Surgical findings and long-term hearing results in 3,050 stapedotomies for primary otosclerosis: a prospective study with the otology-neurotology database.

OBJECTIVE: To evaluate with a new otologic database the results of primary stapes surgery for otosclerosis with up to 14 years of follow-up in a consecutive series of 2,525 patients operated on by the same surgeon with the same technique (stapedotomy and vein graft interposition) and to provide online access to the complete data of this study for the reviewers. To study the effect of specific operative findings (obliterative otosclerosis and simultaneous malleus ankylosis) and age at the time of surgery on the long-term outcome.

STUDY DESIGN: Prospective clinical study using a new computerized otologic database.

SETTING: : Tertiary referral center.

PATIENTS: Two thousand five hundred twenty-five patients who underwent 3,050 stapedotomies for otosclerotic stapes fixation were enrolled in this study from January 1991 to December 2004. Separate analyses were made for two unique pathologies (92 cases of obliterative otosclerosis and 19 cases of simultaneous malleus ankylosis) diagnosed during surgery and for patients in two age brackets (<or=18 yr [28 patients] and >or=65 yr [302 patients]).

INTERVENTION: Stapedotomy with vein graft interposition and reconstruction with either a Teflon piston, a bucket handle prosthesis, or a total prosthesis.

MAIN OUTCOME MEASURES: Preoperative and postoperative audiometric evaluation using conventional audiometry. Air-bone gap (ABG), bone-conduction thresholds, and air-conduction thresholds were all assessed. Postoperative audiometry was performed at 3, 6, 9, 12, 18, and 24 months and then annually for 14 years.

RESULTS: Overall, the postoperative ABG was closed to 10 dB in 94.2% of cases. The mean four-frequency postoperative ABG was 1.7 dB compared with 25.6 dB preoperatively. The mean four-frequency bone-conduction thresholds were unchanged postoperatively. A significant postoperative sensorineural hearing loss (SNHL; >15 dB) was seen in 0.5% of cases in this series. Postoperative ABG was achieved to within 10 dB in 95% of cases of obliterative otosclerosis and in 64.7% of cases of simultaneous malleus ankylosis. A significant postoperative SNHL (>15 dB) was seen in 4.8% of cases of obliterative otosclerosis and was not observed in any cases of simultaneous malleus ankylosis. Postoperative ABG was achieved to within 10 dB in 93.5% of cases in the pediatric series and in 94.5% of cases in the senior series. A significant postoperative SNHL (>15 dB) was seen in 0.7% of cases in the senior group but was not observed in the children.

CONCLUSION: Using a new otologic database, our series confirms that stapedotomy with vein graft interposition for otosclerotic stapes fixation is a safe and successful treatment for long-term hearing improvement. The deterioration in hearing with time after stapedotomy did not exceed the rate of hearing loss because of presbyacusis. Therefore, argon laser stapedotomy with vein graft interposition is our preferred surgical technique in the treatment of otosclerosis. Obliterative otosclerosis and simultaneous malleus ankylosis may be encountered during stapedotomy. Our study shows that reasonable success rates can still be expected in these situations. Stapedotomy results in the elderly and in children are comparable to those obtained in patients of other groups of age undergoing surgery for otosclerosis without an increased risk for complications.