Abstract
Purpose
To determine the rate of persistent tympanic membrane perforation after intratympanic steroid injection. To determine which comorbid conditions and risk factors are associated with prolonged time to perforation closure following intratympanic steroid injection.
Materials and methods
Clinical data were gathered for patients who had undergone intratympanic steroid injection to treat sudden sensorineural hearing loss or Ménière’s disease. Primary outcomes analysis included rate of persistent tympanic membrane perforation, defined as perforation at least 90 days following last injection, and time to perforation healing. Age, sex, number of injections, smoking status, diabetes mellitus, previous head and neck irradiation, and concurrent oral steroids, were analyzed as potential predictors of persistent perforation.
Results
One hundred ninety two patients were included in this study. Three patients (1.6%) had persistent tympanic membrane perforations. All three patients received multiple injections. One patient underwent tympanoplasty for repair of persistent perforation. The median time to perforation healing was 18 days. There was no statistically significant variable associated with time to perforation healing. However, patients with prior history of head and neck radiation averaged 36.5 days for perforation healing compared to 17.5 days with no prior history of radiation and this approached statistical significance ( p = 0.078).
Conclusions
The rate of persistent tympanic membrane perforation following intratympanic steroid injection is low. Patients with a history of radiation to the head and neck may be at increased risk for prolonged time for closure of perforation.
1
Introduction
The use of intratympanic steroid injections has become increasingly more common in the treatment of various inner ear disorders with the rationale of locally delivering higher dosages to target tissues while avoiding adverse effects of systemic administration. Itoh first described the use of intratympanic dexamethasone for the treatment of Ménière’s disease in 1991 with 80% of treated patients showing improvement in vertigo and 74% with a reduction in tinnitus . Additional investigators have repeated these results with intratympanic steroids for vertigo control in Ménière’s disease .
However, intratympanic steroids are probably best known for their therapeutic use in idiopathic sudden sensorineural hearing loss (ISSNHL). ISSNHL is defined as hearing loss of greater than 30 dB in at least three contiguous frequencies that occurs within 3 days and with no identifiable etiology . Systemic corticosteroids are often used as first line therapy largely due to work by Wilson et al. that demonstrated a 61% recovery rate after steroid treatment . However, a significant number of treatment failures remain and systemic corticosteroids are not without complications and may be relatively contraindicated in a subset of patients. Silverstein first reported the use of intratympanic steroids for the treatment of autoimmune inner ear disease as well as ISSNHL in 1996 . Numerous studies have shown that intratympanic steroid injections, whether used for first line therapy or after oral steroids have failed, aid in hearing recovery in ISSNHL .
Multiple protocols for intratympanic steroid treatment have been proposed with various methods of administration, dosages, and frequency. Some otologists advocate for the placement of a ventilation tube to facilitate repeated steroid injections . This also allows for the possibility of administration of steroid drops by the patient at home. Others have proposed the placement of a MicroWick through a ventilation tube into the round window niche or the placement of round window catheters . Some simply administer repeat transtympanic injections using a small gauge needle under local anesthetics .
Although rare, intratympanic steroid injection does not come without its potential adverse effects. Complications include persistent tympanic membrane (TM) perforation, otitis media, otitis externa, mastoiditis, hearing loss, vertigo, otalgia, dizziness, and dysgeusia . Persistent TM perforations are more common with the use of ventilation tubes for steroid administration . To our knowledge, there are few studies looking at the rate of TM perforation in the setting of intraytmpanic steroid injection, particularly when the transtympanic injection technique is utilized. Our goal in this study was to examine the incidence of persistent TM perforation and to identify any risk factors that may contribute to a chronic perforation.
2
Materials and methods
2.1
Study population
A retrospective review was conducted of patients undergoing intratympanic steroid injection at Thomas Jefferson University Hospital Department of Otolaryngology – Head and Neck Surgery from January 1, 2009 to September 1, 2014. Patients included in this study received at least one intratympanic steroid injection for the treatment of Ménière’s disease or ISSNHL. Patients who received intratympanic aminoglycosides were excluded. Patients with incomplete records and inadequate follow-up were excluded.
Patients’ demographic information, clinical presentation, previous treatment history, pre-injection otoscopic examination, pre-injection tympanogram, post-injection otoscopic examination, post-injection tympanogram, comorbid conditions, and post-injection clinical course were collected. Institutional review board approval for this study was given by the Thomas Jefferson University institutional review board.
2.2
Outcome measurements
Primary outcomes analysis included the rate of persistent TM perforation, defined as confirmed perforation 90 days following last injection, and time to perforation healing. Diagnosis of TM perforation was made based on otoscopic examination as well as pre- and post-injection tympanometry. Age, sex, number of injections, smoking status, diabetes mellitus, previous head and neck radiation, and concurrent use of oral steroids were analyzed as potential predictors of persistent TM perforation and time to perforation healing.
2.3
Statistical analysis
Statistical analyses were performed using R software (R Foundation for Statistical Computing, Vienna, Austria). A stepwise negative binomial regression model was created with the integer outcome of time to perforation healing and potential predictors such as age, sex, smoking status, diabetes, previous radiation, concurrent steroids, and number of injections.
2.4
Procedure
Our protocol takes place in the clinic under microscopic control. After informed consent is obtained, the correct ear is confirmed for injection by patient response as well as audiometric review. With the patient supine and the head turned to the opposite side, a drop of phenol is applied to induce local anesthesia on the tympanic membrane. A ventilation hole is made with a 25-gauge spinal needle in the anterior inferior quadrant. A second hole is made and approximately 0.3 to 0.5 mL of 10 mg/mL dexamethasone is injected through a posterior inferior site to fill the middle ear space. Following the injection, the patient is instructed to not speak, minimize swallowing, and to lie in the supine position keeping the treated ear upright for 30 min.
2
Materials and methods
2.1
Study population
A retrospective review was conducted of patients undergoing intratympanic steroid injection at Thomas Jefferson University Hospital Department of Otolaryngology – Head and Neck Surgery from January 1, 2009 to September 1, 2014. Patients included in this study received at least one intratympanic steroid injection for the treatment of Ménière’s disease or ISSNHL. Patients who received intratympanic aminoglycosides were excluded. Patients with incomplete records and inadequate follow-up were excluded.
Patients’ demographic information, clinical presentation, previous treatment history, pre-injection otoscopic examination, pre-injection tympanogram, post-injection otoscopic examination, post-injection tympanogram, comorbid conditions, and post-injection clinical course were collected. Institutional review board approval for this study was given by the Thomas Jefferson University institutional review board.
2.2
Outcome measurements
Primary outcomes analysis included the rate of persistent TM perforation, defined as confirmed perforation 90 days following last injection, and time to perforation healing. Diagnosis of TM perforation was made based on otoscopic examination as well as pre- and post-injection tympanometry. Age, sex, number of injections, smoking status, diabetes mellitus, previous head and neck radiation, and concurrent use of oral steroids were analyzed as potential predictors of persistent TM perforation and time to perforation healing.
2.3
Statistical analysis
Statistical analyses were performed using R software (R Foundation for Statistical Computing, Vienna, Austria). A stepwise negative binomial regression model was created with the integer outcome of time to perforation healing and potential predictors such as age, sex, smoking status, diabetes, previous radiation, concurrent steroids, and number of injections.
2.4
Procedure
Our protocol takes place in the clinic under microscopic control. After informed consent is obtained, the correct ear is confirmed for injection by patient response as well as audiometric review. With the patient supine and the head turned to the opposite side, a drop of phenol is applied to induce local anesthesia on the tympanic membrane. A ventilation hole is made with a 25-gauge spinal needle in the anterior inferior quadrant. A second hole is made and approximately 0.3 to 0.5 mL of 10 mg/mL dexamethasone is injected through a posterior inferior site to fill the middle ear space. Following the injection, the patient is instructed to not speak, minimize swallowing, and to lie in the supine position keeping the treated ear upright for 30 min.
3
Results
The study population consisted of 192 patients with a mean age of 54.0 years (range 16.7–89.1 years) as shown in Table 1 . Median follow-up was 56.0 days (range 4.0–2174). 106 (55.2%) patients were male, whereas 86 (44.8%) patients were female. 30 (15.6%) patients were current tobacco users. 28 (14.6%) patients were diabetic. 14 (7.3%) patients had a previous history of radiation to the head and neck. 61 (31.8%) patients were on concurrent oral steroids while receiving intratympanic steroid injections. 112 (58.3%) patients received one intratympanic steroid injection, 47 (24.5%) received two injections, and 33 (17.2%) received three or greater injections.
| Patients | Percent of total | Median time to healing (days) | p -value | |
|---|---|---|---|---|
| Total patients | 192 | 100 | 18.0 | |
| Gender | 0.879 | |||
| Male | 106 | 55.2 | 15.0 | |
| Female | 86 | 44.8 | 20.0 | |
| Number of injections | 0.113 | |||
| 1 or 2 | 159 | 82.8 | 16.5 | |
| 3 or more | 33 | 17.2 | 31.0 | |
| Tobacco use | 0.968 | |||
| Current smoker | 30 | 15.6 | 18.0 | |
| Non-smoker | 162 | 84.4 | 19.0 | |
| Diabetes | 0.656 | |||
| Diabetic | 28 | 14.6 | 14.5 | |
| Non-diabetic | 164 | 85.4 | 19.5 | |
| Radiation therapy | 0.078 | |||
| Previous radiation therapy | 14 | 7.3 | 36.5 | |
| No history of radiation | 178 | 92.7 | 17.5 | |
| Steroids | 0.116 | |||
| Concurrent oral steroids | 61 | 31.8 | 15.0 | |
| No steroids | 131 | 68.2 | 20.0 |
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