Abstract
Objective
The purpose of this study is to identify prognostic factors affecting outcome in ossicular chain reconstruction (OCR).
Study design and setting
This study is a retrospective case series of electronic database at an academic institution.
Materials and methods
We reviewed 209 cases of chronic supportive otitis media performed from January 2000 through December 2007 and collected demographic, clinical, audiologic, and outcome information. Univariate analyses of group differences in terms of postoperative air-bone gap (ABG) changes were evaluated by analysis of variance. Multiple regression analyses were used to examine the relationship between postoperative ABG and the independent variables.
Results
There were 105 cases of OCR the met the inclusion criteria (44 primary and 61 revision tympanoplasties), with an average follow-up of 19 months. The diagnoses were chronic suppurative otitis media without cholesteatoma in 36 cases and cholesteatoma in 69 cases. The mean preoperative ABG was 34 ± 15 dB, and the mean postoperative ABG was 20 ± 14 dB ( P < 0.001). Of the independent variables analyzed, the type of procedure (ie, OCR performed during second-look tympanoplasty vs canal wall up vs canal wall down), preoperative ABG, and status of malleus handle were predictive of the success of OCR.
Conclusions
Favorable prognostic factors in OCR include smaller preoperative ABG and the presence of an intact malleus handle.
1
Introduction
The goal of ossicular chain reconstruction (OCR) is hearing restoration. The literature is extensive with studies comparing techniques, materials, and patient factors that influence OCR outcome. Factors that provide prognostic indications are important for the surgeon to appreciate so as to better counsel their patients. Austin developed a prognostic staging system based on the presence of the malleus handle and the stapes suprastructure. Based on their results, the absences of both the malleus handle and stapes suprastructure carry the worst prognosis. Bellucci developed a classification system based on the status of the middle ear and the presence of otorrhea. This staging system identifies 4 prognostic groups for successful ossiculoplasty, and cases with the worse prognosis were those associated with persistent otorrhea and nasopharyngeal malformations. Black developed the SPITE method of assessment where 5 prognostic factors were identified: surgical, prosthetic, infection, tissue, and eustachian tube. Kartush developed the middle ear risk index, which incorporates both the Austin and Bellucci grading systems as well as including other risk factors. Values are assigned to each risk factor with the worst possible prognosis, which includes the clinical situation of a persistently wet ear with nasopharyngeal abnormality, no ossicles, revision surgery, and the presence of cholesteatoma. The Kartush staging system was analyzed against a series of patients by Dornhoffer , whereby the ossiculoplasty outcome parameter staging index was developed. Yung et al analyzed a large series of patients who had undergone ossiculoplasties at 6 months and 5 years postoperatively. He found the absence of the malleus handle, and otorrhea were the most unfavorable factors 6 months postoperatively, whereas absence of the malleus handle was the only unfavorable factor 5 years postoperatively. Also, De Vos et al found the status of the malleus handle to significantly affect postoperative air-bone gap (ABG).
There have been very few studies that have used linear or logistic regression models to analyze prognostic factors in OCR . The purpose of this study is to use regression models to assess the prognostic indications of demographic, audiologic, clinical, and disease factors influencing the outcome of OCR in patients with chronic suppurative otitis media with and without cholesteatoma. These were consecutive cases performed by a single surgeon at a tertiary care academic institution with data collected systematically and prospectively.
2
Materials and methods
After obtaining institutional review board approval, an electronic database of 209 consecutive cases was reviewed on patients who had undergone surgery for chronic suppurative otitis media from January 2000 to December 2007. All cases were performed by the senior author. The database was analyzed for those patients who met the inclusion criteria for this study: (1) diagnosis of chronic suppurative otitis media with and without cholesteatoma, (2) minimum follow-up of 3 months, and (3) having on record a preoperative and postoperative audiogram. We selected 105 cases who had undergone OCR, which included 44 primary and 61 revision surgeries.
Data were collected uniformly and prospectively throughout the study period and included demographic, clinical, disease-related, and audiologic information. The demographic information collected included age and sex. Clinical data included diagnosis, primary vs revision surgery, approach (retroauricular, transcanal, endaural), type of procedure (tympanoplasty, canal wall up mastoidectomy, canal wall down mastoidectomy), surgical technique used (incus replacement prosthesis [IRP], partial ossicular replacement prosthesis [PORP], total ossicular replacement prosthesis [TORP]), operative findings (status of ossicles, status of middle ear mucosa, presence of otorrhea, status of external auditory canal, tympanic membrane perforation), type of material used for reconstruction (titanium, hydroxyapatite, bone, cartilage), incorporation of cartilage graft between prosthesis and tympanic membrane, postoperative findings (extrusion), hearing, and follow-up period. The outcome measure was postoperative ABG. All patients underwent an audiogram preoperatively and 3, 6, and 12 months postoperatively as well as annually afterward. Audiologic data were analyzed and reported according to the 1995 American Academy of Otolaryngology-Head and Neck Surgery guidelines . The pure-tone average (PTA) for bone and air conduction at 0.5, 1, 2, and 4 kHz was calculated. From the values obtained at each interval, the bone conduction PTA was subtracted from the air conduction PTA to calculate the ABG. The bone conduction PTA at 1, 2, and 4 kHz was calculated to evaluate for operative damage to hearing. The preoperative and the most recent postoperative audiogram were used to analyze for ABG closure.
The independent variables of this study were sex, age, diagnosis (cholesteatoma, chronic suppurative otitis media only), type of surgery (primary, revision), side (left, right), procedure (OCR performed during second-look tympanoplasty, canal wall up mastoidectomy, canal wall down mastoidectomy), approach (transcanal, endaural, retroauricular), status of external auditory canal (no defect, defect), tympanic membrane perforation, perforation type (none, central, marginal, total), otorrhea (dry, mucoid, purulent), status of the mucosa (normal, diseased), malleus handle (intact, absent), stapes suprastructure (intact, absent), prosthesis material used (titanium, hydroxyapatite, bone, cartilage), technique (IRP, PORP, TORP), use of cartilage interposition graft, and preoperative ABG. The dependent variable was the most recent postoperative ABG. Hearing and age were continuous variables, whereas nominal and ordinal variables were coded as previously mentioned. Univariate analyses of group differences in terms of postoperative ABG improvement were evaluated by Student t test. Analysis of variance (ANOVA) and post hoc Tukey-Kramer were used to evaluate mean differences within groups, which were found to significantly affect postoperative ABG. Bivariate fit analyses were used to evaluate the correlation between the continuous variables (age and preoperative ABG) with the postoperative ABG. Multiple linear regression analysis models (hierarchical linear model) were performed to examine the relationship between the dependent variable, postoperative ABG, and the independent variables. The level of significance α was .05. All calculations were performed with the JMP IN statistical software package (SAS Institute, Inc, Belmont, CA).
2
Materials and methods
After obtaining institutional review board approval, an electronic database of 209 consecutive cases was reviewed on patients who had undergone surgery for chronic suppurative otitis media from January 2000 to December 2007. All cases were performed by the senior author. The database was analyzed for those patients who met the inclusion criteria for this study: (1) diagnosis of chronic suppurative otitis media with and without cholesteatoma, (2) minimum follow-up of 3 months, and (3) having on record a preoperative and postoperative audiogram. We selected 105 cases who had undergone OCR, which included 44 primary and 61 revision surgeries.
Data were collected uniformly and prospectively throughout the study period and included demographic, clinical, disease-related, and audiologic information. The demographic information collected included age and sex. Clinical data included diagnosis, primary vs revision surgery, approach (retroauricular, transcanal, endaural), type of procedure (tympanoplasty, canal wall up mastoidectomy, canal wall down mastoidectomy), surgical technique used (incus replacement prosthesis [IRP], partial ossicular replacement prosthesis [PORP], total ossicular replacement prosthesis [TORP]), operative findings (status of ossicles, status of middle ear mucosa, presence of otorrhea, status of external auditory canal, tympanic membrane perforation), type of material used for reconstruction (titanium, hydroxyapatite, bone, cartilage), incorporation of cartilage graft between prosthesis and tympanic membrane, postoperative findings (extrusion), hearing, and follow-up period. The outcome measure was postoperative ABG. All patients underwent an audiogram preoperatively and 3, 6, and 12 months postoperatively as well as annually afterward. Audiologic data were analyzed and reported according to the 1995 American Academy of Otolaryngology-Head and Neck Surgery guidelines . The pure-tone average (PTA) for bone and air conduction at 0.5, 1, 2, and 4 kHz was calculated. From the values obtained at each interval, the bone conduction PTA was subtracted from the air conduction PTA to calculate the ABG. The bone conduction PTA at 1, 2, and 4 kHz was calculated to evaluate for operative damage to hearing. The preoperative and the most recent postoperative audiogram were used to analyze for ABG closure.
The independent variables of this study were sex, age, diagnosis (cholesteatoma, chronic suppurative otitis media only), type of surgery (primary, revision), side (left, right), procedure (OCR performed during second-look tympanoplasty, canal wall up mastoidectomy, canal wall down mastoidectomy), approach (transcanal, endaural, retroauricular), status of external auditory canal (no defect, defect), tympanic membrane perforation, perforation type (none, central, marginal, total), otorrhea (dry, mucoid, purulent), status of the mucosa (normal, diseased), malleus handle (intact, absent), stapes suprastructure (intact, absent), prosthesis material used (titanium, hydroxyapatite, bone, cartilage), technique (IRP, PORP, TORP), use of cartilage interposition graft, and preoperative ABG. The dependent variable was the most recent postoperative ABG. Hearing and age were continuous variables, whereas nominal and ordinal variables were coded as previously mentioned. Univariate analyses of group differences in terms of postoperative ABG improvement were evaluated by Student t test. Analysis of variance (ANOVA) and post hoc Tukey-Kramer were used to evaluate mean differences within groups, which were found to significantly affect postoperative ABG. Bivariate fit analyses were used to evaluate the correlation between the continuous variables (age and preoperative ABG) with the postoperative ABG. Multiple linear regression analysis models (hierarchical linear model) were performed to examine the relationship between the dependent variable, postoperative ABG, and the independent variables. The level of significance α was .05. All calculations were performed with the JMP IN statistical software package (SAS Institute, Inc, Belmont, CA).
3
Results
One hundred five patients met the inclusion criteria for this study: 44 primary cases and 61 revision cases. There was no sex predilection (male to female ratio of 1.05:1). The mean age at the time of surgery was 38 years, with a range of 6 to 77 years. The average follow-up was 19 months (range, 3–84 months). Table 1 shows the patients’ demographic and clinical data.
| Data | Value |
|---|---|
| No. of patients | 105 |
| Mean age at surgery, range | 38 y (6–77 y) |
| Sex ratio, male/female | 1.05:1 |
| Type of surgery | |
| Primary | 44 |
| Revision | 61 |
| Diagnosis | |
| Chronic otitis media | 36 |
| Cholesteatoma | 69 |
| Follow-up, range | 19 mo (3–84 mo) |
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