Consensus on Treatment of Obstructive Eustachian Tube Dysfunction With Balloon Eustachian Tuboplasty

Abstract

Objective

There is a great variability in diagnosis of obstructive Eustachian tube dysfunction and its treatment by balloon Eustachian tuboplasty (BET). The aim of this paper was to present a consensus on indications, contraindications, methodology, complications and results after BET.

Material & Methods

We obtained a consensus on BET, after a systematic review of the literature on BET from 1966 to November 2018, using MESH terms “Eustachian tube and (dilation or dysfunction)”, including a total of 1.943 papers in Spanish, English, German and French. We selected 139 papers with a relevant abstract, including two international consensuses, seven systematic revisions, and two randomised control trials on BET.

Results

The indications for BT are barotrauma, serous otitis media, adhesive otitis, atelectatic middle ear and failure after tympanoplasty, once obstructive Eustachian tube dysfunction is confirmed. BET is more effective in barotrauma and serous otitis media. There are high-evidence reports on BET showing good results that persist long-term, as compared to conservative medical treatment.

Conclusions

BET is a surgical, minimally invasive treatment that has shown its effectiveness and safety in obstructive Eustachian tube dysfunction in adults and children. It is most effective in barotrauma and serous otitis media.

Resumen

Objetivo

Existe una gran variabilidad en el diagnóstico de la disfunción tubárica obstructiva y su tratamiento mediante la dilatación tubárica con balón (DTB). El objetivo de este trabajo es presentar unas recomendaciones de consenso sobre las indicaciones, contraindicaciones, metodología, complicaciones y resultados de la DTB.

Materiales y métodos

Presentamos un consenso sobre la DTB, mediante revisión sistemática de la literatura desde 1966 hasta noviembre de 2018, términos MESH “Eustachian tube and (dilation or dysfunction)”, recogiendo un total de 1.943 artículos en español, inglés, alemán y francés. Del total de artículos revisados, se seleccionaron 139 cuyo abstract era relevante, incluyendo dos consensos internaciones sobre diagnóstico, siete revisiones sistemáticas y dos ensayos clínicos aleatorizados sobre la DTB.

Resultados

Las indicaciones de la DTB son el barotrauma, la otitis media secretora, la otitis media adhesiva, la atelectasia y el fracaso de una timpanoplastia, siempre que se haya podido demostrar una disfunción tubárica obstructiva crónica. La efectividad de la DTB es mayor en el barotrauma y la otitis media secretora. Hay estudios publicados de elevada evidencia sobre la DTB, cuyos buenos resultados se mantienen a largo plazo, frente a tratamiento médico conservador.

Conclusiones

La DTB es un procedimiento quirúrgico mínimamente invasivo que ha demostrado su efectividad y seguridad en el tratamiento de la disfunción tubárica crónica en adultos y en niños. Las indicaciones en las que es más efectiva son el barotrauma y la otitis media secretora.

Introduction

For many years, once medical treatments had failed,¹ surgical treatment of obstructive Eustachian tube (ET) had been the insertion of transtympanic drains, with repeated treatment on successive occasions in the same ear.

However, from 2009 onwards, a further therapeutic option appeared to resolve tube obstruction, thanks to the works of Sudhoff et al.^2–4 This option is balloon Eustachian tuboplasty (BET). This procedure treats chronic obstructive Eustachian tube dysfunction using a minimally invasive, easy, safe and reliable system.^2–8

Unlike other ablative procedures of the ET,⁹ BET consists of the transnasal introduction of a catheter with a balloon to be dilated in the ET aimed at dilating its cartilaginous section. It is recommended when the patient does not respond to other conservative treatments and chronic Eustachian tube obstruction persists.^2,9

There is actually great variability in the diagnosis and treatment of chronic Eustachian tube dysfunction.¹⁰ Recently several international consensual documents have been published on the diagnosis of this disease.^11,12 However, none of them totally clarify the recommendations to be followed regarding treatment for chronic Eustachian tube obstruction through BET.

The aim of this study was to present a summary of the consensual recommendations reached by a group of experts on the indication, contraindications, methodology, complications and results of the BET.

Material and Method

For this consensual study a group of 5 experts were selected from Spain (the authors) with proven experience in BET (minimum of 30 cases per specialist), whose combined experience amounted to over 250 cases.

This group carried out a systematic review of the literature published from 1966 until 10th November 2018, on the terms MESH Eustachian tube and (dilation or dysfunction, collecting a total of 1943 articles in Spanish, English, German and French which were reviewed by authors in relation to the evidence of each suggestion made.

In fact, out of the total articles reviewed 139 were selected where the abstract was relevant. Of these, to reach a consensus the following were included: 2 consensus on the diagnosis of tube dysfunction,^11,12 7 systematic reviews,^13–19 4 non systematic reviews, 2 randomised clinical trials on BET^20,21 and 2 non randomised comparative studies on BET.^22,23 In addition to many studies on anatomy, physiopathology of tube dysfunction or the diagnosis of it there are highly numerous series of BET cases, both in adults^{3–8,13–19,24–28} and children^29,30 (Fig. 1).

Figure 1.

Search strategy for systematic re view of the literature on balloon Eustachian tuboplasty (BET).

During the face-to-face meetings the selected articles were reviewed, assessing their level of evidence (Tables 1 and 2), and the results were presented. As a result the creation of a proposal for a consensual document on BET was reached.

Table 1.

Results Published After Balloon Eustachian Tuboplasty (BET) With Follow-up of Over 6 Months. Studies With Sackett 2^a Level of Evidence.

	Number of Patients (Ballooning)	Mean Follow-up (Months)	Symptoms: ETS, ETDQ-7 or Improvement in Symptoms	Positive Valsalva	Modified Tympanogram (B–C)	Complication
Poe et al.^5 (2011)	11 (11)	7 (6–14)	NR	0% pre	39% pre	NR
				100% post	15% post
McCoul et al.^34 (2012)	18 (¿?)	6	4.5 pre 2.8 post	NR	71% pre	Epystaxis with hemotympanum after turbinectomy
			P < .001		3% post
Schröder et al.^26 (2013)	12 (20)	12	Improvement of symptoms in 83%	Always + 45%	6/15 ears 40%	NR
				At times + 45%
Silvola et al.^28 (2014)	37 (42)	30 (18–50)	NR	0% pre	39% pre	NR
				80% post	15% post
				P < .0001	P < .0001
Schröder et al.^27 (2015)	(188)	12	3.15 pre vs. 5.75 post	NR	NR	NR
	34	24	73% P < .001
			2.65 pre vs. 6.26 post 82% P < .001
Dalchow et al.^25 (2016)	(43)	12	2.23 pre 2.68 post	NR	NR	No complications
Xiong et al.^54 (2016)	40 (58)	12	Stuffiness P < .05	0% pre	26% pre	No complications
			earache P < .05	98% pos	2% pos
			Tinnitus P < .05	P < .005	P < .05
			Dulled hearing P < .005
Bowles et al.^24 (2017)	39 (55)	6	4.9 pre 2.0 post P < .0001	0% pre	49% pre	No complications
				96% post	6% post^a
Leichtle et al.^31 (2017)	52 (97)	12	NR	13% pre	72% pre	One hemotympanum 3 mild nosebleeds
				88% post	39% post
Luukkainen et al.^46 (2017)	25(38)	37	Improvement in symptoms	57%Valsalva +	NR	NR

ETDQ-7: Eustachian tube dysfunction questionnaire; ETS: Eustachian tube score; P: statistical significance when studied; NR: not reported.

a

% estimated from Fig. 2 of the publication.

Table 2.

Randomised Clinical Trial Son Balloon Eustachian Tuboplasty (BET) Versus Conservative Medical Treatment of Eustachian Tube Dysfunction. Sacket 1b Level of Evidence.

		Number of Patients (Easrs)	ETDQ-7	Positive Valsalva (%)	Normal Type A Tympanogram	Complications
Meyer et al.^21 (2018)	BET	31	–2.9 (SD 1,4)	8/17 (47.1%)	8/14 (57.1%)	No
	Controls	30	–.6 (SD 1.0)	2/14 (14.3%)	1/10 (10%)	No
Poe et al.^20 (2018)	BET	162 (234)	77/137 (56.2%)	32.8%	72/139 (51.8%)	No
	Controls	80 (117)	6/71 (8.5%)	3.1%	10/72 (13.9%)	No

ETDQ-7: Eustachian tube dysfunction questionnaire.

Finally, this proposal was presented at the SEORL Congress in October 2018, where it was discussed and sent to the Otology Committee of SEORL for improvement and endorsement as a final document, the abbreviated version of which is present in this study (the complete version is available as supplementary material).

In this consensual document current BET indications are shown, both for children and adults, together with absolute and relative contraindications, tips on surgical procedure and postoperative care. The most common and most relevant complications were also reviewed together with expectations of BET results according to the disease which caused it.

Concept of Eustachian Tube Dysfunction

ET dysfunction consists in the failure of the ventilator function of the ET on the middle ear. Causes of Eustachian tube dysfunction may be obstructive, patulous and from barotrauma.^1,2,10–12

Both obstructive Eustachian tube dysfunction and barotrauma dysfunction lead to symptoms and signs relating to the poor ventilation of the middle ear. Their symptoms include, among others, the feeling of a stuffed up ear, tinnitus, blocking or inability to balance pressure at middle ear level.^10–12

Patients with obstructive Eustachian tube dysfunction present with symptoms which are compatible with negative pressures in the middle ear, such as tympanic retraction or chronic otitis media images in the otoscopy, negative Valsalva manoeuvres and/or negative pressure in tympannometry.^{1,2,10–12,31–33} Different findings have therefore been proposed to define this disease, which may or may not be coincidental (Fig. 2)^{10–12,31–33}

Figure 2.

Diagnosis of Eustachian tube dysfunction. Of the diagnostic symptoms through the signs in the otoscopy, Valsalva manoeuvre, tympanogram and/or tubomanometry (TMM). Modified by Adil and Poe,¹⁰ Schilder et al.¹¹; Smith et al.¹²

Obstructive Eustachian tube dysfunction may lead to chronic otitis media, tympanic atelectasis and even the appearance of a cholesteatoma.^2,17

Indications for Balloon Eustachian Tuboplasty

Indications for Adult Patients^2,13,16

In patients who suffer from symptoms derived from obstructive ET dysfunction, either uni or bilateral:

• o

  Chronic serous otitis media: after appropriate medical treatment from the failure of the second tympanic drainage in the same ear BET should be considered.

• o

  Mild to moderate adhesive otitis media: Sadé grade i and ii.

• o

  Mild to moderate atelectasis: Sadé grade i and ii.

• o

  Tympanoplasty failure: after failure of a myringoplasty, when there is re-perforation of the tympanic membrane or the start of tympanic retraction with suspicion of ET dysfunction.

• o

  Barotrauma (aviation and diving): sensation of discomfort and pain from pressure in the ears, particularly with changes in atmospheric pressure (dysbarism).

Indications for Paediatric Patients^29,30

From 4 years of age, in children with obstructive ET dysfunction ET, either uni or bilateral:

• o

  Chronic serous otitis media without tympanic retraction: from the failure of the second tympanic drainage in the same ear.

• o

  Serous otitis media with suspicion of chronic ET dysfunction: from the failure of the first, second or third tympanic drainage (to be assessed by the ENT depending on the evolution of the atelctasis).

• o

  Tympanic perforation in one ear and serous or adhesive otitis media in the other ear: assess bilateral BET depending on the evolution of the ET dysfunction in each ear.

Contraindications of Balloon Eustachian Tuboplasty

Absolute

• • o

    Previous treatment with radiation in the area.

  • o

    Previous head trauma with anatomical changes to the area.

  • o

    Cleft lip/palate.

  • o

    Open or patulous ET.

  • o

    Down’s syndrome.

  • o

    Large quantity of scar tissue in the area due to previous surgery.

Relative

• o

  Craneofacial malformation with anatomical changes in the area.

• o

  Adhesive otitis media: Sadé grades iii and iv.

• o

  Atelectasis: Sadé grades iii and iv.

• o

  Cystic fibrosis and dyskinesias.

• o

  Previous ET surgery (excluding previous BET).

• o

  Obstructive nasal disease: septal deviation, sinonasal polyposis (it is recommended to treat this disease first. Only when ET dysfunction persists is it advisable to treat with BET).

Necessary Pre-operative Tests for Balloon Eustachian Tuboplasty

• 1)

  Complete anamnesis.

• 2)

  Questionnaires for ET dysfunction (ETDQ-7),^34–39 validated into Spanish (Table 3).⁴⁰

  Table 3.

  EDTQ-7: Eustachian Tube Dysfunction Questionnaire of McCoul et al.,³⁴ Validated Into Spanish by Herrera et al.⁴⁰

  During the Last Month, What Discomfort Have the Following Symptoms Caused You?
  Symptoms/events	No Discomfort	Moderate Discomfort	Severe Discomfort
  Pressure in the ear	1 2	3 4 5	6 7
  Pain in the ear	1 2	3 4 5	6 7
  Blockage of ears	1 2	3 4 5	6 7
  Symptoms of catarrh in the ear	1 2	3 4 5	6 7
  Clicking on opening in the ear	1 2	3 4 5	6 7
  Buzzing in the ear	1 2	3 4 5	6 7
  Reduced hearing	1 2	3 4 5	6 7
• 3)

  Otoscopy/microscopy: description of the status of the tympanum.

• 4)

  Valsalva and Toynbee manoeuvre during otoscopy (with patient seated): recommended to record on video.

• 5)

  Tympanometry.

• 6)

  Tonal audiometry.

• 7)

  Nasal endoscopy: to rule out nasal and cavum disease, and assess good access to the torus tubarius: recommended to record on video.

• 8)

  Tubanometry: this is not essential it is only an aid, but leads to obtaining the Eustachian Tube Score (ETS), which is of prognostic interest and the ETS-7 when combined with a typanogram.^41–43

• 9)

  Computerised tomography: this is not essential in all cases.^44,45 it would be indicated if after examination there is any suspicion of an acute or previous disease of the temporal bone.

Advice During Balloon Eustachian Tuboplasty

• 1)

  Prior preparation to BET:

• -

  The specific informed consent of the patient must be obtained.

• -

  The application of a topical nasal vasoconstrictor just before starting the intervention.

• 2)

  Recommendations during BET:

• -

  The procedure is generally performed under general anaesthesia or deep sedation with the patient in a supine position, although some authors perform surgery under local anaesthesia.⁴⁶

• -

  There are different balloons available in the market for BET: Tubavent® (Spiggle & Theis, Germany), Area® (Accelerant, U.S.A.) and XprESSTM (Entellus Medical, U.S.A.), which are very similar to one another. One study compares them, without any significant differences between them being observed.²³

• -

  In adult patients the use of optics of 0 or 30 is recommended, performing the BET through the same nostril and using inserters with a 45–60 angulation.

• -

  In paediatric patients, due to their anatomy, the use of optics of 0 or 30 is recommended, performing the BET through the contralateral nostril and using inserters with a 60–70 angulation.

• -

  During the procedure the nostril mucosa should not be damaged with the optics or instruments used for ET insertion, to avoid bleeding.

• -

  When placing the balloon in the inserter the catheter should be positioned in a straight line without turning it and should be introduced smoothly to prevent it folding. We recommend positioning the balloon in the inserter prior to inserting the system into the nostril.

• -

  Once inserted in the Eustachian tube, the catheter is displaced through the canal of the inserter and is fitted carefully onto it, avoiding any resistance.

• -

  Ensure appropriate introduction of the inserter in the ET, to ensure that the balloon is positioned inside it.

• -

  Once the catheter has been correctly positioned inside the tube, the manometer is used to inflate the balloon to a pressure of 10 bar. This pressure is maintained for 2 min.

• -

  If a vibration is felt when the balloon is to be inserted in the ET, this indicates that torsion of the torus has occurred and the catheter is not where it should be. However, once correctly inserted, during inflation, it is common to observe a minor vibration of the ET cartilage which indicates that the procedure is correct.

• -

  Once inflation has terminated, the deflated or inflated balloon may be extracted (producing a suction effect on drawing out mucus).

• -

  If tympanoplasty is performed during the same surgical procedure it is recommended that the balloon be extracted in a deflated state to avoid a suction effect in the tympanic cavity.

• -

  Tuboplasty of the same tube twice may be made if there is doubt that the initial tuboplasty was effective.

Procedures Associated With Balloon Eustachian Tuboplasty

• -

  When it is considered necessary to recommend the performing of BET and a myringotomy in the same procedure, but it is not recommended to place a tympanic drainage tube at the same time as the BET, except in children with adhesive otitis.^47,48

• -

  When combining BET with tuboplasty or a tonsillarectomy, it is recommended to first perform the BET, and then the remainder of the surgery, to avoid any possible bleeding hindering observation of the torus tubarius.⁴⁹

• -

  On occasions it may be beneficial to combine the BET with middle ear surgery, such as myringoplasties or tympanoplasties with mastoidectory, if there is a clinical suspicion of obstructive ET dysfunction that requires BET.⁵⁰

Postoperative Recommendations

• 1)

  Medical treatment.

  • -

    Similar to a nasal surgery. It is recommended to administer analgesics on demand, non steroid oral anti inflmmatories and occasionally topical corticoids.

  • -

    In contrast, the use of oral antibiotics and oral corticosteroids is not recommended during the postoperative period.

• 2)

  Recommendations for the patient.

  • -

    During the first 24 h after the intervention:

    • o

      Patients are recommended not to blow the nose or sneeze with the mouth shut.

    • o

      Patients are recommended to carry out frequent nasal washes for 2 weeks.

  • -

    After the first 24 h following surgery the patients are recommended to:

    • o

      Carry out repeated Valsalva manoeuvres for at least 4 weeks (pinch the nostrils and then, whilst keeping the mouth shut and tensing the stomach muscles, exhale as if you were blowing through the nose. This manoeuvre works equally on ear pressure, whilst also opening the Eustachian tubes). Experience suggests repetition of this manoeuvre 3–5 times per day.

    • o

      If surgery to the middle ear was performed, including myringotomy, combined with BET, the Valsalva manoeuvre is not recommended until one month after surgery, and the guidelines for middle ear surgery are recommended.

    • o

      Patients should be warned that pre-existing tinnitus could increase, together with a buzzing sensation, but that this is a good sign of balloon efficacy.

Complications From Balloon Eustachian Tuboplasty

Few, generally mild complications have been described:

• -

  Mild or moderate pain

• -

  Mild haemorrhaging or bleeding

• -

  Temporary hemotympanum

• -

  Acute otitis media

• -

  Changes to taste sensation

• -

  Temporary peritubaric emphysema, although on very few occasions this may extend through the neck to the mediastinum (incidence of .003%).⁵¹

Postoperative Tests After Balloon Eustachian Tuboplasty

• -

  These are usually the same as in preoperative, aimed at proving the resolution of the Eustachian tube dysfunction (Fig. 2).

• -

  The most common is to assess its efficacy using otoscopy/microscopy, Valsalva and Toynbee manoeuvres, tonal audiometry, tympanogram and postoperative ETDQ-7.

• -

  The tubomanometry may be a more objective tool for assessing tube opening after BET.

Follow-up After Balloon Eustachian Tuboplasty

• -

  For accurate follow-up check-ups with patients after one month, 3 months, 6 months and one year are to be made.

• -

  If there is an associated myringotomy patients must be seen after 15 days.

• -

  For assessment of efficacy the results are considered to be short term (4–6 weeks), medium term (6 months) and long term (>12 months).⁵²

• -

  It is important to know that effectiveness cannot be assessed until 3 months have passed, and that stability may be obtained from 12 months onwards (the patient has experienced all season of the year and climate changes associated with the changing of the seasons).^53,54

Definition of the Results of Balloon Eustachian Tuboplasty

The consensus is that 6 months after surgery a good result is considered to be when:

• 1)

  Serous otitis media: when it is not necessary to insert another tympanic drainage.

• 2)

  Adhesive otitis media (grades i and ii): recovery of tubaric ventilation (not audition) with positive Valsalva manoeuvres and/or improvement in typanogram.

• 3)

  Atelectasis (grades i and ii): recovery of tubaric ventilation (not audition) with positive Valsalva manoeuvres and/or improvement in typanogram.

• 4)

  Failure of tympanoplasty: closure of the tympanic perforation (if there was perforation), improvement and/or stabilization of typanic retraction (if there was retraction).

• 5)

  Barotrauma (aviation and diving): improvement of symptoms, positive Valsalva manoeuvres and/or improvement in typanogram.

Regarding the effectiveness of the BET, the studies published offer the best result when the baseline disease is barotrauma (aviation and diving), followed by serous otitis media (Table 1). In the other indications the results are more uneven. For some authors BET has not even yet presented valid results.⁵⁵

Numerous studies have been published on the BET, the good results of which have been maintained or even improved long term.^{3–7,13–19,24–30} On the other hand, recently 2 randomised clinical trials have been published^20,21 in which the efficacy of BET has been confirmed compared with medical treatment (Table 2).

For Poe et al.²⁰ improvement after treatment was interpreted as a ETDQ-7 < 3, a positive Valsalva manoeuvre (when it was initially negative) and normalisation of the tympanogram to a type A (when it was previously type B/C). These were all more common after BET than after medical treatment, with all 3 being statistically significant. Recently Anand et al.⁵⁶ published the results of this same trial, with 52 weeks of follow-up, showing how the improvements after BET remained over time.

For Meyer et al.²¹ improvement after BET became an improvement of the ETDQ-7, to a positive Valsalva manoeuvre (when it was initially negative) and normalisation of the tympanogram to a type A (when it was previously type B/C). These were all more common after BET than after medical treatment, with those of the ETDQ and the tympanogram being statistically significant.

Without a doubt the BET is a technique which will be increasingly used more by all ENT specialists as shown by the survey conducted by Miccuci et al.⁵⁷

Conclusions

BET is a minimally invasive surgical procedure which has demonstrated its effectiveness and safely in the treatment of chronic Eustachian tube dysfunction in adults and children. It is a treatment which is aimed at improving the aetiology of Eustachian tube disease and not to alleviate its symptoms. The indications for which BET is most effective are barotrauma and serous otitis media. BET is a safe procedure with minimal complications.

Financing

This research received specific finance from the company SH Medical Group for the development of this consensus.

Conflict of Interests

The authors have no conflict of interests to declare.