Myringotomy and Tympanostomy Tube
Number: 0418
Table Of Contents
PolicyApplicable CPT / HCPCS / ICD-10 Codes
Background
References
Policy
Scope of Policy
This Clinical Policy Bulletin addresses myringotomy and tympanostomy tube.
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Medical Necessity
- Aetna considers myringotomy and tympanostomy tube (also known as ventilation tube and grommet) insertion medically necessary for any of the following indications:
- Autophony due to patulous eustachian tube; or
- Barotitis media control; or
- Children with cleft palate and history of otitis media with effusion and persistent hearing loss; or
- Cholesteatoma; or
- Chronic retraction of tympanic membrane or pars flaccida; or
- Complications of otitis media such as meningitis, facial nerve paralysis, coalescent mastoiditis, or brain abscess; or
- Otitis media with effusion after 3 months or longer and bilateral hearing impairment (defined as 20 dB hearing threshold level or worse in both ears) (tympanostomy tube); or
- Recurrent episodes of acute otitis media (more than 3 episodes in 6 months or more than 4 episodes in 12 months) (tympanostomy tube); or
- Severe otalgia in acute otitis media (myringotomy); or
- To obtain a culture (diagnostic tympanocentesis/myringotomy) of the middle ear fluid prior to beginning or changing antimicrobial therapy (this may be necessary in situations such as otitis media that has failed to respond to appropriate antimicrobial therapy, or for otitis media in individuals or neonates who are immunocompromised).
- Tympanostomy tube insertion is considered not medically necessary for children with a single episode of otitis media with effusion (OME) of less than 3 months’ duration.
- Tympanostomy tube insertion is considered not medically necessary for children with recurrent acute otitis media (AOM) who do not have middle ear effusion in either ear at the time of assessment for tube candidacy.
- Balloon dilation of the Eustachian tube (BDET) is considered medically necessary in adults (18 years and older) when all the following criteria are met:
- Diagnosis of chronic Eustachian tube dysfunction (ETD)Footnote*; and
- Tympanogram type B or C; or
- If the member has a history of tympanostomy tube placement, symptoms of obstructive eustachian tube dysfunction improved while tubes were patent; and
- Absence of a co-morbid condition that would be contraindicated for balloon dilation including but not limited to:
- Carotid abnormalities in the skull base; or
- Nasopharyngeal or skull base neoplasm; or
- Patulous eustachian tube; or
- Untreated allergic rhinitis, rhinosinusitis, laryngopharyngeal reflux.
Footnote1* Symptoms have been present for 3 months or longer; and have a significant effect on quality of life (QOL), or functional health status.
- Aetna considers myringotomy and tympanostomy tube (also known as ventilation tube and grommet) insertion medically necessary for any of the following indications:
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Experimental and Investigational
The following procedures are considered experimental and investigational because the effectiveness of these approaches has not been established (not an all-inclusive list):
- Myringotomy and tympanostomy tube insertion for all other indications not listed in Section I (e.g., the prevention of hearing impairment in children with Cornelia de Lange syndrome without above-listed indications for tube placement);
- Use of soft-tissue fillers (e.g., hyaluronic acid and Prolaryn gel) for the treatment of patulous Eustachian tube;
- Use of phosphorylcholine-coated tympanostomy tube and vancomycin-coated tympanostomy tube;
- EarPopper device for the treatment of otitis media with effusion and all other conditions (e.g., eustachian tube dysfunction and negative pressure as a consequence of elevation changes from airline travel, diving, and sinusitis surgery, etc.);
- BDET for the following:
- After initially successful BDET;
- After unsuccessful BDET;
- With tympanoplasty or other middle ear surgery;
- Trans-tympanic balloon dilatation of the Eustachian tube for the treatment of chronic ear disease;
- Tubes Under Local Anesthesia (Tula) System for the treatment of otitis media.
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Policy Limitations and Exclusions
Note: OtoScan laser-assisted myringotomy (also called tympano-laserostomy, laser-assisted tympanostomy [LAT] or OtoLAM) is considered to be as effective as traditional myringotomy and is safe. The same selection criteria apply to both laser myringotomy and the traditional myringotomy.
Background
Myringotomy and Tympanostomy Tube
A myringotomy is an incision of the tympanic membrane to allow ventilation of the middle ear, drainage of middle ear fluid, or to obtain cultures from an infected middle ear. In children with middle-ear effusions, initial treatment often consists of observation or antibiotic therapy even though recent evidence indicated that the benefit of antibiotics for otitis media with effusion (Lous et al, 2005) and acute otitis media (Schilder et al, 2004) is limited. Most cases of otitis media with effusion resolve spontaneously within 3 months of onset.
An alternative to myringotomy with tube placement is a new tympanostomy procedure by CO2 laser without ventilation tubes, (also called tympanolaserostomy or laser-assisted tympanostomy [LAT]). OtoLAM™ (ESC Medical Systems, Needham, MA) is performed with a computer-driven laser and a video monitor to pinpoint the exact location for the hole. It programs the precise size of the hole into the computer. The laser then takes just 1/10 of a second to create the opening, without damaging surrounding skin or structures in the ear. The hole stays open for several weeks and this provides ventilation of the middle ear without the need for tube placement. Studies showed that the CO2 laser was especially effective in vaporizing the tympanic membrane, especially when there was fluid behind the tympanic membrane to protect the promontory. Laser myringotomies maintain patency slightly longer than that produced by cold-knife myringotomy (3 to 6 weeks versus 48 to 72 hours) but have not been proven to be more efficacious in the management of effusion than simple myringotomy. A randomized controlled study (n = 208) found that laser myringotomy is safe but less effective than ventilation tube in the treatment of chronic otitis media with effusion (Koopman et al, 2004).
In an update of the 1994 clinical practice guideline Otitis Media With Effusion in Young Children, developed by the AHCPR, the American Academy of Family Physicians, American Academy of Otolaryngology-Head and Neck Surgery, and the American Academy of Pediatrics Subcommittee on otitis media with effusion (2004) recommended that clinicians should manage children with otitis media with effusion (OME, aged 2 months through 12 years) who are not at risk with watchful waiting for 3 months from the date of effusion onset (if known), or from the date of diagnosis (if onset is unknown). Children with persistent OME who are not at risk should be re-examined at 3- to 6-month intervals until the effusion is no longer present, significant hearing loss is identified, or structural abnormalities of the eardrum or middle ear are suspected. When a child becomes a surgical candidate, tympanostomy tube insertion is the preferred initial procedure. Candidates for surgery include children with OME lasting 4 months or longer with persistent hearing loss or other signs and symptoms, recurrent or persistent OME in children at risk regardless of hearing status, and OME and structural damage to the tympanic membrane or middle ear. The tube usually remains in place for several months, although it may be rejected sooner or remain in place for years. Adenoidectomy should not be performed unless a distinct indication exists (nasal obstruction, chronic adenoiditis); repeat surgery should consist of adenoidectomy plus myringotomy, with or without tube insertion. Furthermore, tonsillectomy alone or myringotomy alone should not be used to treat OME (Rosenfeld et al, 2004).
A Cochrane review (Lous et al, 2005) stated that the most common medical treatment options for OME include the use of decongestants, mucolytics, steroids, anti-histamines and antibiotics. The effectiveness of these therapies, however, has not been established. Surgical treatment options include grommet (ventilation or tympanostomy tube) insertion, adenoidectomy or both. Moreover, the benefits of grommets in children appear small. The effect of grommets on hearing diminished during the first year. Potentially adverse effects on the tympanic membrane are common after grommet insertion. Thus, an initial period of watchful waiting seems to be an appropriate management strategy for most children with OME. Randomised controlled studies are needed before more detailed conclusions about the effectiveness of grommets can be drawn.
In a multi-center, randomized controlled study (n = 395), Paradise et al (2005) concluded that in otherwise healthy children younger than 3 years of age who have persistent middle-ear effusion within the duration of effusion (9 months) that these patients were studied, prompt insertion of tympanostomy tubes does not improve developmental outcomes at 6 years of age.
In a "follow-up" study, Paradise et al (2007) examined tympanostomy tubes and developmental outcomes at 9 to 11 years of age. These researchers enrolled 6,350 infants soon after birth and evaluated them regularly for middle-ear effusion. Before 3 years of age, 429 children with persistent effusion were randomly assigned to undergo the insertion of tympanostomy tubes either promptly or up to 9 months later if effusion persisted. They assessed literacy, attention, social skills, and academic achievement in 391 of these children at 9 to 11 years of age. Mean (+/- SD) scores on 48 developmental measures in the group of children who were assigned to undergo early insertion of tympanostomy tubes did not differ significantly from the scores in the group that was assigned to undergo delayed insertion. These measures included the Passage Comprehension subtest of the Woodcock Reading Mastery Tests (mean score, 98 +/- 12 in the early-treatment group and 99 +/- 12 in the delayed-treatment group); the Spelling, Writing Samples, and Calculation subtests of the Woodcock-Johnson III Tests of Achievement (96 +/- 13 and 97 +/- 16; 104 +/- 14 and 105 +/- 15; and 99 +/- 13 and 99 +/- 13, respectively); and inattention ratings on visual and auditory continuous performance tests. The authors concluded that in otherwise healthy young children who have persistent middle-ear effusion, as defined in this study, prompt insertion of tympanostomy tubes does not improve developmental outcomes up to 9 to 11 years of age.
In an editorial that accompanied the study by Paradise and associates, Berman (2007) stated that the consistency of the findings of Paradise et al during prolonged follow-up periods provided convincing evidence that persistent middle-ear effusion in otherwise normal children does not cause developmental impairments.
Allen (2007) conducted a retrospective chart review to determine if intravenous access is necessary during the performance of myringotomy with tube insertion. The study included 50 pediatric patients divided equally into 2 groups: group 1, who did not have intravenous access established before the procedure, and group 2, who did have intravenous access established. To be enrolled, patients in both groups had to be less 12 years of age or younger, have an American Society of Anesthesiologists physical status classification of P1 or P2, and had to have undergone no adjunctive procedure with the myringotomy. Induction time was significantly shorter in group 1 (average: 6.96 +/- 2.72 mins) than in group 2 (average: 9.80 +/- 3.82 mins; p = 0.004). Operating time and total operating room time were not significantly different between the 2 groups. Additionally, 24 of 25 patients in group 1 had their pain managed with acetaminophen or no medication at all, while 9 of 25 group 2 patients received acetaminophen and 13 received intravenous pain medication. Interestingly, no patients in group 1 required anti-emetics, whereas 4 patients in group 2, who were given intravenous or intramuscular narcotics, received anti-emetic medications. These findings indicate that myringotomy with tube insertion can be safely accomplished without establishing intravenous access. Induction times and time under general anesthesia were significantly increased when intravenous access was obtained. The findings also suggest that acetaminophen provides adequate post-operative pain control in this patient population and that the use of intravenous or intramuscular narcotics increases the risk of post-operative nausea.
Spielmann et al (2008) stated that there is a paucity of evidence to guide the post-operative follow-up of patients undergoing middle-ear ventilation tube insertion for the first time. This study was undertaken to identify current practice at the authors' institution and to inform subsequent change in their follow-up procedure. Two cycles of data collection and analysis were performed. All pediatric patients undergoing ventilation tube insertion for the first time were identified. Patients who had previously undergone ventilation tube insertion or additional procedures such as adenoidectomy or tonsillectomy were excluded. The first data collection period comprised all of the year 2000, and the second 18 months over 2003 to 2004. A minimum of 20 months' follow-up was allowed for. Data regarding clinical findings and audiometry were recorded at each follow-up appointment. A total of 50 patients meeting the criteria for inclusion in the first cohort were identified. There were a total of 156 appointments between surgery and data collection (a mean of 3.12 per child). A total of 113 (72 %) appointments lead to no medical intervention. The only statistically significant difference between patients requiring further ventilation tube insertion (n = 10) and those not requiring further treatment during the study period (n = 40) was the average hearing threshold (p < 0.01). These findings prompted a change in the post-operative regime; all patients undergoing ventilation tube insertion were subsequently seen at 3 months for a pure tone audiogram, and further review depended on clinical and audiometric findings. Records for 84 children were identified and collected for the second cohort, there were a total of 154 appointments (a mean of 1.83 per child). In only 18 appointments (12 %) were normal findings and hearing recorded and children given a further review appointment. Sixteen of 29 (55 %) children with abnormal clinical findings (otorrhea, tube blockage or extrusion) required some form of intervention (p < 0.05). Twenty-six had a mean hearing threshold worse than 20 dB at first review. Nineteen (73 %) required further intervention of some sort (p < 0.01). The authors concluded that these findings demonstrated that the vast majority of review appointments resulted in no clinical intervention. Thus, these investigators question the need for regular follow-up in this patient group. Twenty per cent (10 of 50 and 18 of 84) of the patients required further ventilation tube insertion within the study periods. This is consistent with rates reported in the literature. Children with abnormal clinical findings or a mean hearing threshold greater than 20 dB were significantly more likely to require further intervention. The authors recommended one post-operative review with audiometry, 3 months after surgery. At this initial appointment, further review should be offered to those children with poor hearing, early extrusion, blockage or infection, as they are more likely to require further ventilation tube insertion.
In a Cochrane review on grommets (ventilation tubes) for recurrent acute otitis media in children, McDonald et al (2008) concluded that ventilation tubes have a significant role in maintaining a "disease-free" state in the first 6 months after insertion. They stated that more research is needed to investigate the effect beyond 6 months. Furthermore, clinicians should consider the possible adverse effects of grommet insertion before surgery is undertaken.
Campbell and colleagues (2009) stated that primary ciliary dyskinesia is an autosomal recessively inherited group of disorders of ciliary ultra-structure. Otolaryngologists are frequently involved in the management of some of the most common symptoms of primary ciliary dyskinesia including chronic rhinitis, sinusitis, and OME. A dilemma for otorhinolaryngologists is whether ventilation tubes are of benefit in children with primary ciliary dyskinesia and OME and what effective alternatives exist. The authors addressed this issue via a literature review and case presentation. An extensive review of the literature was undertaken and a discussion of the advantages and disadvantages of ventilation tubes in the management of OME in these children was presented and compared with that of the general population. These investigators presented a case of a 9-month old boy with Kartagener's syndrome and chronic bilateral OME to illustrate their findings. A total of 8 papers were identified, all with small study numbers. The main outcome measures were hearing, otorrhea and tympanic membrane structural changes. The natural history of OME and hearing loss in primary ciliary dyskinesia appears to be fluctuant into adulthood. Thus, OME in primary ciliary dyskinesia does not resolve by the age of 9 years, regardless of treatment, as previously assumed. Ventilation tube insertion (VTI) improves hearing in primary ciliary dyskinesia, but may lead to a higher rate of otorrhea when compared to the general population. Tympanic membrane changes were clinically insignificant. The patient eventually underwent successful insertion of bilateral ventilation tubes with a marked improvement in hearing and language with minimal otorrhea. The authors concluded that the highest level of evidence found for the management of OME in children with primary ciliary dyskinesia was level IV. Currently, the evidence is inconclusive and conflicting. While these findings are promising, clearly higher quality research on a larger number of patients is required to definitively evaluate the management options for OME in these children.
Coated Tympanostomy Tubes
Methicillin-resistant staphylococcus aureus (MRSA) infections and colonization in children have increased in recent years. Moreover, bacterial biofilm formation has been implicated in the high incidence of persistent otorrhea following tympanostomy tube insertion. It has been suggested that the tube material may be an important factor in the persistence of such otorrhea. Development of MRSA otorrhea after tympanostomy tube placement is a growing concern. Jang and associates (2010) evaluated the effect of using vancomycin and chitosan coated tympanostomy tubes on the incidence of MRSA biofilm formation in-vitro. Three sets each of vancomycin-coated silicone tubes (n = 5), commercial silver oxide-coated silicone tubes (n = 5) and uncoated tympanostomy tubes (as controls; n = 5) were compared as regards resistance to MRSA biofilm formation after in vitro incubation. Scanning electron microscopy showed that the surfaces of the silver oxide-coated tubes supported the formation of thick biofilms with crusts, comparable to the appearance of the uncoated tubes. In contrast, the surface of the vancomycin-coated tympanostomy tubes was virtually devoid of MRSA biofilm. The authors concluded that vancomycin-coated tympanostomy tubes resist MRSA biofilm formation. They noted that pending further study, such tubes show promise in assisting the control of MRSA biofilm formation.
In a prospective, randomized, double-blind controlled trial, Hong et al (2011) compared the post-operative complication rates of phosphorylcholine-coated fluoroplastic tympanostomy tubes versus uncoated fluoroplastic tympanostomy tubes. A total of 240 children with recurrent acute otitis media and chronic otitis media with effusion were randomized to receive a phosphorylcholine-coated tube in one ear and an uncoated tube in the other. Post-operatively, patients were assessed at 2 weeks and 4, 8, 12, 18, and 24 months to ascertain the incidence of otorrhea, tube lumen blockage, and early extrusion. Out of 240 children, 5 withdrew and 16 were lost to early follow-up. The mean age was 43.8 months. There were no statistically significant differences in the incidence of post-operative otorrhea, tube blockage, and extrusion. The authors concluded that phosphorylcholine-coated fluoroplastic ventilation tubes do not offer any advantages over uncoated standard fluoroplastic tympanostomy tubes.
The EarPopper Device
The EarPopper is a non-invasive device for treating conditions such as otitis media with effusion, middle ear effusion, aerotitis/barotitis and eustachian tube dysfunction, without the need for surgery or antibiotics. It delivers a constant, regulated stream of air into the nasal cavity through the nostril with a 1-oz infant nasal syringe equipped with a plastic tip. During the moment of swallowing, the air is diverted up the eustachian tube clearing and ventilating the middle ear. The EarPopper relieves the negative ear pressure allowing any accumulated fluids to drain. The Australia and New Zealand Horizon Scanning Network's assessment on "EarPopper™ for the treatment of otitis media in children" (2007) deemed this technology as "yet to emerge"; and it does not receive approval from the Australian Therapeutic Goods Administration. The assessment noted that the evidence suggested that the EarPopper™ may provide a safe and effective treatment option in the short-term with minimal clinical impact on health practitioners as it can be used at home; and recommended that this technology be monitored.
An Agency for Healthcare Research and Quality’s report on "Otitis media with effusion: Comparative effectiveness of treatments" (AHRQ, 2012) stated that "Though not in widespread use, the technique of autoinflation [which is what EarPopper tries to accomplish] has been used as a treatment for OME. The goal of autoinflation is to use either a Valsalva maneuver or external device to equalize middle ear and oropharyngeal pressure, essentially transiently opening the Eustachian tube. A 2006 Cochrane Collaboration study included 6 randomized controlled trials (RCTs) examining the use of autoinflation versus no treatment for hearing loss associated with OME. Studies included children, adults, and special populations and concluded that the evidence for the use of autoinflation in the short-term was favorable; however, given the small number of studies and lack of long-term follow-up, the long-term effects could not be determined".
In a randomized, single-blinded, controlled trial, Banigo et al (2016) provided an independent evaluation of the safety and effectiveness of the EarPopper in improving hearing outcomes in children with OME and reducing the ventilation tube insertion rate. A total of 29 children aged between 4 and 11 years diagnosed with persistent OME lasting at least 3 months with an average hearing of 25 decibels Hearing Leve (dBHL) or worse in the better ear were randomized to a treatment or control group for 7 weeks using random computer-generated codes. Syndromic children, children with developmental delay, previous grommets and cleft palate were excluded. The audiologists were blinded at the final post-treatment audiogram. After the 7-week period, the mean improvement in air conduction across all frequencies was 10.9 dBHL in the treatment group (p < 0.001) and 3.6 dBHL in the control group (p = 0.201). At every frequency, the treatment group had larger improvements in air conduction, the largest being at 4 kHz where the mean air conduction in both ears improved by 14.8 dBHL. Compliance with the EarPopper was over 90 %, the only side-effect reported being discomfort in the ears immediately after use, which resolved and did not affect compliance. The ventilation tube insertion rate was 53.3 % in the treatment group and 78.6 % in the control group. Median follow-up time for all patients is 47.7 months. The authors concluded that the findings of this study showed that the EarPopper is a safe and effective therapeutic option for children with hearing loss from persistent OME, and it reduces the rate of ventilation tube insertion; they stated that more studies with larger sample sizes are needed to support their findings.
Tympanostomy Tube Insertion in Children with Cleft Palate
Hornigold et al (2008) noted that between July 1984 and March 1987, all children that underwent repair for primary cleft palate at the Queen Victoria Hospital were enrolled in a clinical trial. Those found to have OME at time of surgery had a t-tube inserted into 1 randomized ear, while the other ear received no treatment. The object of the study was to re-assess patients from the original trial to discover the impact of the unilateral t-tube 20 years later. A total of 22 patients were identified as potential study participants. Of this group, 14 were contactable and 7 agreed to participate in the follow-up study. Main outcome measures were persistent symptomatology, otoscopy, pure tone audiometry and tympanometry. Follow-up results were compared within the original treatment groups from the primary study, on an intention-to-treat basis. Otoscopically the ears were normal in 2 of the 7 treated ears compared with 4 of the 7 non-treated ears. All the other ear ears had various types of chronic otitis media. Four of the 7 had hearing of greater than 10 dB in the treated ear compared with the non-treated ear. The authors concluded that these findings would indicate need for caution in the use of t-tubes in the cleft population and raises the question of long-term follow-up to assess for secondary cholesteatoma.
In a systematic review, Ponduri et al (2009) examined if early routine grommet insertion in children with cleft palate has a beneficial effect on hearing and speech and language development compared with conservative management. The main outcome measure was the effect of early routine grommet placement on the degree of conductive hearing loss. Secondary outcome measures included differences in hearing level, possible side effects, speech and language development, and quality of life. These researchers identified 368 citations for review. From a review of the titles, 34 potentially relevant papers were selected. Of these, 18 studies met the inclusion criteria, including 8 case series, 6 historical cohort studies, 3 prospective cohort studies, and 1 randomized trial. Most studies were either small or of poor quality or both. The results of the studies were contradictory, with some studies suggesting early placement of grommets was beneficial and others reporting there was no benefit. The authors concluded that there is currently insufficient evidence on which to base the clinical practice of early routine grommet placement in children with cleft palate.
- children aged less than 2 years with recurrent AOM – 16 % of those who had adenoidectomy failed at 12 months whereas 27 % of those who did not have adenoidectomy failed [rate difference (RD) 12 %, 95 % Cl: 6 % to 18 %; number needed to treat (NNT) = 9];
- children aged greater than or equal to 4 years with persistent OME – 51 % of those who had adenoidectomy failed at 12 months whereas 70 % of those who did not have adenoidectomy failed (RD 19 %, 95 % Cl: 12 % to 26 %; NNT = 6).
Kuo and colleagues (2014) stated that no consensus has yet been reached with regard to the link between OME, hearing loss, and language development in children with cleft palate. These researchers examined the effectiveness of VTI for OME in children with cleft palate. A dual review process was used to assess eligible studies drawn from PubMed, Medline via Ovid, Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, and reference lists between 1948 and November 2013. Potentially relevant papers were selected according to the full text of the articles. Relevant data were extracted onto a data extraction sheet. A total of 9 high- or moderate-quality cohort studies were included in this study. Ventilation tube insertion was administered in 38 % to 53 % of the OME cases, and more severe cases appeared more likely to undergo VTI. Compared with conservative forms of management (e.g., watchful waiting), VTI has been shown to be beneficial to the recovery of hearing in children with cleft palate and OME. A growing body of evidence demonstrated the benefits of VTI in the development of speech and language in children with cleft palate and OME. These children face a higher risk of complications than those undergoing conservative treatments, the most common of which are eardrum retraction and tympano-sclerosis, with an incidence of approximately 11 % to 37 %. The authors concluded that this review provided evidence-based information related to the selection of treatment for OME in children with cleft palate. They stated that additional RCTs are needed to obtain bias-resistant evidence capable of reliably guiding treatment decisions.
Guidance from the National Institute for Health and Clinical Excellence (NICE, 2008) states that the care of children with cleft palate who are suspected of having OME should be undertaken by the local otological and audiological services with expertise in assessing and treating these children in liaison with the regional multidisciplinary cleft lip and palate team. Insertion of ventilation tubes at primary closure of the cleft palate should be performed only after careful otological and audiological assessment. Insertion of ventilation tubes should be offered as an alternative to hearing aids in children with cleft palate who have OME and persistent hearing loss.
In a case-series with chart-review study, Kim and colleagues (2017) examined the effect of VTI on long-term hearing outcomes in children with cleft palate. Children with cleft palate diagnosis who underwent surgery at Rady Children's Hospital-San Diego between 1995 and 2002 were included in this analysis. The primary outcome studied was hearing acuity at 10 years of age. Independent variables studied included gender, age at palate repair and first VTI, total number of VTs, number of complications, and presence of tympanic membrane perforation. An increased number of tubes was associated with a greater incidence of hearing loss at age 10, even after adjusting for total number of otologic complications. The timing of initial VTI did not have a significant effect on long-term hearing outcome in this study. The authors concluded that while children with worse middle ear disease were more likely to receive more tubes and have long-term conductive hearing loss as a result of ear disease, the results of this study suggested that multiple VTI may not contribute to improved long-term hearing outcomes. They stated that further research focusing on long-term outcomes is needed to establish patient-centered criteria guiding decision making for VTI in children with cleft palate.
Miscellaneous Information
The American Academy of Otolaryngology-Head & Neck Surgery's clinical practice guideline on "Tympanostomy tubes in children" (Rosenfeld et al, 2013; 2022) provided the following recommendations:
- Clinicians should not perform tympanostomy tube insertion in children with a single episode of OME of less than 3 months’ duration
- Clinicians should obtain an age-appropriate hearing test if OME persists for 3 months or longer (chronic OME) or prior to surgery when a child becomes a candidate for tympanostomy tube insertion
- Clinicians should offer bilateral tympanostomy tube insertion to children with bilateral OME for 3 months or longer (chronic OME) and documented hearing difficulties
- Clinicians should re-evaluate, at 3- to 6-month intervals, children with chronic OME who did not receive tympanostomy tubes until the effusion is no longer present, significant hearing loss is detected, or structural abnormalities of the tympanic membrane or middle ear are suspected
- Clinicians should not perform tympanostomy tube insertion in children with recurrent acute otitis media (AOM) who do not have middle ear effusion in either ear at the time of assessment for tube candidacy
- Clinicians should offer bilateral tympanostomy tube insertion to children with recurrent AOM who have unilateral or bilateral middle ear effusion at the time of assessment for tube candidacy
- Clinicians should determine if a child with recurrent AOM or with OME of any duration is at increased risk for speech, language, or learning problems from otitis media because of baseline sensory, physical, cognitive, or behavioral factors
- The clinician should not place long-term tubes as initial surgery for children who meet criteria for tube insertion unless there is a specific reason based on an anticipated need for prolonged middle ear ventilation beyond that of a short-term tube
- In the perioperative period, clinicians should educate care-givers of children with tympanostomy tubes regarding the expected duration of tube function, recommended follow-up schedule, and detection of complications
- Clinicians should not routinely prescribe post-operative antibiotic ear drops after tympanostomy tube placement
- Clinicians should not encourage routine, prophylactic water precautions (use of earplugs, headbands; avoidance of swimming or water sports) for children with tympanostomy tubes.
- laser myringotomy group and
- myringotomy with ventilation tube insertion group, with follow-up in hearing results and recurrence rates over 5 years.
Follow-Up Care After Grommet Insertion
Mughal and colleagues (2016) stated that grommet insertion is a common procedure in children. A lengthy otolaryngology follow-up can have an adverse impact on clinic waiting times, new patient appointment availability, and pecuniary disadvantage for the hospital. These investigators consolidated research and opinion concerning follow-up care following grommet insertion in a pediatric population. The literature between January 1990 and September 2015 was searched on Medline (Ovid), Google Scholar, PubMed and Web of Science databases. Guidelines and consensus of opinion from the United States advocate that an initial post-operative review should take place within 4 weeks, and subsequent appointments every 6 months until grommet extrusion. Recent audit reports from the United Kingdom have shown that some groups arrange their first post-operative review at 3 months, and subsequent appointments vary considerably from no further follow-up to up to 24 months. Up to 75 % of follow-up appointments were scheduled despite normal audiometry and clinical findings after grommet insertion, suggesting a large cohort of patients may undergo unnecessary specialist clinic reviews. General practitioners (GPs), audiologists or specialist nurses are potential alternative providers of regular reviews to ensure normal hearing thresholds and an adequate tympanic membrane healing course. The authors concluded that follow-up schedules are largely driven by consensus of opinion. They noted that a significant number of follow-up appointments in otolaryngology clinic appear to be redundant. Recently attention has been drawn to earlier discharge from otolaryngology clinic with subsequent follow-up in less resource- and cost-intensive clinics coordinated by GPs, audiologist or nurses, which may help alleviate some out-patient workload on acute hospital trusts.
Treatment of Hearing Impairment in Children with Cornelia de Lange Syndrome
Jung and colleagues (2016) noted that Cornelia de Lange syndrome (CdLS) is a multiple developmental disorder including hearing loss. The hearing impairment in CdLS patients is not only sensori-neural hearing loss (SNHL), but also conductive hearing loss (CHL). The authors examined hearing loss causes in CdLS patients and evaluated the effect of VTI in the cases of CHL. A total of 32 patients clinically diagnosed with CdLS were included in this retrospective case review. Audiological evaluations and imaging studies such as a temporal bone computed tomogram or brain magnetic resonance imaging (MRI) were performed for all patients. Hearing rehabilitation (e.g., VTI, hearing aid fitting, or cochlear implantation) was chosen depending on the audiological condition. Among the 32 CdLS patients who underwent auditory brainstem response test, 81.2 % presented hearing loss. Imaging studies showed that only middle ear lesions without inner ear anomalies were identified in 56.3 %. Notably, the soft tissue lesion in middle ear was identified even in the neonatal MRI. When 7 patients were thought to have CHL due to OME, VTI was applied first. However, VTI rarely improved CHL post-operatively. Moreover, middle ear lesion was not fluid effusion but soft tissue lesion according to the intra-operative finding. These lesions were not eradicated even after revision surgery of VTI. The authors concluded that VTI was ineffective to improve hearing or eradicate OME in CdLS patients.
Janek and associates (2016) stated that patients with CdLS are reported to have CHL and SNHL, but there is little information pertaining to the progression of hearing loss over time. These investigators examined the prevalence of CHL and SNHL in adults and children with CdLS and looked for changes in SNHL over time. They carried out a retrospective chart review of patients with CdLS presenting to a CdLS clinic. Also, a written survey of clinical concerns was collected from additional patients/families seen in the clinic and through the Cornelia de Lange Foundation. A total of 78 patients (50 % female) were included in the chart-review. Mean age was 16.8 ± 11.4 years (range of 0.6 to 50 years) and mean age at diagnosis of hearing loss was 4.6 ± 10.6 years (n = 26); 5 patients (6.4 %) had severe to profound SNHL that improved with time, including 2 who had complete normalization of audiogram results; 35 families/patients completed the clinical survey, and 45.5 % of the families reported a noticeable improvement of hearing over time. The authors concluded that CHL and SNHL are common in CdLS; and more than 50 % of the patients seen in an adult CdLS clinic reported improvement in hearing loss over time, and a subset of patients had an improvement in SNHL. In light of these findings, the authors recommended longitudinal evaluations of hearing loss in these patients with both auditory brainstem response and oto-acoustic emissions testing if SNHL is identified.
Endoscopic Balloon Dilation of the Eustachian Tube
Catalano and colleagues (2012) stated that Eustachian tube dysfunction is a common problem and trans-nasal endoscopic balloon dilation of the Eustachian tube (ET) is a new surgical technique. These researchers reviewed the evolution of this novel technique and studied the preliminary outcomes. Balloon catheter dilation of the 100 Eustachian tubes in 70 adults was performed at a tertiary medical center from January 2009 to January 2011. A 5-mm sinus balloon catheter was endoscopically placed trans-nasally into the proximal ET to dilate the cartilaginous ET. Cases were reviewed with respect to indications, outcomes, and complications. Of the 100 ETs, ear fullness and pressure were improved in 71 % of patients studied for 26.3 weeks (± 3.6). Of 8 patients followed for a minimum of 34 months, 87 % reported persistent improvement; 1 complication was reported. The authors concluded that endoscopic trans-nasal ET balloon dilation is a novel approach to treating ET dysfunction. Benefits can be durable up to 3 years. Moreover, they stated that this technique holds much promise and merits further investigation.
Jurkiewicz et al (2013) noted that the development of minimally invasive procedures such as the balloon dilation Eustachian tuboplasty (BET) is an alternative to the grommet tympanum membrane. BET is applied in the cases where, after elimination of all factors influencing the ET and middle ear functioning, no sufficient improvement is observed. These investigators presented the therapeutic benefits of the BET method in the treatment of Eustachian tube dysfunction (ETD) caused by disorders in the middle ear ventilation. The BET procedure was offered to 4 patients (3 men and 1 woman) after subjective, physical, otorhino-laryngological and audiometric examinations including pure tone audiometry, tympanometry and pressure-swallow test. As the method was novel, pre-interventional CT angiography of the carotid arteries was performed in all patients. Any complications were noticed during and after the procedure (bleeding or damage of regional mucosa) in any patients. These clinical studies assessed the feasibility and safety of the BET during a short-term period – only a 6-week observation. The authors concluded that although patients revealed a significant improvement of ET score, longer long-term studies are needed to determine whether this method will demonstrate lasting benefits and safety in the treatment of chronic Eustachian tube dysfunction.
Moller et al (2014) stated that balloon dilation of Eustachian tube is a novel method for managing chronic ventilatory dysfunction in patients with chronic otitis media, as an alternative to classic grommet insertion. Although few retrospective studies have been conducted the method seems to be rapid, simple and safe with promising short-term results. These researchers presented the method and summarized the results of available studies. Optimization of patient selection is needed and the authors discussed the development of better objective measurement methods as well as the need for randomized prospective studies, which are currently being conducted.
Silvola et al (2014) noted that studies of BET have shown encouraging results in small series with short follow-ups. A pilot study suggested that patients with protracted OME or atelectasis of the tympanic membrane (TM) could benefit from BET. In a prospective study where subjects acted as their own controls, patients from the pilot study and additional cases were enrolled in this cohort with long-term follow-up. Out of 80 patients who underwent BET, 41 consecutive ET operations were included. Subjects' inclusion criteria were OME and/or TM atelectasis, type B or C tympanograms, and inability to inflate their middle ears by Valsalva maneuver. All patients had long-standing ET dysfunction relieved only by repeated tympanostomies. Outcomes included ability to perform a Valsalva maneuver, audiometry, tympanometry, videoendoscopy of the ET with mucosal inflammation rating scores, and otomicroscopy. All cases were dilated successfully, without significant complications. Mean follow-up was 2.5 years (range of 1.5to 4.2 years); 80 % (33/41) could do a Valsalva maneuver post-operatively; none of these ears needed new tympanostomy tubes and subjective symptoms were relieved. Tympanometry results showed overall improvement; 9 patients had persistent perforations and 3 declined removal of the tube. Subjective symptoms were not relieved for 10 % (4/41). The authors concluded that the findings of this study showed that BET could effectively improve ET function in ears with OME or atelectasis. The procedure was well-tolerated and without significant complications.
Shroder et al (2015) stated that ETD is regarded as a “black box” term, reflecting a spectrum of dysfunction. The key to its diagnosis and management is in identifying the etiology and exact pathophysiology of the dysfunction. In a retrospective study, these investigators presented the 5-year findings for the technique of trans-nasal endoscopic balloon dilatation of the cartilaginous part of the ET, BET. The indication for treatment is chronic obstructive ETD. Pre-operatively, the ET score (ETS) was obtained by a clinico-objective assessment involving TMM and reported patient symptom. The measurements were repeated 1, 2, 3, 4 and 5 years post-operatively. A total of 622 patients (1,076 ears) were treated with BET. One year after treatment, the ETS improved from 3.13 (± 2.47 SD) to 5.75 (± 2.76 SD). The ETS improved significantly in 73 % of ears. The average ETS 2 years after treatment improved from 2.65 (± 2.89 SD) to 6.26 (± 3.07 SD). In 82 % of patients, the ETS improved significantly at 5 years. The subjective satisfaction of the patients was approximately 80 %. The authors concluded that these long-term results suggested that BET was a safe and feasible treatment for chronic obstructive ETD with a success rate of more than 70 %. These investigators noted that the findings of this study had important implications for other ET-related clinical entities (e.g., glue ear management (adults and children), continued grommet insertion and tympano-mastoid surgery outcomes).
In a retrospective, cohort study, Gurtler et al (2015) assessed Eustachian tube balloon dilation in the treatment of Eustachian tube dysfunction by objective analysis, especially tubomanometry. Patients undergoing Eustachian tube balloon dilation for treatment of Eustachian tube dysfunction were enrolled in this study. Main outcome measures included subjective improvement, otomicroscopic findings, tympanogram, air-bone gap in pure-tone audiogram, R-value in tubomanometry at 3 pressure measurements (30, 40, and 50 mbar) and the Eustachian Tube Score (ETS). Eustachian tube balloon dilation was performed in 21 patients. The ETS including the R-values, tympanogram, and air-bone gap all showed a statistically positive outcome (p < 0.005) after Eustachian tube balloon dilation. Subjective improvement was seen in 76 %. Normal R-values were achieved in 57 %. Retraction processes of the tympanic membrane improved in 18 % of patients. Only 1 minor bleeding complication occurred. The authors concluded that Eustachian tube balloon dilation constitutes a safe and very promising treatment option for patients with Eustachian tube dysfunction based on early-outcome analysis; ETS and specifically tubomanometry appeared promising as assessment tools but await validation for use in the diagnostic workup and outcome analysis after ETBD. The pathophysiologic mechanism of Eustachian tube balloon dilation remains unclear. They stated that long-term analysis and stratification of patients are needed to better evaluate the definite value of Eustachian tube balloon dilation.
In a retrospective analysis, Maier et al (2015) evaluated the role of balloon dilation of the Eustachian tube in a large cohort of children with Eustachian tube dysfunction who did not respond to other treatments and in whom a tumor could be ruled out as the cause. These researchers retrospectively analyzed the medical records of 66 children (mean age of 8.12 years, range of 4 to 14 years) who underwent balloon dilation of the Eustachian tube using the Bielefeld balloon catheter. There were no complications during surgery. Clinical symptoms improved in more than 80 % of the patients. No patient reported a deterioration of symptoms. Of the participating parents, over 80 % were very satisfied or satisfied with the treatment outcome. The authors concluded that balloon dilation is a rapid, simple, and safe method for treatment of both adults and children with Eustachian tube dysfunction who did not respond to other treatments. Moreover, they stated that further studies, ideally multi-center studies, are needed to optimize the definition of existing and potential new indications for this treatment approach, as well as to establish this treatment in the management of children with refractory chronic Eustachian tube dysfunction.
Randrup and Ovesen (2015) performed a systematic review and meta-analysis of the evidence on balloon Eustachian tuboplasty (BET) as a treatment modality for ETD. These investigators followed the PRISMA guideline and registered with PROSPERO No. CRD42014009461. They searched 12 databases including PubMed and Embase from January 1, 2010 to April 7, 2014 for studies of BET. Main outcome measures included change in symptoms, middle ear pathology, eardrum status, Eustachian tube function tests, hearing, adverse events, complications, and health-related quality of life. Study quality was assessed using the modified Delphi technique quality appraisal tool for case series studies. Risk of bias was assessed using the Cochrane Collaboration's tool for assessing risk of bias. A total of 9 case-series studies with 443 patients (642 tubes) were included; population size ranged from n = 4 (7 tubes) to n = 210 (320 tubes). All studies were of poor quality and featured a high risk of bias. These researchers found reduction of patient symptoms in ETD questionnaire (p < 0.001), post-operative normalization of the tympanic membrane, conversion of type B or type C into type A tympanograms, reduced mucosal inflammation, increased number of positive Valsalva test and Swallowing tests, improvement in Eustachian tube score, reduction in Sino-Nasal Outcome Test (SNOT)-22 score (p = 0.001), and increased quality of life (p = 0.001). No serious adverse events were found. The authors concluded that the evidence of BET is poor and biased. No firm conclusions can be made to identify patients who will benefit from the procedure or to accurately predict surgical results. They stated that randomized controlled trials or case-control trials are needed.
Hwang et al (2016) stated that Eustachian tube dysfunction is a disorder for which there are limited medical and surgical treatments. Recently, Eustachian tube balloon dilation has been proposed as a potential solution. These investigators performed a systematic literature review. Abstracts were selected for relevance, and pooled data analysis and qualitative analysis was conducted. A total of 9 prospective studies, describing 713 Eustachian tube balloon dilations in 474 patients (aged 18 to 86 years), were identified. Follow-up duration ranged from 1.5 to 18 months. Ability to perform a Valsalva maneuver improved from 20 to 177 out of 245 ears following Eustachian tube balloon dilation and, where data were reported in terms of patient numbers, from 15 to 189 out of 210 patients. Tympanograms were classified as type A in 7 out of 141 ears pre-operatively and in 86 out of 141 ears post-operatively. The authors concluded that prospective case series can confirm the safety of Eustachian tube balloon dilation. As a potential solution for chronic Eustachian tube dysfunction, further investigations are needed to establish a higher level of evidence of efficacy.
Williams et al (2016) measured the success of Eustachian tube balloon dilation by comparing pre- and post-operative middle ear pressures using tympanometric testing. A retrospective chart review was performed on all patients who underwent balloon dilation of the Eustachian tube by authors from 2010 to 2014. Pre and post-operative tympanograms were analyzed and categorized based on type (Type A, Type B, Type C). Success was defined by an improvement in tympanogram type: Type B or C to Type A, or Type B to type C. Pre- and post-operative tympanograms were further analyzed using middle ear pressure values. Follow-up ranged from 3 to 15 months. A total of 25 ears (18 patients) were included in the study. Overall 36 % of ears had improvement in tympanogram type, and 32 % had normalization of tympanogram post-operatively. The Jerger tympanogram type improved significantly following the procedure (p = 0.04). Patients also had statistically significant improvement in measured middle ear pressure post-operatively (p = 0.003). The authors concluded that the natural history of Eustachian tube dysfunction is poorly understood, and evidence for current treatments are limited. Eustachian tube balloon dilation is a safe procedure, and produces significant improvement in tympanogram values up to 15 months post-operatively. They stated that further refinement of patient selection and standardization of technique is needed to optimize the effect of this therapy; long-term follow-up data will clarify the persistence of the effect.
Furthermore, an UpToDate review on "Eustachian tube dysfunction" (Poe and Hanna, 2017) states that "The choice of management strategies for isolated Eustachian tube dysfunction remains controversial as randomized trial data are limited, study outcomes vary widely between studies, and much of what is known about the treatment of Eustachian tube dysfunction comes from animal rather than human studies … Balloon dilation is a novel tuboplasty method to increase the patency of the cartilaginous Eustachian tube. Similar to the concept of balloon sinuplasty for the treatment of chronic sinusitis, a balloon catheter is used to dilate the cartilaginous portion through a minimally invasive transnasal endoscopic approach. Initial cadaveric studies and clinical trials are promising. A 2015 systematic review including 9 case series (443 patients) concluded that balloon tuboplasty is a safe procedure but is still lacking good evidence of benefit".
Wang et al (2018) reported a meta-analysis examining balloon dilatation and laser tuboplasty for the treatment of eustachian tube dysfunction (ETD). PubMed, Cochrane, and Embase were searched up to April 18, 2016, with the following keywords: eustachian, middle-ear, eustachian tuboplasty, balloon tuboplasty, laser tuboplasty, laser dilatation, and balloon dilatation. Randomized controlled trials and prospective, retrospective, and 1-arm studies of patients with ETD treated with balloon dilatation or laser tuboplasty were included. Outcome measures were improvement of eustachian tube score (ETS) and tympanometry and Valsalva maneuver results. Two retrospective and 11 prospective studies were included (1063 patients; 942 treated with balloon and 121 with laser tuboplasty). Balloon tuboplasty resulted in a significant improvement of ETS (pooled standardized mean difference [SMD], 0.94; 95 % CI: 0.23 to 1.66; p = 0.009) and, compared with laser tuboplasty, a greater tympanometry improvement rate (pooled event rate = 73 % versus 13 %; p = 0.001). Valsalva maneuver improvement rate was not different between the group results (pooled event rate = 67 % versus 50 %; p = 0.472). The maximum number of studies that provided outcome data for any one measure was only 4, and sensitivity analysis indicated ETS results may have been overly influenced by 2 studies. No balloon tuboplasty studies reported ETS data, preventing comparison between the 2 procedures. The authors concluded that both procedures can improve symptoms of ETD; however, because of the limited numbers of studies reporting data of the outcomes of interest, it remains unclear if one procedure provides greater benefits.
In a prospective, multi-center RCT, Meyer and colleagues (2018) compared BET versus continued medical therapy (control) for treating persistent ETD. Patients with medically refractory persistent ETD were randomized 1:1 to BDET or control. After 6 weeks, control participants had the option to undergo BET if symptoms persisted. Primary efficacy end-point was the comparison between treatment arms in the mean change from baseline in the 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score. Primary safety end-point was complication rate. A total of 60 participants were randomized (31 BET, 29 control). Mean (SD) change in overall ETDQ-7 score at 6 weeks was −2.9 (1.4) for BET compared with −0.6 (1.0) for control: BET was superior to control (p < 0.0001). No complications were reported in either study arm. Among participants with abnormal baseline assessments, improvements in tympanogram type (p < 0.006) and tympanic membrane position (p < 0.001) were significantly better for BET than control. Technical success was 100 % (91 successful dilations/91 attempts) and most procedures (72 %) were completed in the office under local anesthesia. Improvements in the ETDQ-7 scores were maintained through 12 months after BET. The authors concluded that BET was a safe and effective treatment for persistent ETD. Based on improved ETDQ-7 scores, BET was superior to continued medical management for persistent ETD. Symptom improvement was durable through a minimum of 12 months; procedures were well-tolerated in the office setting under local anesthesia.
The authors stated that a limitation of this study was the inability to blind the participants to their treatment. This could lead to the placebo effect, especially with patient-reported outcomes. However, since these researchers also observed significant improvements in objective findings such as tympanometry, otoscopy, and Valsalva maneuver in the BET-arm and not in the control-arm, they believed that any placebo effect was minimal and that the improvements observed in the ETDQ-7 scores were reliable and indicated true symptom improvement. The physicians were also not blinded to the participant's treatment assignment.
In a prospective, multi-center RCT, Poe and associates (2018) evaluated BET with Eustachian tube balloon catheter in conjunction with medical management (MM) as treatment for ETD. These investigators assigned, in a 2:1 ratio, patients aged 22 years and older with ETD refractory to medical therapy to undergo BET with balloon catheter in conjunction with MM or MM alone. The primary end-point was normalization of tympanogram at 6 weeks. Additional end-points were normalization of ETDQ-7 symptom scores, positive Valsalva maneuver, mucosal inflammation, and safety. Primary efficacy results demonstrated superiority of BET with balloon catheter + MM compared to MM alone. Tympanogram normalization at 6-week follow-up was observed in 51.8 % (72/139) of investigational patients versus 13.9 % (10/72) of controls (p < 0.0001). Tympanogram normalization in the treatment group was 62.2 % after 24 weeks. Normalization of ETDQ-7 scores at 6-week follow-up was observed in 56.2 % (77/137) of investigational patients versus 8.5 % (6/71) controls (p < 0.001). The investigational group also demonstrated substantial improvement in both mucosal inflammation and Valsalva maneuver at 6-week follow-up compared to controls. No device- or procedure-related serious adverse events (AEs) were reported for those who underwent BET. The authors concluded that the findings of this study demonstrated superiority of BET with balloon catheter + MM compared to MM alone to treat ETD in adults. Level of Evidence = 1b.
The authors stated that this study had several drawbacks. First, 1/3 of the study patients were randomized to continue MM, which had previously failed to improve ETD. Risk of low enrollment was mitigated by providing patients the option to receive BET after a 6-week follow-up visit. The majority of patients in the control-arm (59/72; 82 %) did opt to cross-over and receive BET before their 12-week follow-up. Thus, 6 weeks post-randomization, the MM group became relatively small and self-selecting in nature, likely biasing any statistical comparison between treatment groups. Second, the 6-week post-treatment follow-up was rather short; therefore, longer follow-up is needed to properly evaluate the durability of these effects. Third, the use of general anesthesia only in the BET group added a potential confounding factor, but numerous studies of intra-nasal interventions under general anesthesia have failed to show improvement in ETD. Lastly, patients were not blinded to treatment due to the nature of study design comparing MM to surgical procedure. The use of a quantitative primary end-point, evaluated in a blinded fashion, minimized the risk of a placebo effect.
Huisman and co-workers (2018) stated that BET is a new entity in the therapeutic approach of ETD. In a systematic review, these investigators evaluated the success of balloon dilation of the tuba auditiva in reducing symptoms in adult patients with ETD. Data sources included Embase, PubMed, and Cochrane Library. The systematic literature search was conducted independently by 2 authors based on title and abstracts, and resulted in 36 articles. These articles were screened as full text, 15 of them were eligible for critical appraisal. Data were extracted from selected studies and presented in this article. A meta-analysis was conducted for 4 subgroups. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was used as a writing guideline for this systematic review. All 15 included studies were case series. A total of 1,155 patients were treated with balloon dilation of the tuba auditiva. Outcome parameters were relief of symptoms, otoscopy, Valsalva maneuver or Toynbee test, audiometry, tympanometry, ETD classification, and Eustachian tube score. All articles showed short-term improvement of original symptoms; some showed further improvement over time. Follow-up ranged from just after therapy to 50 months. Relatively mild and self-limiting complications were described in 36 patients. The authors concluded that all current studies suggested that BET could be a helpful treatment in patients with ETD; however, placebo-controlled trials are still needed.
In a retrospective, cohort study, Satmis and van der Torn (2018) examined the subjective and objective short-term results and safety of trans-nasal BET in adult patients with chronic dilatory ETD. Data collection was performed pre-operatively, 1 and 3 months after BET; the study included a cohort of 42 consecutive patients (66 ears). ETDQ-7 score, bone conduction threshold, air-bone gap, the ability to perform Valsalva's and/or Toynbee's maneuver, tympanic membrane and middle ear conditions were collected pre- and post-operatively. Subjective satisfaction and complications were collected post-operatively. The ETDQ-7 score improved significantly from 4.28 to 3.09 1 month post-operatively and from 4.10 to 2.96 3 months post-operatively. Bone conduction thresholds did not differ significantly post-operatively. A significant improvement of air-bone gap was found post-operatively. The tympanic membrane and middle ear condition showed improvement in 62 %. Subjective satisfaction 1 and 3 months post-operatively was around 43 and 48 %. A small number of minor (self-limiting) complications occurred. The authors concluded that BET has shown to be a safe intervention, which may have a positive effect on objective and subjective indicators for chronic dilatory ETD in adult patients. These researchers observed subjective positive effects in less than 50 % of the patients. For certain indications, there was a measurable positive effect on the findings of the eardrum and ETDQ-7, whereas in other patients it appeared not to have any effect at all. These investigators stated that careful patient selection may improve this success rate; and RCTs with a prolonged follow-up are needed to evaluate the value of BET in comparison to grommets.
Schmitt and associates (2018) noted that currently there is no consensus on the treatment of obstructive ETD (QETD). In case of failure of well-conducted drug and pressure therapy, some investigators recommend balloon dilation. In a retrospective, single-center study, these researchers examined the safety and efficacy of BET. They assessed clinical and tubo-manometric results of BET, complications and satisfaction in a trial carried out between June 2012 and February 2015. Indications were based on clinical and para-clinical signs of obstructive tube dysfunction despite well-conducted MM. A total of 45 procedures were performed in 38 patients. Improvement in clinical symptoms was assessed as 88 %, 80 % and 80 % at 2 months, 6 months, and over 1 year, respectively. Improved function on tubo-manometry was observed in 81 % of cases. The procedure was well-tolerated, with a minor complications rate of only 4 %. The authors concluded that the present findings for safety, tolerance, and efficacy were comparable to those in the literature, despite 1st-line failure in all patients; Eustachian tube function normalized in about 1/3 of cases. These investigators stated that despite these encouraging results, true efficacy remained to be confirmed in prospective studies with higher levels of evidence.
Luukkainen et al (2018) examined the long-term effects of BET from patient's perspective and determined which symptoms of ETD benefited the most from BET. These researchers designed a retrospective postal questionnaire based on the ETDQ-7. The questionnaire covered the severity of present ETD symptoms in comparison with the pre-operative situation, the severity of current overall ear symptoms, and possible surgical interventions following BET. A total of 46 patients who were treated in the authors’ institution between 2011 and 2013 fulfilled the inclusion criteria and 74 % (34 patients; total 52 ears treated with BET) returned the questionnaire with a mean follow-up time of 3.1 years (range of 1.8 to 4.6 years). Pain in the ears, feeling of pressure in the ears, and feeling that ears were clogged had reduced in 75 % of the ears that suffered from these symptoms pre-operatively; and 77 % of all the responders felt that their overall ear symptoms were reduced. A total of 82 % of all the patients stated that they would undergo BET again if their ear symptoms returned to the pre-operative level. The authors concluded that patient satisfaction in the long-term effects of BET was encouraging; these findings may help clinicians in pre-operative patient selection and counselling.
Anand and colleagues (2019) stated that OETD affects up to 5 % of adults; however, available treatment strategies have limitations. It was previously reported that BET with the Eustachian tube balloon catheter + MM resulted in a significantly higher proportion of subjects with normalized tympanograms versus MM alone at 6- and 24-week follow-up. The current analysis extended these initial findings by examining the durability of BET + MM treatment outcomes through 52 weeks. This trial included 21 investigational sites across the United States. These investigators reported on secondary and exploratory end-points for patients with OETD who previously failed MM and were randomized to the BET + MM cohort. Analyses of tympanogram outcomes were reported by ear, unless specified otherwise, as a more accurate measure of durability of the procedure over time. Among subjects randomized to BET + MM, the overall number with normalized tympanograms and ETDQ-7 scores remained comparable to those reported at 6- versus 52-week follow-up: tympanograms, 73 of 143 (51.0 %) versus 71 of 128 (55.5 %); ETDQ-7, 79 of 142 (55.6 %) versus 71 of 124 (57.3 %). The overall number of ears with normalized tympanograms also remained comparable, with 117 of 204 (57 %) versus 119 of 187 (63.6 %). The authors concluded that the findings of the present study suggested that the beneficial effects of BET + MM on tympanogram normalization and symptoms of subjects with refractory OETD showed significant durability that was clinically relevant through 52 weeks. The authors identified a number of study limitations: First, because crossover to the BET + MM group was allowed after 6-week follow-up, the remaining MM group became self-selected, and this limited the ability to perform meaningful comparisons with the control group after 6-week follow-up. Moreover, because the subjects in the treatment cohort were used as their own historical control, the extent of improvement specifically attributable to treatment remains unknown. Subjects were not blinded to treatment. General anesthesia was used only in the treatment cohort and not in the control cohort and therefore is a potential confounding variable. The study was industry funded and coauthors were paid consultants to the device manufacturer.
An UpToDate review on "Eustachian tube dysfunction" (Poe and Hanna, 2019) states that "Balloon dilation of the Eustachian tube (BDET) is a newer technology for performing a tuboplasty to increase the patency of the cartilaginous Eustachian tube and reduce inflammation. A balloon catheter is used to dilate the cartilaginous portion through a minimally invasive trans-nasal endoscopic approach. Initial cadaveric studies and clinical trials are promising. Two systematic reviews (2015, 2018) concluded that BDET is a safe procedure that appears to have benefit, but all of the studies reviewed were retrospective case series with varied indications and outcome measures. The conclusions were that although there is a consistent demonstration of benefit, randomized controlled trials with long-term results were needed. A randomized trial in 323 patients found that 6 weeks after procedural placement of a balloon catheter, normal tympanogram results were demonstrated in 52 % of the device group compared with 14 % of the medical management (nasal spray) group, leading to approval of the device in adults by the US Food and Drug Administration (FDA) in 2016. The results were sustained at 24 weeks postop in the treatment group. Early results in pediatric BDET in Germany are reflected in a report of 52 children (ages 3 to 15, mean 7 years) undergoing the procedure having failed previous tympanostomy tube and adenoidectomy. BDET was done with or without a myringotomy to aspirate effusion and improvement was reported in 71 percent by one year postop". Balloon dilation of the Eustachian tube (BDET) is not listed in the "Summary and Recommendations" section.
Cutler et al (2019) gathered long-term follow-up data on the effectiveness of balloon dilation in the treatment of patients with persistent ETD. The endpoints were the mean change from baseline in the ETDQ-7 score, revision dilation rate, changes in assessments of middle ear function, and patient satisfaction. A total of 47 participants enrolled in the extended follow-up study. Mean follow-up was 29.4 months (range of 18 to 42 months). There was a statistically significant mean (SD) change from baseline in the overall ETDQ-7 score (-2.5 ± 1.2; p < 0.0001). A reduction of 1 or more in their overall ETDQ-7 score was observed by 93.6 % (44/47) subjects. The revision dilation rate was 2.1 % (1/47). Among subjects with abnormal baseline middle ear assessments, 76.0 % had normalized tympanic membrane position (p < 0.0001), 62.5 % had normalization of tympanogram type (p < 0.001), and 66.7 % had positive Valsalva maneuvers (p < 0.0001). Subject satisfaction was 83.0 % at long-term follow-up. The authors concluded that balloon dilation resulted in durable improvements in symptoms and middle ear assessments for patients with persistent ETD at mean follow-up of longer than 2 years.
The authors stated that the drawbacks of this study included the lack of a control beyond 6 weeks follow-up and the lack of subject blinding. The cross-over design meant that there was no control arm to compare outcomes beyond the 6-week period, so it was unclear how many subjects may have had resolution of their ETD symptoms beyond that period without intervention. However, the inclusion criteria were designed to ensure enrollment of subjects with long-standing, persistent ETD who had already failed medical management. At 6-weeks, only 1 out of 27 control subjects (3.7 %) did not qualify for the cross-over due to symptom resolution; thus, these investigators thought it to be very unlikely that any significant number of subjects would have had symptom resolution without intervention such that these long-term results would lack clinical meaning. Subject blinding was not feasible since most of the procedures were performed in the office setting under local anesthesia; however, the consistency of repeated validated subjective and objective outcome measures over an extended period suggested a limited placebo effect. The insignificant change in mean ETDQ-7 score observed in the randomized control group at 6-weeks follow-up (-0.6) was similar to the insignificant changes observed for a recent blinded study comparing placebo and active inferior turbinate reduction treatments for patients with ear symptoms (-0.7); thereby, indicating that the difference observed between the control and balloon dilation was real.
On behalf of the AAO-HNS Foundation, Tucci et al (2019) developed a clinical consensus statement on the use of balloon dilation of the eustachian tube (BDET). An expert panel of otolaryngologists was assembled with nominated representatives of general otolaryngology and relevant subspecialty societies. The target population was adults 18 years or older who are candidates for BDET because of obstructive eustachian tube dysfunction (OETD) in 1 or both ears for 3 months or longer that significantly affects quality of life (QOL) or functional health status. A modified Delphi method was used to distill expert opinion into clinical statements that met a standardized definition of consensus. After 3 iterative Delphi method surveys, 28 statements met the pre-defined criteria for consensus, while 28 statements did not. The clinical statements were grouped into 3 categories for the purposes of presentation and discussion: patient criteria, peri-operative considerations, and outcomes. This panel reached consensus on several statements that clarify diagnosis and peri-operative management of OETD. Lack of consensus on other statements likely reflects knowledge gaps regarding the role of BDET in managing OETD. Expert panel consensus may provide helpful information for the otolaryngologist considering the use of BDET for the management of patients with OETD. The authors stated that BDET is an option for treatment of patients with OETD. Moreover, they stated that further study will be needed to refine patient selection and outcome assessment.
Yin et al (2019) reported outcomes of balloon dilation Eustachian tuboplasty (BDET) combined with tympanostomy tube insertion (TTI) and middle ear pressure equalization therapy in treatment of recurrent secretory otitis media. A total of 51 patients with recurrent secretory otitis media (62 ears) underwent BDET and TTI under general anesthesia, followed by long-term middle ear pressure equalization therapies. The Eustachian tube score (ETS) and Eustachian tube function questionnaire (ETDQ-7) were used for pre- and post-operative (up to 12 months) evaluation of Eustachian tube functions. The mean ETS score was 2.34 ± 0.97 pre-operatively, and 6.17 ± 1.54, 7.23 ± 1.62, 8.24 ± 1.97, and 7.63 ± 1.86 at 1, 3, 6 and 12 months post-operatively, respectively (p < 0.05). The ETDQ-7 score was 4.82 ± 1.07 pre-operatively, and 2.20 ± 0.54, 2.32 ± 0.68, 2.53 ± 0.79, and 2.67 ± 0.76 at 1, 3, 6 and 12 months post-operatively, respectively (p < 0.05). The authors concluded that BDET combined with tympanostomy and catheterization resulted in significant improvement of subjective symptoms and objective evaluation of Eustachian tube functions in most patients with recurrent secretory otitis media, as indicated by the ETS and ETDQ-7 scores, demonstrating high levels of efficacy and patient satisfaction. These researchers stated that although the findings of this study showed that middle ear alternating pressure therapy following BDET and TTI was effective, because of the small sample size (n = 51 patients) and short-term follow-up time (up to 12 months), it was difficult to accurately explain the mechanisms. They stated that long-term prospective studies with large sample sizes are needed to further evaluate the safety and efficacy of this treatment and examine if other more effective treatment models exist.
Ramakrishnan et al (2019) stated that ETD is a common condition afflicting 1 % of the adult population and is said to be higher in the pediatric population. Currently, it is primarily managed with medical therapy; however, newer management techniques like balloon tuboplasty have been introduced. These investigators reviewed the available evidence on BDET in the treatment of chronic ETD covering indications, efficacy, safety, short-term, and long-term outcomes. They carried out a literature search on Google Scholar and PubMed; a total of 21 publications met the inclusion criteria. Based on the literature review the procedure was found to be effective in alleviating symptoms in adult and pediatric patients immediately post-operatively and long-term, up to 5 years. The AE)rate was 3 % and these were mostly minor self-resolving complications. The peri-operative protocol varied from center to center. Balloon tuboplasty was found to be safe and efficacious in the short- and long-term post-operatively in select patients with chronic ETD.
The authors stated that overall the risk of bias of the included studies was high because all studies were case series, without a control group or blinding, and susceptible to selection bias. Only the RCT by Meyer et al (2018), which compared BDET to continued medical therapy limited this bias. Moreover, data needed for adequate comparison between studies and patient populations were not alike in all studies. Furthermore, patient groups were not homogenous: some patients were pre-operatively treated with decongestive nasal spray; others received a ventilation tube; and some patients received other therapy (nasal steroids, decongestants, antibiotics, and tympanoplasty) during or after BDET. Moreover, these researchers stated that for future research on evaluating this promising therapy, 3 points need to be addressed. First, the relationship between symptoms underlying pathology and the extent of measurable tubal dysfunction is not always clear. This made objective measurements and causal determination challenging. Second, there is a need for consensus on the exact indications for BDET. Third, the peri-operative protocol varief from center to center and there is an overall lack of recommendations. Overall, every published case study concluded that BET was safe and effective in the management of ETD, although further long-term, homogenous, controlled studies are needed.
The National Institute for Health and Care Excellence’s practice guideline on “Balloon dilation for chronic eustachian tube dysfunction” (NICE, 2019) stated that “Evidence on the safety and efficacy of balloon dilation for eustachian tube dysfunction is adequate to support the use of this procedure provided that standard arrangements are in place for clinical governance, consent and audit”. Moreover, the committee noted that the procedure was not effective in all patients, and that there was little evidence on the benefit of repeat procedures. Furthermore, the committee was informed that the procedure is only indicated for chronic ETD refractory to medical treatment.
The Canadian Agency for Drugs and Technologies in Health (CADTH, 2019) examined the clinical effectiveness of BET for patients with ETD. A literature search was carried out by an information specialist on key resources including Medline, Embase, the Cochrane Library, the University of York Centre for Reviews and Dissemination (CRD) databases, the websites of Canadian and major international health technology agencies, as well as a focused Internet search. The search strategy was comprised of both controlled vocabulary, such as the National Library of Medicine’s MeSH (Medical Subject Headings), and keywords. The main search concepts were BET and ETD. Where possible, retrieval was limited to the human population. The search was also limited to English language documents published between January 1, 2014 and August 12, 2019. Internet links were provided, where available. One reviewer screened citations and selected studies based on the inclusion criteria. Rapid Response reports were organized so that the higher quality evidence was presented first; thus, health technology assessment reports, systematic reviews, and meta-analyses were presented first. These were followed by RCTs, and non-randomized studies. One health technology assessment was identified regarding the clinical effectiveness of BET for patients with ETD. No relevant systematic reviews, RCTs and non-randomized studies were identified. Additional references of potential interest were provided in the Appendix. One health technology assessment was identified regarding the clinical effectiveness of BET for patients with ETD. The authors aimed to examine the effectiveness of interventions for adults with ETD; however, due to the limited and poor-quality evidence available at the time, they were unable to conclude the effectiveness of BET or any other intervention for ETD.
In a prospective, cohort study, Alper and colleagues (2020) examined the changes in ET function (ETF) with BDET. A total of 11 adults with at least 1 patent ventilation tube (VT) inserted for chronic ETD and history of OME. Subjects with evidence of moderate-to-severe ETD on the side with a VT underwent unilateral BDET. Main outcome measures included changes in ETF parameters after BDET measured by Forced Response Test (FRT), Inflation Deflation Test (IDT), and Pressure Chamber test. With the FRT at 11 ml/min, opening pressure (OP) decreased from 458 ± 160 to 308 ± 173 daPa and closing pressure (CP) from 115 ± 83 to 72 ± 81 daPa at the 3-month post-BDET visit. The IDT and Pressure Chamber test showed that the percentage of middle ear (ME) pressure gradient equilibrated with swallows improved from 28 ± 34 to 53 ± 5 % for positive and from 20 ± 28 to 38 ± 43 % for negative ME pressure. Images from the pre- and post-BDET functional CT scans did not show apparent changes in the anatomy. Comparisons of ETF test parameters pre- and post-BDET suggested that the ET was easier to open and stayed open longer after the procedure. However, during the limited duration of follow-up most subjects continued to have ETD, some requiring VT re-insertion after the study period. The authors concluded that adults with severe ETD may benefit from BDET, however ETD may not be completely resolved and patients may continue to need VTs.
Demir and Batman (2020) noted that BET is used as a 2nd-line treatment in cases in which adenoidectomy, paracentesis, and VT have failed. However, studies have not examined the efficacy of this procedure as a 1st-line treatment. These researchers examined the quality of life (QOL) in children with chronic ETD after BET using the Otitis Media-6 (OM-6) questionnaire. They retrospectively evaluated the data of 62 children with chronic ETD and divided patients into the following groups: 30 cases underwent BET (group 1), and 32 cases underwent VTI from July 2016 to April 2018. The children's parents were instructed to complete the OM-6 questionnaire pre-operatively and at 6 weeks and 1 year post-operatively. The average pre-operative scores were higher than the post-operative scores, and the average 6-week post-operative scores were higher than the average 1-year post-operative scores for both groups 1 and 2. Furthermore, the average 6-week post-operative scores from patients in group 2 were significantly higher than those in group 1. The authors concluded that these findings demonstrated that BET may be a safe, 1st-line intervention that positively affected the QOL in children with chronic ETD.
In a retrospective study, Chen and associates (2020) examined the role and safety of BET in the treatment of OME in children. This trial was carried out between January 2017 and February 2018; 25 OME patients were treated with BET combined with myringotomy and tube insertion (MTI), designated as the BET group, and 24 OME patients were treated with MTI during the same period and served as controls. In addition, all patients received adenoidectomy if found with adenoid hypertrophy. The air-bone conduction gap (ABG) and curative effect were compared between the 2 groups. Tubomanometry (TMM) results were recorded pre-operatively to confirm existence of ETD. Otologic history and examination results of all patients were carefully recorded before the operation, at 6, 12 and 18 months post-operatively. Six months after surgery, ABG difference between the 2 groups was less than 1 dB HL. At 12 months after the operation, ABG in the BET group was smaller than that in the control group. There was a marked ABG deterioration (from 10.1 to 15.9 dB HL) in the control group compared to that in BET. Statistically significant differences in ABG difference between the 2 groups were observed 18 months after surgery with cured and total effective rates of BET at 76.1 % and 93.5 %, respectively. In the control group, these rates were 60.9 % and 89.1 %, respectively. No serious complications and tympanic perforations were found in any participant. The authors concluded that MTI combined with BET was safe and effective in the treatment of children with OME. Compared to simple MTI, application of BET could effectively extend improvement period and increase cured rate, especially after removal of the VT. Directly benefit from the VT, the curative effect was close during the period of tube retention. Moreover, these researchers stated that considering the sample size (n = 25 in the treatment group) and follow-up time (18 months) of this study, related studies targeting large cohorts are needed in the future to validate the benefits of BET in children with OME.
Koumpa and co-workers (2020) examined the opinions of the United Kingdom (UK) consultant body on endoscopic Eustachian tube balloon dilatation in the context of ETD. A 10-question online survey was distributed to ENT consultants currently practicing in the UK (July to September 2018). A total of 137 ENT consultants responded; 23 % reported experience of Eustachian tube balloon dilatation, with a further 10 % planning to start performing the procedure. Of those performing the procedure, 16 % had more than 2 years' experience; 32 % were performing 0 to 5 procedures a year. Eustachian tube balloon dilatation was primarily conducted to treat ETD symptoms, as well as retraction pockets, baro-challenge-induced ETD and OME. The most common reason for not undertaking Eustachian tube balloon dilatation was insufficient evidence of efficacy (65 %); 72 % of consultants thought that creating a national database for audit and monitoring purposes would benefit the specialty. The authors concluded that the majority of UK ENT consultants do not practice Eustachian tube balloon dilatation, citing a lack of high-level evidence to support its use. A national database for auditing and research could facilitate the creation of guidelines.
Swain et al (2020) noted that ETD is a common clinical entity; however, its treatment is still challenging to otorhinolaryngologists. In a retrospective, observational study, these researchers examined the effectiveness of transnasal endoscopic BDET for treatment of chronic ETD. This trial was carried out between May 2018 to June 2019 at IMS and SUM Hospital, Siksha 'O' Anusandhan University, Bhubaneswar, Odisha, India. A total of 21 patients were identified with diagnosis of ETD and assigned to this study. The transnasal endoscopic procedure was performed to dilate the cartilaginous part of the eustachian tube with a balloon catheter. Pre-operative CT was carried out in all cases. All patients were post-operatively examined in 1st, 2nd and 8th weeks after the procedure. BDET was easily performed in all cases of this study. No abnormality including carotid canal was observed before this procedure. All except 2 cases revealed significant improvement in the ET functions; and there was no damage to any vital structures like internal carotid artery in this study. The authors concluded that the majority of the patients participated in this study showed positive outcome following BDET. These researchers stated that BDET is a feasible and safe procedure for dilating the eustachian tube; and this treatment is a very promising and requires more research on this aspect.
In a retrospective study, Utz et al (2020) examined the effectiveness of BDET in active duty military personnel working in hyper- and hypo-baric environments suffering from baro-challenge-induced ETD using functional outcomes. Military divers and aviators diagnosed with persistent baro-challenge-induced ETD resulting in disqualification from performing flight and dive duties and who elected for treatment with BDET were included for analysis. Post-treatment follow-up assessments were undertaken at 1, 6, and 12 months. Outcome measures included successful hyperbaric chamber testing or return to the hyper- or hypo-baric environment without significant baro-challenge-induced ETD symptoms and pre- and post-dilation ETDQ-7 scores. Mean pre-treatment duration of symptoms was 48 months (range of 3 to 120 months). Following treatment, 92 % (12/13) of patients successfully returned to operational duties with resolution of limiting symptoms. Average return to duty time was 8.5 weeks (range of 6 to 24 weeks). The ETDQ-7 scores improved from a mean of 4.33 (2.57 to 6.57) pre-dilation to 2.19 (1.00 to 4.43) post-dilation (Z = 2.73, W = 70, p = 0.0063). Mean duration of follow-up was 38 weeks (range of 13 to 70 weeks). The authors concluded that BDET appeared to be a safe and highly effective therapeutic option for baro-challenge-induced ETD in affected military divers and aviators who worked in hyper- and hypo-baric environments. Moreover ,these researchers stated that further study is needed to examine if similar results can be achieved in more diverse subject populations and to evaluate long-term effectiveness.
In a systematic review and meta-analysis, Zhang et al (2020) examined the efficacy, compliance and collaborative operation of BDET for the treatment of Eustachian tube dysfunction. PubMed, OVID, Embase, Cochrane Library, ProQuest, Web of Science, Chinese biomedical literature database, VIP database, WanFang database, CNKI were searched for papers on auto-inflation for treatment of chronic otitis media with effusion in children (up to March 2020). Statistical analysis was performed by using Cochrane tools and RevMan5.2. A total of 14 articles were included. The results of meta-analysis showed that the effective rate of the BET was 86 % (95 % CI: 0.79 to 0.94); and had statistical significance. The tubo-manometry, ETS, ETDQ-7 of post-operative BDET was better than that of the control group; and had statistical significance. Heterogeneity of tubo-manometry, ETS was relatively small, which was I² = 51 % (OR 3.57, 95 % CI: 1.95 to 6.55) and I² = 59 % (SMD 1.33, 95 % CI: 0.98 to 1.67), respectively. There was no statistical significance between BDET plus tympanic paracentesis compared with those treated with BDET alone. The recurrence rate of the included literature was 5.37 % and the complication rate was only 0.33 %. The authors concluded that balloon Eustachian tuboplasty could be a safe and effective treatment for adult Eustachian tube dysfunction. However, in terms of collaborative surgery and evaluation methods, there is still a need more homogeneous, multi-center randomized controlled studies to obtain more accurate conclusions to guide clinical practice.
Ramakrishnan and Kadambi (2020) stated that chronic eustachian tube dysfunction is a condition that affects a large number of adults every year. While many cases can be managed pharmacologically, there is a significant portion that does not respond to medical treatment alone. Invasive methods from the aural side like grommet or tympanic tube insertion have complications associated with it and often could not address the underlying condition of the nasopharyngeal side of the eustachian tube. BET is a minimally invasive intervention that has been used in countries like Germany and U.S. in the last 10 years. These researchers presented the experience of a new clinical user of BET in India by retrospectively examining the outcomes of the first 10 patients on which the procedure was carried out. A marketed product EustaCare was used for the cases. There was a 90 % procedural success rate within 4 weeks with 1 patient showing no improvement in symptoms even after 8 weeks. There were no AEs associated with the procedure nor technical issues with the product. The product was easy to learn and use. Moreover, these investigators stated that further study is needed to draw any conclusions on long-term safety and efficacy, although historical records and preliminary results for this procedure described in this paper appeared promising.
In a retrospective, multi-center analysis, Tisch et al (2020) presented the findings of BDET-studies for treatment of dilatory ETD in children. 4- to 12-year-old children with chronic otitis media with effusion (COME) for more than 3 months or more than 3 episodes of acute otitis media during the last year, having failed standard surgical therapy at least once were included in this analysis. Main outcome measures were tympanic membrane appearance, tympanometry, and hearing threshold. A total of 299 ETs of 167 children were treated. Mean age was 9.1 years (95 % CI: 8.7 to 9.4 years) . In 249 ears (83.3 %), COME and/or retraction of the tympanic membrane were the indication for BET. Median hearing threshold was 20 dB HL (95 % CI: 0 to 46 dB); 155 ears (51.8 %, 95 % CI: 46.1 to 57.4 %) showed a tympanogram type B. Treatment consisted of BDET without other interventions ("BDET-only") in 70 children, 128 ears. Median length of follow-up for 158 (94.6 %) children was 2.6 months (95 % CI: 0.3 to 16.1 months). After treatment, the tympanic membrane appeared normal in 196 ears (65.6 %, 95 % CI: 60.0 to 70.8 %, p < 0.001). Median hearing threshold improved to 10 dB HL (95 % CI: 0 to 45 dB, p < 0.001). Tympanograms shifted toward type A and C (type A: 39.1 %, 95 % CI: 33.7 to 44.7, p < 0.001). These improvements were also observed in subgroup analyses of "BDET-only" treatment and the indication of "COME", respectively. The authors concluded that BDET improved a variety of dilatory ETD-related ear diseases in children. These researchers stated that the findings of this study provided detailed data for design and planning of prospective studies on BET in children.
In a systematic review and meta-analysis, Froehlich et al (2020) examined the effectiveness of BDET for the treatment of ETD. Data sources included PubMed, Scopus, and Google Scholar. These investigators carried out a systematic review of BDET for the treatment of ETD following PRISMA guidelines to identify RCTs and prospective and retrospective studies published before January 31, 2019. Meta-analysis of proportions evaluated ETDQ7 scores, tympanometry, otoscopy findings, and the ability to perform a Valsalva maneuver. The systematic review identified 35 studies; 12 met inclusion for meta-analysis (448 patients). Mean ETDQ7 scores decreased by 2.13 from baseline to 6 weeks (95 % CI: -3.02 to -1.24; p < 0.001). From baseline to 6 weeks, 53.0 % of patients had improvement in tympanograms (p < 0.001). At the long-term point (3 to 12 months), 50.5 % of patients had improved tympanograms from baseline (p < 0.001). There was no significant difference in the proportion of improved tympanograms at 6 weeks compared to long term (p = 0.535). Normal otoscopy examinations at baseline increased by 30.0 % at 6 weeks (p < 0.001) and 55.4 % in the long-term (p < 0.001). There was a 67.8 % increase in proportion of patients able to perform a Valsalva maneuver in the long-term compared to baseline (p < 0.001). The authors concluded that BDET appeared to be associated with improvement in subjective and objective treatment outcome metrics. The improvement appeared stable at 3 to 12 months after dilation. Patients with ETD were likely to benefit from balloon dilation, especially those with medication-refractory disease.
Plaza et al (2020) stated that there is a great variability in diagnosis of obstructive ETD and its treatment by BDET. These investigators presented a consensus on indications, contraindications, methodology, complications and results following BDET. They obtained a consensus on BDET, after a systematic review of the literature on BDET 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. These researchers selected 139 papers with a relevant abstract, including 2 international consensuses, 7 systematic revisions, and 2 RCTs on BDET. Indications for BDET are barotrauma, serous otitis media, adhesive otitis, atelectatic middle ear and failure after tympanoplasty, once obstructive ETD is confirmed. BDET was more effective in barotrauma and serous otitis media. There were high-quality reports on BDET showing good results that persist long-term, as compared to conservative medical treatment. The authors concluded that BDET is a surgical, minimally invasive treatment that has shown its safety and effectiveness in obstructive ETD in adults and children. It is most effective in barotrauma and serous otitis media.
Formanek et al (2020) noted that BDET is a promising therapeutic option for ETD; however, data are lacking on the effect of BDET in adults with symptoms of chronic ET dysfunction but without a contributing pathology. In a prospective, clinical trial, these investigators examined the effect of BDET in adult patients with only symptoms of chronic ED. This study included adult patients with aerated physiological middle ears and symptoms of ETD for more than 6 months. Compliance with follow-up was 93.3 %. These researchers examined the effects of BDET with tympanometry, assessment of the Valsalva or Toynbee maneuver with tympanometry verification, a ETDQ-7, and pure-tone audiometry. Data were recorded 1 day before surgery and 2, 6, and 12 months after BDET. Therapy was considered successful when the patient exhibited a newly acquired ability to perform the Valsalva or Toynbee maneuver or when the ETDQ-7 score improved by 20 % or more. This trial included 14 ears in the analysis. After 2, 6, and 12 months, therapy was successful, according to the ETDQ-7, in 11/14 (78.6 %; 95 % CI: 48.8 to 94.3), 13/14 (92.9 %; 95 % CI: 64.2 to 99.6), and 12/14 (85.7 %; 95 % CI: 56.2 to 97.5) ears, respectively; these results were statistically significant. The ETDQ-7 scores also significantly decreased at 2, 6, and 12 months after the BDET, when any change was observed. All patients experienced improvement; only 1 patient reported temporary deterioration after 2 months. Treatment was more frequently successful in patients without nasal polyps or pollinosis. The authors concluded that adults with only symptoms of chronic ETD benefitted more and had longer lasting results from BDET, compared to patients with pathologies caused by ETD. These investigators stated that BDET could be recommended for these patients.
In a retrospective, matched cohort study, Toivonen et al (2021) examined the safety and efficacy of balloon dilation of the Eustachian tube (BDET) in pediatric patients. Subjects were patients (less than 18 years of age) with persistent (greater than 1.5 years) chronic Eustachian tube dysfunction (ETD) with previous tympanostomy tube (TT) insertion; BDET was carried out using concomitant myringotomy with/without tube placement and adjunctive procedures if indicated versus controls (TT). Main outcome measures included otitis media with effusion (OME)/retraction with need for additional tube, tympanogram, audiogram, otomicroscopy, ET mucosal inflammation/opening score, and Valsalva maneuver. A total of 46 ETs (26 patients), aged 7 to 17 years (mean of 12.5) underwent BDET. Mean follow-up was 2.3 years (standard deviation [SD], 1.1; range of 6 months to 5 years). Significant improvements were observed for all measures. Tympanic membranes were healthy in 9 % pre-operatively, 38 % at 6 months, 55 % at 12 months, and 93 % at 36 months post-operatively. Tympanograms improved to type A in 50 % at 6 months, 59 % at 12 months, and 85 % at 36 months. Mean scores of mucosal inflammation declined from 3.2 (± 0.6) pre-operatively to 2.5 (± 0.7) at 6 months and 1.7 (± 0.6) at 36 months post-operatively. BDET had lower risk of failure versus TT insertion (adjusted hazard ratio [HR] 0.26; 95 % confidence interval [CI]: 0.10 to 0.70; p = 0.007). Probability of being failure-free at 2 years was 87 % (95 % CI: 70 % to 94 %) after BDET and 56 % (95 % CI: 40 % to 70 %) after TT insertions. The authors concluded that BDET was a safe and possibly effective procedure in selected pediatric patients with chronic ETD.
The authors stated that drawback of this study included the inclusion of adjunctive procedures in this study cohort creating the possibility that some of the benefit attributed to BDET may actually be from the other procedure. On the other hand, after cartilage tympanoplasty, patients have persistent type B tympanograms in spite of improved middle ear pressures and ET function, which may actually under-estimate the efficacy of BDET. The number of subjects in the study was also limited (n = 26); thus, it was not possible to perform significantly powered subgroup analysis of the effect of all the various adjunctive procedures separately. Furthermore, while these researchers tried to match cases and controls as closely as possible, there were some patients who could not be matched perfectly, which may be an additional source of bias. Finally, at the authors’ center they have excluded all patients less than 7 years of age to-date from this procedure; therefore they could not comment on the efficacy of this procedure in that age group.
In a randomized, active-controlled, multi-center clinical trial, Choi et al (2021) examined the safety and effectiveness of navigation-guided BDET compared to medical management (MM) alone in patients with chronic ETD. This was a prospective, multi-center, 1:1 parallel-group RCT. The primary outcome measure was an improvement in the ETDQ-7 score at the 6-week follow-up compared with baseline. Secondary outcome measures included changes in the signs and symptoms during the follow-up, changes in the score for each subcategory of ETDQ-7, type of tympanometry, pure tone audiometry, and the availability of a positive modified Valsalva maneuver. Navigation-guided DBET was safely performed in all patients. A total of 38 ears of 31 patients (19 ears of 16 patients in the BDET group and 19 ears of 15 patients in the control group) completed the planned treatment and 6 weeks of follow-up. More patients in the BDET group (1.99 ± 0.85) had less symptomatic dysfunction than in the control group (3.40 ± 1.29) at 6 weeks post-procedure (p = 0.001). More patients experienced tympanogram improvement in the BDET group at 6 weeks compared to the control group (36.5 % versus 15.8 %) with a positive modified Valsalva maneuver (36.6 % versus 15.8 %, p = 0.014). Furthermore, ABG change was significantly decreased in the BDET group compared to the control group at the 6-week follow-up visit (p = 0.037). The authors concluded that the findings of this prospective, multi-center, RCT study suggested that navigation-guided BDET was a safe and superior therapeutic option compared to MM alone in patients with chronic ETD.
In a retrospective chart review, Howard et al (2021) analyzed the medical records of 43 consecutive encounters of patients under the age of 18 years old who underwent attempted BDET. Charts of patients' post-operative appointments and appointments 30 days following the procedure were reviewed. Any complications that were reported by the surgeons' operative report or documented post-operatively were stratified by the Classification of Surgical Complications as outlined by the American College of Surgeons. Additional data points that were analyzed included concomitant surgical procedures, estimated blood loss, and demographic information. A cohort of 43 pediatric patient encounters were examined. There was a total of 2 complications from BDET (4.7 %) and 1 aborted case. The complications included epistaxis controlled with oxymetazoline and pressure, and vertigo that was later attributed to vestibular migraines; 1 case was aborted due to inadequate exposure. The average age of patients evaluated was 12.4 ± 3.2 years old with a range of 6.6 to 17.7 years old. The authors concluded that in this retrospective cohort, BDET was shown to be a relatively safe intervention with an overall complication rate of 4.7 % in patients as young as 6.6 years old with recurrent or chronic ETD and/or related issues. Level of Evidence = IV. This was a relatively small (n = 43) study that examined the “safety” of BDET.
Standring et al (2021) collected real-world data on the safety and effectiveness of BDET using a seeker-based device in patients with persistent/chronic symptoms of ETD. These researchers carried out a prospective, multi-center, single-arm registry from June 2018 through August 2020 at 10 U.S. centers, including tertiary care and private practices. Primary endpoints included mean change from baseline in the ETDQ-7 and the serious related AE rate. Secondary endpoints included changes in middle ear assessments, surgical intervention rate, and changes in SNOT and Work and Activity Impairment (WPAI) questionnaires. A total of 169 subjects were treated with balloon dilation of the Eustachian tube, with 166 and 154 participants completing the 6-week and 6-month follow-ups, respectively. Repeated measures analysis of the change in ETDQ-7 scores indicated statistically significant improvement (-2.1; 95 % CI: -2.40 to -1.84; p < 0.0001) at 6-month follow-up. The minimum clinically important difference of improvement was achieved by 85 % of participants at 6 months; 4 non-serious AEs were reported. Middle ear functional assessments were improved in the majority of subjects with abnormal baseline findings. There were no statistically significant differences in the change from baseline ETDQ-7 scores between subjects who had concurrent procedures and those who did not. WPAI scores demonstrated significant improvement. The authors concluded that real-world evidence supported the clinical studies demonstrating that BDET with a seeker-based device was a safe and effective procedure to treat ETD symptoms. Level of Evidence = III.
The authors stated that conclusions from this study were limited by the design as a single‐arm series without a control group. Enrollment of only patients who were planning to have an intervention introduced the possibility of selection bias. The use of a patient‐reported subjective assessment as the primary outcome measure carried potential difficulties, including issues related to patient health literacy, the influence of seasonal symptom patterns, and inattentive question responses. Nonetheless, in the real‐world setting a patient‐centered assessment is a relevant determinant of treatment success and patient satisfaction. Furthermore, the latest follow‐up assessment at 6 months after the procedure prevented an inference regarding the long‐term effects of BDET. The unsupervised inclusion of tympanogram types, variable symptom severity, and concurrent procedures allowed an appreciation for the potential role of BDET outside of a controlled setting.
Cheng et al (2021) noted that ETD is a common clinical condition encountered by otolaryngologists. The severity and duration of symptoms range from the mild and transient to the chronic and severe along with secondary pathologies. These investigators examined the safety and effectiveness of BDET in an Australian cohort. They carried out retrospective chart reviews on all patients who underwent BDET from September 2016 to March 2020. The Eustachian Tube Dysfunction Patient Questionnaire (ETDQ-7) was chosen as the primary outcome measure. Secondary outcome measures included subjective global assessment of presenting symptoms, ability to perform Valsalva maneuver and tympanometry. Any complications related to the procedures were reported. A total of 119 eustachian tube operations were included in this study. The patient cohort showed statistically significant improvement of mean EDTQ-7 score from 0.7 to 2.9. Improvement in EDTQ-7 was achieved in 83.9 % of the cases. All patients in the baro-challenge-induced subgroup achieved improvement in ETDQ-7 score. Complete resolution of symptoms with an ETDQ of less than 2.1 was achieved in 37.1 % of the cohort. There were no adverse safety events associated with the procedures. The authors concluded that BDET appeared to have significant improvement on the QOL of patients with ETD, with a low side-effect profile. Baro-challenge-induced and classic dilatory ETD patients showed the most success. The role of BDET in patients with pathology secondary to ETD was less clear and was not well-investigated by the ETDQ-7 score alone.
The authors stated that the drawbacks of this study included the retrospective nature of this study and the lack of control group or blinding was suspectable to bias. The subjective nature of ETDQ-7 and voiced improvement by the patient was also susceptible to placebo bias. The inclusion of patients undergoing concurrent procedures introduced considerable potential source of confounder. However, these researchers felt that the benefit of understanding the impact of concurrent surgeries on an Australian population justified the broader inclusion criteria, which would more closely reflect real-life clinical scenarios.
Saniasiaya et al (2022) stated that eustachian tube dysfunction (ETD) is a chronic entity that has been historically managed with adenoidectomy and ventilation tube insertion. Recently, balloon dilation of the eustachian tube has shown promising results in recalcitrant eustachian tube dysfunction. These investigators reviewed the literature to determine the outcome of eustachian tube balloon dilation in children. They carried out a literature search from 1990 to 2020 by searching several databases over a 1-month period (January 2021) according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and the Cochrane Handbook for Systematic Reviews for Interventions. Primary outcome was defined as the success of the intervention determined by the resolution of symptoms, and secondary outcome was determined by revisions surgery and presence of complications. Only 7 articles were identified based on these researchers’ objectives and selection criteria. All studies included were retrospective cohort case series (Level IV) and 1 cohort of matched controls (Level III). A total of 284 patients were included in this review, with a mean age of 7.8 years. A total of 463 balloon dilation were performed either bilaterally or unilaterally. The most common finding of ETD was middle ear effusion in 5 studies. Balloon dilation of eustachian tube was 2nd-line treatment in 6 studies and 1st-line treatment in 1 study. Improvement of symptoms was identified in all studies via various assessments performed. Revision surgery was performed in 1 study with no major complications reported. The authors concluded that balloon dilation of the eustachian tube may be considered as an alternative procedure following failed standard treatment in children. The quality of evidence is inadequate to recommend widespread use of the technique until a better-quality study has been completed. These researchers stated that future randomized controlled trials (RCTs) with a large sample size are needed to determine the efficacy of this procedure in children.
Keschner et al (2022) noted that with increased focus on surgical management of the eustachian tube, clarifying management decisions benefits patients as well as surgeons. In a retrospective review, these investigators examined the clinical value of repeating the balloon dilation of the eustachian tube (BDET) procedure in patients who did not improve after the initial BDET. This study included 145 BDETs performed on 86 patients between January 1, 2014, and May 1, 2019; and 10 patients underwent BDET more than once. Demographic and outcome data were collected on both single and repeat BDET cohorts. The Eustachian Tube Dysfunction Questionnaire 7 (ETDQ-7) was used as the primary outcome measure when comparing single versus repeat BDET cohorts. In general, the 2 cohorts were similar in terms of sex and age distribution. Tobacco use and radio-allergo-sorbent test-positive results were greater proportionally in the repeat BDET cohort. Pre-operative ETDQ-7 scores were similar in both cohorts. Single BDET patients overall showed significant improvement in ETDQ-7 scores. ETDQ-7 scores for repeat BDET patients who did not improve after the 1st procedure similarly did not demonstrate improvement after the 2nd procedure. The authors concluded that some patients will not improve after an initial BDET procedure. The use of a repeated BDET procedure should be considered in determining how to manage such failures. The results of this limited study suggested that patients who failed to improve meaningfully on ETDQ-7 scores after the initial procedure are unlikely to show substantial improvements after a repeated procedure. Level of Evidence = IV.
Chen et al (2022) noted that otologic symptoms consistent with ETD are common in patients with chronic rhinosinusitis (CRS), but can also occur independently of CRS as primary ETD. It is unclear if CRS+ETD is similar to primary ETD or how treatment outcomes compare. In a systematic review and meta-analysis, these researchers carried out systematic search of PubMed, CINAHL, Scopus, and Cochrane Library following PRISMA. Any study describing ETD in CRS was included. Primary ETD studies were limited to those with pre-operative and post-operative ETDQ-7 scores in ETD treated only with BDET. A total of 16 studies were included: 9 studies with 1,336 consecutive patients with CRS and 7 studies with 161 patients with primary ETD. In studies with specific data, 225 (47.2 %) patients with CRS had a score of greater than 14.5, consistent with ETD. In CRS+ETD, baseline mean ± standard deviation (SD) ETDQ-7 score was 20.7 ± 8.4 and did not differ by polyp status. In primary ETD, mean ETDQ-7 score was significantly higher than CRS+ETD (29.5 ± 8.1, p < 0.0001). Regarding treatment outcomes, CRS+ETD treated with endoscopic sinus surgery (ESS) alone resulted in mean ETDQ-7 in the normal range (13.2 ± 5.3), with a mean change of -7.4 (95 % CI: -10.82 to -3.99) (p < 0.00001). Patients with primary ETD treated with BDET had post-operative ETDQ7 scores of 14.9 ± 7.5 with mean change of -13.9 (95 % CI: -18.01 to -9.88; p < 0.00001). The authors concluded that ETD is noted in approximately 50 % of patients with CRS; outcomes of CRS+ETD treated with ESS alone were similar to those of patients with primary ETD treated with BDET.
In a systematic review and meta-analysis, Aboueisha et al (2022) examined the safety and effectiveness of BDET in the pediatric population. These researchers identified original studies of BDET in a pediatric population in PubMed, Embase, Web of Science, Cochrane, Clinicaltrials.gov and CINAHL. Outcomes of efficacy included audiometric findings and AEs were summarized for each study. A total of 7 articles were included involving 408 children with a mean age of 9.9 years old (95 % CI: 8.8 to 11.1) and a mean follow-up of 19.2 months (95 % CI: 15 to 23). Type B tympanograms decreased after BDET from 64.2 % (95 % CI: 53.3 to 73.8) to 16.1 % (95 % CI: 8.5 to 28.4). ABG decreased after BDET from a mean of 25.3 dB (95 % CI: 18.9 to 31.6) to 10.2 dB (95 % CI: 8.9 to 11.5). The pooled estimate of AEs after BDET was 5.1 % (95 % CI: 3.2 to 8.1), the majority being self-limited epistaxis with no major AEs reported; 3 studies compared BDET to ventilation tube insertion; analysis of post-operative ABG showed a greater decrease in the BDET group (mean difference [MD] -6.4 dB; 95 % CI: -9.8 to -3.1; p = 0.002). The authors concluded that although there are no prospective RCTs, BDET ± tympanostomy tube placement may produce outcomes that are comparable to tympanostomy tube placement in the treatment of OME in the pediatric population. Most children undergoing the procedure were those with recalcitrant disease.
Furthermore, an UpToDate review on "Eustachian tube dysfunction" (Poe, 2021; 2022) states that "Balloon dilation of the Eustachian tube (BDET) is a newer tuboplasty technology used to increase the patency of the cartilaginous Eustachian tube and reduce inflammation. A balloon catheter is used to dilate the cartilaginous portion through a minimally invasive transnasal endoscopic approach. In 2 systematic reviews, BDET was found to be safe with evidence of benefit, but all of the studies were retrospective case series with varied indications and outcome measures. Initial clinical trials were promising, and subsequent trials have demonstrated efficacy of BDET in adults. As an example, in a 2016 randomized trial of 323 adult patients with obstructive Eustachian tube dysfunction, more patients treated with BDET plus medical therapy demonstrated normal tympanograms than those treated with medical therapy alone (54 versus 14 %); these results were sustained at 52 weeks. In addition, BDET may also have a role in the management of children with Eustachian tube dysfunction who have failed previous tympanoplasty". However, balloon dilation of the Eustachian tube (BDET) is not listed in the "Summary and Recommendations" section.
Soft-Tissue Fillers for patulous Eustachian tubes
Schröder et al (2018) stated the Eustachian tube protects against secretion, germs and sound pressure from the nasopharynx, it acts as a drain, and serves pressure equalization in both directions so that the ear drum and sound-conducting apparatus can vibrate optimally. The incidence of Eustachian tube dysfunction in adults is about 1%, in children almost 40%. Symptoms are often unspecific. For diagnosis, the Eustachian tube score (ETS-5) can be used in patients with a perforated ear drum, and the ETS-7 score in patients with intact ear drum. Adenoid hypertrophy is a frequent cause of obstructive tube dysfunction in children. Treatment of obstructive dysfunction includes steroid nasal sprays and regular performance of the Valsalva maneuver, as well as tube dilation with the Bielefelder balloon catheter. The patulous Eustachian tube is treated with saline nasal irrigation, estrogen-nasal ointment, and craniocervical manual therapy; causal treatments are evaluated.
Schröder et al (2015) stated a patulous Eustachian tube ([ET] tuba aperta) may cause symptoms as autophony, breath synchronous tinnitus, pressure sensation, and conductive hearing loss and thus lead to an enormous cutback in quality of life. In combination with "sniffing," it can trigger the development of cholesteatoma. Because of the ambiguous symptoms, the diagnosis can be challenging. A patulous ET can only be diagnosed through a well-structured examination, including patient history, physical examination with thorough observation of the movements of the tympanic membrane, and tympanometry with reflex-decay. Transnasal endoscopic injection of injectable soft-tissue bulking agent into the torus tubarius was performed in 20 patients as a new treatment option for patulous ET. All patients were followed up 6 weeks and 6 and 12 months after treatment. For each intervention, 0.8 to 2 mL of injectable soft-tissue bulking agent was used. In nine patients, more than one procedure was necessary. On follow-up, 10 out of 15 patients were satisfied with the result. Only three out of 15 patients reported no improvement of their symptoms. The procedure was minimally invasive, fast, and easy to perform. The authors concluded there is no gold standard for the therapy of patulous ET. The injection of soft-tissue bulking agent in the torus tubarius is a new minimally invasive therapeutic approach, but much more clinical experience is needed.
Luu et al (2015) determined the effectiveness of currently available medical and surgical interventions for treating symptoms of Patulous Eustachian Tube (PET) through a comprehensive search of MEDLINE (January 1948 to July 8, 2015), EMBASE (January 1974 to July 8, 2015), gray literature, hand searches, and cross-reference checking. The review included original published reports evaluating an intervention to treat the symptoms of patulous eustachian tube in patients 18 years and older. Quality-of-case reviews were assessed with the National Institute of Health (NIH) Quality Assessment Tool for Case Series Studies. The search strategy identified 1,104 unique titles; 39 articles with 533 patients are included. The available evidence consists of small case series and case reports. The most common medical treatment was nasal instillation of normal saline. Surgical treatments were categorized as mass loading of the tympanic membrane, eustachian tube plugging, and manipulation of eustachian tube musculature. The authors concluded that the available evidence for management of patients with PET is poor in quality and consists predominantly of small case series. Further research is needed to determine the comparative efficacy of the current treatments.
Trans-Tympanic Balloon Dilatation of Eustachian Tube
In a systematic review, Jufas and Patel (2016) examined the evidence for balloon dilatation of the Eustachian tube using a trans-tympanic approach. These investigators searched several databases using the terms "dilation" or "dilatation", and "balloon" and "Eustachian tube". Only studies that used a trans-tympanic approach for the procedure were included. These studies were then assessed for risk of bias. A total of 3 studies were included. Each of these studies was a limited case series, with 2 performed on human subjects and 1 on human cadavers. Results of safety and efficacy were conflicting. There was a high risk of bias overall. The authors concluded that there is currently a very narrow evidence base for trans-tympanic balloon dilatation of the Eustachian tube; there are a number of advantages and disadvantages of the technique. These researchers stated that previously identified and theoretical safety concerns will need to be addressed thoroughly in future studies prior to wider clinical use.
In a cadaver pilot study, Kapadia and colleagues (2018) evaluated the safety of trans-tympanic balloon dilatation of the cartilaginous proximal Eustachian tube under endoscopic guidance as it relates to the integrity of the carotid canal. Endoscopic guided trans-tympanic dilatations of the cartilaginous proximal end of the Eustachian tube were performed in 15 ears of 8 fresh frozen cadaver heads. CT scans were done before and after dilatation. Images were reviewed by 2 otologists and 1 radiologist. Balloon catheter placement and dilatation of the proximal Eustachian tube was feasible in all specimens. Endoscopic examination post-dilatation showed a consistent increase in the aperture of the proximal cartilaginous tube in all ears. Review of CT images after dilatation showed no evidence of trauma to the carotid canal in all ears instrumented. The authors concluded that endoscopically guided trans-tympanic dilatation of the proximal Eustachian tube was not associated with damage to the carotid canal in cadaver model. Level of evidence = IV.
In a case-series study, Kapadia and Tarabichi (2018) examined safety and feasibility of trans-tympanic dilatation of proximal (tympanic-end) of the cartilaginous segment of the Eustachian tube in patients undergoing surgery for chronic ear disease. These investigators reviewed the charts of 40 consecutive patients undergoing chronic ear surgery in their practice with manometric evidence of obstruction who underwent attempted trans-tympanic dilatation of proximal (tympanic-end) segment of the Eustachian tube. A range of outcome measures were reported that included pre- and post-dilatation opening pressure measurement of the Eustachian tube, closure of perforation, audiometric data, and complications. Dilatation of proximal (tympanic-end) of the cartilaginous segment of the Eustachian tube was technically feasible in 37 of 40 patients (93 %). Post-dilatation inspection of protympanum showed increased aperture in all dilated tubes. Opening pressure of Eustachian tube declined in 36 of 37 patients (97 %). Residual perforation was evident in 5 of 40 patients (12 %). No facial nerve or carotid complications were observed; 2 patients had severe dizziness (5 %) with 1 patient sustaining severe cochlear loss. The authors concluded that trans-tympanic dilatation increased the patency of the Eustachian tube immediately after instrumentation. No carotid complications were observed. Continuous endoscopic control is needed to avoid subluxation of stapes. Further study of this technique is warranted to identify its role, if any, in chronic ear surgery.
The Tubes Under Local Anesthesia (Tula) System
Cohen and colleagues (2015) stated that tympanostomy tube insertion is the most common pediatric surgery, but it typically requires general anesthesia. To facilitate in-office tube placement without general anesthesia, 2 complementary technologies have recently been developed comprising an iontophoresis system (IPS) for delivering local anesthesia and an integrated tube delivery system (TDS). These researchers evaluated behavioral support techniques used during a clinical study of the new technology for pediatric in-office tube placement without general anesthesia or physical restraints. As part of an institutional review board (IRB)-approved, prospective, 9-center clinical study, pediatric patients requiring tube insertion underwent in-office treatment using the new procedure. The behavior management techniques included preparation, distraction, coaching, and reinforcement for co-operation. The entire procedure was videotaped and 2 independent coders used the validated FLACC (face, legs, activity, cry, consolability) scale to code behavioral distress across 5 procedural phases. A total of 70 pediatric patients aged 8 months to 17 years (mean [M] of 7.0 years; 51 % girls) were enrolled in the study, and 68 had video recordings available for analysis. Of the 68 recordings analyzed, 63 patients completed the procedure and had tubes placed without sedation. Mean FLACC scores ranged from 0.05 to 2.38 (M = 1.25, SD = 0.82) and median (Mdn) FLACC scores ranged from 0 to 1 (Mdn = 0, inter-quartile range [IQR] = 0.05), which indicated "mild" distress. During iontophoresis, eardrum tap (anesthesia assessment), and tube delivery, older children displayed lower distress and girls had higher FLACC scores during the eardrum tap procedural phase. The authors concluded that when combined with the evidence-based behavioral techniques, office-based local anesthesia and tube delivery resulted in minimal distress, suggesting that the new procedure may be a viable method of conducting tympanostomy tube placement in children without having to use general anesthesia.
In a prospective, multi-center (9 centers), single-arm study, Zeiders and associates (2015) evaluated the safety and effectiveness of an IPS to achieve local anesthesia in combination with a TDS for tube placement in pediatric patients in an office setting. This trial conducted at 9 otolaryngology sites in the U.S. Subjects included pediatric patients aged 6 months to less than 22 years requiring tube placement. They were prepared for the procedure using behavioral support techniques and tube placement was attempted under local anesthesia using the IPS in conjunction with the TDS. No physical restraints were allowed and no anxiolytics, analgesics, or sedatives were permitted. Safety was evaluated via the occurrence of AEs and success rates for tube placement under local anesthesia were determined. Tolerability of the procedure was evaluated using the 5-point Wong-Baker FACES Pain Rating Scale and parental satisfaction was assessed using a post-operative survey. A total of 70 (127 ears) were enrolled in the study [mean (SD) age of 7.0 (3.9) years]. No serious AEs were observed in the 70 enrolled patients. Tube placement using the TDS was successful in 96.6 % (114/118) of attempted ears. A single TDS was required in 105 ears, while more than 1 device was required in 9 ears. Of the 70 patients enrolled in study, 63 (90.0 %) successfully received tubes in all indicated ears during their in-office visit. The mean (SD) change in pain score from pre-anesthesia to post-surgery was +0.9 (1.8). Favorable ratings for overall satisfaction with the in-office procedure were obtained from 96.9 % (63/65) of respondents. Tube retention at 2 weeks was 99.1 %. As only 15 patients were enrolled who were 3 years old or younger, the ability to generalize these results to younger patients was limited. The authors concluded that the use of the IPS and TDS technologies enabled safe, reliable, and tolerable placement of tubes in awake, unrestrained pediatric patients. This appeared to be the same study described above by Cohen et al (2015), with the former trial examining the use of behavioral techniques to optimize success of in-office pediatric tympanostomy tube placement without sedation.
Cofer and co-workers (2017) noted that insertion of tympanostomy tubes is a common elective pediatric surgical procedure and is typically performed under general anesthesia. The potential to reduce general anesthetic requirements for young children has led to increased interest in alternatives for tympanostomy tube placement. A tympanostomy tube system, developed to enable tympanostomy tube placement in a single pass on conscious patients under moderate sedation, was evaluated. A prospective study on 128 children and 253 tympanostomy tube placements conducted at 4 centers in the U.S. demonstrated an 88.3 % success rate in performing the procedure under moderate sedation with AEs within normal rates reported in the literature. The authors concluded that the feasibility of completing tympanostomy tube placement under moderate sedation enabled avoidance of general anesthesia and provided additional choices to physicians and parents.
On November 25, 2019, the FDA approved a new system for the delivery of tympanostomy tubes that can be inserted into the eardrum to treat otitis media. The Tubes Under Local Anesthesia (Tula) System is the first ear tube delivery system that can be performed in young children using local anesthesia in a physician’s office setting. The Tula System consists of the anesthetic Tymbion, Tusker Medical tympanostomy tubes, and several devices needed for the delivery of the ear tubes and the anesthetic into the ear drum. The Tula System allows the delivery of an ear tube in the office setting, thus, avoiding the use of general anesthesia. The Tula System employs a small electrical current to administer a local anesthetic into the ear drum before insertion of the tube. It is approved for use in both adults and children as young as 6 months of age. The FDA evaluated data provided by the sponsor from 222 pediatric patients to examine the effectiveness of the Tula System for the delivery of ear tubes. The procedural success rate was 86 % and 89 % in children younger than age 5 and between ages 5 to 12 years old, respectively. The most common AE observed was inadequate anesthesia during the procedure. The Tula System should not be used in patients younger than 6 months of age or patients who have allergies to some local anesthetics. This product is not intended for patients who may have pre-existing issues with their eardrum, such as a perforated eardrum.
UpToDate reviews on "Overview of tympanostomy tube placement, postoperative care, and complications in children" (Isaacson, 2019), "Acute otitis media in children: Prevention of recurrence" (Pelton and Marchisio, 2019), and "Otitis media with effusion (serous otitis media) in children: Management" (Pelton and Marom, 2019) do not mention the use of local anesthetic as a management option.
The American Academy of Otolaryngology-Head and Neck Surgery Position Statement on “In-office placement of tubes in pediatric patients while awake” (AAO-HNS, 2019) noted that “Tympanostomy tubes are safe and effective for managing otitis media in children who meet current guidelines for tube insertion. Although insertion of tympanostomy tubes in children is generally accomplished in the operating room under general anesthesia, insertion in the clinic in appropriately selected patients using shared decision-making between clinicians and families can be appropriate”. However, this AAO-HNS position statement did not provide specific information on the selected groups of patients who may be appropriate for in-office placement of tympanostomy tubes.
The AAO-HNS Position Statement (adopted July 9, 2019) stated that although insertion of tympanostomy tubes in children is generally accomplished in the operating room under general anesthesia, insertion in the clinic in appropriately selected patients using shared decision-making between clinicians and families can be appropriate. Rosenfeld (2020) stated that position statements are approved by the American Academy of Otolaryngology-Head and Neck Surgery or Foundation (AAO-HNS/F) Boards of Directors and are typically generated from AAO-HNS/F committees. Once approved by the Academy or Foundation Board of Directors, they become official position statements and are added to the existing position statement library. In no sense do they represent a standard of care. The applicability of position statements, as guidance for a procedure, must be determined by the responsible physician in light of all the circumstances presented by the individual patient. Adherence to these clinical position statements will not ensure successful treatment in every situation. As with all AAO-HNS/F guidance, this position statement should not be deemed inclusive of all proper treatment decisions or methods of care, nor exclusive of other treatment decisions or methods of care reasonably directed to obtaining the same results. Position statements are not intended to and should not be treated as legal, medical, or business advice.
In a prospective, cohort, multi-center study, Lustig et al (2020) examined technical success, tolerability, and safety of lidocaine iontophoresis and tympanostomy tube placement for children in an office setting. This trial evaluated in-office tube placement in children aged 6 months to 12 years. Anesthesia was achieved via lidocaine/epinephrine iontophoresis. Tube placement was conducted using an integrated and automated myringotomy and tube delivery system. Anxiolytics, sedation, and papoose board were not used. Technical success and safety were evaluated. Patients 5 to 12 years old self-reported tube placement pain using the Faces PainScale-Revised (FPS-R) instrument, which ranged from 0 (no pain) to 10 (very much pain). Children were enrolled into 3 cohorts with 68, 47, and 222 children in the Operating Room (OR) Lead-In, Office Lead-In, and Pivotal cohorts, respectively. In the Pivotal cohort, there were 120 and 102 children in the less than 5 and 5- to 12-year-old age groups, respectively, with a mean age of 2.3 and 7.6 years, respectively. Bilateral tube placement was indicated for 94.2 % of children less than 5 and 88.2 % of children 5 to 12 years old. Tubes were successfully placed in all indicated ears in 85.8 % (103/120) of children less than 5 and 89.2 % (91/102) of children 5 to 12 years old. Mean FPS-R score was 3.30 (standard deviation [SD] = 3.39) for tube placement and 1.69 (SD = 2.43) at 5 mins post-procedure. There were no serious adverse events (SAEs). Non-serious AEs occurred at rates similar to standard tympanostomy procedures. The authors concluded that in-office tube placement in selected patients could be successfully achieved without requiring sedatives, anxiolytics, or papoose restraints via lidocaine iontophoresis local anesthesia and an automated myringotomy and tube delivery system. Moreover, these researchers noted that the full profile of tube retention characteristics is not yet fully known, as follow-up is ongoing; however, 91.8 % (314/342) of implanted tubes were present at the 6-month follow-up. Furthermore, there are limited reports in the literature regarding the time course of tube retention for comparison purposes.
In a prospective, single-arm, multi-center study, Yen et al (2020) examined the safety, tolerability, and technical success of lidocaine iontophoresis and a tympanostomy tube placement system for adults in an office setting to meet regulatory evidence requirements for new drugs and devices. Patients were recruited in 8 community-based practices in the U.S. between June and September 2017. This trial examined tympanic membrane anesthesia and tube placement in 30 adults. Anesthesia was achieved via iontophoresis of a lidocaine/epinephrine solution. Tube placement was conducted using an integrated myringotomy and tube delivery system. Tolerability of tube placement was measured using a patient-reported visual analog scale (VAS) from 0 mm (no pain) to 100 mm (worst possible pain). Mean pain score was compared to a performance goal of 45 mm, where statistical superiority represents mild pain or less. Technical success and safety through 3 weeks post-procedure were evaluated. Twenty-nine (29/30, 96.7 %) patients had tube(s) successfully placed in all indicated ears; 1 patient demonstrated inadequate tympanic membrane anesthesia, and no tube placement was attempted. The mean (SD) pain score of 9.4 (15.7) mm was statistically superior to the performance goal. There were no SAEs; 7 non-serious AEs were related to device, procedure, or drug: inadequate anesthesia (n = 1), vertigo (n = 1), and dizziness (n = 1) at the time of procedure and ear discomfort (n = 1), tube occlusion (n = 2), and medial tube migration (n = 1) post-procedure. The authors concluded that lidocaine iontophoresis provided acceptable tympanic membrane anesthesia for safe, tolerable, and successful in-office tube placement using an integrated myringotomy and tube delivery system.
The authors stated that a drawback of this study was evaluation in adults limiting generalization of performance to a pediatric population. A 2nd drawback was the lack of a control group to compare safety and tolerability to standard tube placement in adults. The objective of the study was not to compare the investigational system to existing options but rather to demonstrate safety and efficacy before the use of the investigational system for pediatric subjects.
Rosenfeld (2020) reviewed current pragmatic issues and controversies related to tympanostomy tubes in children, in the context of current best research evidence plus expert opinion to provide nuance, address uncertainties, and fill evidence gaps. Each issue or controversy is followed by the relevant current best evidence, expert insight and opinion, and recommendations for action. The role of expert opinion and experience in forming conclusions is inversely related to the quality, consistency, and adequacy of published evidence. Conclusions were combined with opportunities for shared decision-making with caregivers to recommend pragmatic actions for clinicians in everyday settings. The issues and controversies discussed included (i) appropriate tube indications, (ii) rationale for not recommending tubes for recurrent acute otitis media without persistent middle ear effusion, (iii) role of tubes in at-risk children with otitis media with effusion, (iv) role of new, automated tube insertion devices, (v) appropriateness and feasibility of in-office tube insertion in awake children, (vi) managing methicillin-resistant Staphylococcus aureus acute tube otorrhea, and (vii) managing recurrent or persistent tube otorrhea. The authors concluded that despite a substantial, and constantly growing, volume of high-level evidence on managing children with tympanostomy tubes, there will always be gaps, uncertainties, and controversies that benefit from clinician experience and expert opinion. In that regard, the issues discussed in this review article will hopefully aid clinicians in everyday, pragmatic management decisions.
The author noted that whether to undertake in-office tube insertion in awake children should be based on clinician experience, clinician ability to interact and reassure caregivers (who will be present and observing), caregiver preference, and judgment regarding the level of cooperation (or lack thereof) to be expected from a given child. The existing literature is too sparse to generalize conclusions about safety or efficacy. It is also too early to judge the potential impact, if any, of new devices for rapid, automated tube insertion) on clinician willingness to embrace this approach.
In a randomized, double-blind, single-center study, England et al (2021) examined local and systemic safety of bilateral iontophoretic administration of lidocaine with epinephrine or lidocaine alone to the tympanic membrane (TM). Healthy adults were randomized to bilateral iontophoretic treatment with 2 % lidocaine, 1:100,000 epinephrine, or 2 % lidocaine (control). Otoscopy, cranial nerve examination, tympanometry, and audiometry safety evaluations were conducted before and 3-days post-procedure. Systemic safety was evaluated via analysis of vital signs taken before and up to 120 mins post-iontophoresis, and blood samples collected before and up to 230 mins post-iontophoresis. A total of 25 subjects were treated with bilateral iontophoresis of either lidocaine and epinephrine (n = 15 subjects) or lidocaine alone (n = 10). Mean plasma epinephrine concentrations for both groups remained within the normal range for endogenous epinephrine. Mean plasma concentrations of lidocaine were not statistically different between groups, ranging from 0.245 to 2.28 ng/ml after administration of lidocaine with epinephrine (immediate post-iontophoresis to 230 mins post-iontophoresis), compared with 1.35 to 2.14 ng/ml after administration of lidocaine alone. The presence of epinephrine slowed the systemic absorption of lidocaine. Lidocaine levels (Cmax 2.24 ng/ml) were approximately 2,000-fold lower than the threshold for minor lidocaine toxicity. No device-, procedure- or drug-related AEs were reported. The authors concluded that the local and systemic safety of bilateral iontophoretic delivery of 2 % lidocaine, 1:100,000 epinephrine to the TM was demonstrated by low plasma levels of drug and absence of both serious and non-serious device-, procedure-, or drug-related AEs. This method of iontophoretically-facilitated anesthesia using the iontophoresis system with 2 % lidocaine, 1:100,000 epinephrine was recently approved by the FDA for use in children (aged 6 months and older) and adults undergoing tympanostomy tube placement, in a physician’s office setting. This study demonstrated safety of bilateral iontophoretic delivery of 2 % lidocaine, 1:100,000 epinephrine to the tympanic membrane using healthy volunteers; it did not provide any data on clinical effectiveness.
These researchers noted that a limitation of the study was evaluation of post-iontophoresis plasma lidocaine and epinephrine levels in healthy adult ears, whereas the predominant target population for this therapy is children with otitis media. TM tissue properties between adults and children are similar. Both pediatric and adult ears with otitis media have been shown to have thicker TMs compared with healthy ears. However, the iontophoresis control unit will maintain a constant current and adjust voltage based on tissue resistance; thus , the current dose, and therefore ions (drug) delivered should be the same for healthy ears and ears with otitis media. Other differences, such as presence of effusion or increased vascularization, may play a role in the time course of systemic absorption. However, given the extremely low levels detected systemically, the inability to fully simulate the clinically relevant tissue is thought to not materially alter the conclusions. A 2nd limitation of the study was the inability to determine the AUC0–1 (area under the plasma concentration–time curve from start of iontophoresis to infinity), as the terminal exponential portion for the individual subject pharmacokinetic curves could not be identified. The lack of a complete pharmacokinetic curve is immaterial to the safety conclusions of the study, as the systemic lidocaine concentration was well below the safety threshold for minor toxicity. An additional limitation to the study was absence of balance by sex. While young women may have increased metabolization of lidocaine compared with men due to greater CYP3A4 activity, the inclusion of a larger proportion of men in each arm (80 % in the lidocaine with epinephrine group and 70 % in the lidocaine alone group) would potentially result in higher observed plasma lidocaine levels representing worst-case given the lack of detection above endogenous epinephrine levels, the lack of sex balance is unlikely to materially alter conclusions.
Cohen et al (2021) examined behavioral strategies to minimize procedural distress associated with in-office tympanostomy tube placement for children without general anesthesia, sedation, or papoose-board restraints. A total of 120 6-month- to 4-year-olds and 102 5- to 12-year-olds were treated at 16 otolaryngology practices. Mean age of children was 4.7 years (SD = 3.18 years), with more boys (58.1 %) than girls (41. 9%). The cohort included 14 % Hispanic or Latinx, 84.2 % White, 12.6 % Black, 1.8 % Asian and 4. 1% “Other” race and ethnicity classifications. The in-office tube placement procedure included local anesthesia via lidocaine/epinephrine iontophoresis and tube placement using an integrated and automated myringotomy and tube delivery system. Behavioral strategies were used to minimize procedural distress. Anxiolytics, sedation, or papoose board were not used. Pain was measured via the faces pain scale-revised (FPS-R) self-reported by the children aged 5 through 12 years. Independent coders supervised by a psychologist completed the face, legs, activity, cry, consolability (FLACC) behavior observational rating scale to quantify children’s distress. Mean FPS-R score for tube placement was 3.30, in the “mild’ pain range, and decreased to 1.69 at 5-min post-procedure. Mean tube placement FLACC score was 4.0 (out of a maximum score of 10) for children aged 6 months to 4 years and was 0.4 for children aged 5 to 12 years. Mean FLACC score 3-min post-tube placement was 1.3 for children aged 6 months to 4 years and was 0.2 for children aged 5 to 12 years. FLACC scores were inversely correlated with age, with older children displaying lower distress. The iontophoresis, tube delivery system and behavioral program were associated with generally low behavioral distress. The authors concluded that these data suggested that pediatric tympanostomy and tube placement could be achieved in the outpatient setting without anxiolytics, sedatives, or mechanical restraints.
These investigators wanted to highlight limitations and future directions. First, the lack of a control condition prohibited attributions of low distress to qualities of the device or behavioral program. However, given the sensitivity of the eardrum, it is challenging if not unethical to conduct tympanostomy absent anesthesia and behavioral support for pediatric patients. However, dismantling studies might aid in identifying key intervention ingredients. Second, generalizability of findings was limited given the inclusion and exclusion criteria that restricted the patient population to children with anatomy compatible with safe use of the devices and anesthetic, and with compliant behavior for the office procedure. Future research might examine if behavioral strategies might be effective for more challenging patients. Third, 2 of the authors were funded for work on the project, which could have introduced investigator bias. That said, all data coding was carried out by researchers who were blind to study hypotheses. Given that the behavioral program appeared to be helpful to some but not all children, the authors encouraged researchers in this area to evaluate additional unique characteristics (e.g., coping styles, temperament) to advance the field in matching intervention components and strategies to individuals.
Furthermore, an UpToDate review on “Overview of tympanostomy tube placement, postoperative care, and complications in children” (Isaacson, 2022) states that “In addition to conventional grommet TTs, three different rapid-insertion TT systems are now on the market. None has received wide acceptance. Little is known of the efficacy, duration, or long-term complications of these modified TTs. Information to support the safety and efficacy of these devices comes from industry-funded studies with modest sample sizes and often lacking a control group. Families should understand that the devices do not make the procedure pain free”.
In a prospective, single-arm trialy, Waldman et al (2023) examined 2-year outcomes after lidocaine/epinephrine iontophoresis and tympanostomy using an automated tube delivery system for pediatric tube placement in-office. Children aged 6 months to 12 years indicated for tympanostomy were enrolled between October 2017 and February 2019. Local anesthesia of the tympanic membrane was achieved via lidocaine/epinephrine iontophoresis and tympanostomy was completed using an automated tube delivery system (the Tula System). An additional lead-in cohort of patients underwent tube placement in the operating room (OR) under general anesthesia using only the tube delivery system. Patients were followed for 2 years or until tube extrusion, whichever occurred first. Otoscopy and tympanometry were performed at 3 weeks, and 6, 12, 18, and 24 months. Tube retention, patency, and safety were evaluated. Tubes were placed in-office for 269 patients (449 ears) and in the OR for 68 patients (131 ears) (mean age of 4.5 years). The median and mean times to tube extrusion for the combined OR and in-office cohorts were 15.82 (95 % CI: 15.41 o 19.05) and 16.79 (95 % CI: 16.16 to 17.42) months, respectively. Sequelae included ongoing perforation for 1.9 % of ears (11/580) and medial tube displacement for 0.2 % (1/580) observed at 18 months. Over a mean follow-up of 14.3 months, 30.3 % (176/580) of ears had otorrhea and 14.3 % (83/580) had occluded tubes. The authors concluded that in-office pediatric tympanostomy using lidocaine/epinephrine iontophoresis and automated tube delivery resulted in tube retention within the ranges described for similar grommet-type tubes and complication rates consistent with traditional tube placement in the OR.
The authors stated that this study had several limitations. First, the study design did not include a control group for comparison of tube retention and safety, requiring a survey of the scientific literature to assess relative performance. The study objective was to examine the safety, procedural success, and tolerability of in-office tube placement using the Tula System. A traditional tympanostomy control arm was determined by the investigators (and FDA) to not be required, as OR tympanostomy was not an appropriate control for in-office procedure outcomes. Furthermore, it was reasonably assumed that the long-term performance of in-office placed tubes would likely be similar to existing tubes of like materials and geometry. Second, in this study, the procedure success rate was 85.8 % and 89.2 % for children less than 5 years old and 5 to 12 years old, respectively. For children with unsuccessful in-office tube placement for 1 or both ears, shared decision-making with caregivers may result in a subsequent OR tube placement procedure. Third, since patients exited the study at the time of tube extrusion, the resolution of certain events (e.g., perforations) or the development of others (e.g., tympanosclerosis) could not always be observed. Fourth, differences in follow-up for the OR and in-office cohorts (mean of 11.3 and 15.1 months, respectively) limited the comparison of AE rates between the 2 groups. Since AE rates were cumulative over the follow-up period, longer follow-up may play a role in the apparently higher observed AE rate for the in-office cohort. Additionally, 30/68 (44 %) of the OR cohort patients enrolled under an initial protocol version that required only a 3-week follow-up, limiting observation of longer-term events such as perforation for these patients. Differences between the OR and in-office procedures (i.e., general versus local anesthetic) were not anticipated to play a role in rates of tube sequelae because the tube was the same. AE rates for the OR and in-office cohorts, and for all patients combined, were presented for full visibility. Fifth, there may be a bias toward over-reporting of certain AEs in this study. This trial used a conservative reporting strategy, in which parent reports of AEs (e.g., otitis media) were accepted without verification. Sixth, as the technology and drug used in the clinical study did not yet have FDA approval, industry sponsorship was needed to support trial activities as the product would not have otherwise been available to the surgeons. Bias was a potential drawback of this trial and was managed via 100 % data verification against medical records, and adjudication of all AEs by an independent non-enrolling otolaryngologist and an audiologist.Cost-Effectiveness of Management Strategies in Recurrent Acute Otitis Media
Noorbakhsh et al (2022) examined the cost-effectiveness of TT placement versus non-surgical medical management, with the option of TT placement in the event of treatment failure, in children with recurrent AOM. These investigators employed a Markov decision model to compare management strategies in children aged 6- to 5 months, using patient-level data from a recently completed, multi-center, randomized clinical trial of TT placement versus medical management. The model ran over a 2-year time horizon using a societal perspective. Probabilities, including risk of AOM symptoms, were derived from prospectively collected patient diaries . Costs and QOL measures were derived from the literature. These researchers carried out 1-way and probabilistic sensitivity analyses, and secondary analyses in pre-determined low- and high-risk subgroups. The primary outcome was incremental cost per quality-adjusted life-year (QALY) gained. TTs cost $989 more per child than medical management. Children managed with TTs gained 0.69 more quality-adjusted life-days (QALDs) than children managed medically, corresponding to $520,855 per QALY gained. Results were sensitive to the costs of oral antibiotics, missed work, special childcare, the societal cost of antibiotic resistance, and the QOL associated with AOM. In probabilistic sensitivity analyses, medical management was favored in 66 % of model iterations at a willingness-to-pay threshold of $100,000/QALY. Medical management was preferred in secondary analyses of low- and high-risk subgroups. The authors concluded that for young children with recurrent AOM, the additional cost associated with TT placement outweighed the small improvement in QOL. These investigators stated that medical management for these children was an economically reasonable strategy.
Timing of Elective Removal of Tympanostomy Tubes
Tan et al (2022) noted that TT placement is the most common surgical procedure in children. Less than 10 % of TT do not self-extrude. This study was a systematic review (SR) on elective TT removal in the pediatric population: timing, perforation rates, and role of simultaneous repair. A PICOTS (population, intervention, comparison, outcome, timing, setting) question was formulated: In pediatric patients who have retained TT, what is the preferred time to elective removal of such tubes, and what are the outcomes in terms of perforation rates? Does an intervention at the time of TT removal improve perforation rates? These investigators searched 4 major electronic databases: Embase, Medline, CDSR, CCRCT for studies published before February 19, 2020. EndNote was used to gather references, review abstracts, and obtain full text articles. Inclusion criteria were studies reporting patients aged 0 to 18 years undergoing elective TT removal with follow-up greater than 3 months. Exclusion criteria included patients greater than 18 years of age, duplicate patient series, or case series with fewer than 5 patients. Studies that were not available in English, not available in full text, and those that only addressed long-acting TT were excluded. Data were pooled and meta-analysis was carried out to examine how timing of TT removal, patching of the tympanic membrane, or any TM intervention at TT removal affected outcomes. A total of 1,064 references were found; and 63 studies met criteria for full text review. Of these, 17 were selected for SR. MINORS (Methodological Index for Nonrandomized Studies) scores were low-revealing high bias among the studies. Reported perforation rates after elective TT removal ranged from 0 % to 57 %; 4 studies had data suitable for comparative meta-analysis, which showed a significant increase in perforation rates after elective removal of TT after 3 years compared to removal before 3 years (odds ratio 2.89; CI: 1.78 to 4.69). No difference in perforation rates were identified when TM intervention versus no intervention at time of TT removal was performed (6 studies: odds ratio 1.21; CI 0.71 to 2.07). No difference in perforation rates was identified when the type of TM intervention was compared, including freshening of TM edges, to patching with various materials (paper, fat, gelfoam/gelfilm, trichloroacetic acid) (3 studies: odds ratio 1.07; CI: 0.52 to 2.19). The authors concluded that from the data reviewed in this SR and meta-analysis, elective TT removal at or before 3 years' retention showed decreased perforation rates. However, TM intervention at the time of TT removal was not shown to lower perforation rates. These investigators stated that in the absence of tube complications such as granuloma formation, non-functional tube, or chronic tube otorrhea, it may be reasonable to wait up to 3 years to electively remove a retained TT.
References
The above policy is based on the following references:
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