Otosclerosis revision surgery in Sweden: hearing outcome, predictive factors and complications.

PURPOSE: To describe the procedures and investigate the hearing outcomes and complications after revision surgery for patients with otosclerosis in Sweden and compare these with previously published reports and to investigate factors that may predict the outcomes of revision surgery. METHODS: A total of 254 patients from the Swedish Quality Register for otosclerosis surgery who underwent surgery at 21 clinics were identified as having undergone revision surgery for otosclerosis from 2003 to 2013. Clinical records and audiograms from each of these patients were collected and analyzed. RESULTS: Improvement in hearing by 20 dB or more and closure of air-bone gap (≤ 20 dB) was achieved in 43% and 69% of patients after a first revision operation and in 46% and 70% of patients after a second revision operation. Most patients who underwent surgery because of dizziness were relieved of their dizziness. Postoperative deafness occurred in 2.3% of patients. Prior successful otosclerosis surgery predicted successful revision surgery, especially after a second revision operation. Fixation of the incus or malleus and finding of no obvious reason for the conductive hearing loss predicted a worse hearing outcome. CONCLUSIONS: The hearing results after revision surgery in Sweden is somewhat inferior to those of previously published results involving large centers. Postoperative deafness may be as much as fivefold more common after revision surgery than after primary surgery. Meticulous reading of previous charts and honest counseling regarding the risks and expectations is mandatory before planning revision surgery for otosclerosis.

Surgical technique in stapedotomy hearing outcome and complications.

OBJECTIVES/HYPOTHESIS: The aim of this study was to investigate different stapes surgery techniques in relation to hearing outcome and risk for complications such as tinnitus, hearing deterioration, dizziness, and taste disturbance. STUDY DESIGN: Retrospective database review. METHODS: The study was based on data from the Swedish Quality Register for Otosclerosis Surgery (SQOS). Two study protocols were completed by the surgeon, and a questionnaire was distributed to each patient 1 year after surgery. A total of 832 patients operated on during 2013 to 2016 were included. Pure-tone audiometry was performed preoperatively and 1 year after surgery. RESULTS: There was no significant difference in postoperative high-frequency hearing thresholds among the subgroups at the 1-year follow-up. The CO2 + drill laser group had the best hearing outcome according to the following criteria: air-bone gap closure ≤10 dB, air-conduction improvement >20 dB, and bone conduction not worsened >5 dB. The overall complication rate was low in all analyzed groups. The most commonly reported symptom after surgery was newly developed or worsened tinnitus (6%). Subjective hearing 1 year after surgery was reported to be better or much better in 91% of the patients. CONCLUSIONS: The combination of a drill and CO2 laser or a drill and potassium-titanyl-phosphate laser resulted in the best hearing outcome in this study from the SQOS. There were no major differences in high-frequency hearing outcome when comparing the different surgical techniques. Complications from surgery were rare, and patient satisfaction was very high 1 year after the operation. LEVEL OF EVIDENCE: NA Laryngoscope, 130:790-796, 2020.

Incus Necrosis and Blood Supply: A Micro-CT and Synchrotron Imaging Study.

BACKGROUND: Incus necrosis is a common complication following stapes surgery and is associated with impaired microcirculation. The objective of this study was to investigate the vascular anatomy of the human incus by using light microscopy, micro-computed tomography (micro-CT), and synchrotron phase-contrast imaging (SR-PCI) for a novel three-dimensional (3D) analysis of the middle ear, mucosal folds, major vascular pathways, and intraosseous vascular bone channels. METHODS: One-hundred-and-fifty temporal bones from the Uppsala collection were analyzed under light microscopy. Twenty temporal bones underwent high-resolution micro-CT scanning, and an additional seven specimens underwent SR-PCI at the Canadian Lightsource in Saskatoon, Canada. One of these specimens was from an individual who had undergone stapes surgery. Data were processed with volume-rendering software to create 3D reconstructions using scalar opacity mapping for bone transparency, cropping, and soft tissue analyses. RESULTS: Micro-CT and SR-PCI with 3D rendering revealed the extensive vascular plexus within the un-decalcified incus bone communicating with the exterior surface. The relationship between the vessels, lenticular process, and incudostapedial joint were clearly observed. SR-PCI allowed for histologic-level detail while preserving the specimen and its 3D relationships. CONCLUSION: SR-PCI with 3D reconstructions confirmed the main vascular supply to the lenticular process along the intraosseous lenticular vessels. This is the first synchrotron analysis of a patient having undergone stapes surgery, and it suggests that incus necrosis associated with stapes surgery may be caused by a disruption of the lenticular blood flow induced by the prosthesis loop, and not by strangulation of mucosal vessels as has been previously described.

Special Anatomic Considerations in Otosclerosis Surgery.

The anatomy of the vestibular organs together with considerations of the middle and inner ear anatomy relevant to stapes surgery is discussed. An archival collection of macerated and freshly frozen human temporal bones underwent micro-computed tomography (CT) with subsequent volume-rendering. Three-dimensional (3D) reconstructions and the topographic anatomy of the oval window were considered. Micro-CT and 3D rendering revealed the relationship between the otolith organs and the oval window. Anatomic variations were extensive and included the distance between the footplate and the reconstructed macula margins. A "no-go" zone is suggested for the surgeon to avoid injury during stapes surgery.

Stapes surgery in Sweden: evaluation of a national-based register.

The aim of the National Quality Registries is to monitor the outcome of healthcare given to patients. The Swedish Quality register for otosclerosis surgery is one of the nine official national registers for ear, nose and throat diseases in Sweden. Since 2004, surgical and audiological results and patient satisfaction scores have been systematically collected from a majority of the ear, nose and throat clinics performing stapes surgery in Sweden. The results of 1688 patients who underwent primary operations for otosclerosis were evaluated for 24 out of totally 26 clinics performing stapes surgery, between 2004 and 2010. The most common surgical technique reported was stapedotomy accomplished in an overnight stay. A majority of patients experienced improved hearing, and were satisfied with the preoperative counselling. Successful surgery, defined as an ABG closure ≤10 dB HL, was achieved in 69%, improvement in AC by ≥20 dB in 63% and BC not worsened by more than ≥5 dB in 93% of the patients. An overall low incidence of postoperative complications was reported. The outcome for ABG and BC was demonstrated to be independent of the number of operations performed by each clinic. An evaluation of the register and the results from the SQOS revealed that stapes surgery is a safe procedure with good hearing outcomes, low complication rates and a high rate of patient's satisfaction on a national level.

Taste disturbance after stapes surgery: an evaluation of frequency, severity, duration, and quality-of-life.

CONCLUSION: The incidence of taste disturbance after stapes surgery is high (61.9%), whereas the majority (94.8%) recovers within 1 year. More severe surgical nerve trauma caused more disturbance, implying that the nerve should be handled carefully during surgery. OBJECTIVES: Patients operated on for otosclerosis seem more often to complain about post-operative taste disturbance than those operated on for chronic otitis media, although the chorda tympani nerve more seldom becomes maltreated in stapedotomy. These observations seem paradoxical. It is unclear to what extent a post-operative taste disturbance affects the quality-of-life. This study aims to shed light on the occurrence of post-operative taste disturbances, on possible prognostic factors, and to what extent post-operative taste disturbance impairs the quality-of-life. METHODS: One hundred and thirty-four adults undergoing primary stapedotomy were included. Questionnaires on taste disturbance and quality-of-life (SF-36) were answered before and after surgery, until 1 year post-operatively. RESULTS: Eighty-three (61.9%) study persons reported post-operative taste disturbance. Seven (5.2%) reported persisting disturbance at 1 year. Surgically more traumatized chorda tympani nerves correlated with more severe taste disturbance post-operatively than less traumatized. Taste disturbance at 1 year post-operatively correlate with a decrease of the physical function domain in the SF-36.

High-frequency hearing, tinnitus, and patient satisfaction with stapedotomy: A randomized prospective study.

Otosclerosis is a common disorder that leads to conductive hearing loss. Most patients with otosclerosis also have tinnitus, and surgical treatment is known to improve hearing as well as tinnitus. Some patients however experience worsening of tinnitus after the operation, but there are no known factors that allow surgeons to predict who will be at risk. In this prospective observational study on 133 patients undergoing stapedotomy, we show that postoperative air conduction thresholds at very high stimulus frequencies predict improvement of tinnitus, as assessed with proportional odds logistic regression models. Young patients were significantly more likely to experience reduction of tinnitus and patients whose tinnitus became better were also more satisfied with the outcome of the operation. These findings have practical importance for patients and their surgeons. Young patients can be advised that surgery is likely to be beneficial for their tinnitus, but a less positive message should be conveyed to older patients.

A randomised, double blind trial of N-Acetylcysteine for hearing protection during stapes surgery.

BACKGROUND: Otosclerosis is a disorder that impairs middle ear function, leading to conductive hearing loss. Surgical treatment results in large improvement of hearing at low sound frequencies, but high-frequency hearing often suffers. A likely reason for this is that inner ear sensory cells are damaged by surgical trauma and loud sounds generated during the operation. Animal studies have shown that antioxidants such as N-Acetylcysteine can protect the inner ear from noise, surgical trauma, and some ototoxic substances, but it is not known if this works in humans. This trial was performed to determine whether antioxidants improve surgical results at high frequencies. METHODS: We performed a randomized, double-blind and placebo-controlled parallel group clinical trial at three Swedish university clinics. Using block-stratified randomization, 156 adult patients undergoing stapedotomy were assigned to intravenous N-Acetylcysteine (150 mg/kg body weight) or matching placebo (1:1 ratio), starting one hour before surgery. The primary outcome was the hearing threshold at 6 and 8 kHz; secondary outcomes included the severity of tinnitus and vertigo. FINDINGS: One year after surgery, high-frequency hearing had improved 2.7 ± 3.8 dB in the placebo group (67 patients analysed) and 2.4 ± 3.7 dB in the treated group (72 patients; means ± 95% confidence interval, p = 0.54; linear mixed model). Surgery improved tinnitus, but there was no significant intergroup difference. Post-operative balance disturbance was common but improved during the first year, without significant difference between groups. Four patients receiving N-Acetylcysteine experienced mild side effects such as nausea and vomiting. CONCLUSIONS: N-Acetylcysteine has no effect on hearing thresholds, tinnitus, or balance disturbance after stapedotomy. TRIAL REGISTRATION: ClinicalTrials.gov NCT00525551.

Surgical treatment of congenital aural atresia - is it still justified?

CONCLUSION: Surgery candidacy based on the surgical accessibility of the middle ear seems more valuable than the use of a preoperative grading system. Also patients with severe malformations can benefit from surgical reconstruction. OBJECTIVE: To evaluate the long-term results of the primary surgical treatment of patients with congenital auricular atresia (CAA). METHODS: One hundred patients with CAA underwent surgical reconstruction between 1985 and 2010. The mean follow-up time was 40 months. All patients were retrospectively scored using the Jahrsdoerfer grading scale and divided into two groups according to the grade of their malformation. Group 1 included 20 patients with scores of 4-6 and group 2 included 80 patients with scores of 7-10. Pre- and postoperative air conduction (AC), bone conduction (BC), pure-tone average 'air-bone gap' (PTA4-ABG), surgical findings, postoperative complications, and revision surgeries performed were determined and compared between the two groups. RESULTS: For 90% of the patients in group 1 and 79% of the patients in group 2, the postoperative ABG was within 0 and 30 dB. The most common complications were recurrent infection, lateralization of the tympanic membrane, and restenosis of the ear canal.

Evaluation of cost-utility in middle ear implantation in the 'Nordic School': a multicenter study in Sweden and Norway.

CONCLUSION: Hearing restoration using an active middle ear implant (AMEI) is a highly cost-effective treatment for a selected group of patients with no other possibilities for auditory rehabilitation. OBJECTIVES: To evaluate the cost-utility of using an AMEI for hearing rehabilitation. METHODS: This was a prospective, multicenter, single-subject repeated study in six tertiary referral centers. Twenty-four patients with sensorineural (SNHL), conductive (CHL), and mixed hearing loss (MHL) were implanted with the AMEI Vibrant Soundbridge® (VSB) for medical reasons. All patients were previously rehabilitated with conventional hearing aids. Multiple validated quality of life patient questionnaires, Health Utilities Index (HUI 2 and 3), and Glasgow Hearing Aid Benefit Profile (GHABP) were used to determine the utility gain and quality adjusted life years (QALY). Directly related treatment costs for the implantation were calculated and related to utility gain and QALY. RESULTS: The cost/QALY for patients with SNHL was estimated at €7260/QALY, and for patients with C/MHL at €12 503/QALY.

Non-echo planar diffusion-weighted MRI increases follow-up accuracy after one-step step canal wall-down obliteration surgery for cholesteatoma.

CONCLUSION: Non-echo planar (non-EPI) diffusion-weighted (DW) magnetic resonance imaging (MRI) increases the number of detected cholesteatoma after one-step canal wall-down (CWD) obliteration surgery for cholesteatoma compared with clinical evaluation alone. OBJECTIVE: To evaluate the use of DW-MRI for detection of cholesteatoma after surgical treatment using a CWD obliteration technique. METHODS: Thirty-eight adult patients (41 ears) treated with an identical one-step CWD obliteration surgical technique were included in a prospective and blinded study. All patients were investigated with non-EPI and EPI DW-MRI 1-9 months after the clinical examination. Follow-up time after primary surgery varied between 10 and 234 months. DW-MRI was assessed by two neuroradiologists and compared with clinical results. Inter-rater agreement was calculated. Positive non-EPI DW-MRI cases underwent revision surgery within 18-159 days after imaging. RESULTS: Seven of 41 cases were evaluated as positive for cholesteatoma on non-EPI DW-MRI. Since one patient refused surgery six of these seven cases underwent surgical revision and all were verified. There was agreement between clinical and non-EPI findings in five of eight cases. EPI findings correlated poorly with non-EPI and clinical findings. Inter-rater agreement (Cohen's kappa) was 0.91 for non-EPI DW-MRI (p < 0.001) and -0.062 for EPI DW-MRI (p = 0.43).

Surgical treatment of adult cholesteatoma: long-term follow-up using total reconstruction procedure without staging.

CONCLUSIONS: A total of 330 cases of adult cholesteatoma were operated with canal-wall down (CWD) and total reconstruction procedure (TRP) without staging. Independent of preoperative middle ear conditions, cholesteatoma extent and localization, long-term improvement of hearing with a low incidence of residual and recurrent disease were achieved. OBJECTIVES: To evaluate long-term surgical and hearing results using a well-defined surgical technique without staging in adult cholesteatoma. METHODS: The same CWD surgical technique, including obliteration of the mastoid cavity, reconstruction of the canal wall, and ossiculoplasty with autologous bone, was used by three senior surgeons (1982-2004). Preoperative and postoperative pure tone average (PTA) for air conduction (AC), bone conduction (BC), and air-bone gap (ABG) were assessed and compared 1, 3, and 6 years after surgery. Various prognostic factors with potential influence on long-term hearing outcome were evaluated. RESULTS: Recurrence of AC occurred in 10%, residual disease in 3%. Six years after surgery all patients except one had a dry ear and over 92% of all cases were water resistant. Three patients developed complete deafness. Long-lasting improvement and/or preservation of hearing, with maintenance of PTA-ABG closure in 68% of all cases within 20 dB, were obtained. Sixty-four (19%) ossicular revisions were performed.

High frequency hearing following stapes surgery.

CONCLUSION: Our results indicate that a pre-existing sensorineural hearing loss (SNHL) is not a potential risk factor for further hearing loss in stapes surgery. OBJECTIVE: The study evaluated whether pre-existing SNHL in otosclerosis constitutes a risk factor for further hearing loss in stapedotomy. METHODS: Preoperative and postoperative audiometric evaluation including air (AC) and bone conduction (BC) hearing levels were assessed together with collection of surgical records from 338 consecutively operated cases for primary otosclerosis using a database. Patients were operated by the same surgeon between 2000 and 2006. In all, 291 patients were operated on 1 side and 47 patients were operated on both sides. Ages ranged from 16 to 76 years. Stapedotomy was performed in all cases except five (stapedectomy). Cases were separated into four different groups based on preoperative AC hearing levels at 4, 6, and 8 kHz: group I, <30 dB HL; group II, 30-50 dB HL; group III, 51-70 dB HL; group IV, >70 dB HL). RESULTS: Hearing deterioration at 4, 6, and 8 kHz (>10 dB) was observed in 6.5% of all cases. Patients with normal preoperative hearing were found to be more prone to further SNHL 4, 6, and 8 kHz (range 13-25 dB) at surgery, while patients in group IV, with preoperative SNHL impairment, remained unaffected.

Surgical treatment of paediatric cholesteatoma: long-term follow up in comparison with adults.

OBJECTIVE: This study was designed to analyse long-term results after surgery of acquired (ACH) and congenital cholesteatoma (CCH) of the middle ear in children and compare these with adults. METHODS: Computer-based analysis of consecutively operated paediatric patients for ACH and CCH in a tertiary referral centre was made in 57 cases under the age of 12 operated 1983-2004 by three surgeons using identical technique. A canal wall down and total reconstruction procedure (TRP) with obliteration of the mastoid cavity, canal wall reconstruction, ossiculoplasty with consistent use of autologous bone and an "aeration enhancement procedure" (AEP) with silicon sheet in selected cases were used. Pre- and post-operative PTA (0.5-3 kHz) and pure-tone average air-bone gap (PTA-ABG) together with surgical parameters were assessed 1, 3 and 6 years following surgery. RESULTS: Results showed stable hearing over 6 years with low incidence of persistent and recurrent disease comparable with results from adult patients. In nearly half of the cases, silastic sheeting was used. In 21 cases, stapes was eroded. Bone conduction thresholds levels remained unaffected 6 years after surgery. No deaf ears, postoperative facial dysfunction or other lesions related to surgery were observed. Six years after surgery every evaluated ear was found to be water-resistant and infection -free. CONCLUSION: Our results suggest that one-stage eradication of ACH and CCH in children using total reconstruction procedure (TRP) provide long-term improvement or preservation of hearing, with a low incidence of persistent or recurrent disease. No difference in surgical outcome between children and adults was found.