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\begin{document}

\title{Our experiences with revision stapedotomies: The role of periprosthetic
fibrosis formation in the development of unsatisfactory hearing results
after stapedotomy.}



\author[1]{Gábor Polony}%
\author[1]{Anita Gáborján}%
\author[1]{Laszlo Tamas}%
\author[1]{László Székely}%
\affil[1]{Semmelweis Egyetem}%


\vspace{-1em}



  
  \date{May 15, 2024}


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\selectlanguage{english}
\begin{abstract}
KEY POINTS: - Our goal was to indentify the most common and most
influential postoperative reasons causing persistent ABG. Our focus was
concentrated on the mechanical dysfunctions in the middle ear, with
special regard to postoperative fibrosis formation. - Periprosthetic
adhesion formation was seen in 64\% of the cases, and it was the primary
cause behind the unsatisfactory hearing result in 32\% of all cases -
There was no significant difference in the level of persistent ABGs
across groups of fibrosis and surgical failure after primary surgery -
Periprosthetic fibrosis is the most common reason for compromised
audiological outcomes after stapedotomy, and has the same negative
effect on ABG development as any other surgical failure, while the
revision could be more challenging in these cases - The use of the most
atraumatic surgical technique and preservation of intact intratympanic
mucosa is a key factor during middle ear surgery.%
\end{abstract}%



\sloppy


\textbf{Our experiences with revision stapedotomies: The role of
periprosthetic fibrosis formation in the development of unsatisfactory
hearing results after stapedotomy.}

\textbf{KEY WORDS:fibrosis,stapedotomy,revision stapedotomy, stapes
surgery, audiological results, hearing, microsurgery, middle ear
surgery, stapes prosthesis,}

\textbf{KEY POINTS:}

\textbf{-} Our goal was to indentify the most common and most
influential postoperative reasons causing persistent ABG. Our focus was
concentrated on the mechanical dysfunctions in the mieddle ear, with
special regard to postoperative fibrosis formation.

\textbf{-} Periprosthetic adhesion formation was seen in 64\%of the
cases, and it was the primary cause behind the unsatisfactory hearing
result in 32\% of all cases

\textbf{-} There was no significant difference in the level of
persistent ABGs across groups of fibrosis and surgical failure after
primary surgery

\textbf{-} Periprosthetic fibrosis is the most common reason for
compromised audiological outcomes after stapedotomy, and has the same
negative effect on ABG development as any other surgical failure, while
the revision could be more challenging in these cases

\textbf{-} The use of the most atraumatic surgical technique and
preservation of intact intratympanic mucosa is a key factor during
middle ear surgery.

\emph{Abbreviations:}

TM- tympanomeatal

ISJ-incudostapedial joint

AC-air conduction

BC-bone conduction

ABG-air-bone gap

PTA-(extended) pure tone average

LPI-long process of incus

TOST- two-one-sided t-tests

\textbf{Introduction}

Stapedotomy is considered as an efficient and safe surgical option in
the treatment of stapes fixation. It has been shown that
thepostoperative ABG of 10 dB or less (which is defined as surgical
success according to AAO-HNS guidelines(1)) could be achievedin 87-97\%
of the cases(2). Although this number has to be considered as a high
success rate, it means that at least one revision is needed in 13-3\% of
the surgeries. According to the available data,revision surgeries are
generally more difficult to perform and their audiological results are
inferior to primary surgeries(3).The prevention of primary failureseems
to be themost favorable optionto achievesuperior results.Revision
surgeries offerthe opportunity to recognize the exact reasons behind
unsatisfactory results. According to previous data, intratympanic
adhesion formation is one of the most common finding during revisions(4,
5), but its influence on the hearing results is not clearyet.Our goal
was to indentify the most common and most influential postoperative
reasons during our revison surgeries, causing persistent ABG. We focused
on the mechanical dysfunctions in the middle ear, with special regard to
postoperative fibrosis formation. Our hypothesis wasthat postsurgical
inflammation and scar tissue formation in the middle ear could be the
main reason behind compromised ABG gain.

\emph{Materials and methods:}

\emph{Compliance with Ethical Standards:}

\subsubsection*{Conflict of interest}

{\label{conflict-of-interest}}

The authors declare that they have no conflict of interest.

\textbf{Ethical approval}

This research was approved by '{[}removed for blind peer review{]}.For
this type of study, formal consent is not required.

\emph{Patients:} A retrospective case series study of 25revision
stapedotomy was performed. The surgeries were carried out between
2013-2020,at the Department of Oto-Rhino-Laryngology, Head and Neck
Surgery {[}removed for blind review{]}. The indication for revision was
10 dB or higher persistent ABG-PTA. The presumed preoperative clinical
diagnosis of stapes fixation before primary intervention was made by PTA
testing, tympanometry, stapedius reflex, and physical examination, and
was confirmed with palpation during the surgery. Out of the 25 cases, 7
patients were male and 18were female, with an average age of 50.52
(SD11.5) years.

\emph{Surgical technique:} In all of the cases, the same standardized
surgical approach was applied and performed by the same senior surgeon.
After an endaural approach, the posterior TM flap was lifted, and the
cause of failure was verified by the palpation of the ossicular chain
andwith microscopic examination. According to the intratympanic
findings, prosthesis replacement orrepositioning was performed, and
adhesions were removed. Infive cases, malleovestibulopexy wasperformed.
Stapedectomy was performed in one case only, otherwise, small fenestra
technique was preferred.

The prosthesis loop was bridged with a small connective tissue to
prevent the slipping and necrosis of the long process. The TM flap was
restored, meatal incisions were overlaid with sterile silicone sheets,
and the ear canal was stuffed with ofloxacin-impregnated absorbable
hemostatic gelatin sponge (Spongostan) pieces. The incision was closed
with sutures.

The length of the applied prosthesis was 4.5mm in 56\%, 5mm in 8\%,and
6mm in 20\% of the cases, with a diameter of 0.4mm in 32\% and 0.6mm in
52\%. The majority (52\%) of the applied pistons were Schuknecht
fluoroplastic, stainless, slim shaft wire pistons (Gyrus Acmi, USA),
Richards Platinum Fluoroplastic Pistons (Olympus, Japan) were applied in
32\% of the cases. In the remaining surgeries the originalpistons were
used(16\%).

\emph{Methods:}

In all the cases, the exact reason behind theunsatisfactory primary
results and the surgical solution was noted. Intratympanic problems were
classified based on whetherthe failure was related to scar tissue
formation (periprosthetic adhesion, ossicular chain fixation)or any
other specific surgery-related complication (LPI necrosis, prosthesis
dislocation, ossicular luxation etc.). Fibrosis was considered as the
main reason if it was the only finding during surgery.

The average postoperative follow-up time was 147 days (SD 155.7; range
28-614), which could be considered as a reliable indicator of the
long-term results(6).

The AC levels were measured at 0.125; 0.25; 0.5; 1; 2;4; 8kHz, and the
BC were registered at 0.25; 0.5; 1; 2;4kHz. Evaluation was done
according to the Committee on Hearing and Equilibrium guidelines of the
American Academy of Otolaryngology Head and Neck Surgery (AAO-HNS) (1).
The thresholdswere reported, and the extended pure tone average was
calculated from 0.5; 1; 2; 3 kHz frequencies. The 3 kHz values were
considered as the mean of 2 and 4 kHz (7). The ABG was calculated from
same-time measurements. These data were retrospectively analyzed
statistically (IBM SPSS v. 25., Armonk, New York, USA) to define
descriptive data and the difference between types of surgical
failure.BootstrappedIndependent Samples t-test was used for analyzing
group differences, while intervention success was examined with Paired
Samples t-test. TOST test with the effect size of '1'was used to
determine equivalence and non-inferiority(TIBCO Statistica). The
statistical significance level was p<\selectlanguage{english}0.05.

\emph{Results:}

Fig1. The average postoperative AC-PTA was 46.4dB, which is
significantly better compared to the61.5dB preoperative value. ABG-PTA
also significantly improved after the surgical intervention:15.9dB vs
31.1dB. No significant difference could be seen between pre- and
postoperative BC-PTAs, 30.4dB vs 30.5dB.The minimum of 30dB AC-PTA was
achieved in 44\% of the cases. In 56\%, at least 10 dB ABG gain was
achieved, while the 10dB or better ABG closure was 44\%, ABG closure
between 10-20dB prevailedin 20\%. Fig2 Intratympanicfibrosis wasthe most
common finding during revision; with a prevalence of 64\%, in 32\% it
was the main reason behind compromised ossicular chain mobility. In the
remaining 36\%,the main problem was due to surgical failures. The most
common prosthesis-related complication was the disconnection between the
piston loop and the LPI. Both fibrosis and surgical failure was noticed
in 32\% (fig2). According tofig2, the highest hearing gains were
accomplished in cases where the cause of failure was LPI-prothesis
disconnection, while in the cases with adhesions as the primary cause of
failure, the hearing gains were the lowest. Fig3

Althought in the presence of intratympanic fibrosis mean ABGgain and
hearing gain was lower compared to other cases (fig3a), no statistically
significant difference could be found (p=0,087;p=0.095). On this
basis,TOST test was performed to determine equivalence. Concerning
hearing gain and ABGgain,equivalence was rejected, and the
non-inferiority of the intratympanic fibrosis associated negative effect
was shown compared to the other group(p=0.94 upper tailed; p=0.037 lower
tailed and p=0.94; p=0.03 respectively).

There was no statistically significant difference between preoperative
(after primarystapes surgery) ABG and AC PTA levelsacross 'fibrosis' and
'no fibrosis' groups (fig3b) (p=0.44 and p=0.96 respectively).

\emph{Discussion:(4)}

\emph{Primary findings:} Revision stapedotomy is avaluable treatment
option in case of unsatisfactory hearing results after primary
stapedotomy.However, our results -- in consensus with other data -- show
that audiological outcomes in these cases are still inferior to primary
surgeries.From this standpoint, the efficacy of the first operation is
extremely importantin stapes surgery.

The experience duringrevision surgeries could be helpful in
understanding the reasons behind unsatisfactory results. In our series,
periprosthetic adhesions were the leading cause behind mechanical
failures.Adhesive processes were not only very common, their negative
impact on hearing results was the same as that of any other
prosthesis-related complication. Furthermore,after revision surgery, in
the presence of intratympanic adhesions,audiological resultswere not
superiorcomparedto theremaining cases. The difficulty of managing
patients with adhesions was described previously in the literature(4).

This finding highlights the importanceof the most atraumatic surgical
technique, the preservation of intact intratympanic mucosa, and the
prevention of post-surgical scar tissue formation.

Using perioperative corticosteroid treatment to prevent postoperative
fibrosis is already a topic of discussion(8). Our group was the first to
describethat the above adjuvant treatment contributes to a significantly
better ABG closure after primary CO\textsubscript{2}laser stapedotomy
compared to the control group(9).Our assumption was that
thiscontribution is manifested through the prohibition of scar tissue
formation.

\emph{}

\emph{Limitations:}

Due to the retrospective setting and the low number of cases, the
statistical power of this study islimited, which could explain why no
statistical difference,but non-inferiority was demonstrated.

The data represents the results of a single institution and a single
surgeon. Evaluation is based exclusively on subjective hearing tests,
however, pure-tone audiometry is still considered as the gold standard
for monitoring hearing outcomes after middle ear surgery.

\emph{Conclusion:}In our experience, revison stapedotomy is an efficient
treatment option in case of persistent ABG after primary surgery.
Periprosthetic fibrosis is the most common reason behindcompromised
audiological outcomes after stapedotomy. We also concluded that fibrosis
formation itself has at least the same negative effect on ABG
development as any other surgical failure, although revision could be
more challenging in such cases. According to these findings, the
exclusion of postoperative inflammatory reactions in the middle ear are
mandatory for optimal results. The role of perioperative corticosteroid
treatment could play a major role in this process. Further investigation
is recommended concerning this topic.

1. Committee on Hearing and Equilibrium guidelines for the evaluation of
results of treatment of conductive hearing loss. AmericanAcademy of
Otolaryngology-Head and Neck Surgery Ffoundation, Inc. Otolaryngol Head
Neck Surg. 1995;113(3):186-7.

2. Vincent R, Sperling NM, Oates J, Jindal M. Surgical findings and
long-term hearing results in 3,050 stapedotomies for primary
otosclerosis: a prospective study with the otology-neurotology database.
Otol Neurotol. 2006;27(8 Suppl 2):S25-47.

3. Magliulo G, Cristofari P, Terranova G. Functional hearing results in
revision stapes surgery. Am J Otol. 1997;18(4):408-12.

4. Pedersen CB. Revision surgery in otosclerosis--an investigation of
the factors which influence the hearing result. Clin Otolaryngol Allied
Sci. 1996;21(5):385-8.

5. Kanona H, Bhutta MF, Lavy J. Our approach to revision stapes surgery
and the outcomes from 49 procedures at a UK tertiary centre. Clin
Otolaryngol. 2017;42(4):931-5.

6. Andersen SA, Ohman MC, Sorensen MS. The stability of short-term
hearing outcome after stapedotomy: a prospective database study. Acta
Otolaryngol. 2015;135(9):871-9.

7. Gurgel RK, Popelka GR, Oghalai JS, Blevins NH, Chang KW, Jackler RK.
Is it valid to calculate the 3-kilohertz threshold by averaging 2 and 4
kilohertz? Otolaryngol Head Neck Surg. 2012;147(1):102-4.

8. Li J, Heinz C, Zurek-Imhoff B, Heiligenhaus A. Intraoperative
intraocular triamcinolone injection prophylaxis for post-cataract
surgery fibrin formation in uveitis associated with juvenile idiopathic
arthritis. J Cataract Refract Surg. 2006;32(9):1535-9.

9. Szekely L, Gaborjan A, Danos K, Szaloki T, Fent Z, Tamas L, et al.
Mid-term evaluation of perioperative i.v. corticosteroid treatment
efficacy on overall and audiological outcome following CO2 laser
stapedotomy: a retrospective study of 84 cases. Eur Arch
Otorhinolaryngol. 2020;277(4):1031-8.\selectlanguage{english}
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