and pitch level fol-
lowing a deep breath. MPT was measured using multi-
dimensional voice program software (Kay PENTAX, Lincoln
Park, NJ). The longest MPT was selected for further statistical
analysis.
For acoustic data analysis, a sustained vowel /a/ vocalized
after one breath (≥3 s) was recorded (Computerized Speech Lab,
Kay PENTAX, Lincoln Park, NJ). Freeware Praat version 6.1
was used to determine the parameters, including jitter (%; cycle-
to-cycle variation in pitch), shimmer (%; cycle-to-cycle variation
in amplitude of vibration), and signal-to-noise ratio (SNR).
To evaluate the Södersten and Lindestad classification
(S&L),18 flexible videolaryngoscopy was performed to evaluate
the type of pre-, intra-, and postoperative vocal fold closure dur-
ing phonation.
Generally, the funnel of the implant’s housing could be pal-
pated through the skin for postoperative adjustment. As Fig. 2A
shown, if the balloon was not inflated, the vocal fold may be not
closed well. The filling of the silicone cushion pushes the vocal
process inferomedially, causing an arytenoid rotation and opti-
mizing glottal closure (Fig. 2B). Using ultrasound (in-plane tech-
nique, Fig. 2C), the sonographic features of the implant,
longitudinal axis, and needle entrance angle can be determined.
This step is important for determining the entrance angle for the
needle. After confirming the implant’s location and axis, a 1 mL
syringe connected to a 24-G needle, filled with implant-specific
Hsieh et al.: Thyroplasty for Vocal Fold Paralysis
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Fig. 1. (A) Determining the appropriate implant size. (B) The distance, “D”, from the midline of thyroid cartilage to the anterior margin of the
window. A, B: anterior and posterior to the inferior thyroid tubercle, respectively; M1: midpoint of anterior thyroid cartilage border line; M2:
point on posterior thyroid cartilage border, line passing through points M1 and M2 is parallel line passing through points A and B; H: height of
upper window margin leaving an inferior strut of 1.5–2 mm for female and 2–3 mm for male.

TABLE I. One patient with a history of recurrent nasopharyngeal

Implant Size and Related Thyroid Ala Length, Distance, and carcinoma died 4 months after MT due to brain metasta-
Maximum Filling Volume. sis. The other 12 patients were able to complete their
Thyroid ala length 6-month follow-up visits. Preoperatively, all patients
VOIS-Implant
Size
(anteroposterior,
M1–M2) (mm)
Distance
(D) (mm)
Maximum Filling
Volume (mL)
(n = 13) showed significant glottal insufficiency; of these,
six had right-sided (n = 6) and seven had left-sided
X-small 28–33 7 0.17 (n = 7) UVFP. It is known that laryngeal dimensions vary
Small 33–38 10 0.25 not only between sexes but also between individuals.
Medium 38–42 8 0.30 Among the eight male patients, five VOIS-M (medium
Large >42 12 0.30 size, n = 5) and three VOIS-L (large size, n = 3) devices
were implanted, whereas three VOIS-XS (x-small size,
n = 3) and two VOIS-S (small size, n = 2) devices were
implanted in the five female patients. Table II lists the
MFV (Table I), was advanced through the skin to reach the port demographic characteristics of all 13 patients, including
membrane of the implant (Fig. 2D). All participants completed etiologies, implant size, and filling volume injected during
postoperative 1 week, 7 weeks, 6 months follow-up visits. The surgery and postoperatively.
necessity for postoperative adjustments were evaluated and per-
formed during the follow-up visits after perceptual evaluation of
voice quality by GRBAS and vocal fold closure assessment with a
flexible videolaryngoscope. Emptying the silicon cushion is cru- Subjective Questionnaire of VHI-30
cial before re-filling with 0.9% saline solution in 0.02 mL steps to The subjective voice-related handicaps were assessed
adjust and optimize the glottal closure. using VHI-30 scores, which improved significantly from a
preoperative mean of 75.0
22.9 to a postoperative mean
of 23.0
17.2, 21.9
18.5, and 20.6
19.7 at the 1-week,
Statistics Analyses 7-week, and 6-month follow-up visits, respectively. Differ-
Statistical analysis was performed using Statistical Pack- ences between the preoperative and postoperative time
age for Social Science (version 22.0; SPSS, Inc., IBM Company, points were statistically significant (Wilcoxon signed-rank
Chicago, IL). All continuous variables are expressed as mean and test, P < .001). No statistically significant differences
standard deviation. The Wilcoxon signed-rank test was used to were noted between follow-up visit results.
compare the outcomes of all the voice parameters. Significance
was set at P < .05. Cohen’s d was applied to measure the effect
size to indicate the standardized difference between the pre- and
postoperative means (small effect = 0.2, medium effect = 0.5, Functional Voice Assessment: GRBAS-Scale
large effect = 0.8). and MPT
Preoperative values of Gpreop = 2.7 significantly
improved to postoperative values of Gpostop-1w = 0.5
RESULTS at 1 week; Gpostop-7w = 0.2 at 7 weeks; and Gpostop-
Thirteen patients, including five women and eight 6m = 0.3 at 6 months (P < .05, Wilcoxon signed-rank test).
men, were enrolled from April 2020 to December 2020, All the other GRBAS-scores significantly improved during
with a median age of 62 years (range: 42–75 years). follow-up. (Table III; P < .05, Wilcoxon signed-rank test).

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Fig. 2. Postoperative adjustment of VOIS. (A) Deflated silicon cushion; (B) inflated silicon cushion pushing on the vocal process of the aryte-
noid cartilage; (C) localization of the implant port using ultrasound; (D) transcutaneous silicone cushion adjustment.

TABLE II.
Demographic Characteristics and Diagnoses of Patients With Unilateral Vocal Fold Paralysis.
Injection Postoperative
No. Gender Age Diagnosis Palsy side Implant size volume (mL) adjustment (mL)

1 M 62 Thyroid papillary carcinoma s/p total thyroidectomy (tumor R M 0.1 7 W: 0.1 ! 0

invasion)
6 M: 0 ! 0.15
2 F 71 Lung cancer post lobectomy & mediastinal lymph node resection R XS 0.07 ()
3 F 42 Descending aorta aneurysm s/p heart surgery L XS 0.1 ()
4 M 53 Recurrent laryngeal cancer post second radiation therapy with R L 0.05 7 W: 0.05 ! 0.12
right side ORN of arytenoid cartilage, s/p arytenoidectomy
5 M 69 Achalasia s/p esophagectomy L M 0.1 7 W: 0.05 ! 0.1
6 M 70 Intubation related, Right neck A-V fistula s/p embolization (ECA- R M 0.12 ()
IJV)
7 F 61 Idiopathic L XS 0.07 7 W: 0.07 ! 0
6 M: 0 ! 0.02
8 M 54 ESRD with hyperparathyroidism s/p ethanol injection L M 0.1 7 W: 0.1 ! 0.15
9 M 45 Esophageal ca L L 0.07 ()
10 M 69 Esophageal ca L L 0.1 ()
11 F 73 ESRD with hyperparathyroidism s/p parathyroidectomy R S 0 ()
12 M 56 Recurrent nasopharyngeal carcinoma s/p radiation therapy R M 0.1 ()
13 F 75 Idiopathic, breast cancer L S 0.05 ()

6 M = postoperative 6 months; 7 W = postoperative 7 week; A-V = arterial–venous; EAC-IJV = external carotid artery-internal jugular vein; ESRD = end
stage renal disease; ORN = osteoradionecrosis; s/p = status post.

No significant differences were found between variables postoperative 1-week, six patients were perceptually
at any of the postoperative check points. rated as mild (G1) and seven patients had complete reso-
Before surgery, the G score was rated as severe (G3) lution of hoarseness (G0). After postoperative adjustment
in nine patients and moderate (G2) in four patients. At at the 7-week follow-up visit, five of the six patients had

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Table III.
VHI-30 Scores, Perceptual GRABS Scale and Maximum Phonation Tme (MPT) Prior and After Medialization Thyroplasty (MT) with VOIS.
Postoperative 1 Wk Postoperative 7 Wk Postoperative 6 Mo
Preoperative
Mean
SD Mean
SD P Value (Cohen’s d) Mean
SD P Value (Cohen’s d) Mean
SD P Value (Cohen’s d)

VHI-30 75.0
22.9 23.0
17.2 .002 (2.57) 21.9
18.5 .002 (2.55) 20.6
19.7 .004 (2.55)
G (grade) 2.7
0.5 0.5
0.5 .001 (4.64) 0.2
0.4 .001 (5.59) 0.3
0.5 .002 (5.07)
R (roughness) 2.6
0.5 0.7
0.5 .001 (4.06) 0.4
0.5 .001 (4.36) 0.3
0.5 .001 (4.77)
B (breathiness) 2.6
0.5 0.3
0.5 .001 (4.86) 0.2
0.4 .001 (5.24) 0.2
0.4 .002 (5.64)
A (asthenia) 2.2
0.7 0.2
0.4 .001 (3.47) 0.1
0.3 .001 (3.76) 0.2
0.4 .002 (3.70)
S (strain) 2.0
0.6 0.4
0.5 .002 (3.11) 0.1
0.3 .001 (3.98) 0.3
0.4 .002 (3.54)
MPT (s) 2.3
1.6 5.1
2.9 .001 (1.09) 5.7
3.7 .001 (0.95) 6.5
4.4 .002 (1.12)

P value: compare to preoperative results with Wilcoxon signed-rank test, Cohen’s d values measuring the effect size to indicate the standardized difference
between the pre- and postoperative means.
MPT = Maximum Phonation Time; SD = standard deviation.

Fig. 3. Acoustic analyses of voice before and after thyroplasty. (A) Jitter. (B) Shimmer. (C) Signal-to-noise ratio. Pre: pre-operation, 1W: 1 week
post-operation, 7W: 7 weeks post-operation, 6M: 6 months post-operation. *P < .05.

an improvement in the G score, with three returning to
normal (G0) and one improving from moderate to mild
(G2 to G1). One patient without improvement in G score
still showed slight swelling of the vocal fold.
The MPT was used to assess glottal efficiency
(Table III). The preoperative MPT had a mean of 2.7 s,
which increased to a mean of 5.1 s, 5.7 s, and 6.3 s at the
1-week, 7-week, and 6-month postoperative-follow-up
visits. All postoperative MPTs showed a significant
increase from preoperative MPT and remained stable
throughout follow-up (P < .05).
Acoustic Voice Analysis
The jitter, shimmer, and SNR are shown in Figure 3.
The preoperative mean jitter was 4.1
3.0%, which
decreased to 0.8
0.9%, 0.8
0.6%, and 0.7
0.4 at 1-,
7-weeks, and 6-months follow-up visits (P = .012,
Wilcoxon signed-rank test). The average shimmer was
1.4
0.3% preoperatively and decreased to 0.6
0.4,
0.6
0.3, and 0.5
0.2 at the 1-week, 7-week, 6-month
postoperative follow-up (P = .005, Wilcoxon signed-rank
test). The average SNR improved from 0.7
0.1 preoper-
atively to 0.95
0.07, 0.95
0.07, and 0.96
0.06 at the
1-week, 7-week, and 6-month follow-up (P = .001,
Wilcoxon signed-rank test). All variables showed statisti-
cally significant improvement after MT and remained sta-
ble throughout postoperative follow-up.
Videolaryngoscopy
Preoperatively, 11 patients had incomplete closure
along the folds (degree 6), one had incomplete closure of
the posterior two-thirds of the folds (degree 5), and one
had spindle-shaped incomplete closure (type A) (Table IV).
All except one patient received intraoperative adjustment
by injecting 0.9% saline solution with volumes ranging
0.05–0.12 mL to optimize closure along entire cartilagi-
nous glottis. One week after surgery, complete closure
(degree 1) was achieved in eight patients (62%), whereas
four patients (30%) had incomplete closure in the cartilagi-
nous part (degree 2), and one patient had triangular
incomplete closure of the posterior third of the vocal folds
(degree 4). At the 7-week follow-up, complete closure was
seen in seven patients (54%), whereas two patients (15%)
had incomplete closure degree 2, three patients (23%) had
triangular incomplete closure anterior to the vocal pro-
cesses (degree 3), and one patient had incomplete closure
degree 5 due to a gradual decrease in laryngeal edema and
swelling. Five patients required adjustment at that visit

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Table IV.
Pre- and Postoperative Closure Type—Södersten and Lindestad Classification.
Time – Points in
Post–OP 7 Wk (n = 13) Post–OP 6 Mo (n = 12*)
Pre-op (n = 13) Post–OP 1 Wk (n = 13)
Södersten and Lindestad Preinjection Postinjection Preinjection Postinjection

Incomplete closure in degree† 6 11

5 1 1
4 1 2
3 1 3 1 1 1
2 4 1 + (1)‡ (1)‡ (1)‡ 2 + (1)‡
Complete closure 1 8 7 10 8 8
Other incomplete closure pattern§ A 1
B
C
D

*One patient missed the 6-month follow-up visit due to relapse of nasopharyngeal carcinoma with brain metastasis.
†
Incomplete closure in degree: (6) all along the folds, (5) posterior 2/3 of the folds, (4) triangular incomplete closure of posterior 1/3 of the folds, (3) triangular
incomplete closure anterior to the vocal process, (2) incomplete closure of the cartilaginous part.
‡
Female patient with normal GRBAS-scores—no adjustment performed.
§
Other incomplete closure pattern: (A) spindle-shaped incomplete closure, closure at the vocal processes, (B) spindle-shaped with incomplete closure at
the post. 1/3 of the membranous folds, closure at the vocal processes, (C) spindle-shaped with incomplete closure at the ant. 1/3 of the membranous folds, clo-
sure at the vocal processes, (D) hourglass-shaped with incomplete closure at the ant and post. Thirds of the folds, closure at the vocal processes and mid-
membranous portion of the folds.

Fig. 4. The videolaryngoscope of the same patient with left side vocal palsy before and after thyroplasty. (A) Pre-surgery. (B) 7 weeks after sur-
gery before balloon adjustment. (C) 7 weeks after surgery after balloon adjustment. (D) 6 months after surgery.

and three (degree 3) out of five patients achieved complete incomplete closure degree 4. This patient (No. 4 in
closure (degree 1) after adjustment. One of the remaining Table II) had recurrent laryngeal carcinoma (T1N0M0, s/p
two patients improved from incomplete closure degree 5 to radiation therapy and concurrent chemoradiotherapy),

Laryngoscope 132: August 2022 Hsieh et al.: Thyroplasty for Vocal Fold Paralysis
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radiation-induced-osteoradionecrosis, and right arytenoi-
dectomy with adhesion. Considering the fragility of the
post-radiation larynx, the implant was upsized in 0.05-mL
steps to avoid complications. The filling volume was
completely removed from patient No. 1 due to a strained
voice; glottal closure, therefore, changed from incomplete
closure degree 2 to incomplete closure degree 3. The total
amount of normal saline injected ranged 0.02–0.15 ml. At
the 6-month follow-up, complete closure was observed in
eight patients (67%, n = 12), whereas one patient had
incomplete closure degree 4 and the other had incomplete
closure degree 3, which improved to incomplete closure
degree 3 and incomplete closure degree 2, respectively.
Implant adjustment was not performed in patient No. 4 at
the 6-month follow-up visit. In total, three patients
received one adjustment, whereas two patients received
two adjustments.
Figure 4 shows a male patient diagnosed with left-
sided UVFP and incomplete vocal fold closure (degree
6, Fig. 4A). After MT with VOIS-Implantation, laryngeal
edema gradually decreased over time and a posterior glot-
tal chink appeared at the 7-week follow-up visit (Fig. 4B),
with a perceptive voice quality score of G1R2B1A1S1.
Simultaneously, VOIS-Implant adjustment was arranged
to fine-tune his voice quality and closure of the posterior
glottal chink (Fig. 4C). At the 6-month follow-up-visit,
laryngeal swelling was noted to be completely resolved,
and complete closure of the glottal gap was noted (Fig. 4D)
with his voice returning to normal (G0R0B0A0S0).
All patients tolerated the MT procedure without any
intra- or postoperative complications.
DISCUSSION
Type I thyroplasty is a widely accepted treatment for
UVFP. However, variations in thyroid cartilage dimen-
sions between different ethnic groups, sexes, and individ-
uals19,20 make it difficult to standardize procedures,
especially if the implant shape,21 dimensions, and site
cannot be determined prior to the surgery, leading to dis-
crepancies in results.22 Imaging studies, such as preoper-
ative CT-scans23 or digital volume tomography,24 have
been proposed for planning MT procedures to individually
customize implants.
MT medializes the anterior larynx by compressing
the paralyzed vocal fold with an alloplastic or autologous
material. However, a wide posterior glottal chink cannot
be corrected with MT alone, making it necessary to com-
bine the procedure with AA. However, the role of AA in
the treatment of UVFP is still controversial.2,7,25 AA is
associated with increased morbidity because it involves
significant laryngeal manipulation of the cricoarytenoid
joint, resulting in increased operating time, airway
edema, and dysphagia.26
In this nonrandomized prospective study, we evalu-
ated the effectiveness and safety of APrevent® VOIS, a
newly designed implant for MT. Compared to existing
implants,8 the VOIS could be adjusted intra- and postop-
eratively in 13 Asian patients with permanent UVFP. All
VOIS-Implantation procedures were standardized and
performed with a specifically designed APrevent® Tool
Laryngoscope 132: August 2022
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15314995, 2022, 8, Downloaded from https://onlinelibrary.wiley.com/doi/10.1002/lary.29958 by National Taiwan University, Wiley Online Library on [09/01/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
Set, mainly used for the design and accurate fenestration
of the thyroid cartilage as described by Ho.15–17 As
reported previously,16 the standardized procedure could be
easily and safely performed. Based on our preliminary results
with the APrevent® VOIS, objective voice outcomes, including
MPT, jitter, shimmer, and SNR, all demonstrated obvious
improvement and remained stable for at least 6 months after
surgery. The subjective voice-related handicaps evaluated
using the VHI-30 showed clear improvement after the
MT. Although the mean postoperative MPTs at all follow-up
periods showed significant improvement, however, they were
comparatively low in our study. The only patient with
MPT > 10 seconds is a choir-singer, having received voice
training, whereas other patients did not receive any voice
training. Their preoperative MPT were also very low when
compared to that of Caucasians,7,15,27 indicating certain fac-
tors influencing the outcome. Based on our literature
review,28,29 we have found similar results in Taiwanese
patients after type I thyroplasty. Possible factors may be body
weight, age, voice training, tonal versus non-tonal languages,
emotions etc.
Unlike other static implants,9,24 the novel implant
system enables the surgeon to perform intraoperative fine
adjustment by delivering or removing 0.9% saline solu-
tions into/from the silicone cushion without having to
repeatedly insert and remove the implant into/from the
cartilage fenestration, thus reducing tissue manipulation
and possible airway compromise. Adjustments were per-
formed under concomitant perceptual voice evaluation
and simultaneous videofiberscopic examination to evalu-
ate the glottal closure and ensure patency of the airway.
In most cases (n = 12; 92%), the implant had to be
inflated after insertion to better conform to the variations
in laryngeal dimensions.
Five patients received postoperative fine adjustment
via the cervical transcutaneous approach to fine-tune and
optimize the glottal closure and improve the perceptive
voice quality. The most common time point for adjust-
ment was the 7-week follow-up visit (n = 5; 38%), which
is the moment when the laryngeal edema had mostly sub-
sided. In all but one patient, the injection port could be
palpated. It is important to empty the entire silicone
cushion prior to fluid re-filling to ensure that the correct
amount of fluid inside could be recorded. Voice quality
can be fine-tuned by adjusting in 0.02 mL steps based on
the patient’s condition. These advantages might reduce
the revision rates for MT and AA by decreasing surgical
complications and allowing better adaptation to changes
in laryngeal condition.7,26
Limitations of this study include small sample size,
short follow-up periods, single rater GRBAS assessment,
lack of other aerodynamic parameters aside from MPT,
and lack of videostroboscopy.
CONCLUSION
The novel APrevent® VOIS implant showed good voice
outcomes and improved voice-related problems in patients
with UVFP. No intra- or postoperative complications
were noted, which may be attributed to the procedural
standardization and adjustability of the VOIS-Implant.
Hsieh et al.: Thyroplasty for Vocal Fold Paralysis

Intraoperative adjustment is very helpful to easily con-
form the implant to laryngeal variations, whereas post-
operative adjustment enables implant adaptation to
steadily changing conditions in post-MT larynges. The
latter can be performed safely using ultrasound. The
long-term clinical efficacy and stability of these results
will be further explored.
Acknowledgments
This study was funded by the Taiwanese Ministry of Eco-
nomic Affairs in context with the A+ Industrial Innova-
tive R&D program for Fast Track Clinical Trial Plans
entitled “Pivotal Multi-Center Clinical Trial with the
adjustable APrevent® VOIS for glottic insufficiency”,
grant number. 1090003304. The authors would like to
thank Aprevent Biotech company for providing and
supporting this study with the APrevent® VOIS implants
and tool set.
BIBLIOGRAPHY
1. Schiedermayer B, Kendall KA, Stevens M, Ou Z, Presson AP, Barkmeier-
Kraemer JM. Prevalence, incidence, and characteristics of dysphagia in those
with unilateral vocal fold paralysis. Laryngoscope 2020;130:2397–2404.
2. Siu J, Tam S, Fung K. A comparison of outcomes in interventions for unilat-
eral vocal fold paralysis: a systematic review. Laryngoscope 2016;126:
1616–1624.
3. Isshiki N, Morita H, Okamura H, Hiramoto M. Thyroplasty as a new pho-
nosurgical technique. Acta Otolaryngol 1974;78:451–457.
4. Crolley VE, Gibbins N. One hundred years of external approach
medialisation thyroplasty. J Laryngol Otol 2017;131:202–208.
5. Hajioff D, Rattenbury H, Carrie S, Carding P, Wilson J. The effect of Isshiki
type 1 thyroplasty on quality of life and vocal performance. Clin
Otolaryngol Allied Sci 2000;25:418–422.
6. Isshiki N, Tanabe M, Sawada M. Arytenoid adduction for unilateral vocal
cord paralysis. Arch Otolaryngol 1978;104:555–558.
7. Mortensen M, Carroll L, Woo P. Arytenoid adduction with medialization
laryngoplasty versus injection or medialization laryngoplasty: the role of
the arytenoidopexy. Laryngoscope 2009;119:827–831.
8. Abraham MT, Gonen M, Kraus DH. Complications of type I thyroplasty and
arytenoid adduction. Laryngoscope 2001;111:1322–1329.
9. Daniero JJ, Garrett CG, Francis DO. Framework surgery for treatment of
unilateral vocal fold paralysis. Curr Otorhinolaryngol Rep 2014;2:119–130.
10. Lundeberg MR, Flint PW, Purcell LL, McMurray JS, Cummings CW. Revision
medialization thyroplasty with hydroxylapatite implants. Laryngoscope
2011;121:999–1002.
Laryngoscope 132: August 2022
15314995, 2022, 8, Downloaded from https://onlinelibrary.wiley.com/doi/10.1002/lary.29958 by National Taiwan University, Wiley Online Library on [09/01/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
11. Anderson TD, Spiegel JR, Sataloff RT. Thyroplasty revisions: frequency and
predictive factors. J Voice 2003;17:442–448.
12. Rosen CA. Complications of Phonosurgery: results of a National Survey.
Laryngoscope 1998;108:1697–1703.
13. Young VN, Zullo TG, Rosen CA. Analysis of laryngeal framework surgery:
10-year follow-up to a national survey. Laryngoscope 2010;120:1602–1608.
14. Hoffman MR, Witt RE, McCulloch TM, Jiang JJ. Preliminary investigation
of adjustable balloon implant for type I thyroplasty. Laryngoscope 2011;
121:793–800.
15. Ho GY, Leonhard M, Denk-Linnert DM, Schneider-Stickler B. Pre- and
intraoperative acoustic and functional assessment of the novel APrevent®
VOIS implant during routine medialization thyroplasty. Eur Arch
Otorhinolaryngol 2020;277:809–817.
16. Ho GM CM, Tzou CHJ, Meng S, Reissig L, Weninger WJ, Hess MM.
Development of a surgical procedure for UVFP patients using an adjust-
able implant. Paper presented at: 12th Congress of The European
Laryngological Society; London, UK. Abstract ID: 221 2018, May 16–
May 19.
17. Ho GM. Accuracy of thyroid cartilage fenestration and arytenoid
repositioning in thyroplasty. Lecture at: 13th Congress of the European
Laryngological Society; Germany, Digital 2021, May 28.
18. Södersten M, Lindestad PA. Glottal closure and perceived breathiness dur-
ing phonation in normally speaking subjects. J Speech Lang Hear Res
1990;33:601–611.
19. Jotz GP, Stefani MA, da Costa P, et al. A morphometric study of the larynx.
J Voice 2014;28:668–672.
20. Sahoo S, Mallick A, Sethi A, Joshi H, Ghotra A. Morphometric cadaveric
analysis of thyroid cartilage in Indian adults with comparative review of
studies on other ethnic population. Int J Otorhinolaryngol Head Neck
Surg 2021;7:287–291.
21. Zhang Z, Chhetri DK, Bergeron JL. Effects of implant stiffness, shape and
medialization depth on the acoustic outcomes of medialization
laryngoplasty. J Voice 2015;29:230–235.
22. Desuter G, Cartiaux O, Pierard J, et al. Accuracy of thyroid cartilage fenes-
tration during Montgomery Medialization Thyroplasty. J Voice 2020;34:
609–615.
23. Frizzarini R, Gebrim EM, Imamura R, Tsuji DH, Moyses RA, Sennes LU.
Individually customized implants for laryngoplasty-are they possible ?
J Voice 2012;26:619–622.
24. Mousli A. Application of digital volume tomography (DVT) to prepare a
thyreoplastik operation [dissertation]. University Medical Center
Hamburg-Eppendorf; 2015.
25. Hess MM, Fleischer S. Laryngeal framework surgery: current strategies.
Curr Opin Otolaryngol Head Neck Surg 2016;24:505–509.
26. Misono S, Merati AL. Evidence-based practice: evaluation and management
of unilateral vocal fold paralysis. Otolaryngol Clin North Am 2012;45:
1083–1108.
27. Desuter G, Dedry M, Schaar B, van Lith-Bijl J, van Benthem PP,
Sjögren EV. Voice outcome indicators for unilateral vocal fold paralysis
surgery: a review of the literature. Eur Arch Otorhinolaryngol 2018;275:
459–468.
28. Tsai MS, Yang MY, Chang GH, Tsai YT, Lin MH, Hsu CM. Autologous thy-
roid cartilage graft implantation in medialization laryngoplasty: a modi-
fied approach for treating unilateral vocal fold paralysis. Sci Rep 2017;7:
4790.
29. Tsai YT, Tsai MS, Chang GH, et al. Patient-related factors of medialization
laryngoplasty with autologous thyroid cartilage. Healthcare (Basel) 2020;
8:521.
Hsieh et al.: Thyroplasty for Vocal Fold Paralysis
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