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Eur Arch Otorhinolaryngol (2016) 273:607–613

DOI 10.1007/s00405-015-3602-0

OTOLOGY

First results of Endonasal dilatation of the Eustachian tube (EET)


in patients with chronic obstructive tube dysfunction
Carsten V. Dalchow1 • M. Loewenthal1 • N. Kappo1 • F. Jenckel1 • B. B. Loerincz1 •

R. Knecht1

Received: 20 November 2014 / Accepted: 8 March 2015 / Published online: 19 March 2015
Ó Springer-Verlag Berlin Heidelberg 2015

Abstract For years, several surgical and non-surgical Chronic obstructive tube dysfunction  Tubomanometry 
therapeutic strategies in Eustachian tube dysfunction have Ear-related symptoms
been described. The Endonasal dilatation of the Eustachian
tube (EET) utilising a balloon catheter is a feasible option
in patients with symptoms of chronic obstructive Eus- Introduction
tachian tube dysfunction. However, long-term results in a
large series are missing. In a prospective case series, 217 The prevalence of Eustachian tube dysfunction in adults is
patients (342 cases) with symptoms of chronic Eustachian approximately 1 % [1]; this can cause considerable and
tube dysfunction underwent uni- or bilateral EET at the chronic discomfort with feeling of fullness in the ear,
ENT Department of the University of Hamburg, Germany, snapping and clicking noise, otalgia, hearing loss, vertigo,
between September 2010 and April 2013. A tube score recurrent otitis media and even cholesteatoma. Patients
consisting of the type of tympanogram and the R value of often report of problems performing a Valsalva manoeuvre
the tubomanometry was used to evaluate pre- and postop- or difficulties with barometric changes. Nearly 40 % of the
erative tube function. All patients underwent follow-up children under the age of 10 years suffer from temporary
with a post-operative interval of 3–12 months. The mean Eustachian tube dysfunction [1], predominantly caused by
value of the pre-treatment tube score was 2.23 ± 1.147 and adenoid hyperplasia and mucosal swelling due to infec-
significantly improved to 2.68 ± 1.011 1 year after EET. tions. Other reasons for chronic dysfunction include upper
There was a significant increase in the tube score during respiratory tract infections, chronic or allergic rhi-
follow-up. The co-variables time period, tympanoplasty nosinusitis, nasal obstruction, laryngopharyngeal reflux,
and pressure range showed a significant impact on the tube anatomic conditions and nasopharyngeal pathologies [2–4].
score. EET is a minimally invasive and effective treatment Although several diagnostic procedures and therapeutic
of chronic obstructive tube dysfunction. It is a safe pro- strategies have been described in the past [5], applicable and
cedure without causing significant complications. Never- effective methods are still missing. A detailed anamnesis and
theless, long-term results of larger, placebo-controlled an in-depth ENT examination with otoscopy is one of the
multicentre studies are needed to confirm its effectiveness. most important steps to gain information about the ventila-
tory function of the system. However, a tympanic membrane
Keywords Endonasal dilatation of the Eustaschian tube that appears normal does not exclude a Eustachian tube
(EET)  Balloon dilatation of the Eustachian tube (BET)  dysfunction. Furthermore, the otoscopy should be combined
with the Valsalva and Toynbee manoeuvre. The tympa-
nometry is another available instrument that is routinely used
& Carsten V. Dalchow in the clinical setting. Other methods like imaging of the
c.dalchow@uke.de Eustachian tube with MRI and CT scans or fluoroscopy [6–
1 8], transtympanic and transnasal endoscopy (photo-
Department of Otorhinolaryngology, University Medical
Centre Hamburg-Eppendorf (UKE), Martinistrasse 52, tubometry) and catheterisation of the tube [9–11], sono-
20246 Hamburg, Germany tubometry [12], inflation–deflation test [13] and the use of

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pressure chambers [14] are quite sophisticated techniques underwent uni- or bilateral Endonasal dilatation of the
with only a little additive informative value. A new and Eustachian tube (EET) at the ENT Department of the
practicable Eustachian function test is the modified tubo- University of Hamburg, Hamburg-Eppendorf, Germany,
manometry by Estève, first described in 2001 [15]. In con- between September 2010 and April 2013. A total of 342
trast to the other methods mentioned, it can give information EETs (167 left and 175 right ears) were performed. Re-
about the Eustachian tube function in either intact or defec- vision surgery procedures were excluded. The patients’
tive tympanic membranes. Beside otoscopy and tympa- informed consent has been obtained regarding their in-
nometry, tubomanometry by Estève is the currently routinely clusion and evaluation of their results in this prospective
used diagnostic tool before surgical intervention. Tube scores case series. In 124 cases, a tympanoplasty was performed
including swallowing, Valsalva manoeuvre, otomicroscopy before or during EET. The patient cohort consisted of 98
and the results of tubomanometry [16, 17] as well as ques- women (45.2 %) and 119 men (54.8 %), with a median
tionnaires like the ETDQ-7 [18] were developed to assess age of 45.58 ± 19.67 years (range from 6 to 88 years).
Eustachian tube dysfunction value before and after treatment. Patients were questioned about subjective ear pressure
As for the different Eustachian tube function tests, the and feasibility of performing a Valsalva manoeuvre via a
range of treatment is wide and goes from observation to visual analogue scale from 0 (minimum) to 10 (max-
pharmacological and surgical options. Poe and Gopen [19] imum). All patients underwent clinical ENT examination
determined a mucosal oedema of the Eustachian tube ori- including endoscopic nasopharyngoscopy with examina-
fice in 83 % of patients with tube obstructive complaints, tion of the Eustachian tube orifice and otomicroscopy with
but a recent randomised, placebo-controlled trial showed performance of the Valsalva and Toynbee manoeuvre.
that the use of steroid nose spray over 6 weeks could not Pure tone audiometry, tympanometry and the tubo-
improve Eustachian tube function in patients with otitis manometry (TMM) by Estève completed diagnostic in-
media with effusion or negative middle ear pressure com- vestigation. Tympanogram types were classified as
pared to placebo [20]. proposed by Jerger (type A, B and C). A special tube
Several surgical attempts have been made to improve score consisting of the type of tympanogram and the
Eustachian tube function. Myringotomy and tympanosto- R value of the TMM was used to evaluate pre- and
my tubes can equalise the negative middle ear pressure but postoperative tube function (Table 1). Clinical and au-
do not address the real cause of dysfunction. Repeated tube diological examinations were repeated on the first post-
insertion or long-acting tubes are often needed in chronic operative day, after 1 month and after 3, 6, 9 and
dysfunction and present a persistent risk for inflammation, 12 months at our department.
permanent perforation, tympanosclerosis and even choles- Before surgery, all patients received a digital volume
teatoma. Poe identified a 5-mm long segment of the tubal tomography (DVT) of the temporal bone once to recognise
lumen directly inferior to the bony cartilaginous isthmus as anatomical pathologies of the Eustachian tube and cranial
the cause for obstructive Eustachian tube dysfunction [21]. base and to identify possible internal carotid artery canal
The idea of temporarily dilating the cartilaginous portion of dehiscence close to the bony part of the Eustachian tube in
the Eustachian tube through the nasopharyngeal orifice the tubal lumen. Prior to EET, all patients received con-
using a flexible balloon catheter has emerged as a potential servative treatment such as detumescent nasal sprays with
therapeutic option in the clinical setting [17, 22]. In several or without cortisone, systemic cortisone treatment or tube
studies, improvements in dysfunction symptoms, perfor- training without improving their symptoms.
mance of Valsalva manoeuvre and tubomanometer scores
have already been observed [17, 18, 23, 24].
Table 1 Eustachian tube score
The purpose of this study was to present follow-up data
of patients with chronic Eustachian tube dysfunction R value Tympanogram type Score
treated with balloon dilatation between September 2010
0 B 0
and April 2013 at the ENT Department of the University of
C 1
Hamburg, Hamburg-Eppendorf, Germany.
A 2
\1 or1 B 2
C 3
Materials and methods
A 4
[1 B 1
Patient characteristics and preoperative data
C 2
A 3
In this prospective case series, 217 patients with symp-
toms of chronic obstructive Eustachian tube dysfunction 0 no tube opening, 4 regular tube opening

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Eur Arch Otorhinolaryngol (2016) 273:607–613 609

Tubomanometry ranging from 0 (no tube opening) to 4 (regular tube


opening). The scoring system was developed to compare
The tubomanometry (TMM) by Estève is a non-invasive pre- and postoperative results by statistical analysis.
method to determine the threshold pressure and the time
from nasal pressure application to the opening of the Endonasal dilatation of the Eustachian tube
Eustachian tube (Esteve 2001). Through a nasal adapter,
which occludes both nostrils, a pressure generator re- Dilatation of the fibrocartilaginous part of the Eustachian
leases controlled positive boluses of gas consisting of 30, tube was performed under general anaesthesia. Initially,
40 and 50 mbar. These pressure values correspond to a nasal mucosa was ebbed away with privin-containing
change of atmospheric pressure of 300, 400 and 500 tamponades. After removing the tamponades, the distal
altitude difference. While the patient swallows a bolus of part of the inflexible applicator containing the balloon
water, another pressure sensor in the external auditory catheter (Spiegel & Theiss, Overath, Germany) was placed
canal registers the pressure change by movement of the in the pharyngeal orifice of the Eustachian tube under vi-
tympanic membrane through the gas transport from the sual control with a 45° microendoscope. The catheter was
nasopharynx to the middle ear. Pressure curves measured then carefully and slowly moved forward into the tube until
both in the nasopharynx and in the external auditory an automatic attachment point. Insertion had to run easily
canal are demonstrated on a pressure–time diagram without any resistance. The balloon was blocked with
(Fig. 1). 0.9 % saline solution to a length of 20 mm and a width of
The time until the Eustachian tube opens is defined as 3.28 mm, to a maximum pressure of 10 bars for 2 min.
the opening latency index or R value: When correctly positioned, a fasciculation of the velum
P1 C1 could be observed. The procedure was finished by re-
R = C2 C1 = 0.56
R \ 1: regular opening of the Eustachian tube moving the catheter after pumping down the balloon.
R [ 1: delayed opening of the Eustachian tube After surgery, the patients received cefuroxim
R % 0: no opening of the Eustachian tube 2 9 500 mg (Cefuroxim SandozÒ, Sandoz Pharmaceuti-
cals GmbH, Holzkirchen, Germany) prophylactically for
Eustachian tube score 5 days and on the first postoperative day a single shot of
250 mg prednisolone (Solu-DecortinÒ H 250 mg, Merck
The score was calculated as the amount of the tym- Serono, Darmstadt, Germany) to reduce peri- and in-
panogram type (A, B or C by Jerger) and the R value tratubal mucosal swelling.

Fig. 1 Pressure–time diagram of the tubomanometry with pressure in pressure and relaxation of the velum, P1–P2 pressure generation
curves of the nasopharynx (lower curve) and the middle ear (upper time in the middle ear, P2–P3 pressure plateau in the middle ear with
curve). C1–C2 pressure generation time in the nasopharynx, C2–C3 maximal tympanic membrane movement, Eustachian tube is open,
pressure plateau in the nasopharynx, C3–C4 nasopharyngeal decrease P3–P4 middle ear decrease in pressure

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Statistical analysis The co-variables time period [6 months: p = 0.008; CI


(0.30; 1.97), 12 months: p = 0.003; CI (0.34; 1.66)] and
Results were documented in Excel (MS Office 2003) and tympanoplasty [p = 0.001; CI (0.64; 1.84)], as well as the
analysed using SPSS (SPSS Version 21, Inc., Chicago, factor pressure range [p = 0.001; CI (0.93; 0.19)], had a
Illinois, USA). A mixed model containing pressure range, significant impact on the tube score (Table 3). Patients who
availability of tympanoplasty and the time period as fixed underwent a tympanoplasty showed lower tube scores than
effects as well as patients as a random effect was used to patients without (Table 4). The tube score increased with
compare the results of the tube score pre- and postop- higher applied pressure during tubomanometry.
eratively. Significance level was defined as p \ 0.05 and Patients who did not show any improvement of symp-
confidence interval (CI) as 95 %. The tube score showed a toms or tube score underwent revision surgery. Revision
normal distribution. surgery was performed in 38 of 342 cases and was not
included in statistical evaluation.
Preoperative CT scans did not show any internal carotid
Results canal dehiscence or tubal abnormality.

Uni- or bilateral EET was performed in 380 cases (n = 217


patients, 98 females and 119 males) at the ENT department Discussion
of the University of Hamburg, Germany, between
September 2010 and April 2013. There were no peri- or A proper function of the Eustachian tube is necessary to
postoperative complications registered. None of the pa- equalise pressure between the middle ear and the atmo-
tients showed postoperative bleeding, emphysema, tinnitus, sphere. Otherwise, negative pressure in the middle ear can
vertigo or pain. In the follow-up period, no patulous Eus-
tachian tube could be observed.
The tube score was measured preoperatively (n = 202)
and postoperatively after 1 month (n = 175), 3 (n = 92), 6
(n = 43), 9 (n = 29) and 12 months (n = 19). The mean
value of the tube score was 2.23 (±1.147 SD) preoperatively
and significantly improved to 2.68 (±1.011 SD) 12 months
after surgery (Table 2). The tube score 1 month after surgery
(2.23 ± 1.147 SD) decreased under the pre-treatment tube
score (2.68 ± 1.011 SD), but then showed a significant in-
crease (p \ 0.05) during follow-up (Fig. 2). The highest tube
score (‘‘4’’) was mostly registered 12 months after surgery
(26.8 %; R \ 1 = 55.6 %) and fewest after 1 month
(13.4 %) (Table 2). The lowest tube score (‘‘0’’) was mostly
measured 3 months after surgery (8.8 %) and never appeared
after 12 months (R [ 1 = 28.4 %). R = 0 mostly appeared
preoperatively (24.3 %). We did not find any impact of the
values ‘‘ear’’ or ‘‘patient’’ on the outcomes.
Fig. 2 Median value (MV) of the tube score measured pre- and
Table 2 Frequency of different tube scores (%) pre- and postoperatively (1 = preoperative, 2 = 1 month, 3 = 3 months,
postoperatively 4 = 6 months, 5 = 9 months, 6 = 12 months postoperatively)

Time period (month) Score (%) MV SD


Table 3 Impact of the co-variables time period, tympanoplasty and
0 1 2 3 4 pressure range on the tube score
Preoperative 5.5 21.3 36.5 17.8 18.9 2.23 1147 Rating p value 95 % CI
1 7.8 24.9 33.2 20.7 13.4 2.07 1142 Min. Max.
3 8.8 16.2 32.4 20.2 22.4 2.31 1234
6 8.2 19.7 27.0 22.1 23.0 2.32 1255 6 months 1.134584 0.008 0.297712 1.971456
9 5.0 30.0 18.8 20.0 26.3 2.33 1290 12 months 1.000397 0.003 0.338063 1.662731
12 0.0 12.2 34.1 26.8 26.8 2.68 1011 TPL 1.240937 0.000 0.638713 1.843161
Pressure 0.141496 0.000 0.092761 0.190230
MV median value, SD standard deviation

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Table 4 Tube score in TMM mbar (p = 001)


dependency of the
tympanoplasty status and the 1 (30 mbar) 2 (40 mbar) 3 (50 mbar)
pressure range of the
tubomanometry (TMM) TPL (p \ 001) 1.47582732 (1.10, 1.85) 1.61141817 (1.15, 2.07) 1.74700903 (1.21, 2.29)
No TPL 2.240221 (1.62, 2.86) 2.3758119 (1.68, 3.08) 2.51140275 (1.73, 3.29)

lead to hearing loss by decreased motion of the tympanic surgery. In two patients, the pre-existing tinnitus got worse
membrane and the ossicular chain, otalgia and discomfort during the first 2 weeks after EET and in some patients,
and is often the basis for chronic middle ear diseases like few and self-limiting nasal bleeding occurred. The latter
otitis media with effusion or even cholesteatoma. Pau et al. was attributed to perioperative anti-coagulative medication
[25] demonstrated the importance of an efficient ventilation (ASS, Clopidogrel, Cumarin). In eight patients, EET was
system in a self-model. The Endonasal dilatation of the combined with tympanoplasty and in six patients this was
Eustachian tube (EET), established first in 2009 [26], is a with sinus surgery. In both settings, Eustachian tube
feasible alternative to common therapy of tympanostomy function improved postoperatively. In comparison with
tubes. The detailed mechanism of tube dilatation has not EET alone, EET combined with sinus surgery showed less
yet been established. In cadaver studies the effect of the improvement. Thus, sinus surgery should be initially per-
EET was explained by causing microfractures of the car- formed before EET. A score consisting of clicking during
tilaginous part of the Eustachian tube [24, 27], Moreover, swallowing, Valsalva manoeuvre and R value of the dif-
the corresponding tissue is altered and post-inflammable ferent TMM pressure steps was used to examine postop-
adhesions are loosened, thus decreasing the need for high erative success.
pressure to open the Eustachian tube. Tisch et al. [28] Tisch et al. [28] reported a subjective improvement of
performed an MRI scan directly pre- and postoperatively symptoms in 71.4 % and a postoperative ability to perform
and could not find any oedema or bleeding as a result of a Valsalva manoeuvre in 90 % of the 210 patients exam-
fracturing. A change in sensitivity of the proprioreceptors ined. One of the patients developed postoperative, self-
of the peritubal musculature or a squeezing mechanism limiting emphysema up to the mediastinum after forced
more than an effect on the tubal wall could be another Valsalva manoeuvre. To clarify the question of whether
explanation. more than one EET can be performed, 27 patients with a
In our study, the tube score improved after EET from history of multiple middle ear effusion and surgeries un-
2.23 (±1.147 SD) preoperatively to 2.68 (±1.011 SD) derwent 3–5 EETs every 12 weeks. A complete regression
12 months after surgery. No complications had been ob- of symptoms was reached in 18 patients without any
served. EET was technically easy to perform without any complications. This underlines the EET to be a safe and
intraoperative difficulties. EET presented itself as a safe micro-invasive procedure. However, in our study, tube
and successful procedure. In particular, patients after ventilation did not improve until 3 months and was highest
tympanoplasty showed lower score levels and benefited after 12 months. Therefore, revision surgery should not be
from tube dilatation shown by higher post-treatment tube performed within the first 3–6 months.
scores. After completion of treatment with EET in our Poe et al. [23] described an improvement of Valsalva
centre, there has been a significant loss to follow-up over manoeuvre in all 11 patients after 6 months. Multiple other
time. The reasons for this may include the high proportion studies showed similar successful results [16, 17, 22, 30].
of long-distance patients, lacking travel refunds in their Nearly all of these studies declare an accomplished
health insurance, as well as the presumably generally good indication finding. Regarding the wide range of Eustachian
outcomes, as far as our study centre was able to reach the tube dysfunctions, not all seem to be eligible for EET. A
patients or their local doctors via emails and phone calls to practicable classification may help to identify suitable pa-
confirm this assumption. Another study of Eustachian tube tients. Also, postoperative results may show even better
function before and after tympanoplasty early confirmed results. Diagnostic tools and postoperative success cur-
that the operation has a higher rate of success with good rently lean on different tube scoring systems [16, 24]. The
Eustachian tube function and frequently failed to close problem of these systems is that they are mostly non-
perforations in patients without sufficient tubal function validated tests and do not give clear evidence of tubal
[29]. To improve long-term surgical outcome, EET should dysfunction. Tympanograms, TMM and performance of
be performed several months before tympanoplasty. Valsalva manoeuvre should, therefore, be more or less
Schröder et al. [24] registered a postoperative im- helpful to decide whether the EET is necessary or not.
provement of dysfunction symptoms in 80 % of 66 patients Also, examination and test results often just give infor-
2 months and in 90 % of 12 patients 12 months after mation about momentary conditions. Recently, a tube score

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consisting of usual criteria (otomicroscopy, tympanogram The risk of injuring peritubal structures like the internal
and Valsalva manoeuvre) was completed by mucosal in- carotid artery has been described in tubal injections and
flammation score (1 = normal, 2 = mild, 3 = moderate treatments of patulous Eustachian tubes [39]. Preoperative
with compromise and 4 = severe inflammation with CT scan should exclude carotid canal dehiscence and the
complete failure of tubal opening) [16]. Postoperatively, risk of fracturing the bony canal, leading to bleeding and
the score improved significantly, supporting the hypothesis rupture during EET. A retrospective clinical trial of 284
that inflammation within the Eustachian tube plays an patients undergoing EET examined the relationship be-
important role in tubal dysfunction. The authors suppose tween the Eustachian tube and the internal carotid artery
that the reduction of inflammation may be due to crushing [40]. Carotid canal dehiscence next to the Eustachian tube
of irreversibly injured mucosa and that healthy tissue can was diagnosed in 18 patients (6.3 %). One patient had bi-
re-grow after intervention. lateral carotid canal dehiscence. Postoperative complica-
The ETDQ-7 questionnaire is a recently developed tions occurred in three patients: unilateral soft tissue
symptom score tested for validity and reliability in 50 pa- emphysema in two patients and a unilateral hypoglossal
tients and 25 controls [31], including 7 questions con- paresis in one patient. All of the patients had a normal CT
cerning tubal dysfunction symptoms from 1 (no problem) scan. No complication occurred in the group of ra-
to 7 (severe problem), but it is not used as standard. The diologically diagnosed carotid canal dehiscence. In the
absence of standardised assessment, the wide variations of author’s opinion, EET can be performed despite carotid
inclusion criteria and the heterogeneous pool of patients canal dehiscence as long as dilatation is restricted to the
make it difficult to compare results [32]. There is an out- cartilaginous part of the Eustachian tube. Temporal bone
standing need for consensus on the diagnostic criteria as CT scan seems not to be predictive of postoperative com-
suggested in the novel ETS-7 questionnaire that includes plications and should not be used routinely before EET.
two additional items [33]. Furthermore, a long-term rela- Only when EET performance fails will a postoperative CT
tionship between a good tube score and a good middle ear be useful in recognising tubal pathologies. The DVT used
pressure in chronic otitis media must be shown. With our in our study presents a good, fast and feasible alternative,
present data and the scoring used in our study, it remained producing three-dimensional voxels of anatomical data
difficult to prove successful treatment, especially in pre- with generally lower total radiation doses compared to
viously operated ears with tympanoplasty. conventional CT.
Beside the EET, several other surgical treatment op- EET is a safe and effective treatment procedure in pa-
tions exist. Inserting silk threads, polyethylene tubes or tients with chronic Eustachian tube function and it can also
drilling the bony part of the Eustachian tube are all at- be applied in children. Nevertheless, long-term results of
tempts that have been made to improve tubal function [34, larger, placebo-controlled multicentre studies have to be
35], but are obviously quite invasive procedures, leading acquired to fully confirm the effectiveness of EET. A
to various complications. Poe et al. [36] described laser validated, standardised instrument is needed to select
Eustachian tuboplasty (LETP) as a safe and efficacious indication criteria and a questionnaire to assess quality of
procedure. Microdebrider Eustachian tuboplasty should life before and after EET has to be established.
remove inflamed soft tissue from the tubal orifice and
make it wider [37]. Both interventions are also more in- Conflict of interest This research was funded by the Department of
ORL, University Medical Centre, Hamburg-Eppendorf (UKE),
vasive than the EET and postoperative development of Germany.
scar and synechiae formation with occlusion of the tubal
orifice; strictures and other complications are to be
awaited in long-term results. References
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