Feasibility of 3D-printed middle ear prostheses in partial ossicular chain reconstruction.

Despite advances in prosthesis materials, operating microscopes and surgical techniques during the last 50 years, long-lasting hearing improvement remains a challenge in ossicular chain reconstruction. Failures in the reconstruction are mainly due to inadequate length or shape of the prosthesis, or defects in the surgical procedure. 3D-printed middle ear prosthesis might offer a solution to individualize treatment and obtain better results. The aim of the study was to study the possibilities and limitations of 3D-printed middle ear prostheses. Design of the 3D-printed prosthesis was inspired by a commercial titanium partial ossicular replacement prosthesis. 3D models of different lengths (1.5-3.0 mm) were created with Solidworks 2019-2021 software. The prostheses were 3D-printed with vat photopolymerization using liquid photopolymer Clear V4. Accuracy and reproducibility of 3D printing were evaluated with micro-CT imaging. The acoustical performance of the prostheses was determined in cadaver temporal bones with laser Doppler vibrometry. In this paper, we present an outline of individualized middle ear prosthesis manufacturing. 3D printing accuracy was excellent when comparing dimensions of the 3D-printed prostheses and their 3D models. Reproducibility of 3D printing was good if the diameter of the prosthesis shaft was 0.6 mm. 3D-printed partial ossicular replacement prostheses were easy to manipulate during surgery even though they were a bit stiffer and less flexible than conventional titanium prostheses. Their acoustical performance was similar to that of a commercial titanium partial ossicular replacement prosthesis. It is possible to 3D print functional individualized middle ear prostheses made of liquid photopolymer with good accuracy and reproducibility. These prostheses are currently suitable for otosurgical training. Further research is needed to explore their usability in a clinical setting. In the future, 3D printing of individualized middle ear prostheses may provide better audiological outcomes for patients.

Assessment of subjective image quality, contrast to noise ratio and modulation transfer function in the middle ear using a novel full body cone beam computed tomography device.

BACKGROUND: Multi slice computed tomography (MSCT) is the most common used method in middle ear imaging. However, MSCT lacks the ability to distinguish the ossicular chain microstructures in detail resulting in poorer diagnostic outcomes. Novel cone beam computed tomography (CBCT) devices' image resolution is, on the other hand, better than MSCT resolution. The aim of this study was to optimize imaging parameters of a novel full body CBCT device to obtain optimal contrast to noise ratio (CNR) with low effective dose, and to optimize its clinical usability. METHODS: Imaging of five anonymous excised human cadaver temporal bones, the acquisition of the effective doses and the CNR measurements were performed for images acquired on using Planmed XFI® full body CBCT device (Planmed Oy, Helsinki, Finland) with a voxel size of 75 µm. All images acquired from the specimens using 10 different imaging protocols varying from their tube current exposure time product (mAs) and tube voltage (kVp) were analyzed for eight anatomical landmarks and evaluated by three evaluators. RESULTS: With the exception of protocol with 90 kVp 100 mAs, all other protocols used are competent to image the finest structures. With a moderate effective dose (86.5 µSv), protocol with 90 kV 450 mAs was chosen the best protocol used in this study. A significant correlation between CNR and clinical image quality of the protocols was observed in linear regression model. Using the optimized imaging parameters, we were able to distinguish even the most delicate middle ear structures in 2D images and produce accurate 3D reconstructions. CONCLUSIONS: In this ex vivo experiment, the new Planmed XFI® full body CBCT device produced excellent 2D resolution and easily created 3D reconstructions in middle ear imaging with moderate effective doses. This device would be suitable for middle ear diagnostics and for e.g., preoperative planning. Furthermore, the results of this study can be used to optimize the effective dose by selecting appropriate exposure parameters depending on the diagnostic task.

Hearing impairment in Angolan children with acute bacterial meningitis with and without otitis media.

AIM: Bacterial meningitis (BM) is a common cause of hearing loss in childhood. Our aim was to investigate bacterial aetiology, hearing impairment and outcome in childhood BM with vs. without otitis media (OM) in Angola. METHODS: Hearing was tested by auditory brainstem response in 391 (76%) children with confirmed BM. The bacteria identified from the ear discharge were compared to those from cerebrospinal fluid (CSF). The hearing findings were compared among children with vs. without OM on days 1 and 7 of hospitalization, and at follow-ups of 1, 3 and 6 month(s). RESULTS: No correlation was found in bacteriology between the ear discharge and CSF. On day 7 in hospital, hearing impairment (>40 dB) was common, regardless of whether concomitant OM or not (in 27% vs. 30%, respectively). Any hearing deficit on day 7 was associated with a higher risk of complicated or fatal clinical course (OR 2.76, CI95% 1.43-5.29, p = 0.002). CONCLUSION: No significant difference prevailed in hearing thresholds between children with or without OM in hospital on day 7 or at later follow-ups. Any hearing impairment during hospital stay associated with a higher risk for complicated clinical course or death.

Spoken Language Skills in Children With Bilateral Hearing Aids or Bilateral Cochlear Implants at the Age of Three Years.

OBJECTIVES: Early hearing aid (HA) fitting and cochlear implants (CIs) aim to reduce the effects of hearing loss (HL) on spoken language development. The goals of this study were (1) to examine spoken language skills of children with bilateral HAs and children with bilateral CIs; (2) to compare their language skills to the age-norms of peers with normal hearing (NH); and (3) to investigate factors associated with spoken language outcomes. DESIGN: Spoken language results of 56 Finnish children with HL were obtained from a nationwide prospective multicenter study. Children with HL comprised two groups: children with mild-to-severe HL who used bilateral HAs (BiHA group, n = 28) and children with profound HL who used bilateral CIs (BiCI group, n = 28). Children's spoken language comprehension, expressive and receptive vocabulary, and phonological skills were compared with normative values of children with NH at the age of three years. Odds ratio (OR) was calculated to compare proportions of children below age-norms in BiHA and BiCI groups. Factors associated with spoken language outcomes were modeled with analysis of covariance. RESULTS: At the age of 3 years, 50%-96% of children with HL performed 1 SD or more below the mean of the normative sample of age-peers with NH in spoken language skills, depending on the language domain. Receptive vocabulary and phonological skills were the most vulnerable language domains. In receptive vocabulary, 82% of the children in the BiHA group and 50% of the children in the BiCI group scored 1 SD or more below the normative mean. The BiHA group was 4.4 times more likely to have poorer receptive vocabulary than the BiCI group. In phonological skills, 96% of children in the BiHA group and 60% of the children in the BiCI group scored 1 SD or more below the normative mean. The BiHA group was 18.0 times more likely to have poorer phonological skills than the BiCI group. The analysis of covariance models showed that unaided pure-tone average, PTA0.5-4 kHz, had a significant effect on spoken language comprehension in the BiHA group. For the BiCI group, age at HL diagnosis and age at CI activation had a significant effect on expressive vocabulary. High maternal level of education had a significant effect on language comprehension and expressive vocabulary and female gender on phonological skills. CONCLUSIONS: At the age of 3 years, especially receptive vocabulary and phonological skills caused difficulties for children with HL showing also considerable individual variation. Children with bilateral HAs seemed to be more likely to have poorer receptive vocabulary and phonological skills than children with bilateral CIs. A variety of factors was associated with outcomes in both groups. Close monitoring of spoken language skills of children with HL is important for ensuring similar opportunities for all children with HL and timely intervention, when needed.

MANF supports the inner hair cell synapse and the outer hair cell stereocilia bundle in the cochlea.

Failure in the structural maintenance of the hair cell stereocilia bundle and ribbon synapse causes hearing loss. Here, we have studied how ER stress elicits hair cell pathology, using mouse models with inactivation of Manf (mesencephalic astrocyte-derived neurotrophic factor), encoding an ER-homeostasis-promoting protein. From hearing onset, Manf deficiency caused disarray of the outer hair cell stereocilia bundle and reduced cochlear sound amplification capability throughout the tonotopic axis. In high-frequency outer hair cells, the pathology ended in molecular changes in the stereocilia taper region and in strong stereocilia fusion. In high-frequency inner hair cells, Manf deficiency degraded ribbon synapses. The altered phenotype strongly depended on the mouse genetic background. Altogether, the failure in the ER homeostasis maintenance induced early-onset stereociliopathy and synaptopathy and accelerated the effect of genetic causes driving age-related hearing loss. Correspondingly, MANF mutation in a human patient induced severe sensorineural hearing loss from a young age onward. Thus, we present MANF as a novel protein and ER stress as a mechanism that regulate auditory hair cell maintenance in both mice and humans.

Evaluation of pure-tone audiometric protocols in vestibular schwannoma screening.

The objective was to evaluate the pure-tone audiogram-based screening protocols in VS diagnostics. We retrospectively analyzed presenting symptoms, pure tone audiometry and MRI finding from 246 VS patients and 442 controls were collected to test screening protocols (AAO-HNS, AMCLASS-A/B, Charing Cross, Cueva, DOH, Nashville, Oxford, Rule3000, Schlauch, Seattle, Sunderland) for sensitivity and specificity. Results were pooled with data from five other studies, and analysis of sensitivity, specificity and positive likelihood ratio (LR+) for each protocol was performed. Our results show that protocols with significantly higher sensitivity (AMCLASS-A/B, Nashville) show also significantly lowest specificity, and tend to have low association (positive likelihood ratio, LR+) to the VS. The highest LR+ was found for protocols AAO-HNS, Rule3000 and Seattle. In conclusions, knowing their properties, screening protocols are simple decision-making tools in VS diagnostic. To use the advantage of the highest sensitivity, protocols AMCLASS-A + B or Nashville can be of choice. For more reasonable approach, applying the protocols with high LR+ (AAO-HNS, Rule3000, Seattle) may reduce the overall number of MRI scans at expense of only few primarily undiagnosed VS.

Development of otology specific outcome measure: Ear Outcome Survey-16 (EOS-16).

PURPOSE: An important outcome measure of patient care is the impact on the patient's health-related quality of life (HRQoL). Current ear-specific HRQoL instruments are designed for one diagnosis and emphasize different subdivisions such as symptoms, hearing problems, psychosocial impact, and the need for care. The optimal length of the recall period has not been studied. For these reasons, a new survey is needed that would cover most chronic ear diseases. METHODS: A preliminary 24-item survey (EOS-24) was created. Untreated adult patients (included n = 186) with one of seven different chronic otologic conditions from all university hospitals in Finland were recruited to respond to EOS-24 and the 15D general HRQoL instrument. The recruiting otologists evaluated the severity of the disease and the disability caused by it. A control group was recruited. Based on the patients' responses in different diagnosis groups, the items were reduced according to pre-defined criteria. The resulting survey was validated using a thorough statistical analysis. RESULTS: The relevance and necessity of the original 24 items were thoroughly investigated, leading to the exclusion of 8 items and the modification of 1. The remaining 16 items were well-balanced between subdivisions and were useful in all seven diagnosis groups, thus constituting the final instrument, EOS-16. The most suitable recall period was three months. CONCLUSIONS: EOS-16 has been created according to the HRQoL survey guidelines with a versatile nationwide patient population. The survey has been validated and can be used for a wide range of chronic ear diseases as a HRQoL instrument.

Improvements in Hearing and in Quality of Life after Sequential Bilateral Cochlear Implantation in a Consecutive Sample of Adult Patients with Severe-to-Profound Hearing Loss.

Bilateral cochlear implantation is increasing worldwide. In adults, bilateral cochlear implants (BICI) are often performed sequentially with a time delay between the first (CI1) and the second (CI2) implant. The benefits of BICI have been reported for well over a decade. This study aimed at investigating these benefits for a consecutive sample of adult patients. Improvements in speech-in-noise recognition after CI2 were followed up longitudinally for 12 months with the internationally comparable Finnish matrix sentence test. The test scores were statistically significantly better for BICI than for either CI alone in all assessments during the 12-month period. At the end of the follow-up period, the bilateral benefit for co-located speech and noise was 1.4 dB over CI1 and 1.7 dB over CI2, and when the noise was moved from the front to 90 degrees on the side, spatial release from masking amounted to an improvement of 2.5 dB in signal-to-noise ratio. To assess subjective improvements in hearing and in quality of life, two questionnaires were used. Both questionnaires revealed statistically significant improvements due to CI2 and BICI. The association between speech recognition in noise and background factors (duration of hearing loss/deafness, time between implants) or subjective improvements was markedly smaller than what has been previously reported on sequential BICI in adults. Despite the relatively heterogeneous sample, BICI improved hearing and quality of life.

Low inter-rater consistency in semantic profiles of tinnitus-like sounds rated by tinnitus patients.

Characterizations of the tinnitus sound percept are always based on a subjective description by the person affected. Since the experimenter cannot have access to the tinnitus percept, it is not possible to verify whether individuals use the adjectives describing the sound in the expected way, i.e., whether a label given to the tinnitus percept corresponds to the label that the experimenter or another individual would give to the same sound percept. However, if it is assumed that tinnitus patients can reliably describe their own tinnitus, then they should also be able to reliably describe tinnitus-like sounds, presented acoustically. In this study, 26 tinnitus patients used a tablet computer to rate 18 pre-defined adjectives on their level of descriptiveness for their own tinnitus percept as well as 17 tinnitus-like sounds presented via headphones. The main interest of the current study was to calculate intraclass correlation (ICC) and Krippendorff's alpha coefficients for the rating profiles of the acoustically-presented sounds, in order to quantify how well the individuals agreed on the ratings of known sounds, i.e., whether the adjectives would receive similar ratings from all participants for a specific tinnitus-like sound. The results show that the level of agreement was low for all adjectives and sounds, meaning that the different individuals did not use the adjectives in a consistent manner. The conclusion is that subjective tinnitus descriptions should be interpreted with great caution, and that the inherent variability involved in the characterization of sounds by naïve listeners can contribute to the observed heterogeneity in tinnitus symptoms and treatment outcomes.

An exploratory investigation of speech recognition thresholds in noise with auralisations of two reverberant rooms.

OBJECTIVE: Speech-in-noise tests are widely used in hearing diagnostics but typically without reverberation, although reverberation is an inextricable part of everyday listening conditions. To support the development of more real-life-like test paradigms, the objective of this study was to explore how spatially reproduced reverberation affects speech recognition thresholds in normal-hearing and hearing-impaired listeners. DESIGN: Thresholds were measured with a Finnish speech-in-noise test without reverberation and with two test conditions with reverberation times of ∼0.9 and 1.8 s. Reverberant conditions were produced with a multichannel auralisation technique not used before in this context. STUDY SAMPLE: Thirty-four normal-hearing and 14 hearing-impaired listeners participated in this study. Five people were tested with and without hearing aids. RESULTS: No significant differences between test conditions were found for the normal-hearing listeners. Results for the hearing-impaired listeners indicated better performance for the 0.9 s reverberation time compared to the reference and the 1.8 s conditions. Benefit from hearing aid use varied between individuals; for one person, an advantage was observed only with reverberation. CONCLUSIONS: Auralisations may offer information on speech recognition performance that is not obtained with a test without reverberation. However, more complex stimuli and/or higher signal-to-noise ratios should be used in the future.

The long-term learning effect related to the repeated use of the Finnish matrix sentence test and the Finnish digit triplet test.

Objectives: To assess are there learning-related improvements in the speech reception thresholds (SRTs) for the Finnish matrix sentence test (FMST) and the Finnish digit triplet test (FDTT) in repeated use over 12 months.Design: Test sessions were scheduled at 0, 1, 3, 6 and 12 months, and each session included five FMST measurements and four FDTT measurements. The within-session and inter-session improvements in SRTs were analysed with a linear mixed model.Study sample: Fifteen young normal-hearing participants.Results: Statistically significant mean improvements of 2.0 dB SNR and 1.2 dB SNR were detected for the FMST and the FDTT, respectively, over the 12-month follow-up period. For the FMST, majority of the improvement occurred during the first two test sessions. For the FDTT, statistically significant differences were detected only in comparison to the first test session and to the first test measurement of every session over the 12-month follow-up.Conclusions: Repeated use of the FMST led to significant learning-related improvements, but the improvements appeared to plateau by the third test session. For the FDTT, the overall improvements were smaller, but a significant within-session difference between the first and consecutive FDTT measurements persisted throughout the test sessions.

The efficacy of microphone directionality in improving speech recognition in noise for three commercial cochlear-implant systems.

Objectives: To investigate the effect of fixed and adaptive microphone directionality on speech reception threshold (SRT) in noise when compared to omnidirectional mode in unilateral cochlear-implant (CI) use for three different CI systems.Methods: Twenty-four CI recipients with bilateral severe-to-profound hearing loss participated in the study. Eight recipients of each CI system were enrolled, and their SRT in noise was measured when the speech and noise signals were co-located in the front to serve as a baseline. The acute effect of different microphone directionalities on SRT in noise was measured with the noise emanating at 90° in the horizontal plane from the side of the CI sound processor (S0NCI).Results: When compared to the baseline condition, the individual data revealed fairly similar patterns within each CI system. In the S0NCI condition, the average improvement in SRT in noise for fixed and adaptive directionalities over the omnidirectional mode was statistically significant and ranged from 1.2 to 6.0 dB SNR and from 3.7 to 12.7 dB SNR depending on the CI system, respectively.Discussion: Directional microphones significantly improve SRT in noise for all three CI systems. However, relatively large differences were observed in the directional microphone efficacy between CI systems.

Tinnitus and suicide: An unresolved relation.

Tinnitus is an auditory phantom sensation which can be a devastating condition for the affected person causing annoyance and discomfort. It may be associated with psychiatric conditions. Patients with highly annoying tinnitus and different comorbidities may have a higher risk of expressing suicidal behaviour and ideation. We aimed to review available reports on the prevalence of suicide and suicidal behaviour with tinnitus patients in order to collate current concepts and to identify possible alarming signs and risk factors. A comprehensive search for appropriate studies listed in PubMed, Ovid and Cochrane databases was conducted using appropriate keyword combinations. We identified 22 publications including original articles, case reports and reviews of which 10 fit our stringent search criteria. Most importantly, from the present studies it appears not feasible to univocally conclude on the co-incidence of tinnitus and suicide. This is due to methodological differences in these approaches, complex interrelations between tinnitus and other psychiatric comorbidities and confounding factors such as the inclusion of patients suffering from post-traumatic stress disorder. More concerted actions involving different medical disciplines are needed to reflect the ethiological heterogeneity of tinnitus and suicide or suicidal behaviour to test for a relationship.

Otitis Media-associated Bacterial Meningitis in Children in a Low-income Country.

BACKGROUND: Otitis media (OM) is a common childhood infection that may result in bacterial meningitis (BM). However, OM-associated BM remains poorly characterized. We aimed to study the occurrence, clinical presentation and outcome of this type of childhood BM in Luanda, Angola. METHODS: Five hundred twelve children from our previous clinical BM trial, with the ear meticulously examined, were analyzed whether they had or not OM, and according to their age, ≤12 month old and >12 month old. Prospectively collected clinical data, laboratory test results and outcome for these groups were assessed. RESULTS: Sixty-two children (12%) had OM-associated BM, of whom 39 had otorrhea. Ear discharge was more common in older children (median age 45 months old vs. 12 months old; P < 0.001). Children with OM often showed an additional infectious focus (n = 20, 32% vs. n = 82, 18%; P = 0.016), were dehydrated (n = 16, 26% vs. n = 66, 15%; P = 0.04), and showed higher odds of complicated clinical course or death (odds ratios 2.27, 95% CI: 1.004-5.15, P = 0.049) compared with children without OM. The >12-month-old children with OM often arrived in poor clinical condition with coma and/or ptosis. Otorrhea was associated with HIV positivity. Infants with otorrhea frequently lived under poor socioeconomic conditions. CONCLUSIONS: Children with OM-associated BM were prone to many problems, such as being especially ill at presentation, undergoing a difficult clinical course and showing a higher risk of complicated or fatal outcome. HIV infection and malnutrition were common in children with otorrhea, which was also associated with low socioeconomic status.

tACS-mediated modulation of the auditory steady-state response as seen with MEG.

BACKGROUND: Previous studies have shown that transcranial electrical stimulation can be successfully applied during simultaneous MEG measurements. In particular, using beamforming they have established that changes of stimulus induced as well as evoked activity can be inspected during transcranial alternating current stimulation (tACS). OBJECTIVE/HYPOTHESIS: We studied tACS-mediated changes of the auditory steady-state response (ASSR), hypothesizing that-due to the putatively inhibitory role of alpha oscillations-these evoked responses would be diminished. METHODS: We compared ASSRs in conditions with and without 12-Hz and 6.5-Hz sinusoidal 1.5 mA tACS, applied bilaterally over temporal areas. Source-level activity was estimated using a linearly constrained minimum variance beamformer and compared across tACS conditions using paired t-tests following a condition-internal normalization procedure. CONCLUSIONS: By separating the electrical and auditory stimulation to non-overlapping parts of the frequency spectrum, we were able to compare auditory-evoked steady-state activity across tACS conditions. We observed a significant decrease in normalized ASSR power in the 12-Hz tACS condition, illustrating that tACS could induce immediate changes in auditory evoked activity. This study sets a methodology to further interrogate the causal roles of oscillatory dynamics in auditory cortices, as well as suggests perspectives for employing tACS in clinical contexts.

Prognostic Value and Changes of Auditory Brain Stem Response in Children With Bacterial Meningitis in Luanda, Angola.

OBJECTIVE: To assess the role of single and repeated auditory brain stem response (ABR) in predicting mortality and severe neurological injury among children having bacterial meningitis (BM) in Luanda, Angola. METHODS: The morphology of ABR traces of 221 children (aged 2 months to 12 years) from admission day was analyzed and compared with age-matched normative data. Absence and delay of traces were compared with mortality and mortality or severe neurological injury in subgroup analyses. Outcome was also evaluated with repeated ABR of 166 children based on presence or absence of responses at 80 dB nHL (normal hearing level) stimulation level. RESULTS: Individually, the absence of typical ABR waveform did not signify poor outcome. At the group level, latencies and interpeak latencies (IPLs) were significantly prolonged among patients with BM in comparison with controls, and the prolongation correlated with higher mortality or severe neurological sequelae. CONCLUSIONS: We confirmed the effect of BM on neural conduction time in auditory pathway. However, ABR in similar settings seems not useful for individual prognostication, although at the group level, delayed latencies, IPLs, or both associated with poorer outcome.

Attenuation of Positive Valence in Ratings of Affective Sounds by Tinnitus Patients.

Affective processing appears to be altered in tinnitus, and the condition is to a large extent characterized by the emotional reaction to the phantom sound. Psychophysiological models of tinnitus and supporting brain imaging studies have suggested a role for the limbic system in the emergence and maintenance of tinnitus. It is not clear whether the tinnitus-related changes in these systems are specific for tinnitus only, or whether they affect emotional processing more generally. In this study, we aimed to quantify possible deviations in affective processing in tinnitus patients by behavioral and physiological measures. Tinnitus patients rated the valence and arousal of sounds from the International Affective Digitized Sounds database. Sounds were chosen based on the normative valence ratings, that is, negative, neutral, or positive. The individual autonomic response was measured simultaneously with pupillometry. We found that the subjective ratings of the sounds by tinnitus patients differed significantly from the normative ratings. The difference was most pronounced for positive sounds, where sounds were rated lower on both valence and arousal scales. Negative and neutral sounds were rated differently only for arousal. Pupil measurements paralleled the behavioral results, showing a dampened response to positive sounds. Taken together, our findings suggest that affective processing is altered in tinnitus patients. The results are in line with earlier studies in depressed patients, which have provided evidence in favor of the so-called positive attenuation hypothesis of depression. Thus, the current results highlight the close link between tinnitus and depression.

Patient satisfaction in the long-term effects of Eustachian tube balloon dilation is encouraging.

OBJECT: To investigate the long-term effects of balloon Eustachian tuboplasty (BET) from patient's perspective and to discover which symptoms of Eustachian tube dysfunction (ETD) benefit the most from BET. METHOD: We designed a retrospective postal questionnaire based on the seven-item ETD questionnaire (ETDQ-7). Our questionnaire covered the severity of present ETD symptoms in comparison with the preoperative situation, the severity of current overall ear symptoms, and possible surgical interventions after BET. Forty-six patients treated in our institution between 2011 and 2013 fulfilled the inclusion criteria and 74% (34 patients; total 52 ears treated with BET) returned the questionnaire with a mean follow-up time of 3.1 years (range 1.8-4.6 years). RESULTS: Pain in the ears, feeling of pressure in the ears, and feeling that ears are clogged had reduced in 75% of the ears that suffered from these symptoms preoperatively. Seventy-seven percent of all the responders felt that their overall ear symptoms were reduced. Altogether, 82% of all the patients stated that they would undergo BET again if their ear symptoms returned to the preoperative level. CONCLUSION: Patient satisfaction in the long-term effects of BET is encouraging. These results may help clinicians in preoperative patient selection and counselling.

Balloon Eustachian tuboplasty under local anesthesia: Is it feasible?

OBJECTIVE: To study whether balloon Eustachian tuboplasty (BET) is a feasible and safe procedure under local anesthesia. STUDY DESIGN: Prospective multicenter case-control study. METHODS: Patients undergoing either BET (n = 13) or endoscopic sinus surgery (ESS) (n = 12) under local anesthesia, with the possibility of sedation and analgesia, were monitored during the procedure and recovery period for possible adverse effects. After the procedure, the patients responded to a questionnaire assessing their experience. RESULTS: No adverse effects were detected in the BET group. Patients in the BET group reported similar Visual Analog Scale scores for pain during the operation as the ESS group (5.0 ± 0.7 vs. 3.2 ± 0.7, mean ± standard error of the mean). However, patients in the BET group experienced more discomfort (4.2 ± 0.6 vs. 2.5 ± 0.3, respectively, P = 0.049). Seventy-seven and 92% of the patients in the BET and ESS groups, respectively, considered the anesthesia and pain relief to be sufficient. Patients from both the BET and ESS groups were almost devoid of pain 1 to 2 hours postoperatively (0.8 ± 0.2 and 1.4 ± 0.3, respectively). In total, 12 of 13 patients in the BET group, and all 12 patients in the ESS group, would choose local anesthesia with sedation and analgesia if they needed to undergo the same procedure again. CONCLUSION: BET is a safe and feasible procedure under monitored anesthesia care, including local anesthesia along with sedation and analgesia. There is need for further methodological improvement to reduce pain and discomfort during the operation. LEVEL OF EVIDENCE: 4. Laryngoscope, 127:1021-1025, 2017.

Prevention of Biomaterial Infection by Pre-Operative Incubation with Human Cells.

BACKGROUND: Cells of tissues and biofilm forming bacteria compete for the living space on the surface of an implant. We hypothesized the incubation of the implant (titanium, polydimethylsiloxane, and polystyrene surface) with human cells before implantation as a strategy to prevent bacterial adhesion and biofilm formation. METHODS: After 24 hours of incubation with human osteogenic sarcoma SaOS-2 cells (1 × 105 cells/mL), the materials were incubated for 4.5 hours or two days with Staphylococcus aureus in serial 1:10 dilutions of 108 colony-forming units/mL. The bacterial adherence and biofilm biomass on materials pre-incubated with SaOS-2 cells were compared with our previous results on materials incubated only with bacteria or in simultaneous co-culture of SaOS-2 cells and S. aureus. Fluorescent microscopy and crystal violet stain were used. The number of viable SaOS-2 and bacterial cells present was tested using colorimetric methods (MTT, LDH) and drop plate method, respectively. RESULTS: The pre-treatment with human cells was associated with a reduction of bacterial colonization of the biomaterial at 4.5 hours and 48 hours compared with the non-pre-treated materials. The presence of bacteria decreased the number of viable human cells on all materials. ( Supplementary Fig. 1 ; see online supplementary materials at www.liebertpub.com/sur ). CONCLUSIONS: These results suggest that the pre-operative incubation of prostheses with host cells could prevent infection of biomaterials.