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At that time the function of the ET was believed to be an avenue for hearing or respiration. It was not until 1683 when Duverney proposed that the ET served as the channel through which the air of the middle ear was renewed that the actual function of the ET was first postulated. Finally, with the advent of fiberoptic endoscopy in the late 20th century the dynamic nature of the ET was understood.
We now understand that the ET regulates middle ear pressure with respect to atmosphere pressure, facilitates clearance of middle ear secretions, and protects the middle ear from sound and accumulation of nasopharyngeal secretions.
This is due to a dynamic valve-like region created by the insertion of the tensor veli palatine muscle located 12 to 20 mm distal to the nasopharyngeal orifice. The tensor veli palatine contracts, initiating a coordinated sequence in concert with the other peri-tubal muscles, which opens the ET.
Three categories of Eustachian tube dysfunction
Eustachian tube dysfunction (ETD) refers to inadequate function of the ET and is defined in 3 categories: dilatory, patulous, and barometric challenge. Dilatory ETD refers to the inability of the valve to appropriately open the ET, leading to negative pressure in the middle ear.
The third category, barometric challenge ETD results from the inability of the ET to regulate acute pressure changes, for example, when flying or diving. Dilatory ETD is the form most amenable to balloon treatment, and dilatory ETD is the focus of the remainder of this article.
Dilatory Eustachian Tube Dysfunction
Typical dilatory ETD is characterized by signs and symptoms of negative pressure in the middle ear. Common symptoms include aural fullness with hearing loss or tinnitus. When severe, patients may experience otalgia and may develop serous otitis media and complications such as atelectasis, retraction pockets, or even cholesteatoma.
has shown that the most common cause of dilatory ETD is mucosal inflammation within the cartilaginous ET, often because of allergic rhinitis, chronic rhinosinusitis, laryngopharyngeal reflux (LPR), or exposure to tobacco smoke.
Dilatory ETD affects 30% to 80% of people at some point during childhood.
Patients with ETD typically present with aural fullness or hearing loss. Common causes of ETD include allergic rhinitis, chronic rhinosinusitis LPR, and barometric pressure changes. Eustachian tube dysfunction is often multi-factorial and it is important that all contributing factors are identified. It is also essential to recognize conditions that mimic ETD including temporal mandibular joint disorders, nasopharyngeal mass, cochlear hydrops, and superior canal dehiscence. Physicians can differentiate among the various forms of ETD and other common causes of aural fullness with a history, physical examination, and directed testing as depicted in the flowchart in Fig. 1.
Type A Tympanogram
Testing for all patients with aural fullness begins with audiogram and tympanometry. If the patient has a type A tympanogram additional testing is necessary. Tympanic reflex testing should be obtained to look for decay caused by excessive excursion of the tympanic membrane (TM), suggesting patulous ETD. A history of sensitivity or vertigo when exposed to loud sounds suggests superior canal dehiscence syndrome. This can be corroborated with a non-contrast computerized tomography (CT) scan of the temporal bones and internal auditory canals (IACs) with 0.5-mm cuts reformatted in the plane parallel and perpendicular to the superior semicircular canal demonstrating dehiscence of the superior semicircular canal,
Work up patients with suspected ETD and a type A tympanogram
Reflex decay tympanogram
Non-contrast CT scan of the temporal bones and IACs “superior canal dehiscence protocol”
Cervical VEMPS and ocular VEMPS
If the diagnostic work up is normal or inconsistent with the patient’s symptoms, it is often useful to perform a myringotomy. Myringotomy improves middle ear ventilation. If the symptoms resolve after the myringotomy it is likely the patients symptoms will resolve after balloon dilation of the Eustachian tube (BDET), which also improves ventilation of the middle ear. However, if the symptoms persist following myringotomy it is recommended to evaluate for a temporal mandibular joint disorder, as it can cause aural fullness.
Finally, patients with type A tympanograms, normal tympanic reflex decay, normal CT cervical VEMPS, and ocular VEMPS ECOG and without symptom resolution following myringotomy may have barometric challenge ETD. This is less common than dilatory ETD and is defined as aural fullness and pain when presented with a barometric challenge. These patients are more difficult to diagnose because their symptoms are transient and only occur with barometric pressure changes. Balloon dilation of the Eustachian tube is very effective in patients with barometric challenge ETD.
Type B or C Tympanogram
A type B or C tympanogram suggests dilatory ETD. Further testing may be unnecessary, although a temporal bone CT scan should be considered in the setting of an atypical history or unclear pathology. A CT scan can be beneficial also in understanding the relation between the internal carotid artery and the ET, as well as identifying potential obstructing pathology such as cartilaginous anomalies or tumors.
Otoscopy in patients with dilatory ETD may reveal TM retraction or effusion. It is important to remember that while retraction pockets in the posterior superior quadrant or attic may have originated from ETD, they may persist or progress because of unrelated inflammatory mechanisms, despite the resolution of ETD.
Nasal endoscopy is used to evaluate for inflammatory or neoplastic disease. The ET orifice is located just posterior to the inferior turbinate. To optimize the view of the ET orifice during opening and closing, a flexible endoscope should be brought to the tubal orifice and directed 45° laterally and superiorly relative to the nasal floor. This can be accomplished from the ipsilateral or contralateral nasal cavity.
Dilatory ETD must be differentiated from patulous ETD. A patient with dilatory ETD typically has a type B or C tympanogram. In contrast, a patient with patulous ETD will have a type A tympanogram, positive reflex decay, and will report autophony and fullness that worsens with activity. Atelectasis, non-fixed TM retraction, or middle ear effusion suggest dilatory ETD, whereas medial and lateral excursions of the TM with ipsilateral nasal breathing indicate patulous ETD. If patulous ETD is suspected, having the patient exercise for several minutes before otoscopy may provoke symptoms and visible TM movement with respiration.
Patients are surveyed about pressure, ear pain, a feeling of clogged or muffled hearing, ear symptoms during sinusitis or common cold, crackling sounds or tinnitus in one or both ears over the last month. Patients respond with a number from 1 to 7 (no problem to severe problem).
Treatment of dilatory Eustachian tube dysfunction
Medical treatment of ETD consisting of routinely performing a Valsalva maneuver and either 4 weeks of nasal steroids or 1 week of oral steroids should be performed before considering BDET. Although it has not been demonstrated to significantly alter the course of refractory ETD, it does help establish candidacy for BDET.
Kujawaski ushered in the modern era of ET surgery in 1997 by describing the first Eustachian tuboplasty. He approached the ET both transorally and transnasally to obliterate mucosa and cartilage from the posterior cushion using a laser.
published their study exploring the use of sinus balloons as a device to treat dilatory ETD. One of the advantages of BDET over other treatments for ETD is that it directly targets the cause of dilatory ETD at both the mucosal and submucosal level. Kivekäs and colleagues
demonstrated histologic evidence that the balloon causes both shear and crush injury of the epithelium, but spares the basal layer, allowing for rapid healing. In addition, the balloon crushes lymphocytes and lymphoid follicles within the submucosa leading to the formation of a fibrous scar. This combination significantly reduces the overall inflammatory burden and may provide lasting clinical improvement in ET dilatory function and middle ear ventilation.
Over the last 10 years BDET has been demonstrated to be efficacious. Multiple studies have demonstrated symptomatic as well as objective clinical improvement in patients undergoing BDET for ETD.
demonstrated that, at 6-week follow-up, treated compared with untreated patients experienced normalization of tympanograms (51.8% versus 13.9%) and ETDQ-7 scores (56.2% versus 8.5%). Balloon dilation of the Eustachian tube has emerged as the surgical treatment of choice for dilatory ETD, and there is growing interest in performing this procedure in the office.
As with any new procedure, determining who will benefit, can be challenging. A recent randomized controlled trial demonstrated the effectiveness of BDET in patients with ETD, as defined by aural fullness greater than 12 weeks in combination with a type B or C tympanogram, along with a positive ETDQ-7 score greater than 14 despite either using nasal steroids for at least 4 weeks or oral steroids for 1 week (Box 2).
Failed medical management including Valsalva and either 4 weeks of nasal steroids or 1 week of oral steroids
Physicians should be cautious when considering in-office BDET for patients with barometric-induced ETD. Balloon dilation of the Eustachian tube changes the barometric pressure in the middle ear, which may trigger pain or vertigo. These symptoms can be mitigated by using a vestibular suppressant such as diazepam, anesthetizing the TM, which blunts the isobarometric reflex arc, and inflating the balloon slowly, at a rate of 1 atmospheric pressure (ATM) per second.
Successful BDET improves ET function and normalizes middle ear pressure. Following the procedure, most patients can Valsalva immediately and many report benefit within a few days. This can be objectively followed by tympanograms, and clinically followed with ETDQ-7 scores. The tympanograms and ETDQ-7 scores usually normalize within 6 weeks and these results have been shown durable over time.
Before considering BDET under local anesthesia, nasopharyngoscopy should be performed to evaluate the patient for any anatomic challenges that may complicate the procedure or require additional surgical intervention for access. Special attention should be given to the nasal airway, looking for a nasal obstruction, such as septal deviations or spurs, extension of the inferior turbinate into the nasal airway, as well as lateral adenoid hypertrophy. If any of these findings are present it may make the procedure challenging and the physician may prefer to perform BDET as well as any additional indicated procedure in a more controlled environment.
Adequate anesthesia is critical to the success of in-office BDET. There are 3 specific considerations. First, the transnasal approach to the nasopharynx requires good topical anesthesia for the nasal cavity. Second, mechanical receptors of the TM, promontory, and nasopharynx create a neuronal reflex arc that regulates pressure in the middle ear. These receptors are uniquely sensitive to the barometric changes that will be induced during the procedure.
To minimize discomfort as well as limit vertigo, patients should be premedicated with a vestibular suppressant such as 10 mg of diazepam 90 minutes before the procedure. On arrival to the office the patient should be evaluated and if necessary another 10 mg of diazepam along with 5 mg of hydrocodone can be administered.
The patient should then be positioned at 45° angle in either an examination room chair or procedure table. Oxymetazoline should be sprayed into each nostril, 5 drops 7% tetracaine/7% lidocaine compounded into an otic solution should be placed onto the ipsilateral TM via the external auditory canal, and 2 cottonoids soaked in 2% tetracaine should be placed along the nasal floor bilaterally and left to sit for approximately 10 minutes. The cottonoids should then be removed and approximately 0.5 mL of compounded 7% tetracaine/7% lidocaine cream should be applied to the ET orifice via a low profile cannula such as the Weiss catheter (Grace Medical, Memphis, TN, USA). This, in combination with the topical anesthetic drops placed on the TM earlier, disrupt the isobarometric reflex arc. The tetracaine-soaked cottonoids should then be replaced and allowed to sit for another 10 to 15 minutes (Box 3). The cottonoids can then be removed and the procedure initiated.
5 drops compounded 7% tetracaine/7% lidocaine drops on TM
2% tetracaine-soaked cottonoids along the nasal floor bilaterally
0.5 mL 7% tetracaine/7% lidocaine cream in ET orifice
Replace tetracaine-soaked cottonoids along the nasal floor
Equipment and supplies
The endoscope runs parallel to the dilation device throughout most of the procedure, so it is recommended that a monitor and endoscopic camera be used along with an angled endoscope to maximize visualization.
In addition to using an angled endoscope, it is important to be aware of the endoscope’s length before the procedure. Some of the shorter endoscopes can easily get caught on the dilation systems, preventing advancement of the balloon catheter in to the ET lumen.
It is also important to have suction available to evacuate any fluids that might obstruct the orifice or true lumen of the ET. The suction catheter can also function as a cannula to deliver the topical anesthesia to the lumen of the ET.
Balloon dilation of the Eustachian tube should be performed with a 30° or 45° rigid endoscope to allow for direct visualization of the ET orifice as shown in Video 1. This direct view with an angled endoscope significantly reduces the risk for inadvertent tissue trauma and creation of false passages. Currently there are 2 dilation systems approved by the Federal Drug Administration for use under local anesthesia, and although they both use a noncompliant balloon, the catheters themselves differ significantly (see Video 1).
The AERA Dilation System
The AERA Dilation system (Acclarent, Irvine CA, USA) uses a 55° angled guide to introduce a 6 × 16-mm noncompliant flexible balloon catheter into the nasopharyngeal orifice of the ET. Under direct visualization, the balloon catheter should be gently advanced superiorly, navigating the S-shaped curve in the ET until the catheter encounters resistance at the bony-cartilaginous isthmus. Once the balloon is fully inserted into the cartilaginous ET, the yellow mark indicates the end of the balloon and should be visible along the medial edge of the anterior cushion of the ET, ensuring the balloon is not inserted too deeply. The assistant then inflates the balloon at approximately 1 ATM per second until the pressure reaches 12 ATM. The balloon should then be held in the inflated position for 2 minutes then deflated and slowly retracted into the guide. The entire system is then withdrawn from the nose.
The Xpress Dilation system (Entellus, Plymouth MN, USA) rigid balloon catheter was originally designed for dilation of the sinus ostia, but has been adapted for BDET and is available in diameters of 5, 6, and 7 mm and lengths of 8, 18, and 20 mm, which slide along a reshapeable ridged rail. The manufacturer’s instructions contain little information to inform the choice of balloon size. However, most of the data in the scientific literature have been generated with a 6 × 16-mm balloon. The distal end of the rail contains a 2-cm mark. At this location the rail should be bent approximately 45°. This bend will be a visual indicator of the depth of ET cannulation. Then, under direct visualization, the rigid rail is introduced into the ET orifice, and advanced until the angle of the rigid rail is even with the medial edge of the anterior cushion of the ET. The balloon is then advanced along the rail to its full length until the balloon cannot be advanced any further, indicating that the balloon has reached the tip of the rail. The assistant inflates the balloon approximately 1 ATM per second until it reaches 12 ATM. It is held into position for 2 minutes and then deflated. Because of the length of the cartilaginous ET (on average 24 mm long), the instructions for use recommend performing 2 dilations at staggered lengths based on device markings when using the 8 mm balloon to achieve the desired result. The balloon dilation system is then removed.
Gently retract the posterior cushion medially with the rail or guide, to allow for visualization of the ET lumen, providing guidance while advancing the balloon.
Avoid removing the balloon while inflated, as the resultant negative pressure can cause significant discomfort
Slow dilation at 1 ATM per second minimizes the risk of triggering the isobarrometric arc, allowing for a more comfortable procedure
Balloon dilation of the Eustachian tube is a relatively safe procedure; however, because of the anatomic location of the ET, as well as its role in regulating middle ear pressure, there are several safety considerations that should be kept in mind when performing this procedure in the office.
Sudden pressure changes within the middle ear can precipitate vertigo. In addition to premedication with a vestibular suppressant such as diazepam, the risk of vertigo can be mitigated by ensuring that the central lumen of the balloon catheter is free of guidewires and other obstructions to allow for release of back pressure during dilation. Todt and colleagues
demonstrated that middle ear pressure during BDET depends on the speed of inflation and maximum inflation pressure. Middle ear pressure during dilation averages approximately 71 daPa, and while this is not enough to rupture the round window or healthy TM, it can cause significant discomfort. Connecting the ventilation ports to suction should also be avoided as the resultant negative pressure generated in the middle ear can be uncomfortable.
The overall safety profile of the procedure is quite good; however, minor tears of the mucosal lumen, epistaxis, exacerbation of tinnitus, temporary deafness or vertigo, and subcutaneous emphysema and patulous ETD have been reported after BDET.
Temporary deafness and vertigo may occur related to the topical anesthetic. When applying topical anesthesia within the ET it important to use a cream or ointment rather than a gel, which has a potential to liquefy at body temperature and has a risk of being absorbed into the inner ear via the round window and cause symptoms. For this reason, it is also important to evaluate the TM before placing the medication in the external ear canal to rule out any perforations or patent pressure equalization tubes.
The risk of a false passage can be decreased by using an angled endoscope to directly visualize the ET lumen, especially when navigating the balloon through the S-shaped curve of the ET. Natural tissue planes provide little resistance to penetration by either the balloon catheter or shapeable rail depending on the system used. Without direction visualization, one may be unaware of being in a false passage. It is important to recognize this when it occurs and cannulate the true lumen before dilating, not only to avoid damaging surrounding soft tissue, but also to ensure the balloon has an opportunity to come in contact with the respiratory epithelium during inflation. When a false passage does occur, it is important to counsel the patient not to Valsalva and sneeze with their mouth open to minimize the risk of subcutaneous emphysema.
Patients usually recover easily. Their post-treatment symptoms are most often characterized by aural fullness due to ET trauma produced by the procedure. Nausea, nasal congestion, epistasis, vertigo, ear and neck pain, headache, and sore throat occasionally occur and usually resolve quickly.
Patients should continue the use of nasal steroids, as well as gently performing the Valsalva maneuver every hour while awake. If there is any concern for a false passage or mucosal tear it is recommended to wait at least a week before attempting the Valsalva maneuver, sneeze with their mouth open, refrain from flying, lifting heavy objects, or forcefully blowing their nose for 2 weeks after the procedure to minimize the risk of subcutaneous emphysema. It also beneficial to keep the head elevated for the first 48 to 72 hours to reduce swelling within the ET. Over-the-counter analgesics such as acetaminophen or non-steroidal anti-inflammatory drugs are usually sufficient to cover any post-operative pain.
Most studies in the literature describe BDET performed under general anesthesia. However, in one of the first studies looking at the effectiveness of BDET, Catalano and colleagues
retrospectively reviewed 100 cases BDET, of which 37% of the procedures were performed under local anesthesia in the office. The patients had an average follow-up of 26 weeks, 71% of patients experienced improvement in ear fullness and pressure and 87% reported persistent improvement. The average dilation time varied between 10 and 30 seconds, with a pressure of 6 to 8 ATM, and with some of the procedures having to be discontinued after 10 seconds because of pain. As the technique of BDET has evolved, it has become customary to dilate the ET for approximately 2 minutes with a pressure of 10 to 12 ATM.
In a recent randomized controlled trial looking at clinical efficacy, BDET showed significant improvement in ETDQ-7 scores at 6 weeks, and that improvement was maintained through 12 months. Importantly 72% of the procedures were performed under local anesthesia with no complications, and all patients tolerated the procedure.
Balloon dilation of the Eustachian tube is a relatively new procedure and currently lacks a specific current procedural terminology code for the procedure. The AMA recommends the use of the middle ear unlisted code, 69799. This code lacks specific reimbursement recommendations based on the site of service designations, and, as a result, it is difficult to receive sufficient reimbursement from third-party payers to cover the cost of the devices required to perform this procedure in the office. However, it has been the author’s experience that most patients are willing to cover the cost of the procedure in exchange for the benefits of undergoing this procedure in the office setting.
Dilatory ETD has long posed significant diagnostic and treatment challenges to the clinician. Recent advances in technology have led to a better understanding of the dynamic function of the ET, allowing for more effective treatment options. Balloon dilation of the Eustachian tube has emerged as a promising treatment of dilatory ETD. With the right patient selection, operative technique, and anesthesia protocol, BDET can easily be performed in an office setting under local anesthesia, significantly reducing cost and minimizing the risk of general anesthesia.
Disclosure Statement: Dr. Dean is a consultant for Acclarent Inc., Biosense Webster , Bioinspire, Airnex, and Immertec, and hope equity or stock options in BioInspire; Immertec; and This American Doc (TAD).