Background The purpose of this study was to investigate the efficacy of bevacizumab (“Avastin”) for the treatment of epistaxis in hereditary hemorrhagic telangiectasia (HHT). Methods In this double blind, placebo controlled trial, 15 adult patients with HHT with a minimum of 2 epistaxis episodes per week were randomized. A history of thromboembolic events or recent or planned surgery led to exclusion. Patients received a single intranasal submucosal injection (10 mL) of 100 mg bevacizumab or placebo. The primary outcome was the relative reduction of average daily epistaxis visual analog score (VAS). Results Average daily posttreatment VAS scores decreased by 27% in the bevacizumab group and by 3% in the placebo group (p = .57). The reduction in HHT epistaxis severity scores was ‐0.61 greater in the bevacizumab group compared to the placebo group (p = .34). Conclusion Results show a trend toward reduced epistaxis with bevacizumab. This further supports the use of bevacizumab in HHT. Clincial Trials. gov number: NCT01314274 © 2014 Wiley Periodicals, Inc. Head Neck 37: 783–787, 2015
Speech and music test scores improved statistically significantly after conversion from CIS to FSP strategy. Twelve of 14 patients preferred the new FSP speech processing strategy over the CIS strategy.
Objective To assess the audiological and long‐term medical and technical follow‐up outcomes of an active middle ear implant. Methods This was a retrospective medical chart analysis of all patients provided with an active middle ear implant in a tertiary academic medical referral center between September 1, 1998, and July 31, 2015. Main outcome measures were medical and technical complications, revisions, reimplantations, explantations, coupling approaches, mean time of use, pre‐ and postoperative hearing thresholds, functional hearing gain across frequencies (250–4,000 Hz), and Freiburg monosyllablic word test at 65 dB. Results One hundred and three patients were identified. Fifteen were implanted bilaterally (n = 118 Vibrant Soundbridge devices [MED‐EL, Innsbruck, Austria]). Seventy‐seven devices were implanted for sensorineural and 41 for mixed and conductive hearing loss. Patients used the implant for 6.7 years (range 0.7 months–17.9 years) on average. Ninety‐one patients (77.12%) were using the device at the end of the observation period. An overall complication rate of 16.1% was observed. The revision and explantation rates were higher for devices implanted between 2004 and 2006. The device failure rate was 3.4%. Audiological evaluation showed significant hearing gains for both hearing loss patient groups. Conclusion This long‐term follow‐up reveals the reliability of the active middle ear implant in a single center. Overall complication rate and device failure rate are acceptable. The complication rate was higher during implementation of alternative coupling approaches. The audiological benefit was satisfactory in patients with all hearing loss types. The majority of implanted patients used the implant at the end of the observation period. Level of Evidence 4 Laryngoscope , 129:477–481, 2019
Bone-conduction implants are a standard therapeutic option for patients with conductive, unilateral, or mixed hearing loss who either do not tolerate conventional hearing aids or can benefit from surgery. The aim of this study was to evaluate long-term medical and technical outcomes, and audiological results with the Bonebridge transcutaneous bone-conduction implant. This retrospective study included all patients implanted with a bone-conduction hearing implant at a tertiary medical referral center between March 2012 and October 2018. Medical and technical outcomes included the mean length of implant usage, medical and technical complications (skin and wound infection, lack of benefit, technical failure), explantations and revisions, coupling approaches, implant failure rate, implant survival and the implant loss for added follow-up years. Auditory results were measured by functional hearing gain and the Freiburger monosyllabic test at 65 dB sound pressure level. Sixty-four patients were included in the study; five of these were implanted bilaterally (69 devices). Five unilaterally implanted patients were lost to follow-up. The mean follow-up was 27.1 months (range: 0.2 months–6.3 years). The mean implant usage was 25.9 months (range: 0.2 months–6.3 years). Fifty-seven implants (89.1%) were in use at the end of the follow-up period. Complications occurred in six ears (9.4%). Five implants (7.8%) were explanted without reimplantation. Device failure occurred in one implant (1.6%), which was possibly caused by recurrent head trauma. The rate of implant loss due to technical device failure (damage to device) was 1 per 72 follow-up years. The mean improvement on the Freiburger monosyllabic test (52.1%, p = 0.0001), and in functional hearing gain across frequencies (26.5 dB, p = 0.0001) was significant. This single-center follow-up reveals the medical and technical reliability of a transcutaneous bone-conduction implant for hearing rehabilitation because complication and revision rates were low. The majority of patients still used the device at the end of the observation period. Implantation resulted in favorable hearing outcomes in comparison to that of unaided conditions. Cautious patient selection mainly regarding co-morbidities, the history of chronic otologic diseases and proper surgical technique seems to be crucial in reducing complications.
Mean speech perception scores showed a trend towards improvement for all tests. A statistically significant (p < 0.05) improvement was only observed for the sentence test in noise at 10 dB SNR.
It has been shown that glucocorticoids reduce the hearing threshold shifts associated with cochlear implantation. Previous studies evaluated the administration of glucocorticoids immediately before surgery or the repeated pre- or perioperative systemic application of glucocorticoids. The aim of this study was to evaluate the effects of a sustained release dexamethasone hydrogel in hearing preservation cochlear implantation. To address this issue, a guinea pig model of cochlear implantation was used. 30 normal hearing pigmented guinea pigs were randomized into a group receiving a single dose of a dexamethasone/poloxamer407 hydrogel one day prior to surgery, a second group receiving the hydrogel seven days prior to surgery and a control group. A silicone cochlear implant electrode designed for the use in guinea pigs was inserted to a depth of 5 mm through a cochleostomy. Compound action potentials of the auditory nerve (frequency range 0.5-32 kHz) were measured preoperatively, directly postoperatively and on postoperative days 3, 7, 14, 21 and 28. Following the last audiometry, temporal bones were harvested and histologically evaluated. Dexamethasone hydrogel application one day prior to surgery resulted in significantly reduced hearing threshold shifts at low, middle and high frequencies measured at postoperative day 28 (p < 0.05). Application of the hydrogel seven days prior to surgery did not show such an effect. Dexamethasone application one day prior to surgery resulted in increased outer hair cell counts in the cochlear apex and in reduced spiral ganglion cell counts in the basal and middle turn of the cochlea, a finding that was associated with a higher rate of electrode translocation in this group. In this study, we were able to demonstrate functional benefits of a single preoperative intratympanic application of a sustained release dexamethasone hydrogel in a guinea pig model of cochlear implantation.
Objective: The aim of the study was to evaluate the predictive value regarding postoperative hearing benefit of electrically evoked auditory brainstem response audiometry in sporadic vestibular schwannoma patients undergoing simultaneous tumor resection and cochlear implantation. Design: Patients were included in a prospective study conducted between October 2016 and January 2019. Setting: The study was conducted at a tertiary care center. Participants: Subjects with unilateral sporadic vestibular schwannoma were screened for study participation. Patients underwent translabyrinthine vestibular schwannoma resection and cochlear implantation simultaneously. Intervention: Electrically evoked brainstem response audiometry was performed during surgery before and after tumor removal using an intracochlear test electrode to objectively evaluate nerve conduction. Main Outcome Measure: Electrically evoked brainstem response audiometry results were correlated with postoperative sound field audiometry, word recognition tests, and speech reception thresholds. Quality of life was assessed before and 12 months after translabyrinthine tumor removal and cochlear implantation. Results: Five patients, three male and two female, were included in the study and followed for at least 1 year after implantation. Three of the five patients are daily cochlear implant users with open set speech recognition. Two individuals with negative intraoperative electrically evoked auditory brainstem response results showed no auditory perception with cochlear implant. Conclusions: Simultaneous translabyrinthine vestibular schwannoma resection and cochlear implantation with intraoperative electrically evoked auditory brainstem response measurements is a feasible and promising option for sporadic vestibular schwannoma patients. Preservation of electrically evoked auditory brainstem responses seems to predict good subsequent hearing outcomes.
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