Prospective evaluation of disease-specific quality of life measurements after stapes surgery using Nitinol Head Prostheses.

OBJECTIVES: To analyze health-related quality of life (HRQoL) and audiological results after stapes surgery using a Nitinol Head Prosthesis (NHP). METHODS: Study-Design Prospective longitudinal study. Patients Patients undergoing stapes surgery for otosclerosis and stapes reconstruction with a NHP between January 2018 and December 2018 (n = 48). Intervention Audiological measurements preoperatively and at 6 months follow-up as well as two questionnaires assessing HRQoL, i.e., the Stapes Plasty Outcome Test 25 (SPOT-25) and the Glasgow Benefit Inventory (GBI). Main outcome measures Correlation of pure tone average (4PTA 0.5-3 kHz) with questionnaires assessing HrQOL preoperatively and at follow-up after stapes surgery. RESULTS: Patients showed a significantly reduced air-bone-gap (ABG, 0.5, 1, 2, 3 kHz) at the follow up visit (median: 11.3 dB, IQR 5.0-14.4) compared to the preoperative measurements (median 27.5 dB, IQR 21.9-36.3). Disease-specific HRQoL improved significantly in all scales of the SPOT-25 apart from the subscore "tinnitus". Postoperatively, the subscore "hearing function" correlated well only with the ABG (r = 0.59, p = 0.001). The SPOT-25 and GBI total scores showed a moderate negative correlation (r = - 0.59, p = 0.008). CONCLUSIONS: Stapes surgery leads to significant improvements of hearing and the HRQoL. However, correlations between HRQoL questionnaire scores and the audiometric outcomes were inconclusive, indicating that the use of HRQoL measures for the assessment of stapedotomy outcomes to complement objective outcomes should be encouraged.

Stapes surgery leads to significant improvement in quality of life, independently from the surgical method: evaluation of stapes surgery using different prostheses and different quality of life measurements.

OBJECTIVES: To compare quality-of-life (QoL) measurements with audiological results after stapes surgery with two different prostheses. METHODS: This is a retrospective longitudinal study. All patients required stapes surgery for otosclerosis and ossicular chain reconstruction with either a titanium band prothesis (TBP) or receiving a nitinol head prosthesis (NHP). Intervention was between January 2011 and March 2017 patients received stapes-surgery with either TBP (n = 95) or NHP (n = 50). Audiological measurements at three different time points (preoperatively, early follow up < 3 months, late follow-up > 3 months) were compared and two different QoL-inventories, the Glasgow-Benefit-Inventory (GBI) and the Stapes-Plasty-Outcome-Test-25 (SPOT-25) were investigated postoperatively. The main outcome measures were Pure tone average (PTA) at 0.5, 1, 2, 3 kHz at early and late follow up after stapes surgery were compared and correlated with the subjective benefit on the QoL inventories. The perforation method and the type of surgery were analyzed as potentially influencing factors. RESULTS: All patients showed a significantly reduced air bone gap (ABG 0.5, 1, 2, 3) at the two follow-up visits (visit 2: mean: 13.6 dB, SD 7.7; visit 3: mean: 12.7 dB SD 8.1) compared to preoperative measurements (mean: 28.9 dB, SD 9.9) and subjectively benefitted from stapes surgery (mean GBI score: 21.55; SD 20.60, mean SPOT-25 score: 28.03; SD 18.53). The outcome of the two questionnaires correlated with each other. Neither the hearing-outcome nor the subjective benefit was significantly influenced by the prosthesis, the perforation method or the type of anesthesia. CONCLUSIONS: Both prostheses were safe and led to comparable hearing results as well as to subjective benefits in the Health-related-Quality-of-Life (HrQoL). A combination of the two questionnaires is recommendable for postoperative quality control.