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fold injection augmentation with carboxymethylcellulose and discuss the management of airway swelling follow-ing this reaction.Introduction
Glottis insuf ﬁciency due to true vocal fold immobility is important to manage to reduce risk of
aspiration and improve voice function
Vocal fold injection augmentation with carboxymethylcellulose is consid-
ered a safe and effective treatment for glottis insuf ﬁciency, commonly due to vocal fold immobility.
Methods
Retrospective medical records review and case report.
Results
We report a unique case of an adult female with vocal fold immobility that was treated with injection
laryngoplasty using carboxymethylcellulose and subsequently developed a local reaction requiring intubationand tracheostomy placement.Conclusion
Otolaryngologists should be aware of this rare, but life-threatening complication and counsel
patients accordingly when obtaining consent
If there are signs and symptoms of airway edema, the patientshould be transferred to the ICU for airway watch, intravenous steroids, and possible intubation.
Key Words: Case report −Carboxymethylcellulose −Injection laryngoplasty −Adverse reaction −Renu Gel −Pro-
laryn Gel.
INTRODUCTION
Managing glottis insuf ﬁciency due to true vocal fold immo-
bility is important to reduce risk of aspiration and toimprove voice function
Glottis insuf ﬁciency is treated by
medialization of the vocal fold, either through surgicalplacement of a permanent implant or injection with a vari-ety of temporary ﬁller materials
When performing injection
augmentation, the type of material is an important consider-ation and generally classi ﬁed by durability and therefore,
duration of effect
For patients who have permanent vocal
fold immobility and are either poor surgical candidates orwho do not want surgery, materials with extended durabilitysuch as calcium hydroxyapatite and autologous fat may beideal
In contrast, patients that have the potential to regainvocal fold mobility, substances with less durability are thepreferred choice
These ﬁllers provide a natural trial period
in which the patient ’s disease process has the opportunity to
resolve, while also maintaining glottis suf ﬁciency for
improving voice and swallowing outcomes in the interim.Commonly used materials in this class include carboxy-methylcellulose (CMC) and hyaluronic acid
Two commer-cial CMC gels with similar formulations are Prolaryn Geland Renu Gel.Besides viscoelasti c properties and dur ability, an essen-
tial requirement of an injected material is its safety pro-
ﬁle
This is particularly important for vocal fold
augmentation given the critical nature of this anatomicalsite
Adverse effects at the larynx can have severe conse-
quences related to a patient ’s airway status, swallow
function, and voice quality
A retrospective review of228 awake vocal fold augmentation procedures withCMC found no airway complications, supporting the
general safety of the mate rial as a treatment option.
1A
group who reviewed the FDA ’s MAUDE Adverse Event
Database from 2009 to 2020 found seven reported com-
plications following CMC injection, but on further anal-ysis found that the complicat ions were likely unrelated
to the injection material.
2Our investigation of this data-
base revealed two relevant entries from 2016 document-
ing airway swelling following CMC injection; however,
the clinical detail regarding these events is markedly lim-
ited
One MAUDE entry describes ﬂuid collection at a
Renu Gel injection site suspicious for abscess.
3The sec-
ond MAUDE entry involves a patient who experiencedrespiratory distress and was s ubsequently intubated after
24 hours of observation followi ng injection of Prolaryn
Gel to the interarytenoid space.
4
Here we report a case describing a rare complication
of vocal fold injection augm entation with carboxymeth-
ylcellulose in which a patient experienced a local reac-tion resulting in acute airway compromise
necessitatingintubation and eventual tracheostomy placement
Thepurpose is to identify local allergic reaction as a rarecomplication of vocal fold i njection augmentation, to
describe the warning signs and management of airwayswelling following this proce dure, and to discuss a possi-
ble mechanism for this occurrence.Accepted for publication January 19, 2023.
This case was presented as a poster presentation at the Fall Voice Conference on
October 7, 2022 in San Francisco, California.Consent: Written consent was obtained
from the patient prior to journal submission.

From the *Keck School of Medicine of University of Southern California, Los
Angeles, California, USA; yCaruso Department of Otolaryngology, Head and Neck
Surgery, Keck School of Medicine of University of Southern California, Los Angeles,California, USA; and the zDepartment of Surgery, Division of Otolaryngology-Head
and Neck Surgery, McMaster University, Hamilton, Ontario, Canada.
Address correspondence and reprint requests to: Benjamin van der Woerd, McMas-
ter University, 50 Charlton Avenue East, Hamilton
, ON, L8N 1Y3, Canada
E-mail:
[email protected]
Journal of Voice, Vol
&&, No.&&, pp.&&−&&
0892-1997© 2023 The Voice Foundation
Published by Elsevier Inc
All rights reserved.
https://doi.org/10.1016/j.jvoice.2023.01.026ARTICLE IN PRESS
Downloaded for Anonymous User (n/a) at McMaster University from ClinicalKey.com by Elsevier on September 07,
2023
For personal use only
No other uses without permission
Copyright ©2023
Elsevier Inc
All rights reserved
CASE
The case involves a 70-year-old female who underwent anuncomplicated right true vocal fold injection augmentationwith CMC (Renu Gel) for right true vocal fold immobilitywith glottis insuf ﬁciency in the postoperative inpatient set-
ting following an uncomplicated right far lateral craniotomy
with partial resection of a hemangioblastoma associated
with cranial nerves CN VII-X
The injection was done witha disposable 23-gauge needle in a percutaneous fashion withclean technique over the thyrohyoid membrane
Prior toinsertion of the needle, an alcohol pad was used to clean theskin.
On post-injection day 1, the patient developed acute stri-
dor, severe respiratory distress, and exhibited tripoding.
The patient was started on oxygen via nasal cannula and

fold injection augmentation with carboxymethylcellulose and discuss the management of airway swelling follow-ing this reaction.Introduction

Glottis insuf ﬁciency due to true vocal fold immobility is important to manage to reduce risk of

aspiration and improve voice function

Vocal fold injection augmentation with carboxymethylcellulose is consid-

ered a safe and effective treatment for glottis insuf ﬁciency, commonly due to vocal fold immobility.

Methods

Retrospective medical records review and case report.

Results

We report a unique case of an adult female with vocal fold immobility that was treated with injection

laryngoplasty using carboxymethylcellulose and subsequently developed a local reaction requiring intubationand tracheostomy placement.Conclusion

Otolaryngologists should be aware of this rare, but life-threatening complication and counsel

patients accordingly when obtaining consent

If there are signs and symptoms of airway edema, the patientshould be transferred to the ICU for airway watch, intravenous steroids, and possible intubation.

Key Words: Case report −Carboxymethylcellulose −Injection laryngoplasty −Adverse reaction −Renu Gel −Pro-

laryn Gel.

INTRODUCTION

Managing glottis insuf ﬁciency due to true vocal fold immo-

bility is important to reduce risk of aspiration and toimprove voice function

Glottis insuf ﬁciency is treated by

medialization of the vocal fold, either through surgicalplacement of a permanent implant or injection with a vari-ety of temporary ﬁller materials

When performing injection

augmentation, the type of material is an important consider-ation and generally classi ﬁed by durability and therefore,

duration of effect

For patients who have permanent vocal

fold immobility and are either poor surgical candidates orwho do not want surgery, materials with extended durabilitysuch as calcium hydroxyapatite and autologous fat may beideal

In contrast, patients that have the potential to regainvocal fold mobility, substances with less durability are thepreferred choice

These ﬁllers provide a natural trial period

in which the patient ’s disease process has the opportunity to

resolve, while also maintaining glottis suf ﬁciency for

improving voice and swallowing outcomes in the interim.Commonly used materials in this class include carboxy-methylcellulose (CMC) and hyaluronic acid

Two commer-cial CMC gels with similar formulations are Prolaryn Geland Renu Gel.Besides viscoelasti c properties and dur ability, an essen-

tial requirement of an injected material is its safety pro-

ﬁle

This is particularly important for vocal fold

augmentation given the critical nature of this anatomicalsite

Adverse effects at the larynx can have severe conse-

quences related to a patient ’s airway status, swallow

function, and voice quality

A retrospective review of228 awake vocal fold augmentation procedures withCMC found no airway complications, supporting the

general safety of the mate rial as a treatment option.

1A

group who reviewed the FDA ’s MAUDE Adverse Event

Database from 2009 to 2020 found seven reported com-

plications following CMC injection, but on further anal-ysis found that the complicat ions were likely unrelated

to the injection material.

2Our investigation of this data-

base revealed two relevant entries from 2016 document-

ing airway swelling following CMC injection; however,

the clinical detail regarding these events is markedly lim-

ited

One MAUDE entry describes ﬂuid collection at a

Renu Gel injection site suspicious for abscess.

3The sec-

ond MAUDE entry involves a patient who experiencedrespiratory distress and was s ubsequently intubated after

24 hours of observation followi ng injection of Prolaryn

Gel to the interarytenoid space.

4

Here we report a case describing a rare complication

of vocal fold injection augm entation with carboxymeth-

ylcellulose in which a patient experienced a local reac-tion resulting in acute airway compromise

necessitatingintubation and eventual tracheostomy placement

Thepurpose is to identify local allergic reaction as a rarecomplication of vocal fold i njection augmentation, to

describe the warning signs and management of airwayswelling following this proce dure, and to discuss a possi-

ble mechanism for this occurrence.Accepted for publication January 19, 2023.

This case was presented as a poster presentation at the Fall Voice Conference on

October 7, 2022 in San Francisco, California.Consent: Written consent was obtained

from the patient prior to journal submission.

From the *Keck School of Medicine of University of Southern California, Los

Angeles, California, USA; yCaruso Department of Otolaryngology, Head and Neck

Surgery, Keck School of Medicine of University of Southern California, Los Angeles,California, USA; and the zDepartment of Surgery, Division of Otolaryngology-Head

and Neck Surgery, McMaster University, Hamilton, Ontario, Canada.

Address correspondence and reprint requests to: Benjamin van der Woerd, McMas-

ter University, 50 Charlton Avenue East, Hamilton

, ON, L8N 1Y3, Canada

E-mail:

[email protected]

Journal of Voice, Vol

&&, No.&&, pp.&&−&&

Published by Elsevier Inc

https://doi.org/10.1016/j.jvoice.2023.01.026ARTICLE IN PRESS

Downloaded for Anonymous User (n/a) at McMaster University from ClinicalKey.com by Elsevier on September 07,

2023

For personal use only

No other uses without permission

Elsevier Inc

CASE

The case involves a 70-year-old female who underwent anuncomplicated right true vocal fold injection augmentationwith CMC (Renu Gel) for right true vocal fold immobilitywith glottis insuf ﬁciency in the postoperative inpatient set-

ting following an uncomplicated right far lateral craniotomy

with partial resection of a hemangioblastoma associated

with cranial nerves CN VII-X

The injection was done witha disposable 23-gauge needle in a percutaneous fashion withclean technique over the thyrohyoid membrane

Prior toinsertion of the needle, an alcohol pad was used to clean theskin.

On post-injection day 1, the patient developed acute stri-

dor, severe respiratory distress, and exhibited tripoding.

The patient was started on oxygen via nasal cannula and