[Balloon dilatation of the Eustachian tube during middle ear surgery : Study planning and first experiences during recruitment]. / Ballondilatation der Tuba auditiva bei Mittelohroperationen : Studienplanung und erste Erfahrungen bei der Rekrutierung.

BACKGROUND: Eustachian tube dysfunction is considered a major contributor to chronic middle ear disease. In clinical case series, the results of balloon dilation (balloon Eustachian tuboplasty, BET) as a treatment for Eustachian tube dysfunction have been reported. OBJECTIVE: This study aims to analyze whether patients undergoing planned surgery for chronic middle ear disease would benefit from additional BET. METHODS: In a randomized controlled, patient and observer (not surgeon)-blind clinical study, 100 adult patients with planned surgery for chronic middle ear disease will be investigated. Patients will be randomized into two groups, one of which (50%) will receive additional BET of the affected side during the planned surgery. Eustachian tube function will be evaluated using the Valsalva maneuver and tubomanometry according to Estève, as well as on the basis of patient reports. Various scores will be used as outcome measures, including ETS-5 (Eustachian Tube Score 5), the extended version ETS-7, and the ETDQ-7 (Seven-Item Eustachian Tube Dysfunction Questionnaire). Follow-up is at 3, 6, and 12 months. RESULTS: From June to December 2015, 162 patients underwent microscopic ear surgery. Inclusion criteria were not fulfilled by 90 patients. Of the remaining 72 patients with chronic middle ear disease, 12 patients (17%) have been randomized so far, 28 (39%) did not exhibit Eustachian tube dysfunction, and 32 (44%) patients could not be included for other reasons. CONCLUSION: The rate of recruitment was lower than expected. Depending on the case number calculations for the patient groups identified in the study for whom BET might be particularly beneficial, multicenter studies in specific disease groups may follow.

[Stapes surgery for otosclerosis using a new titanium prosthesis with a superelastic nitinol clip: First experiences]. / Stapeschirurgie bei Otosklerose mit einer neuen Titanprothese mit superelastischem Nitinol-Clip: Erste Erfahrungen.

BACKGROUND: Coupling of the prosthesis to the long process of the incus is a critical step in stapes surgery. We report first experiences with the NiTiFLEX® stapes prosthesis, a further development of the Soft CliP® stapes prosthesis (Kurz, Dusslingen, Germany). Instead of pure titanium, the CliP® now consists of nitinol, a superelastic nickel-titanium alloy. This further reduces the pressure exerted on the long process of the incus, aiming to improve coupling and minimize the risk of incus luxation. METHODS: In a monocentric, retrospective cohort study, we evaluated air-bone gap reduction (4PTA0.5-4 kHz), understanding of monosyllables at 65 and 80 dB SPL stimulation levels, and adverse effects, such as changes in bone conduction (4PTA0.5-4 kHz). During a 12-month period (May 2014 to April 2015), stapes surgery was performed in 21 otosclerosis patients using the NiTiFLEX® prosthesis. The footplate was perforated using a CO2 laser (scanning mode; 0.7 mm; 20-21 W) in almost all cases. The diameter of the titan piston was 0.4 mm. Immersion at an angle of almost 90° thus results in a gap between the footplate perforation and the piston of 0.15 mm. Positioning onto the long incus process was performed with a 90°microhook (0.6 mm). RESULTS: In all cases the NiTiFLEX® stapes prosthesis was inserted without complications. The mean bone conduction threshold did not change significantly postoperatively and the mean air-bone gap (4PTA0.5-4 kHz) improved on average from 29.0 to 9.5 dB HL. Handling of the prosthesis was rated as very good. CONCLUSION: The limited experience of this study suggests that the NiTiFLEX® stapes prosthesis is a successful further development of the Soft CliP® technique with very good intraoperative handling qualities. While long-term results from larger studies are needed, this case series demonstrates that the hearing outcome is comparable to other prostheses.