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\begin{document}

\title{A Commentary on the Management of Total Laryngectomy Patients}



\author[1]{Max Hennessy et al.}%
\affil[1]{Affiliation not available}%


\vspace{-1em}



  
  \date{May 18, 2024}


\begingroup
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\selectlanguage{english}
\begin{abstract}
The Coronavirus disease-2019 (COVID-19) pandemic has rapidly spread
across the world, placing unprecedented strain on the healthcare system.
Healthcare resources including hospital beds, ICUs, as well as personal
protective equipment (PPE) are becoming increasingly rationed and scare
commodities. In this environment, the laryngectomee (patient having
previously undergone a total laryngectomy) continues to represent a
unique patient with unique needs. Given their surgically altered airway,
they pose a challenge to manage for the otolaryngologist within the
current COVID-19 pandemic. In this brief report, we present special
considerations and best practice recommendations in the management of
total laryngectomy patients. We also discuss recommendations for
laryngectomy patients and minimizing community exposures.%
\end{abstract}%



\sloppy


\textbf{Full author list}

Max Hennessy, MD\textsuperscript{1}, Darrin V. Bann, MD,
PhD\textsuperscript{1}, Vijay A. Patel, MD\textsuperscript{1}, Robert
Saadi, MD\textsuperscript{1}, Greg A. Krempl, MD\textsuperscript{2},
Daniel G. Deschler, MD\textsuperscript{3}, Neerav Goyal, MD,
MPH\textsuperscript{1}, Karen Y. Choi, MD\textsuperscript{1}

\textsuperscript{1}Department of Otolaryngology -- Head and Neck
Surgery, The Pennsylvania State University, College of Medicine,
Hershey, PA

\textsuperscript{2}Department of Otolaryngology -- Head and Neck
Surgery, The University of Oklahoma Health Sciences Center, Oklahoma
City, OK

\textsuperscript{3}Department of Otolaryngology -- Head and Neck
Surgery, Massachusetts Eye and Ear Infirmary, Boston, Massachusetts



\textbf{Introduction}

Coronavirus disease-2019 (COVID-19) was first reported in Wuhan, Hubei
province, China in December 2019 and has since rapidly spread across the
globe, infecting 952,000 people and causing 48,000 deaths as of April
2\textsuperscript{nd}, 2020.\textsuperscript{1} This disease is caused
by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), a novel
coronavirus closely related to the SARS and Middle Eastern Respiratory
Syndrome (MERS) viruses. \textsuperscript{1,2} The exact route of
transmission remains unknown but the primary mechanism of spread is
believed to be via respiratory droplets and
aerosols.\textsuperscript{3}Due to the high viral load present in the
upper airway, otolaryngologic procedures are considered high risk for
occupational exposure and a number of otolaryngologists have been
infected with COVID-19.\textsuperscript{4}

The most common initial symptoms of COVID-19 are cough, fever, fatigue,
increased mucous production, dyspnea, sore throat, and
myalgias.\textsuperscript{5} Ground-glass opacities are found on chest
computed tomography in 56\% of patients on admission, with 2.3\% of
patients eventually requiring mechanical
ventilation.\textsuperscript{6}In an analysis of 72,314 COVID-19
patients in China, the overall case-fatality rate was 2.3\% but was
7.3\% in patients with pre-existing conditions (10.5\% for
cardiovascular disease, 7.3\% for diabetes, 6.3\% for chronic
respiratory disease, 6.0\% for hypertension, and 5.6\% for
cancer).\textsuperscript{5} Notably, symptoms can take 1-2 weeks to
manifest from the time of infection, and asymptomatic patients can still
be contagious.

Total laryngectomy, which results in an interruption between the upper
airway and trachea with complete respiratory dependence through a
tracheostoma, represents a unique challenge for patient management in
the setting of COVID-19. Laryngectomy patients are at risk for poor
outcomes with COVID-19 due to frequently present medical comorbidities
including chronic pulmonary disease, peripheral vascular disease,
cardiac disease, cerebrovascular disease, diabetes, the underlying
cancer history, and a propensity for atelectasis due to loss of upper
airway resistance.\textsuperscript{7} Furthermore, as the majority of
laryngectomy patients have a smoking history, they are also prone to
acute infections due to impaired mucociliary function and mucosal
irritation from cold, dry inspired air.\textsuperscript{7} In addition,
salvage total laryngectomy can result in post-operative wound
complications and prolonged hospital stays and greater risk of exposure
to the virus as hospitals are inundated with COVID 19 patients. If
infected, laryngectomy patients carry a high risk of transmitting viral
particles to health care workers or members of the community due to
their significantly altered anatomy and to aerosolization of tracheal
secretions.\textsuperscript{8,9}

\textbf{Infection Control Precautions in Total Laryngectomy Patients}

Direct examination and instrumenting the head and neck region during
physical examination of the infected patient represents a significant
transmission hazard for the physician and ancillary support staff due to
the high viral load present in the upper aerodigestive
tract.\textsuperscript{4} Unfortunately, many patients are asymptomatic
early in infection, and some patients may remain asymptomatic throughout
the course of the infection. Currently, COVID-19 testing is limited by
access to supplies and lengthy turnaround times, and therefore, patients
with unknown COVID-19 testing should be presumed positive until testing
becomes readily available with rapid results.

The best approach for testing laryngectomy patients for COVID-19 also
requires consideration. COVID-19 testing is most commonly performed via
nasopharyngeal swab. Although laryngectomy patients have no significant
airflow through the nasal cavity or nasopharynx, they can still develop
sinonasal disease.\textsuperscript{10} However, as the primary
respiratory flow is via the tracheostoma, the trachea and lungs may
serve as an additional site of direct inoculation. Therefore, is
important to consider testing for SARS-CoV-2 in tracheal aspirates as
well as in the nasal passages for laryngectomy patients. This is
consistent with CDC recommendations of lower respiratory track specimens
if available.\textsuperscript{11}

Any manipulation of the upper aerodigestive tract that precipitates
cough, including endoscopic examination of the nasal cavity, oral
cavity, and pharynx must be treated as an aerosol-generating procedure
that has a high risk of virus transmission. To limit COVID-19
transmission and preserve medical resources including personal
protective equipment (PPE), the American College of Surgeons (ACS) and
the American Academy of Otolaryngology -- Head and Neck Surgery
(AAO-HNS) have recommended otolaryngologic procedures be deferred unless
the procedure is medically necessary in a high
acuity.\textsuperscript{12,13}

Given the extensive alterations in anatomy, their cancer history, and
risk of airway complications related to tracheoesophageal fistulae (TEF)
or tracheoesophageal prostheses (TEP), laryngectomy patients may still
require acute face to face encounters. As such, special considerations
to minimize the risk of SARS-CoV-2 transmission should be undertaken.
The proper use of PPE is important in the setting of COVID-19. In these
patients, unconditioned air enters the tracheostoma, which can lead to
increased coughing.\textsuperscript{3} Inherently, tracheostomas
generate a greater aerosol load in comparison to normal respiration
through the upper airway.\textsuperscript{9} During the SARS outbreak in
2003, viral RNA was detected in high concentrations in tracheal
aspiration samples, indicating the virus also replicates in tracheal
secretions.\textsuperscript{14} With this in mind, extra care must be
taken to protect against aerosolized particles generated when examining
and interacting with laryngectomy patients in both the inpatient and
outpatient setting.

We recommend using enhanced PPE, which we define as an N95 respirator
and face shield or a powered air-purifying respirator (PAPR), as well as
a disposable surgical cap, gown, gloves, and consideration for shoe
covers when evaluating any laryngectomy patient with unknown, suspected,
or positive COVID-19 status. Standard PPE, as defined by the
Occupational Health and Safety Administration (OSHA), can be used for
COVID-19-negative patients.\textsuperscript{15} Proper PPE compliance is
critical in maintaining its efficacy and the appropriate sequence of
donning and doffing of the equipment is vital.\textsuperscript{11} It is
important to note, however, that the use of an N95 respirator and face
shield may not be 100\% effective at preventing COVID-19 transmission.
In fact, two recent meta-analyses failed to demonstrate the superiority
of N95 respirators over standard surgical masks in preventing
influenza.\textsuperscript{16,17} Due to the increased protection
afforded and possible reusability, a PAPR is preferred over an N95
respirator and face shield for high-risk procedures, when available, so
long as there is appropriate physician comfort and training with a
PAPR.\textsuperscript{4,18,19} The availability of PAPR can vary greatly
from center to center. Additional options for enhanced PPE to consider
include N100 and reusable elastomeric respirators if available.

\emph{Outpatient Clinic Setting}

Certain practices can minimize transmission of this highly contagious
virus in the outpatient setting, the most effective measure being the
deferral of all non-urgent visits and performing telemedicine visits
when a physical exam is not necessary (i.e. pathology and radiographic
imaging results). The federal government has taken steps to greatly
expand telemedicine services under Medicare and Medicaid with HIPAA
flexibilities and this was made retroactive to January 27,
2020.\textsuperscript{20}

When in-office visits are absolutely necessary (e.g. postoperative
visits, tracheoesophageal prosthesis (TEP) complications, symptoms
concerning for cancer recurrence, etc.), screening prior to the visit
for symptoms of COVID-19 and self-quarantine measures may help reduce
transmission risks. An example of pre-arrival instructions for patients
are listed in Table 1. To minimize aerosolized particle spread from a
laryngectomy patient, the tracheostoma should be covered with a heat
moisture exchanger (HME), preferably with an integrated viral/bacterial
hydroscopic filter, and a physical barrier over the stoma such as a
surgical mask, scarf, or shirt, prior to their arrival to the
clinic.\textsuperscript{21,22}

Two major manufacturers (Atos, InHealth) produce an HME with these
filters: Atos Provox\selectlanguage{ngerman}® Micron HME\selectlanguage{english} filters virus and bacterial particles
(https://www.atosmedical.com/product/provox-micron-hme/), and the
InHealth Technologies(r) Blom-Singer(r) HME filters bacterial particles
(https://www.inhealth.com/category\_s/47.htm). In addition laryngectomy
patients should, where feasible, be encouraged to use adhesive base
plates such as the Provox(r) StabiliBase\selectlanguage{english}
(https://www.atosmedical.com/product/provox-stabilibase/) or the
Blom-Singer TruSeal Adhesive Housing
(https://www.inhealth.com/product\_p/truseal\_standard.htm). These
incorporate the HME and when properly applied will prevent airflow
outside of the HME, and reduce mucous contamination of clothing or other
physical barriers.

While scarves and shirts are not as effective as surgical masks in
reducing inhaled aerosol spread, they do provide some protection in
reducing aerosol projection.\textsuperscript{21,22} Attempts should be
made to minimize the time the patient spends in common areas and
check-in procedures should be expedited or performed in an examination
room when possible.

During the visit, only necessary personnel should enter the patient room
with the appropriate PPE as noted above. Defer nasopharyngoscopy and
tracheoscopy if possible. Pledgets with lidocaine and/or oxymetazoline
are preferable to atomized medications if anesthesia and decongestion
are necessary. When performing flexible tracheoscopy, attempts should be
made to minimize mucosal stimulation and resultant coughing. Following
flexible tracheoscopy, the scope should be immediately handed off and
cleaned to prevent contamination of counters and scope holders in the
exam room. If suctioning is required, having patients self-suction will
allow for providers and staff to leave the room during the time of
suctioning. However, it should be noted that viable SARS-CoV-2 has been
recovered from aerosols for up to 3 hours.\textsuperscript{23} Following
the visit, institutional protocol for room decontamination should be
followed while allowing an appropriate wait time for aerosols to settle.
For patients with moderate to high risk of COVID-19, consider
disinfecting all surfaces to reduce the risk of transmission, as
SARS-CoV-2 has been shown to be viable on some surfaces for up to 24-72
hours.\textsuperscript{24}

\emph{Management of TEP Complication} s

TEP complications are unique to the laryngectomy population, including
device dislodgement and leakage related to device failure in the tract.
Typically, these complications can be managed in the office using
standard PPE. However, due to the potential risk of SARS-CoV-2, the
standard management and timing to address these complications is subject
to change. Optimally, a negative pressure room and HEPA filtration can
minimize the risk of viral transmission, and should be considered in the
COVID-19 era.\textsuperscript{25} However, this is not necessarily
practical from a healthcare resource utilization and workflow
standpoint. Figure 1 presents a possible decision algorithm in managing
TEP complications including dislodgement of the prosthesis and leak
around the prosthesis.

A patient with a TEF or leak around a TEP is at an increased risk of
aspiration with potential sequelae including pneumonia, which could lead
to devastating outcomes if patients contract COVID-19. In the event of a
dislodged TEP, radiographic imaging can serve as a diagnostic tool to
replace flexible bronchoscopy or tracheoscopy in evaluating for an
airway foreign body. This can begin with standard X-rays of the chest
and abdomen but may be augmented with CT
imaging.\textsuperscript{26}Certainly, if the patient is in respiratory
distress from an aspirated TEP, urgent surgical intervention is
indicated regardless of COVID-19 status. As noted above, these patients
should be presumed to be COVID-19 positive until proven otherwise and
enhanced PPE should be implemented. Precautions to minimize
aerosolization of particles while in transport to the operating room and
prior to intubation should be taken, such as covering the stoma with an
HME and surgical mask. For patients who do not have an HME or
laryngectomy tube, a tracheotomy tube with an HME can be considered,
though this may worsen their coughing.

In the stable patient, the main goal is to safely temporize and
troubleshoot any TEP complications until the risk of COVID-19
transmission is sufficiently lowered or testing is readily available.
Management at home should initially be attempted by the patient. If the
patient has a TEP plug, this can be placed to attempt to reduce any
leakage, though this will result in aphonia. Additionally, patients can
try alternative diet measures such as thickened liquids to reduce
leakage. A dislodged (non-aspirated) TEP may also be conservatively
managed at home by placing a red rubber catheter or dilator into the
TEF, if the patient is familiar with this procedure. An advantage to
this measure is that the red rubber catheter can serve as alternate
means of nutrition until TEP replacement becomes a viable option.

If in-office evaluation is necessary, ideally the patient should be
tested for COVID-19 prior to evaluation. If testing is negative and
symptoms are mild, the patient can undergo quarantine for 48 hours and
then return to the clinic at a later date for TEP insertion. Some
centers recommend a second rapid COVID-19 test is recommended following
the 48-hour quarantine prior to evaluation of intervention to mitigate
risk associated with false negative results.\textsuperscript{27}However,
this algorithm may remain infeasible until national testing supplies and
capacity are no longer severely limited.

In the event of a TEP complication for a known COVID-19 positive
patient, all efforts should be made by the patients to temporize
themselves at home without coming to the hospital, so long as they are
medically stable to remain at home. Once the patient is recovered from
the infection, they may then proceed with further management. For
COVID-19 positive patients, we strongly recommend the use of PAPR for
all personnel in the room during any procedures that manipulate the
airway.\textsuperscript{15} If a PAPR is not available, consider the use
of a level 4 surgical gown with helmet in addition to donning an N95
respirator and shoe covers. Involved personnel should be kept to the
bare minimum during instrumentation of the stoma in a known COVID-19
positive patient.

\emph{Inpatient Management}

As is the case for any laryngectomy patient admitted to the hospital, it
is crucial for the care teams involved to understand the surgically
modified airway anatomy. Namely, it is imperative that all physicians
and ancillary staff be cognizant of the fact that laryngectomy patients
cannot be oxygenated, bag-masked, or intubated through the upper airway.
Ideally, it is best for these patients to be tested for COVID-19,
resource permitting. However, if testing is not feasible, all
precautions should be taken to minimize risk of transmission of
aerosolized particles. Again, strong consideration should be given to
placing a laryngectomy tube or baseplate with an HME, with or without an
integrated viral/bacterial hydroscopic filter, in the stoma. If the
patient has a significant cough or secretions, measures such as
placement of a tracheotomy tube in the stoma with an attached HEPA
filter and closed-line suction on admission, or placing patients in a
negative pressure room to minimize the spread of viral particles into
the hallway, may be considered.\textsuperscript{9} Placing patients on a
closed-circuit system such as a mechanical ventilator, even if pressure
support is not needed, has been utilized to reduce aerosolization of
viral particles.\textsuperscript{3,25} However, this may not be feasible
from a resource utilization standpoint, and as such, any efforts that
reduce aerosolized viral spread with a physical barrier over the stoma
as outlined above should be considered.

Laryngectomy patients should also be counseled to self-suction, if
possible, so other care providers may be absent from the room during
suctioning to minimize the risk of aerosolized
transmission.\textsuperscript{25} As these patients are unable to clear
secretions from the nasal cavities, we strongly recommend against
suctioning nasal secretions and instead suggest patients dab or wipe any
nasal discharge. Use of enhanced PPE during all interactions with these
patients should be considered until they are known to be COVID-19
negative.

For the COVID-19 negative laryngectomy patient admitted to the hospital,
we recommend placing an HME with an integrated viral/bacterial
hydroscopic filter over the stoma at all times, in addition to wearing
mask over their stoma and face.\textsuperscript{9,28} Patients should
refrain from touching their stoma unnecessarily and should thoroughly
wash their hands before and after performing any tracheostoma care.
Stoma care may also be reduced to a daily event, if safe to do so, to
reduce potential contamination of the peristomal skin. The laryngectomee
must be cognizant of self-contamination while speaking using a TEP, and
consider frequent hand sanitation (washing, hand sanitizer, gloved
hands, etc.). A hands-free device can eliminate this concern.

\emph{Best Practices for the Laryngectomy Patient in the Community}

Just as it is important for laryngectomy patients to take precautions
while in the clinic and hospital setting, it is vital that they protect
themselves and others in the community from COVID-19. Due to the
increased aerosolization risk, the potential to become ``super
spreaders'' necessitates that total laryngectomy patients always cover
their stoma in public. As previously mentioned, the best protection
against aerosolization and inhalation of viral particles in the
community is to cover the stoma with an HME that includes a bacterial
and/or viral filter. Many patients prefer to use laryngectomy tubes, but
during this pandemic an HME attached to the stoma with a baseplate
allows for a seal that will force all air through the HME, thus further
minimizing aerosolization. If the patient is unable to obtain a good
seal with the HME base plate, they can use laryngectomy tubes that
accept HME filters. At this time, we strongly recommend disposal of HMEs
after community exposure.

In addition to wearing an HME at all times, we encourage patients to
wear a surgical mask, 100\% cotton turtleneck, or scarf over their stoma
to pre-filter inspired air, as these have been found to provide some
measure of aerosol and particle filtration, albeit not to the same level
as a dedicated filter as linked above.\textsuperscript{21,22} For
patients in whom an HME is not an option, we still recommend the use of
alternate coverings like a cotton turtleneck or scarf
alone.\textsuperscript{21,22} This measure still affords for alternative
methods of protection for laryngectomy patients regardless of
socioeconomic status. An N95 respirator over the stoma would likely be
of limited value as compared to those alternate options given the
inability to create an appropriate seal around the stoma. Covering the
mouth and nose are also important as these sites remain a potential
vector of viral inoculation. The landscape surrounding COVID-19 is
rapidly changing, and guidelines will continue to evolve, however, at
this time general recommendations are for laryngectomy patients to wear
a face mask in addition to an HME with viral filter and additional
stomal covering with a surgical mask or other garment.

If a laryngectomy patient develops symptoms of COVID-19 they should seek
testing, which should be both upper aerodigestive (nasopharynx) and
lower respiratory (tracheal), and if positive patients should
self-quarantine. All patients should continue to follow quarantine
recommendations as issued by their home states and national governments.

\emph{Conclusion}

Total laryngectomy patients represent a unique challenge during the
SARS-CoV-2 pandemic given their propensity for aerosolization of
secretions, and concomitant respiratory comorbidities that put them at
risk for higher mortality from COVID-19. At this time, it is critical to
postpone all non-urgent patient interactions in the clinic setting and
to develop new outpatient clinic workflow procedures to reduce aerosol
particle transmission. In this patient cohort, when testing for
SARS-CoV-2, it is important to include testing for the presence of the
virus in tracheal aspirates as well as in the nasal passages. We
recommend that until SARS-CoV-2 testing becomes more widely available,
the same precautions used for COVID-19 positive patients should be
implemented for laryngectomy patients with the use of enhanced PPE for
all head and neck exams. Procedures such as TEP replacement,
non-critical nasal endoscopy, or nasopharyngoscopy should be delayed
when possible and patients should be counseled on appropriate
temporizing measures that can be taken. If intervention is required, all
efforts to lower clinical suspicion for COVID-19 infection should be
taken with rapid testing, if available, and appropriate quarantine prior
to any procedures. The use of HMEs and covers over the stoma can help
limit exposure and transmission risk related to this patient population.

\textbf{Table 1:} Patient Instructions for the Laryngectomee Prior to
Their Clinic Visit\selectlanguage{english}
\begin{longtable}[]{@{}ll@{}}
\toprule
\begin{minipage}[b]{0.47\columnwidth}\raggedright\strut
\textbf{Standard Post-Op} --Negative Pre-Arrival Screen\strut
\end{minipage} & \begin{minipage}[b]{0.47\columnwidth}\raggedright\strut
-Place HME filter over tracheostoma -Wear surgical mask over mouth and
nose -Wear surgical mask over stoma with HME -Tie upper strings around
neck, use additional extension string to connect the two lower mask
strings together under the arms and behind the back. -If patient does
not have a mask at home, wear a scarf or t-shirt over tracheostoma and
HME filter. -Provide mask in clinic. -Expedited check-in -Proceed
directly to designated exam room upon arrival\strut
\end{minipage}\tabularnewline
\midrule
\endhead
\begin{minipage}[t]{0.47\columnwidth}\raggedright\strut
\textbf{Any Reason for Visit} -Positive COVID Pre-Arrival Screen\strut
\end{minipage} & \begin{minipage}[t]{0.47\columnwidth}\raggedright\strut
-Do not come to clinic -Proceed straight to nearest ED or designated
drive-through checkpoint for testing -Reschedule visit pending
results\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.48\columnwidth}\raggedright\strut
\textbf{Dislodged TEP}\strut
\end{minipage} & \begin{minipage}[t]{0.48\columnwidth}\raggedright\strut
-Same as standard postoperative instructions -Have patient place red
rubber catheter or dilator in fistula if possible to preserve fistula
and reduce aspiration risk\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.48\columnwidth}\raggedright\strut
\textbf{TEP Leak}\strut
\end{minipage} & \begin{minipage}[t]{0.48\columnwidth}\raggedright\strut
-Same as standard postoperative instructions -If leakage is from center
of TEP, have patient place TEP plug to reduce aspiration risk -If
leakage around prosthesis, consideration of diet modification and the
use of thickening agents\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.48\columnwidth}\raggedright\strut
\textbf{Cancer Surveillance or Concern for Recurrence}\strut
\end{minipage} & \begin{minipage}[t]{0.48\columnwidth}\raggedright\strut
-Same as standard postoperative instructions -If bleeding is present
causing coughing or aspiration risk, proceed to nearest ED, utilizing
same precautions to cover tracheostoma, mouth, and nose\strut
\end{minipage}\tabularnewline
\bottomrule
\end{longtable}



\par\null\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/FINAL-FIG-1-TEP/FINAL-FIG-1-TEP}

\end{center}
\end{figure}

\textbf{Figure 1} . A guide to determining approach to TEP complications
during the COVID-19 pandemic.

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