Audiometric evaluation after stapedotomy with Fisch titanium prosthesis

Braz J Otorhinolaryngol. 2013;79(3):325-35. DOI: 10.5935/1808-8694.20130058 ORIGINAL ARTICLE BJORL .org Audiometric evaluation after stapedotomy with Fisch titanium prosthesis Andre Luiz de Ataide1, Gerson Linck Bichinho2, Tatiana Mauad Patruni3 Keywords: ossicular replacement; otosclerosis; prostheses and implants; titanium. Abstract O tosclerosis causes the fixation of the stapes and conductive hearing loss, usually corrected with the use of hearing aids or through stapedotomy and the replacement of the involved stapes with a prosthesis. Titanium has been the most recently used material of choice in stapedotomy prostheses. Only two prostheses are commercially available in Brazil. There are no reports in the literature on the Fisch-type Storz titanium stapes piston prosthesis. Objective: This retrospective study aims to look into the auditory outcomes of patients submitted to stapedotomy and titanium stapes piston prosthesis implantation. Method: The criteria described by the American Academy of Otolaryngology were used to compare pre and postoperative air-bone gaps seen in audiometry tests. Results: The mean low-frequency postoperative air-bone gap was 12.9 dB; the mean high-frequency air-bone gap was 5.2 dB (mean 9.1 dB); median gap was 8.8 dB, with a minimum of 1.3 dB and a maximum of 21.6 dB; standard deviation was 5.7 dB, and p < 0.001. Twenty-five (75.8%) patients had air-bone gaps of 10 dB and under; 32 (96.9%) patients had gaps of 20 dB and under; and all patients had gaps of 30 dB and under. Conclusion: The Fisch-type titanium stapes piston prosthesis presented outcomes consistent with the literature and can be used safely in stapedotomy procedures. 2 1 MSc. in Health Technology (Coordinator of the Cochlear Implant Group at the Pequeno Príncipe Hospital). PhD in Biomedical Engineering at the Université de Technologie de Compiègne (Professor in the Health Technology Graduate Program at PUC/PR). 3 Specialist in Otorhinolaryngology (MD, ENT). Send correspondence to: André Luiz de Ataide. Rua Acyr Guimarães, nº 195, apto. 222. Batel. Curitiba - PR. Brazil. CEP: 80240-230. Paper submitted to the BJORL-SGP (Publishing Management System - Brazilian Journal of Otorhinolaryngology) on August 7, 2012; and accepted on February 8, 2013. cod. 9951. Brazilian Journal of Otorhinolaryngology 79 (3) May/June 2013 http://www.bjorl.org / e-mail: 325 INTRODUCTION of many surgeons and has been widely used in the treatment of otosclerosis7. The number of stapedotomy procedures varies significantly between countries, ethnic groups, and levels of access to health care2,6,8. The diseased stapes bone is removed during stapedotomy and is replaced with a piston prosthesis that conveys the sound stimulus from the incus to the footplate of the removed stapes. Since the introduction of the concept of ossicular repair in 1950, many different materials have been used to manufacture prosthetic devices designed to repair the ossicular chain to its original anatomy and physiology and correct cases of conductive hearing loss. The search for the ideal prosthesis is an ongoing process. Autologous materials are often contaminated with prior infection and have limited availability. Homografts and tissue banks with ossicles from patients and cadavers have also been abandoned due to the risk of diseases being transmitted from donor tissue to the receptor9. Since the introduction of Plastipore by Shea in 1976, ear surgeons have been waiting for a definitive solution in the area of alloplastic materials to provide them with biocompatibility, stiffness to convey sound, long-term duration, and minimal difficulty from the standpoint of the surgical technique and skill9. Many materials have been attempted, such as teflon, platinum, gold and titanium. Titanium was first used in ossicular repair in Germany in 1993. Its advantages include significant tensile strength and low weight when compared to ceramics, plastics, and other metals. Titanium biocompatibility has also been alluded to by various authors1,10. Titanium prostheses have been correlated with excellent clinical outcome. Dalchow et al.10 published their extensive experience with more than 700 patients. Zenner (2001) et al. reported gains in frequencies between 2 and 3 KHz provided by the low weight and the stiffness of the titanium device. In addition to the well-documented advantages in biocompatibility and function, titanium prostheses, unlike other metallic prostheses, do not pose hazard when exposed to the high intensity magnetic fields of MRI examination. Only two makes of titanium stapes piston prostheses have been approved by the Brazilian Health Surveillance Authority (ANVISA). The device made by KURZ® has been available for a few years in Brazil and its clinical outcomes and characteristics have been extensively described in the literature4,11,12. Otosclerosis or otospongiosis is a hereditary disease characterized by degeneration of the otic capsule, focal bone neoformation, and increased local vascularization. The main clinical symptom described by patients is hearing loss, followed by tinnitus. This disease affects between 0,5% and 1,0% of the world’s population, and presents bilateral involvement in 70% to 85% of the cases. Prevalence rates are higher among females and subjects in their thirties and forties1. Prevalence varies based on ethnicity. Higher rates are seen among Caucasians, with up to 10% of such population presenting some degree of otosclerosis2. The most frequently affected region of the optic capsule is the area around the oval window and the footplate of the stapes. The disease leads to the fixation of the stapes and consequently compromises the function of the ossicular chain, even when the malleus and the incus are normal. This is why conductive hearing loss is more common in otosclerosis, although mixed or sensorineural cases may also be observed, particularly in cases of extensive disease or cochlear otosclerosis. The malleus and incus are rarely involved3,4. Historically, the first description of stapes fixation to the oval window was based on an autopsy performed by Antonio Valsalva in 1753. The first stapes mobilization surgical correction was performed by Kessekl in 1878. Politzer and Sibenmann condemned the procedure in 1900 and it remained in disbelief until Rosen used it in 1953. But it was John Shea, in 1956, who introduced the stapedectomy procedure and performed the first stapedotomy in 1960. The main goal in the treatment of otosclerosis is to improve patient hearing. This goal can be achieved by fitting patients with hearing aids or through otological microsurgery. Despite the progressive improvements in the technological base and sound quality of hearing aids, surgery must be offered whenever possible as an option to improve hearing, given that most of the involved subjects are young adults, who often resist to the idea of wearing hearing aids, whether it is for cosmetic, social, or cult (...truncated)