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\begin{document}

\title{Triple Semicircular Canal Occlusion Combined with Endolymphatic Sac
Decompression: An Effective Surgical Strategy for Vertigo Control of
Intractable Meniere's Disease}



\author[1]{Bingbin Xie}%
\author[1]{Meiqun Wang}%
\author[1]{Yunxia Jiang}%
\author[1]{Wen Xie}%
\author[1]{Shaorong Zhang}%
\author[1]{Yuehui Liu}%
\affil[1]{The Second Affiliated Hospital of Nanchang University}%


\vspace{-1em}



  
  \date{June 13, 2024}


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\selectlanguage{english}
\begin{abstract}
Objective: To investigate the symptomatic relief and functional
preservation of a novel surgical strategy combined with triple
semicircular canal occlusion and endolymphatic sac decompression in
patients with intractable Meniere's disease. Design: Retrospective
analysis. Setting: Patients with intractable Meniere's disease in the
Department of Otolaryngology Head \& Neck in the Second Affiliated
Hospital of Nanchang University between July 2015 and June 2019.
Participants: Data from 46 patients diagnosed with Meniere's disease,
and underwent surgery Methods: Triple semicircular canal occlusion
combined with endolymphatic sac decompression was performed in all
patients with intractable Meniere's disease. Pre- and postoperative
vertigo attacks, hearing levels, tinnitus, aural fullness, and
equilibrium function rehabilitation were analyzed at defined time points
during follow-up. Results: A significant vertigo control rate was
observed in all patients postoperatively. The overall control rate of
vertigo postoperatively was 100\% in the entire follow-up, with a
complete control rate of 97.8\% and a substantial control rate of 2.2\%.
The rate of hearing preservation was 54.35\%, and all patients suffering
from hearing deterioration were at stages III and IV. The rate of
tinnitus and aural fullness alleviation was 65.8\% and 100\%,
respectively. Four patients failed to regain the equilibrium function
postoperatively. Conclusion: Combining triple semicircular canal
occlusion with endolymphatic sac decompression is an efficient strategy
for vertigo control in patients with intractable Meniere's disease.
Patients in advanced stages suffered more from hearing function
deterioration. Hearing preservation and tinnitus alleviation warrant
further investigation.%
\end{abstract}%



\sloppy


\textbf{ABSTRACT}

\textbf{Objective:} To investigate the symptomatic relief and functional
preservation of a novel surgical strategy combined with triple
semicircular canal occlusion and endolymphatic sac decompression in
patients with intractable Meniere's disease.

\textbf{Design:} Retrospective analysis.

\textbf{Setting:} Patients with intractable Meniere's disease in the
Department of Otolaryngology Head \& Neck in the Second Affiliated
Hospital of XXX University between July 2015 and June 2019.

\textbf{Participants:} Data from 46 patients diagnosed with Meniere's
disease, and underwent surgery

\textbf{Methods:} Triple semicircular canal occlusion combined with
endolymphatic sac decompression was performed in all patients with
intractable Meniere's disease. Pre- and postoperative vertigo attacks,
hearing levels, tinnitus, aural fullness, and equilibrium function
rehabilitation were analyzed at defined time points during follow-up.

\textbf{Results:} A significant vertigo control rate was observed in all
patients postoperatively. The overall control rate of vertigo
postoperatively was 100\% in the entire follow-up, with a complete
control rate of 97.8\% and a substantial control rate of 2.2\%. The rate
of hearing preservation was 54.35\%, and all patients suffering from
hearing deterioration were at stages III and IV. The rate of tinnitus
and aural fullness alleviation was 65.8\% and 100\%, respectively. Four
patients failed to regain the equilibrium function postoperatively.

\textbf{Conclusion:} Combining triple semicircular canal occlusion with
endolymphatic sac decompression is an efficient strategy for vertigo
control in patients with intractable Meniere's disease. Patients in
advanced stages suffered more from hearing function deterioration.
Hearing preservation and tinnitus alleviation warrant further
investigation.

\textbf{Keywords:} Semicircular canal occlusion; Endolymphatic sac
decompression; Meniere's disease; Vertigo; Hearing Loss

\textbf{Key points:}

\begin{enumerate}
\tightlist
\item
  Triple semicircular canal occlusion an efficient strategy for vertigo
  control in patients with intractable Meniere's disease
\item
  The surgery can block the movement of endolymph in the canals to
  eliminate vertigo attacks induced by position changing
\item
  Advanced stage MD suffered more from hearing deterioration
  postoperative
\item
  The aural fullness remission was satisfactory postoperative
\item
  Rehabilitation of vestibular function is important to patients
  restoring equilibrium postoperative
\end{enumerate}



\textbf{INTRODUCTION}

Meniere's disease (MD) is an inner ear disorder characterized by
intermittent episodes of vertigo lasting from minutes to hours,
incurring fluctuating sensorineural hearing loss, tinnitus, and aural
pressure in the affected ear. Numerous treatment options are currently
used with the aim of reducing the severity and incidence of vertigo
attacks, preventing disease progression, and treating the effects of end
organ damage such as hearing loss, tinnitus, and chronic imbalance, and
providing symptomatic relief\textsuperscript{1}. Lifestyle modification
and medical treatment were recommended as the first line of care
provided to those patients. More than 85\% of patients with MD are
helped by such treatment strategies\textsuperscript{2}. However, vertigo
persists despite an optimal conservative treatment in approximately 10\%
of cases. These cases are considered to have intractable
MD\textsuperscript{3}. The quality of life of these patients were
seriously affected by the symptoms of the disease, especially during
vertigo episodes. A common problem is the difficulty in controlling
vertigo effectively while preserving hearing. To date, many different
methods have been attempted to treat these patients, including a variety
of surgeries. Endolymphatic sac surgery has been proven safe and
effective in the alleviation of intractable vertigo in only 50\% to 75\%
of patients\textsuperscript{4-6}. However, Thomsen and colleagues
concluded that endolymphatic sac surgery presented no advantages
compared with a placebo operation\textsuperscript{7}. Semicircular canal
occlusion has been used as an alternative treatment in intractable
benign paroxysmal positional vertigo with varying degrees of success.
The surgery aims to ablate movement of the endolymph in the canals and
therefore to eliminate vertigo attacks aroused by rotational movements.
It is also a prospective method in vertigo management in patients with
MD.

The aim of this study is to evaluate the effectiveness of triple
semicircular canal occlusion (TSCO) combined with endolymphatic sac
decompression (ESD) in controlling vertigo attacks, tinnitus, and aural
fullness, and to evaluate its effect on hearing level and equilibrium
function rehabilitation. Here, we present a retrospective analysis on 46
patients with MD who underwent TSCO combined with ESD. The analysis
includes symptom control and management and markers of functional
preservation.

\textbf{PATIENTS AND METHODS}

After obtaining institutional review board approval from the XXX, we
carried out a retrospective analysis on 46 patients diagnosed with MD,
according to AAO-HNS criteria\textsuperscript{8}, who were treated by a
surgical strategy that combined TSCO and ESD in the Department of
Otolaryngology Head \& Neck Ssurgery in XXX between July 2015 and June
2019. All information based on patients' medical records and follow-up
interviews (telephone or questionnaire), including clinical symptoms,
previous treatments, surgical procedures, and control of vertigo
attacks, tinnitus and aural fullness, preservation of hearing,
rehabilitation of equilibrium function, postoperatively, was collected
up until July 2020.

The inclusion criteria consisted of:  only patients in the definite
category of the MD, according to a diagnostic scale based on clinical
criteria\textsuperscript{8};  patients who underwent medical therapy
and lifestyle modifications for at least 6 months without improvement
and who had more than 6 vertigo attacks for the last 6 months before the
surgery;  patients who had a strong desire for surgery. The exclusion
criteria were: (1) patients with intractable MD not responding to the
inclusion criteria; and (2) patients with active mastoid or middle ear
diseases.

\textbf{Surgical protocol}

All patients were placed under general anesthesia, and facial nerve
monitoring electrodes were put in place. A standard mastoidectomy was
performed through a postauricular incision, with decompression of the
sigmoid sinus. The facial nerve and three semicircular canals were
identified and skeletonized, after which the endolymphatic sac was
identified posterior to the posterior semicircular canal, along the
posterior fossa plate, below Donaldson's line. The bone over the sac was
widely removed for decompression. A fenestration was made at a spot on
the posterior canal as far as possible away from the ampulla, keeping
the membranous labyrinth intact. Next, a small piece of soft tissue was
filled into the fenestration to tightly block the membranous labyrinth
over a short segment, after which, the fenestration was finally sealed
with bone wax to further safeguard against perilymph leakage.
Thereafter, the superior and horizontal semicircular canals were blocked
using the same method.

\textbf{Hearing evaluation}

In this study, pure-tone average (PTA), calculated using 0.5-, 1-, 2-,
and 3-kHz air conduction thresholds, was used to evaluate the hearing
level of the patients. The 3-kHz threshold used in this study was
interpolated by averaging the thresholds at 2 and 4 kHz, because the
3-kHz threshold is not routinely tested in China. The postoperative
evaluation included three time points, at 6 months,12 months and 18
months postoperatively. Hearing deterioration or improvement was
assessed according to the \emph{A New Standardized Format for Reporting
Hearing Outcome in Clinical Trials} \textsuperscript{9}. Hearing
deterioration was defined as a PTA elevating [?]10 dB when compared with
the hearing level preoperatively. The definition of stages was based on
the hearing levels of patients pre-operatively\textsuperscript{10}. In
brief, a stage I corresponded to a PTA < 25 dB HL, stage II
corresponded to a PTA of 25 - 40 dB HL, stage III corresponded to a PTA
of 41-70 dB HL and stage IV corresponded to a PTA >70 dB HL. The word
recognition score cannot be reported in this study due to the variety of
dialects. It is difficult to acquire reliable scores using a single
standardization scale when evaluated patients speak different types of
dialects.

\textbf{RESULTS}

In this study, the demographic and symptoms information on the patients
undergoing TSCO combined with ESD are presented in Table 1. In brief, 19
male and 27 female patients (male: female ratio = 0.70: 1) were
included. The mean age of these patients at the time of surgery was 58
years (ranging from 33 to 79 years). The duration of disease was 118.2
months (ranging from 48 to 360 months), and the vertigo episodes during
the last 6 months occurred an average of 6.84 times (ranging from 2 to
42 times). All patients in this study complained of hearing loss, and
most of them suffered from aural fullness and tinnitus, especially
during the vertigo episode.

Post-operatively, all patients suffered from temporary vertigo and
imbalance and presented with spontaneous nystagmus immediately
post-operatively. Vertigo disappeared in all patients within 3 days,
while the imbalance was alleviated in all patients within 4-5 days, and
30 patients totally recovered their balance within 2 months, with an
average recovery time of 12.6 days. However, there were 4 patients who
still felt unstable or like they were floating at the latest follow-up
interview because none of them persisted with vestibular rehabilitation
postoperatively. No patients had facial paralysis, cerebrospinal fluid
leakage, infection, or other complications.

The overall control rate of vertigo post-operatively was 100\% in the
whole follow-up, with a complete control rate of 97.8\% (45/46) and a
substantial control rate of 2.2\% (1/46). The average numbers of vertigo
attacks over the course of 6 months pre- and post-operatively was
6.727\selectlanguage{ngerman}±7.807 and 0.0625±0.348 (F = 499.67, \emph{p = 0.000} ),
respectively. Only one patient suffered from two vertigo attacks in the
6 months post-operatively (Table 2). However, the vertigo was alleviated
when the patients took diuretics and betahistine, and never reoccurred
over the course of the entire follow-up time. The number of patients
suffering from aural fullness pre- and post-operatively was 44 and 0
(\emph{p=0.000} ), respectively (Table 2). Out of the 46 patients
included in this study, 38 patients suffered from persistent or
bothersome tinnitus preoperatively. However, this number was decreased
to 12 (X\textsuperscript{2}=21.959, \emph{p= 0.000} ) postoperatively
(Table 2). The tinnitus evaluation was carried out according to
the\emph{Clinical Practice Guideline: Tinnitus (2014)}
\textsuperscript{11}.

According to the pre-operative staging of hearing, among these 46
patients, there were 2 in stage I, 11 in stage II, 21 in stage III and
12 in stage IV. Fifteen patients had unserviceable hearing
pre-operatively (PTA more than 60 dB HL). No patients in stage I or II
suffered from hearing deterioration postoperatively. However, 6 patients
(6/21, 28.57\%) in stage III presented with hearing deterioration 6
months postoperatively when compared with their preoperative state. That
number increased to 9 (9/21, 42.86\%) and 16 (16/21, 76.19\%) at 12
months and 18 months postoperatively, respectively. Otherwise, patients
in stage IV presented hearing deterioration were 2 (2/12, 16.67\%), 3
(3/12, 25\%), and 5 (5/12, 41.67\%) at 6, 12, and 18 months
postoperative, respectively. Finally, there was a total of 21 patients
(21/46, 45.65\%) suffering from hearing deterioration at 18 months
postoperatively, and all patients suffering from hearing deterioration
were at stage III and IV. The rate of hearing preservation was only
54.35\% at 18 months postoperatively (Table 3). The overall PTA was
59.33±17.2 dB HL and 68.28±24.0 dB HL pre-operatively and
post-operatively, respectively, which reflected a significant difference
compared between pre- and postoperatively (Table 2).

\textbf{DISCUSSION}

The primary goals of numerous treatment options currently used for MD
treatment are first to prevent or at least reduce the frequency and
severity of vertigo attacks, and, secondarily, to prevent disease
progression, treat the effects of end organ damage like hearing loss,
tinnitus, and chronic imbalance, and provide symptomatic relief. A main
consideration regard to the choice of treatment strategy is the
patient's hearing status, and whether it is usable or not. Nonablative
procedures have been advocated for patients with usable or serviceable
hearing. Surgical procedures for the treatment of this disease can be
classified into three categories. The first category, an ablative
procedure, includes selective vestibular neurotomy or labyrinthectomy.
Although vestibular neurectomy has a very high efficiency of vertigo
control, the risk of operation is high\textsuperscript{12}, and it is
only implemented in patients with total deafness\textsuperscript{2} and
with an intense desire to receive surgical treatment. The second
category, a traditional functional preserved strategy, involves all
types of endolymphatic sac surgeries (decompression and drainage).
Endolympahtic sac surgery, as a conservative operation, was often used
in intractable MD patients. The theory behind the surgery is to relieve
the pressure of the endolymphatic fluid, thereby decreasing episodic
vertigo attacks induced by endolymphatic hydrops\textsuperscript{13,14}.
So far, endolymphatic sac surgery has been universally acknowledged and
used, and has generally considered to be a safe surgical option because
hearing is maintained postoperatively\textsuperscript{13,15}. However,
many patients relapsed with episodic vertigo postoperatively, and the
control rate of vertigo was only 60\textasciitilde{}80\%; the benefit of
this strategy is still under debate as it yields inconsistent results
compared to placebo surgery\textsuperscript{16,17}.

The third category is semicircular canal occlusion/plugging, a novel
procedure proposed for the management of intractable peripheral vertigo
by many specialists, which aims to block the movement of endolymph in
the canals and therefore to eliminate vertigo attacks induced by
position changing\textsuperscript{3}. Since semicircular canal occlusion
was first applied to treat intractable benign paroxysmal positional
vertigo in 1990, many investigators have begun to apply this method for
the treatment of intractable peripheral vertigo, with results showing
that plugging surgery represents a safe option \textsuperscript{18}.
However, the investigation of semicircular canal plugging/occlusion
applied to patients suffering from MD has scarcely been discussed to
date. Yin et al\textsuperscript{19} applied TSCO to three patients with
MD who underwent unsuccessful ESD or a mastoid shunt, demonstrating that
two cases reached complete vertigo control with the other reached
substantial vertigo control. In this study, TSCO combined with ESD was
applied to patients with intractable MD as the primary surgical strategy
for the purpose of controlling vertigo. The overall vertigo control rate
was 100\%, with a complete control rate of 97.8\% and a substantial
control rate of 2.2\%. The vertigo control rate was higher than the rate
reported by Zhang et al\textsuperscript{20,21} and Charpiot et
al\textsuperscript{22}. All patients in this study were satisfied with
the vertigo control postoperatively during the follow-up period. Our
data directly suggested that combining TSCO and ESD is an efficient
strategy for vertigo control in patients with intractable MD.

As a nonablative procedure, TSCO combined with ESD provided a satisfying
vertigo control rate in this study. However, the total hearing
preservation rate was 82.61\%, 73.91\%, and 54.35\% at 6-months,
12-months, and 18-months postoperative, respectively. This was
inconsistent with the data from Zhang\textsuperscript{20}, who reported
a rate of 70.9\% for hearing preservation in a 2-year follow-up.
However, 76.19\% of patients were in stage III (16/21) and 41.67\% of
patients in stage IV (5/12) with hearing loss, no patients in stages I
or II pre-operatively (13 patients) complained of hearing loss
postoperative. The results of this study suggested that patients in
advanced stages (stages III and IV) suffered more from progressive
hearing deterioration postoperatively as time elapsed, which suggested
that vertigo control cannot simultaneously halt the progression of
cochlear function deterioration. Although the group of patients suffered
from hearing deterioration including 15 patients who presented with no
serviceable hearing function pre-operatively (Table 4). However, this
group of patients lost the opportunity to use the hearing aids to
improve their social communication in daily life. Residual hearing
preservation remains a significant challenge to address prior to the
selection of an optimal strategy for intractable MD patients.

Why does hearing deteriorate over time? Animal studies demonstrated that
factors such as lymph leak, bleeding into the inner ears, serous
labyrinthitis, and infections were all considered to potentially induce
hearing loss during surgery\textsuperscript{23,24}. Hearing loss caused
by those factors is reversible\textsuperscript{25}. However, transaction
of the membrane labyrinth intraoperatively usually causes irreversible
hearing loss\textsuperscript{25}. Otherwise, in our study, all patients
suffered from hearing loss postoperatively were in stages III and IV. In
this case, it remains difficult to determine exactly what the factors
affecting the auditory function directly are postoperatively. Our data
do not support the notion that the surgery procedure itself, or the
labyrinthitis postoperatively, directly deteriorated the hearing.
Blocking the movement of endolymph in the canals can eliminate vertigo
attacks induced by position changing but cannot halt the development of
MD on cochlear function deterioration, especially at advanced stages.
Whether surgery, disease stages, or other potential risks (such as aging
and lifestyle) were factors directly inducing hearing loss over time
postoperatively still needs to be further investigated. A long-term
follow-up is necessary to investigate the auditory function
postoperatively.

The aural fullness remission was consistent with the vertigo control in
this study. The tinnitus control rate is 65.8\%. Patients still bothered
with persistent or bothersome tinnitus had severe hearing loss. However,
this cannot rule out the possibility that tinnitus is related to
auditory function damage in MD. In this study, 30 patients regained
their balance within 2 months, with an average recovery time of 12.6
days. There were 4 patients who still felt unstable or like they were
floating at the latest follow-up interview because none of these 4
patients persisted with vestibular rehabilitation postoperatively.
Vestibular rehabilitation is important and effective for vestibular
function compensation in patients postoperative. The vestibular
dysfunction induced by TSCO and ESD is reversible, and vestibular
rehabilitation should be recommended to all patients postoperative.

In conclusion, combining TSCO and ESD is an efficient strategy for
vertigo control in patients with intractable MD. However, the hearing
functions were deteriorating gradually postoperatively in patients at
advanced stages. The hearing preservation and tinnitus relief still
warrant further illumination.

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