Objective Investigation of long-term satisfaction and correlation with audiometric measurements after osseointegrated bone-conduction device (OBCD) surgery for patients with single-sided deafness (SSD). Patients Thirty-six patients implanted with an OBCD for SSD. Study Design Retrospective review in a university medical center. Intervention Rehabilitative. The patients were implanted after a test with an OBCD worn on a headband during 15 days in a daily use. The patients were implanted if the test gave us satisfaction. Main Outcome Measures A series of audiometric tests, including speech perception in noise, prosthetic gain, and sound localization measurements, with and without OBCD on headband before surgery and on the transcutaneous implant remote from the surgery. Assessment of benefit and satisfaction using the modified Entific Medical System Questionnaire (EMSQ), the Abbreviated Profile of Hearing Aid Benefit (APHAB), and the Glasgow Benefit Index (GBI). Results The mean follow-up is 2.2 years. Approximately 64% of the patients use their OBCD more than 8 hours per day and 82% more than 4 hours per day. Mean satisfaction score is 7.3/10. The APHAB and GBI show a significant benefit (APHAB ease of communication before and after implantation, +21; GBI total score, +17). These results show an improvement in speech perception in noise with the OBCD, but no differences between the preoperative and postoperative tests. There is no improvement in sound localization. A high level of satisfaction is correlated with good results on the pre operative speech perception in noise. Conclusion The OBCD is an effective way of rehabilitation for SSD. The BAHA improves the speech perception in noise but provided no significant improvement in sound localization as revealed in the postoperative test. With 3 questionnaires we noticed an improvement in the quality of life with the OBCD.
Background: Bevacizumab—a humanized monoclonal antibody—has been widely used to treat patients with hereditary hemorrhagic telangiectasia (HHT), but no randomized trial has yet been conducted.Methods: This study is a double‐blind multicenter randomized phase 2 trial with a 1:1 active‐treatment‐to‐placebo ratio. We included patients over the age of 18 with a confirmed diagnosis and the need for at least four red blood cell (RBC) units transfused in the 3 months before study enrollment. Bevacizumab was administered at a dose of 5 mg/kg every 14 days with a total of six injections. The primary efficacy criterion was a decrease of at least 50% in the cumulative number of RBC units transfused in a 3‐month period before and after treatment.Results: A total of 24 patients (12 in each group) were included and randomized at 4 different centers. In intention‐to‐treat analysis, 63.6% of patients (7/11) in the bevacizumab group versus 33.3% of patients (4/12) in the placebo group decreased the number of blood transfusions by at least 50% (p = 0.22). Hemoglobin levels significantly improved at 6 months in the bevacizumab versus placebo group (p = 0.02). The pharmacokinetics study revealed that patients with high exposure to bevacizumab had a significant decrease in RBC transfusions (p = 0.03). Fifty‐nine adverse events were observed, 34 in the placebo arm versus 25 in the bevacizumab arm.Conclusion: Though the present trial was underpowered, patients with HHT receiving bevacizumab required numerically fewer red blood cell transfusions than those receiving placebo, particularly those with high exposure.
13 February 2018 in Otolaryngology–Head and Neck Surgery