10.14639/0392-100X-N1705
Objective. The treatment of choice for Ménière disease (MD) aims at preventing severity and frequency of vertigo attacks. The purpose of this study was to evaluate the effectiveness of ventilation tube (VT) placement on vertigo control in patients affected by MD with no response to standard medical therapy.Methods. 76 consecutive outpatients diagnosed with definite MD who failed medical therapy received VT insertion at the Department of Otolaryngology Head and Neck Surgery, “Ospedale del Mare”, Naples, Italy, with a 3-year follow up.Results. Over the long term, VT placement was effective in controlling vertigo in 61.8% of patients. In the control group treated with standard preventive care (SPC) alone, all patients continued to experience recurrent vertigo during the entire study. Comparison of survival curves by using the log-rank test shows that significant differences in survival exist between subjects treated with VT placement and the control sample (p = 0.001).Conclusions. Our long-term follow-up confirms that VT placement is an effective and safe management option in intractable definite MD, especially in the elderly or in those refusing more invasive treatments.
text/xml
1827-675X
1705
en
Giuseppe Tortoriello
http://creativecommons.org/licenses/by-nc-nd/4.0
ACTA Otorhinolaryngologica Italica
ventilation tube
Symptom improvement after transtympanic tube placement in Ménière’s disease: preliminary observations
Text.Serial.Journal
https://www.actaitalica.it/
41
Vestibology
2021-11-05
2021-05-15
2021-11-02
2021-11-02
467-473
1
Giuseppe Tortoriello
2021/11/05
10.14639/0392-100X-N1705
467
UOC ENT Ospedale del Mare, Naples, Italy
1827-675X
ventilation tube
en
473
Symptom improvement after transtympanic tube placement in Ménière’s disease: preliminary observations
https://www.actaitalica.it/article/download/1705/683
41
ACTA OTORHINOLARYNGOLOGICA ITALICA 2021;41:467-473; doi: 10.14639/0392-100X-N1705




Vestibology


Symptom improvement after transtympanic tube
placement in Ménière’s disease: preliminary
observations
Miglioramento dei sintomi con tubicino trans-timpanico nella malattia di Ménière:
osservazioni preliminari
Vincenzo Marcelli1, Lucrezia Spadera1, Erica De Bernardo1, Giuseppe Barba1, Eugenio Martino1, Marcello Gentile2,
Giuseppe Tortoriello1
1
    UOC ENT Ospedale del Mare, Naples, Italy; 2 ENT Clinica Santa Patrizia, Naples, Italy


SUMMARY
Objective. The treatment of choice for Ménière disease (MD) aims at preventing severity
and frequency of vertigo attacks. The purpose of this study was to evaluate the effectiveness
of ventilation tube (VT) placement on vertigo control in patients affected by MD with no
response to standard medical therapy.
Methods. 76 consecutive outpatients diagnosed with definite MD who failed medical ther-
apy received VT insertion at the Department of Otolaryngology Head and Neck Surgery,
“Ospedale del Mare”, Naples, Italy, with a 3-year follow up.
Results. Over the long term, VT placement was effective in controlling vertigo in 61.8% of
patients. In the control group treated with standard preventive care (SPC) alone, all patients
continued to experience recurrent vertigo during the entire study. Comparison of survival
curves by using the log-rank test shows that significant differences in survival exist between
subjects treated with VT placement and the control sample (p = 0.001).                             Received: May 15, 2021
Conclusions. Our long-term follow-up confirms that VT placement is an effective and safe           Accepted: June 18, 2021
management option in intractable definite MD, especially in the elderly or in those refusing
more invasive treatments.                                                                          Correspondence
                                                                                                   Vincenzo Marcelli
KEY WORDS: Ménière, therapy, vertigo attacks, ventilation tube                                     via Difesa 102, 84043 Agropoli (SA), Italy
                                                                                                   E-mail: vincenzo.marcelli@hotmail.it
RIASSUNTO
                                                                                                   Funding
Obiettivo. Il trattamento della malattia di Ménière (MD) mira a prevenire gravità e fre-
                                                                                                   None.
quenza delle crisi di vertigine. Lo studio ha valutato l’efficacia del posizionamento del
tubicino di ventilazione (VT) trans-timpanico nel controllo delle vertigini nei pazienti affetti
                                                                                                   Conflict of interest
da MD non responsivi alla terapia medica standard.                                                 The Authors declare no conflict of interest.
Metodi. 76 pazienti con diagnosi di MD definita non responsivi alla terapia medica sono
stati trattati con posizionamento del VT presso l’UOC ORL dell’Ospedale del Mare, Napo-
li, Italia, con un follow-up di 3 anni.                                                              How to cite this article: Marcelli V, Spadera L,
Risultati. Il posizionamento del VT si è dimostrato efficace nel controllare le crisi di verti-      De Bernardo E, et al. Symptom improvement af-
gine nel 61,8% dei pazienti. Nel gruppo controllo, sottoposto alla sola terapia preventiva           ter transtympanic tube placement in Ménière’s
                                                                                                     disease: preliminary observations. Acta Otorhi-
standard (SPC), tutti i pazienti hanno riportato persistenza di crisi di vertigine ricorrente
                                                                                                     nolaryngol Ital 2021;41:467-473. https://doi.
durante l’intero periodo di studio. Il confronto delle curve di sopravvivenza mediante log-          org/10.14639/0392-100X-N1705
rank test ha evidenziato differenze statisticamente significative nella sopravvivenza tra i
soggetti trattati con VT e il campione di controllo (p = 0,001).                                   © Società Italiana di Otorinolaringoiatria
Conclusioni. I nostri risultati confermano che tale procedura può rappresentare il tratta-         e Chirurgia Cervico-Facciale
mento di scelta nella gestione efficace e sicura di tali soggetti, specialmente se anziani o
che rifiutino trattamenti più invasivi.                                                                           OPEN ACCESS
PAROLE CHIAVE: Ménière, terapia, crisi di vertigine, tubicino di ventilazione                      This is an open access article distributed in accordance with
                                                                                                   the CC-BY-NC-ND (Creative Commons Attribution-Non-
                                                                                                   Commercial-NoDerivatives 4.0 International) license. The
                                                                                                   article can be used by giving appropriate credit and mentio-
                                                                                                   ning the license, but only for non-commercial purposes and
                                                                                                   only in the original version. For further information: https://
                                                                                                   creativecommons.org/licenses/by-nc-nd/4.0/deed.en




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V. Marcelli et al.




Introduction                                                      Despite these interesting and promising premises, none of
                                                                  these methods has ever entered the routine treatment of MD
Several studies reported improving symptoms in patients
                                                                  refractory to drug therapy. The reasons can be attributed,
with Ménière’s disease (MD) 1-5 and an inhibiting effect on
                                                                  for example, to the small number of patients subjected to
the development of endolymphatic hydrops 6 by transtym-
                                                                  this treatment, to the limited follow-up of these patients and
panic ventilation tube (VT) placement.
                                                                  to the hypothetical side effects of the method (in particular,
Tumarkin in 1966 1 suggested that Eustachian tube obstruc-
                                                                  predisposition to middle ear infections).
tion may in some cases start a chain of events leading to
                                                                  On this basis, we thought that our patients who are refrac-
MD, and insertion of a grommet may lead to the arrest of
                                                                  tory to therapy could be treated with transtympanic ventila-
this course of events or even to its reversal; in his paper, he   tion tube placement to provide a release of middle ear pres-
came to the suggestive conclusion that: “brings us in head-       sure and to prevent externally provoked inner ear pressure
on conflict with the widely accepted belief that MD is pure-      changes, before proceeding with more invasive treatments.
ly and exclusively an inner-ear syndrome”. While doubt-           On this basis, we decided to recruit a significant number
ing the long-term results, rather smaller than with the other     of patients refractory to therapy, to treat them with tran-
more destructive surgical treatments, in 1969 Lall 2 wrote        stympanic ventilation tube placement to provide a release
that “the relative ease, speed and safety of this procedure       of middle ear pressure and to prevent externally provoked
are important factors and suggest that it may be worthwhile       inner ear pressure changes and perform long follow-up, be-
to try the grommet operation as an initial step in surgical       fore proceeding with more invasive treatments.
management”. In 1988, Montandon et al. 3 report that “the
insertion of a transtympanic ventilation tube prevented the
occurrence of vertiginous attack in 82% of a series of 28         Materials and methods
patients suffering from typical Ménière syndrome with in-         This is a prospective study from January 2017 to December
capacitating vertigo resistant to medical treatment”. With a      2019 including 76 outpatients who were seen in clinical
more limited sample, Sugawara et al. 4 also concluded that        consultation at the Department of Otolaryngology Head
“this treatment might represent a short-term effect for the       and Neck Surgery, “Ospedale del Mare” Hospital, Naples,
reduction of persistent vertigo in some patients with MD          Italy, with a clinical diagnosis of unilateral definite MD,
and so it might become a treatment option because of its          according to the AAO- HNS criteria 10. We recruited 76 pa-
simple and less-invasive procedures”. On the other hand, in       tients (26 males, 50 females) with no response to medical
2008 Dornhoffer and King 5 demonstrate that the use of the        therapy for at least 6 months (Tab. I). All patients, aged
Meniett device, a small, portable, low-pressure pulse gen-        from 37 to 74 years (mean age 51 years), had been suffer-
erator, “may be used to provide longer-term reduction of          ing MD for a pre-operative period ranging from 9 to 34
vestibular symptoms in patients with MD”. Finally, Kimura         months. The affected ear was the left in 32 patients (42.1%)
and Hutta 6 in 1997 demonstrated that “middle ear venti-          and the right in 44 patients (57.9%). Exclusion criteria were
lation procedures mechanism significantly reduced the             history of inflammatory middle ear disease, middle ear sur-
subsequent development of endolymphatic hydrops” and              gery, vestibular migraine, according to the updated diag-
that “the inhibition of hydrops was presumed to be due to         nostic criteria 11, high-resolution CT scanning abnormality
pressure release into the middle ear and/or improved oxy-
genation of the middle and inner ears. Findings suggest the
possible merit of a tympanostomy as a treatment for MD in         Table I. Intractable MD patient demographics.
carefully selected patients refractory to medical manage-                                                     Pre-operative data
ment”.                                                                Total sample 8 (n.)                                      76
Although the aetiology of MD is not fully understood, the             Sex (M:F)                                              0.52:1
publications mentioned above are based on the fact that               Average age (yrs) ^                                    51 ± 9
pressure equalisation disorders within the compartments               Ear side (L:R)                                         0.73:1
of the inner ear are believed to play a major role in patho-          V-HIT n. (%) of pts with
physiology 7. External pressure has been shown to have an                hypofunction*                                      42 (55.3)
influence on the inner ear pressure 8, modulating cochlear               hyperfunction*                                     24 (31.6)
and vestibular hair cell function 9. Under certain conditions,           normal function*                                   10 (13.1)
middle ear pressure alterations might trigger the triad of            Pure tone average (dBHL) ^                           33.5 ± 3.9
symptoms by evoking pressure disturbances in the inner            ^
                                                                   Data are presented as the means ± standard deviation.* Data refer to the affected ear.
ear.                                                              MD: Ménière’s disease; M: male; F: female; L: left; R: right; yrs: years.




468
                                                                Definite Ménière’s disease and middle ear pressure: preliminary observations




of the temporal bone and 1.5 MRI abnormality of the brain.      ment on vertigo control, we also monitored a control sam-
All patients had undergone our routine preventive therapy       ple of 9 patients (average age 54.3 years; 5 women and 4
protocol (standard preventive care, SPC) for six months         males) who refused the surgical procedure and continued
with any success, as follows:                                   with SPC only.
• hyper hydric (two litres of water per day) and low in         To assess the changes of the hearing threshold, we con-
   sodium (< 1500 mg/day) diet;                                 sidered the average of bone conduction in pure tone au-
• betahistine 24 mg orally twice a day;                         diogram of 0.25, 0.5, 1 and 2 kHz. Hearing change (PTA)
• SPC flakes 1 gram per kg per day;                             defined as improved (gain of more than 10 dB), unchanged
• corticosteroid cycles for 8-12 days;                          (± 10 dB) or worse (loss of more than 10 dB) was consid-
• diuretic, glycerol phleboclysis at 10%, 500 cc slow drop,     ered clinically significant and was evaluated 7 days after
   according to the frequency of vertigo.                       surgery and once every 6 months for 3 years. All patients
Given the ineffectiveness of this protocol, all patients were   were free to present for immediate evaluation in the event
subjected to the insertion of Shepard-type ventilation tube     of sudden changes in the hearing threshold.
(VT) on the affected ear under microscopic control and lo-      The study protocol adheres to the principles outlined in the
cal anaesthesia following audiological and vestibular re-       Declaration of Helsinki.
valuation. However, the entire study sample continued the
therapy provided by our protocol for the two months fol-        Statistical analyses
lowing the surgical procedure.                                  We used Kaplan-Meier time-to-event methods to quantify
The pre-operative vestibular evaluation was performed           the percentages of subjects who would have adequate con-
with head impulse test (vHIT) (‘‘ICS Impulse’’ system; GN       trol of their vertigo using a particular definition of “fail-
Otometrics, http://www.icsimpulse.com.): the patient was        ure”. For all patients, we defined failure as requiring in-
asked to stare at an earth-fixed target (3-cm diameter spot     tratympanic gentamicin (IT) injections to control vertigo
located 1.5 m in front), then 20 horizontal impulses (10°-      or dropped out of the study for any reason. Time to failure
20° amplitude) were randomly administered for each side.        is measured in months, and patients were followed over a
A gain of vestibulo-oculomotor reflex (VOR) equal to or         period of up to 27.2 ± 13.5 months on average (ranging
lower than 0.79 and/or an asymmetry index (AI) between          from 1 to 36 months). Data were analysed using statisti-
the right and left sides greater than 25% were assumed as       cal packages for social sciences (SPSS), version 26 (SPSS
pathological.                                                   Inc., Chicago, IL, USA).
The audiological assessment included otomicroscopy, pure
tone audiometry by air and bone conduction, tympanom-
                                                                Results
etry and acoustic reflex threshold.
The treatment outcomes, vertigo and hearing, were evalu-
ated according to AAO-HNS criteria 12.                          Otological conditions
The frequency of vertigo attacks experienced during the 6       Medical history did not show any previous pathologies af-
months before treatment was compared with the number            fecting the middle ear, and otomicroscopy was normal in
of attacks experienced between 6 months and 12 months           all patients. The tympanogram showed normal compliance
(1-year follow-up), between 18 and 24 months (2-year fol-       of the tympanic membrane and the middle ear compart-
low-up), and between 30 and 36 months (3-year follow-up)        ment (type A tympanogram) and in most patients acoustic
after treatment. In order to express the effect of treatment    reflexes were present and suggestive of the presence of re-
on vertigo attacks, a numeric value was calculated as here:     cruitment.
the average number of definitive attacks per month after
ventilation tube placement was divided by the number that       Vertigo control
occurred prior to ventilation tube placement. Control of ver-   Before the insertion of the VT, 42 patients (55.3%) present-
tigo, as determined by the numeric value, was categorised       ed vestibular hypofunction of the affected ear (at least one
as follows: 0 = A, complete control; 1-41 = B, substantial      semicircular canal presented a deficit of the dynamic gain
control; 41-80 = C, limited control; 81-120 = D, insignifi-     of the VOR evaluated with the vHIT), 24 patients (31.6%)
cant control; > 120 = E, worse (poor) control; F, secondary     showed normal vestibular function of the affected ear and
treatment initiated because of vertigo-related disability.      10 patients (13.1%) showed a vestibular hyperfunction of
The patient was always free to present for immediate evalu-     the affected ear (at least one semicircular canal presented
ation in the event vestibular symptoms recur.                   a dynamic gain of the VOR above the norm evaluated with
In order to better evaluate the clinical impact of VT place-    the vHIT) (Tab. I).



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V. Marcelli et al.




                                                                                  Comparison of survival curves by log-rank test showed that
                                                                                  statistically significant differences in survival exist between
                                                                                  subjects treated with VT placement and patients receiving
                                                                                  SPC alone (control sample) (p = .001) (Fig. 2). The overall
                                                                                  drop-out rate was 17.2%.
                                                                                  More specifically, at an average of 5 months after insertion
                                                                                  of the VT, 10 patients of 76 (13.1% of the initial sample)
                                                                                  showed inadequate control of symptoms and required IT
                                                                                  gentamicin administration, which led to vertigo control.
                                                                                  At 12 months after treatment, the sample consisted of
                                                                                  66 patients. 54 patients (73.7% of the initial sample) had
                                                                                  complete control of vertigo (Category A) and 12 patients
                                                                                  (15.8%) substantial control (Category B). In 7 patients of
                                                                                  both categories (9.2%), 5 of Category A and 2 of Category
Figure 1. Control of vertigo attacks following ventilation tube placement ac-     B, vertigo attacks reappeared on an average of 8 months
cording to AAO-HNS criteria: short-, medium-, and long-term results.
                                                                                  after the application of the VT. At the control, the VT was
                                                                                  blocked and the symptoms disappeared after its cleaning.
Over the long term, VT placement was effective in con-                            At 24 months, 4 patients of 66 (5.3% of the initial sam-
trolling vertigo sufficiently to avoid IT gentamicin treat-                       ple) were no longer present: 3 patients did not show up for
ment in 47 of 76 patients (61.8%). More specifically, at                          follow-up at 18 months and 1 for follow-up at 24 months.
the end of 36-month follow-up, 36 patients (47.3%) had                            At an average of 17 months after insertion of the VT, 5 pa-
complete (Category A) vertigo control, with an additional                         tients of 62 (6.6%) showed the reappearance of symptoms
14.5% (N = 11) achieving substantial (Category B) control                         and after 4 months on average underwent IT gentamicin
(Fig. 1). The remaining 21.0% of 76 patients required IT                          treatment, which led to control of the vertigo.
gentamicin injections to treat recurrent vertigo at an aver-                      57 patients (75.0%) still showed Category A or B symp-
age of 10.6 ± 9.5 months (range: 2-30 months). In the con-                        tomatology (A = 49, 64.5%; B = 8, 10.5%). In 11 patients
trol group treated with SPC alone, all patients continued to                      of these two categories (14.5%, 8 patients of Category A
experience recurrent vertigo over the entire study period,                        and 3 of Category B) vertigo attacks reappeared on aver-
but only 3 accepted to receive IT gentamicin treatment with                       age at 17 months after VT placement. In 3 patients, the VT
subsequent symptoms relief (Fig. 2).                                              presented an occlusion while in 8 patients it spontaneously
                                                                                  fell out. The symptoms disappeared after cleaning the tube
                                                                                  and positioning a new one.
                                                                                  At 36 months, 9 patients of 57 (11.8%) were no longer pre-
                                                                                  sent. 3 did not show up for follow-up at 30 months and the
                                                                                  other 6 for follow-up at 36 months.
                                                                                  At 28 months after VT placement, only 1 patient of 57
                                                                                  (1.3%) showed reappearance of symptoms and after 2
                                                                                  months, received IT gentamicin administration, which led
                                                                                  to control of the vertigo.
                                                                                  Complete vertigo control (Category A) was achieved in
                                                                                  36 patients (47.4%) and substantial control (Category B)
                                                                                  was accomplished in 11 patients (14.5%). These patients
                                                                                  observed a hyper hydric and low-sodium diet and only in
                                                                                  very rare cases was it necessary to resort to symptomatic or
                                                                                  preventive drugs.
     SPC: Standard Preventive Care; VT: Ventilation tube.                         A more detailed description of the data is shown in Table II.
                                                                                  As for the control sample, 3 patients (including a fireman)
Figure 2. Kaplan-Meier “survival” plot after VT placement. The green curve        of 9 (33.3%) decided to undergo IT gentamicin 8 months
indicates the percentage of patients remaining on VT for vertigo control over
time after its insertion. The lowermost blue curve indicates survival following
                                                                                  on average after starting therapy; all were no longer dizzy.
SPC alone. Failure is defined as requiring IT gentamicin treatment for vertigo    The remaining 6 patients (66.7%) continued not to respond
control and as dropped out of the study.                                          to routine therapy.



470
                                                                              Definite Ménière’s disease and middle ear pressure: preliminary observations




Table II. Outcomes of VT placement.
 Patients (n = 76)                                         1-year follow-up                 2-year follow-up                   3-year follow-up
                                                             6-12 months                      18-24 months                       30-36 months
 Category A                                                   54 (73.7%)                        49 (64.5%)                        36 (47.4%)
 Category B                                                   12 (15.8%)                         8 (10.5%)                        11 (14.5%)
 IT gentamicin                                                10 (13.1%)                         5 (6.6%)                          1 (1.3%)
 Drop-out                                                      0 (0.0%)                          4 (5.3%)                         9 (11.8%)
 Total                                                        76 (100%)                         66 (86.8%)                        57 (75.0%)
IT: intratympanic; VT: ventilation tube.



Changes in hearing                                                            (41.7%), which was resolved by cleaning in all cases. Six
At 6-12 months after treatment, there was no hearing change                   patients (25.0%) had to follow local therapy following in-
in any patient (Fig. 3). At 18-24 months after treatment,                     flammation and secretion of the treated ear, without any
hearing was unchanged in 51 (89.5%) of 57 patients and                        consequence in auditory or vestibular function. In the other
was worse in the remaining 6 (10.5%). At 30-36 months of                      patients (N = 8, 33.3%), the VT spontaneously fell out after
treatment, hearing was unchanged in 32 (68.1%) of 47 pa-                      17 months on average and a new ventilation device in the
tients and was worse in 15 (31.9%). There were no patients                    same ear replaced the previous one in all cases.
who showed improved hearing levels.                                           At present, follow-up is still active and we are still enroll-
                                                                              ing patients.
Tinnitus and fullness
In none of the treated patients was there significant reduc-                  Patient compliance
tion in the perception of tinnitus, probably a sign of a chron-               Despite the inevitable limitations caused by VT (swim-
ic and clearly irreversible degeneration of the hair cells and                ming, bathing in the sea, shower), no patient reported being
a mechanical distortion of the transduction mechanisms.                       particularly affected by the procedure.
On the other hand, 31% of patients (13 of 42 patients) re-
ported at least partial reduction in fullness, a phenomenon                   Discussion
attributed to the reduction of the pressure load on the inner                 To our knowledge, this is the first work involving a large
ear guaranteed by VT and to a more general improvement                        number of patients with long-term follow-up.
in the homeostasis of the inner ear.                                          Overall, 36 months after VT placement, 62% of patients
                                                                              suffering from unilateral definite MD not responding to
Adverse events                                                                medical therapy had excellent symptomatic control, with-
In the VT group, adverse events occurred in 24 cases                          out negative effects on the hearing threshold and without
(31.6%), with VT blockage being the most common event                         particular side effects.
                                                                              The pathophysiological mechanisms underlying these ex-
                                                                              cellent results are still unclear and we believe this could
                                                                              be one of the reasons why this procedure is not commonly
                                                                              performed. Tumarkin 1 hypothesised that endolymphatic
                                                                              hydrops in MD developed by blockage of the eustachian
                                                                              tube, creating a negative pressure in the middle ear and
                                                                              causing a suction effect on the endolymphatic system in the
                                                                              inner ear with an incompetent cochlear aqueduct. Even if
                                                                              this hypothesis was confirmed by Lall 2, who reported that
                                                                              50% of patients had good symptom control, Cinnamond 13
                                                                              and Hall and Brackmann 14 subsequently considered the
                                                                              hypothesis unfounded and the treatment useless. More re-
                                                                              cently, Montandon et al. 3 treated 28 intractable patients
                                                                              with ventilation tubes and showed improvement or a com-
Figure 3. Changes in hearing level following ventilation tube placement:
short- medium- and long-term results. Patients dropped out of the study or    plete remission of vertiginous attacks in 23 patients (82%),
underwent secondary treatment with IT gentamicin were excluded.               showing that the ears of these patients were sensitive to



                                                                                                                                                    471
V. Marcelli et al.




pressure changes, with symptoms improved by proper mid-           which is well known in the treatment of MD. However, in
dle ear ventilation. Interestingly, these authors reported a      our work, we believe that we can definitively exclude it:
recurrence of vertigo attacks in 15 (53.6%) patients whose        patients who spontaneously returned to our observation due
VT became obstructed or extruded and the disappearance            to the reappearance of the vertiginous syndrome could not
of attacks immediately after the reinsertion of a VT. Ogawa       have been aware that the VT had been occluded or had been
et al. 15 showed similar good results in 15 patients: com-        extruded, as later demonstrated during the check-up.
plete control of vertigo in three patients and substantial
control in seven patients at one year, and complete control       Limitations and further research
in seven patients and substantial control in three patients at    The limitations of our study are represented by the limited
two years. These authors also reported recurrence of ver-         number of patients and by the follow-up which, despite
tigo attacks when the tube became obstructed or extruded          having reached three years, cannot yet guarantee a very
and the disappearance of attacks after the VT was replaced.       long-term efficacy, considering that the disease has phases
What are the hypotheses that can explain these encourag-          of long spontaneous remissions.
ing results? Park et al. 16 showed in a sample of 22 patients     Our hope is that our work will be continued and carried on
that the relief of vertigo cannot be attributed to improved       by other centres as well, to increase the number of patients
canal-dependent VOR function or to improved saccule               treated, evaluate the results and allow longer follow-up. In
function. Kimura and Hutta 6 demonstrated that middle-ear         this way, it will be possible to better clarify aspects of the
ventilation procedures significantly reduced experimen-           pathophysiology of MD and confirm the role of pressure
tally induced endolymphatic hydrops in guinea pigs and            equalisation within the compartments of the inner ear.
the authors attributed this result to pressure release into the
middle ear and/or improved oxygenation of the middle and
inner ears. In humans, middle ear pressure is positive in         Conclusions
the morning and during sleep 18,19: VT placement into the         The large number of patients with long-term follow up al-
middle ear should decrease middle ear pressure to an am-          low us to consider the results obtained as particularly reli-
bient pressure level 20 reducing perilymph and endolymph          able. We believe that VT placement represents an effective
pressures 21,22 and the development of hydrops. Other pos-        and safe management option for intractable MD and we
sible indications derive from the well-known “alternobaric        consider it as a first choice therapy, especially in patients
vertigo” experienced by up to 5% of otherwise healthy             who do not want to undergo more invasive treatments.
subjects 23: the effect of the variation of the atmospheric
pressure can clearly be greater in the presence of hydrops
and a circulatory insufficiency in the inner ear caused by
                                                                  Acknowledgements
overpressure is also suggested. On the other hand, the hy-        The author would like to thank Elisabetta Cristiano, Anto-
dropic inner ear may be hypoxic, resulting in increases in        nio Giannone and Domenico D’Errico for their friendship
endolymphatic pressure 24. VT placement into the middle           and cooperation.
ear should improve the oxygen supply to the middle and
inner ears and may re-energise and restore some function-         References
ing of the stria vascularis and spiral ligament cells and thus
                                                                  1
                                                                      Tumarkin A. Thoughts on the treatment of labyrinthopathy. J
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                                                                      Lall M. Ménière’s disease and the grommet [a survey of its therapeutic
baric oxygen pressure chamber supposedly due to an in-                effects]. J Laryngol Otol 1969;83:787-791. https://doi.org/10.1017/
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                                                                      Montandon P, Guillemin P, Hausler R. Prevention of vertigo in
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toration of Na+/K + pumps in the inner ear 25. Fujita et al. 17       ORL J Otorhinolaryngol Relat Spec 1988;50:377-381. https://doi.
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