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Objective: To investigate the anatomical status of the round window niche and hearing outcome of cochlear implantation (CI) after explorative tympanotomy (ExT) with sealing of the round window membrane in patients with sudden sensorineural hearing loss at a tertiary referral medical center. Methods: Between January 1, 2007, and July 30, 2020, 1602 patients underwent CI at our department. Out of these, all patients previously treated by ExT with sealing of the round window membrane because of unilateral sudden hearing loss were included in the study. A retrospective chart review was conducted concerning method of round window membrane sealing, intraoperative findings during CI, postoperative imaging, and hearing results. Results: Twenty one patients (9 females; 8 right ears; 54.3 years [± 12.9 years]) underwent ExT with sealing of the round window membrane with subsequent CI after 26.6 months (± 32.9 mo) on average. During CI, in 76% of cases (n = 16), the round window niche was blocked by connective tissue due to the previous intervention but could be removed completely in all cases. The connective tissue itself and its removal had no detrimental effects on the round window membrane. Postoperative computed tomography scan showed no electrode dislocation. Mean postoperative word recognition score after 3 months was 57.4% (± 17.2%) and improved significantly to 73.1% (± 16.4%, P =.005) after 2 years. Conclusion: Performing CI after preceding ExT, connective tissue has to be expected blocking the round window niche. Remaining tissue can be removed safely and does not alter the round window membrane allowing for a proper electrode insertion. Short- and long-term hearing results are satisfactory. Consequently, ExT with sealing of the round window membrane in patients with sudden sensorineural hearing loss does not impede subsequent CI that can still be performed safely. [ABSTRACT FROM AUTHOR]

Purpose: This multicentric, retrospective study aimed to analyze the short-term safety and effectiveness of the mCLIP Partial Prosthesis. Methods: Patients underwent tympanoplasty with implantation of a mCLIP Partial Prosthesis. Follow-up examination included ear microscopy and pure-tone audiometry to determine the post-operative pure tone average of the frequencies 0.5, 1, 2 and 3 kHz (PTA4). The post-operative PTA4 air bone gap (ABG) was used to evaluate the audiological outcome. A post-operative minimum and maximum follow-up period was not defined. Thus, the follow-up times of each study center were different, which resulted in different follow-up times for the audiological analysis and for adverse events (AE). Results: 72 (66 adults, 6 children) patients were implanted with the mCLIP Partial Prosthesis. 68 (62 adults, 6 children) patients underwent audiological examination; all 72 patients were examined for adverse events. All patients (N = 68): 72.1% of the patients showed a PTA4 ABG of ≤ 20 dB. Individual post-operative bone conduction (BC) PTA4 thresholds were stable in 67 patients. The mean post-operative follow-up time was 78 ± 46 days. Children (N = 6): 5 out of 6 children showed a PTA4 ABG of ≤ 20 dB. None of the children reported a BC PTA4 deterioration of > 10 dB HL after the implantation. The mean post-operative follow-up time was 101 ± 45 days. Adverse events (all patients, N = 72): 15 (14 adults, 1 child) patients had AEs (27 AEs and 2 Follow-Ups). The mean post-operative follow-up time was 375 days. Conclusion: Clinical data show satisfactory audiological parameters after implantation of the mCLIP Partial Prosthesis. The prosthesis is safe and effective for implantation in children and adults. Trial registration number: NCT05565339, 09 September 2022, retrospectively registered. [ABSTRACT FROM AUTHOR]

Multiple sclerosis is a disease of the central nervous system characterized by recurrent inflammatory demyelinating lesions in the early disease stage. Lesion formation and mechanisms leading to lesion remyelination are not fully understood. Matrix Assisted Laser Desorption Ionisation Mass Spectrometry imaging (MALDI–IMS) is a technology which analyses proteins and peptides in tissue, preserves their spatial localization, and generates molecular maps within the tissue section. In a pilot study we employed MALDI imaging mass spectrometry to profile and identify peptides and proteins expressed in normal-appearing white matter, grey matter and multiple sclerosis brain lesions with different extents of remyelination. The unsupervised clustering analysis of the mass spectra generated images which reflected the tissue section morphology in luxol fast blue stain and in myelin basic protein immunohistochemistry. Lesions with low remyelination extent were defined by compounds with molecular weight smaller than 5300 Da, while more completely remyelinated lesions showed compounds with molecular weights greater than 15,200 Da. An in-depth analysis of the mass spectra enabled the detection of cortical lesions which were not seen by routine luxol fast blue histology. An ion mass, mainly distributed at the rim of multiple sclerosis lesions, was identified by liquid chromatography and tandem mass spectrometry as thymosin beta-4, a protein known to be involved in cell migration and in restorative processes. The ion mass of thymosin beta-4 was profiled by MALDI imaging mass spectrometry in brain slides of 12 multiple sclerosis patients and validated by immunohistochemical analysis. In summary, our results demonstrate the ability of the MALDI–IMS technology to map proteins within the brain parenchyma and multiple sclerosis lesions and to identify potential markers involved in multiple sclerosis pathogenesis and/or remyelination. [ABSTRACT FROM AUTHOR]

Background: Cochlear implantation is an efficient treatment for postlingually deafened adults who do not benefit sufficiently from acoustic amplification. Implantation is indicated when it can be foreseen that speech recognition with a cochlear implant (CI) is superior to that with a hearing aid. Especially for subjects with residual speech recognition, it is desirable to predict CI outcome on the basis of preoperative audiological tests. Purpose: The purpose of the study was to extend and refine a previously developed model for CI outcome prediction for subjects with preoperative word recognition to include subjects with no residual hearing by incorporating additional results of routine examinations. Results: By introducing the duration of unaided hearing loss (DuHL), the median absolute error (MAE) of the prediction was reduced. While for subjects with preoperative speech recognition, the model modification did not change the MAE, for subjects with no residual speech recognition before surgery, the MAE decreased from 23.7% with the previous model to 17.2% with the extended model. Conclusions: Prediction of word recognition with CI is possible within clinically relevant limits. Outcome prediction is particularly important for preoperative counseling and in CI aftercare to support systematic monitoring of CI fitting. [ABSTRACT FROM AUTHOR]

Abstract: In this contribution, we present and evaluate a method for characterizing stapes prostheses by their mechanical transfer function. The measurements were carried out after a stapedotomy surgery was performed in three human temporal bones conserved in 4% formaldehyde. The inner ear was drained of fluid. Successively, one of three different stapes prostheses was inserted. After such preparation, the prosthesis piston movement compared to the incus movement is measured with laser vibrometry. The magnitude transfer function considered is defined as the amplitude of the prosthesis piston movement compared to the amplitude of the incus movement. Measurements were made in a frequency range from 500Hz to 4kHz. The measured amplitudes roughly ranged between 10nm and 100nm. A great advantage of the presented method is the fact that only a small portion of the ossicular chain influences the measurement, mainly the joint between the prosthesis and the incus. Furthermore, the usage of cadaver temporal bones allows for an automated measurement setup, long term experiments and the access of measurement positions inapproachable during in vivo measurements. With this method, the different kinds of prostheses could be evaluated on incuses of different diameters. [Copyright &y& Elsevier]

The study presented here evaluates the hearing results after the implantation of a new nickel–titanium (Nitinol) prosthesis in stapes surgery; on heating, this prosthesis crimps itself around the long process of the incus. In addition, we compare the outcome with results published in the literature. The medical records of all patients who underwent surgery for otosclerosis with implantation of a Nitinol piston during the period 2004–2006 were evaluated retrospectively. 83 patients (58 women and 25 men), with a provisional diagnosis of otosclerosis that was confirmed during surgery in all but one of the cases, were treated by primary stapes surgery (85 ears). We were able to include 53 patients (55 ears) who had audiograms with air and bone conduction preoperatively and both 2–6 weeks and about 1 year after surgery. We found a mean air–bone gap (ABG) for the frequencies 0.5, 1, 2 and 4 kHz (ABG4000) of 10.4 ± 5.5 dB after a mean postoperative follow-up period of 24.5 ± 16 days, and of 7.4 ± 3.7 dB after 462 ± 119 days. For the frequencies 0.5, 1, 2 and 3 kHz (ABG3000), the results were 9.1 ± 4.8 and 6.4 ± 3.9 dB. The differences in preoperative versus postoperative air–bone gap, referred to as ABGC, after 25 and 462 days, respectively, were 19.4 ± 8.9 and 22.3 ± 8.8 dB for AGB4000, and 19.5 ± 8.8 and 22.2 ± 8.9 for ABG3000. Very good results were achieved with a new nickel–titanium prosthesis that crimps itself around the long process of the incus, thus facilitating stapes surgery and at the same time stabilizing the high quality of the results. However, no long-term results after 10 years or more, which would allow a final judgment, are yet available. [ABSTRACT FROM AUTHOR]

Purpose: This multicentric, retrospective study provides safety and performance data of the MED-EL total ossicular replacement prostheses (TORP). Methods: Patients underwent tympanoplasty with mXACT Total Prosthesis Center, mXACT Total Prosthesis Offcenter or mXACT PRO Total Prosthesis. The clinical data were retrospectively analyzed. Follow-up examination included access to the medical record (for adverse events) of the patients, ear microscopy and pure-tone audiometry to determine the post-operative pure tone average of the frequencies 0.5, 1, 2 and 3 kHz (PTA4). The post-operative PTA4 air bone gap (ABG) was used to evaluate the audiological outcome. A post-operative minimum and maximum follow-up period was not defined. Results: 103 patients were implanted with a TORP. 102 (88 adults, 14 children; 37 CHL, 64 MHL, 1 not specified) patients were analyzed for safety and 92 (79 adults, 13 children) patients for performance of the prostheses. Adverse events results (N = 102): In 1 patient (child, mXACT Total Prosthesis Offcenter) a prosthesis dislocation was reported, which lead to a revision surgery. No prosthesis extrusion or migration was reported. Audiological results (N = 92): 49 (53.3%) of the 92 patients had a PTA4 ABG of ≤ 20 dB and therefore a successful rehabilitation. The mean post-operative PTA4 ABG of all 92 patients was 21.0 ± 9.7 dB. The first endpoint, improvement in post-operative PTA4 ABG of ≤ 20 dB by ≥ 25% of the patients was achieved. The individual Δ BC PTA4 (post-operative minus pre-operative BC PTA4) thresholds were stable (within ± 5 dB HL) in 91 (98.9%) patients. 1 patient had a BC PTA4 deterioration of 11.3 dB HL. Conclusion: The MED-EL TORPs are safe and effective for middle ear reconstruction. Trial registration number NCT05565339, September 09, 2022, retrospectively registered. [ABSTRACT FROM AUTHOR]

Background: The reconstruction of anterior or subtotal tympanic membrane perforations is critical due to the risk of anterior graft medialisation and retraction or recurrent perforation. Method: After reconstruction of the tympanic membrane by means of grafting, a rectangular cartilage strut (length 6 mm, breadth 2 mm, thickness 0.1 mm) is prepared using a cartilage knife and scalpel. This strut graft is placed between the cartilage graft and the promontory in the anterior inferior part of the middle ear cavity. Conclusion: Our experience shows that using a U-shaped cartilage strut to sustain the tympanic reconstruction effectively prevents the medialisation of the graft and recurrent perforations. [ABSTRACT FROM AUTHOR]

Objectives: The aims of our study were to investigate the clinical and audiometric outcome of the surgical treatment of postinflammatory medial meatal fibrosis (PIMMF) and to review the histopathologic changes in the specimens of the fibrotic plug, in order to try to shed light on the pathogenesis of the disease. Materials and Methods: The clinical records and the histopathologic specimens of all patients who underwent tympanomeatoplasty for PIMMF at the ENT Clinic of the University of Erlangen between 2006 and 2020 were evaluated retrospectively. Results: Thirty-four patients (41 primary surgical procedures) made up our study cohort. Of this, 28 cases were managed by means of meatoplasty and 13 cases with tympanomeatoplasty. The mean preoperative air–bone gap (ABG) was 27.8 dB (10-44 dB). Postoperative ABG was significantly improved compared to preoperative values at both short- and long-term follow-ups (P <.001 for both). No significant difference was noted between short-term and long-term ABG (P =.240). An ABG ≤20 dB was achieved in 65.8% of patients (short term) and 50% (long term). The overall rate of revision surgery for restenosis was 29.3% (12/41). Histopathologic reevaluation of the fibrotic plugs revealed a mosaic of patterns with frequent occurrence of secondary cholesteatoma-like lesions and keloid-like tissue changes. Lichenoid submucosal inflammation and increased ectopic ceruminous gland lobules were seen less frequently. Discussion: The moderate long-term outcome of surgical management and the identification of histologic changes with therapeutic implications might pave the way for alternative nonsurgical treatment options. [ABSTRACT FROM AUTHOR]

Purpose: The aims of this study were to compare speech recognition at different postoperative times for both ears in bilaterally implanted patients and to assess the influence of the time of deafness, frequency-to-place mismatch, angular insertion depth (AID) and angular separation between neighbouring electrode contacts on audiometric outcomes. Methods: This study was performed at an academic tertiary referral centre. A total of 19 adult patients (6 men, 13 women), who received sequential bilateral implantation with lateral wall electrode arrays, were analysed in retrospective. Statistical analysis was performed using two-sided t test, Wilcoxon test, median test, and Spearman's correlation. Results: Postlingually deafened patients (deafness after the age of 10) had a significantly better speech perception (WRS65[CI]) than the perilingually deafened subjects (deafness at the age of 1–10 years) (p < 0.001). Comparison of cochlear duct length between peri- and postlingually deafened subjects showed a slightly significantly smaller cochleae in perilingual patients (p = 0.045). No association between frequency-to-place mismatch as well as angular separation and speech perception could be detected. There was even no significant difference between the both ears in the intraindividual comparison, even if insertion parameters differed. Conclusion: The exact electrode position seems to have less influence on the speech comprehension of CI patients than already established parameters as preoperative speech recognition or duration of deafness. [ABSTRACT FROM AUTHOR]

Background: When performing magnetic resonance imaging (MRI) in patients with a cochlear implant (CI), complication rates vary widely in the literature. The primary objective of this retrospective study was to determine the prevalence of complications, in particular magnet dislocation, in patients with CI undergoing 1.5 Tesla (T) MRI. As a secondary objective, the prevalence of magnet dislocation for specific cochlear implant device types was elaborated. Methods: In a single-center retrospective study, all patients with a cochlear implant presenting for an MRI examination at 1.5 T at our institution between January 1st, 2010 and December 31st, 2020 were included. Implants with axial and diametrical magnets were included in the study. MRI safety measures were applied before imaging. The prevalence of complications was evaluated. Magnet dislocation rates were calculated for device types with at least 20 MRI exposures. Results: During the study period, 196 MRI examinations were performed in a total of 128 patients, accounting for 149 different implants (21 implanted bilaterally) with a total of 231 implant exposures to MRI (average 1.69 ± 1.57; min. 1, max. 12). Complications were reported in 50 out of 231 cochlear implant exposures (21.6%). Magnet dislocation occurred in a total of 27 cases (11.7%). Dislocation rates were 29.6% for the Cochlear® CI500 series (24 dislocations from 81 exposures), 1.1% for the Cochlear® CI24RE series (1 from 87) and 0% for the MED-EL® Synchrony (0 from 36). The dislocation rate for the CI500 was significantly higher than for the CI24RE (χ2(1) = 26.86; p < 0.001; ϕ = 0.40) or the Synchrony (χ2(1) = 13.42; p < 0.001; ϕ = 0.34). Conclusions: For 1.5 T MRI, the risk of magnet dislocation ranges from 0 to 29.6% and depends on the CI device type. Implants with a diametrical magnet can be considered potentially MRI-safe, whereas in CIs with axial magnets, the CI500 is at high risk of magnet dislocation. Therefore, apart from a strict indication for an MRI and adherence to safety protocols, post-MRI follow-up examination to rule out magnet dislocation is recommended. [ABSTRACT FROM AUTHOR]

Objective: Anchoring grafts for tympanic membrane (TM) reconstruction in anterior and subtotal TM defects is essential to prevent medialisation and can be facilitated by cartilaginous bending spring tympanoplasty (CBST). The purpose of this study was to analyse the impact of spring cartilages on middle ear transfer functions and patient hearing levels. Methods: In six fresh-frozen human temporal bones a cartilage graft (measuring 6 × 2 mm with a thickness of 0.1–0.2 mm) was formed into a 'U'-shaped bending spring, to be placed between the medial tympanic wall and the tympanic underlay grafts. The stapes velocity for excitation by exponential sweeps from 400 to 10,000 Hz was measured with a laser Doppler vibrometer. The resulting middle ear transfer functions were compared with the reconstructed middle ear. For clinical evaluation, 23 ears in 21 patients with chronic otitis media and an intact ossicular chain were operated using CBST. At each follow-up visit, the patients underwent pure-tone audiometry and the Freiburg monosyllabic speech test at a presentation level of 65 dB SPL for the word recognition score (WRS). Results: The measured stapes velocities at one-third octave midband frequencies averaged 3.56 × 10–2 ± 9.46 × 10–3 (mm/s/Pa) compared to 3.06 × 10–2 ± 6.86 × 10–3 (mm/s/Pa) with the bending and underlay cartilage in place (p = 0.319; r = 0.32). The bending spring tympanoplasty reduced the transfer function by 1.41 ± 0.98 dB on average. In the clinical part of the study, the graft success rate was 96% (22 out of 23 patients) after a mean follow-up of 5.8 ± 2.4 months (min. 3.5 months, max. 12.0 months). The air–bone gap improved significantly by 6.2 dB (± 6.6 dB; p < 0.001; r = 0.69), as well as the WRS from 61.8 ± 33.3% preoperatively to 80.0 ± 20.9% postoperatively (p = 0.031; r = 0.35). Conclusion: Experimental data as well as initial clinical results suggest that CBST is an effective method for reconstructing anterior or subtotal defects of the tympanic membrane with satisfactory audiologic results and graft success rates comparable to previously described methods. It can, therefore, be added to the arsenal of tympanoplasty techniques for anterior and subtotal TM perforations. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to investigate the feasibility and reliability of transcutaneous ultrasound for the detection of complications after cochlear implantation. Methods: In a single center retrospective cohort study, 115 consecutive cases of suspected complications after cochlear implantation (intervention group) were examined. The rate of pathologic ultrasound findings for specific leading symptoms and diagnoses was compared to a control group comprising twenty consecutive cochlear implants in symptom-free patients. Results: Diagnostic ultrasound showed distinctly more pathologic findings in the intervention group (n = 67; 58.3%; p < 0.001) compared to the control group (n = 1; 5%). Ultrasound revealed significantly more pathologic findings in haematoma or seroma around the implant (n = 17; 100%; p < 0.001; ϕ = 0.94) and magnet dislocation (n = 44; 97.7%; p < 0.001; ϕ = 0.92) confirmed by a strong effect. Ultrasound examination showed a medium to high effect size in patients presenting with local infections (n = 3; 21.4%; p = 0.283; ϕ = 0.25) and skin flap oedema (n = 2; 50%; p = 0.061; ϕ = 0.51). In contrast, ultrasound examinations displayed a low effect size in undefined cephalgia (0%; p = 0.444; ϕ = 0.17) and device malfunction or failure (0%; p > 0.999; ϕ = 0.13). Conclusion: Transcutaneous ultrasound can be advocated as a feasible and effective method in the diagnostic work-up of magnet dislocation and haematoma or seroma around the implant following cochlear implantation. Contrary, ultrasound findings can be expected to be inconspicuous in patients presenting with undefined cephalgia and device malfunction or failure. [ABSTRACT FROM AUTHOR]

Purpose: Flat-detector computed tomography (FD-CT) is the standard for cochlear implant (CI) imaging. FD-CT systems differ in technical characteristics. Our aim was an evaluation of two different FD-CT generations with different protocols and hardware regarding image quality, radiation dose, and scan time. Methods: Two temporal bone specimens (− / + CI = TB0/TB1) were scanned using three different scanners: two FD-CT systems with different scanning protocols (standard FD-CT: 20 s 70 kV, 20 s 109 kV; high-speed FD-CT [HS-FD-CT]: 7 s 109 kV, 9 s 109 kV, 14 s 72 kV) and MS-CT (5 s 120 kV). Acquired datasets were evaluated in consensus reading regarding qualitative and quantitative parameters: addressing CI- and cochlea-specific parameters, cochlea delineation, lamina spiralis ossea visibility, distinction of single CI electrodes, determination of intracochlear implant position, stapes delineation, and mastoidal septation were assessed. Addressing protocol-specific parameters, radiation dose (dose-length-product/DLP), and scan time were assessed. Results : Two HS-FD-CT protocols (14 s/9 s) provide higher or equivalent diagnostic information regarding CI- and cochlea-specific parameters compared to both standard FD-CT protocols. The fastest HS-FD-CT protocol (7 s)—providing inferior diagnostic information compared to all other FD-CT protocols—still exceeds MS-CT. The highest DLP was recorded for the 14 s HS-FD-CT protocol (TB1 = 956 mGycm); the lowest DLPs were recorded for the 7 s HS-FD-CT protocol (TB0 = 188 mGycm) and for MS-CT (TB0 = 138 mGycm), respectively. HS-FD-CT allows a significant reduction of scan time compared to standard FD-CT. Conclusion: High-speed FD-CT improves visualization of temporal bone anatomy and postoperative assessment of CIs by combining excellent image quality, fast scan time, and reasonable radiation exposure. [ABSTRACT FROM AUTHOR]

In recent years, further technical developments of ultrasound scanning techniques, such as tissue harmonic imaging (THI) and compound imaging (CI), have become available and promise considerable improvement in image quality. No comparative assessments have yet been made of their systematic use in the head and neck. We studied 313 lesions of the head and neck detected on ultrasound scanning. Ultrasound images were obtained using a state-of-the-art scanning system. Two experts evaluated the images obtained for each lesion with conventional B-scan mode (BSCAN), THI, CI, and tissue harmonic compound imaging (THICI) with respect to four different aspects of image quality. Largely concordant results were found for each of the parameters studied: overall image quality, tissue contrast, lesion conspicuity, and internal structure. Evaluations of CI and THICI were frequently ranked higher ( p < 0.001) than BSCAN and THI ( p < 0.001). Images obtained in BSCAN mode often had better scores than images in THI mode alone ( p < 0.001). Comparison of CI and THICI showed no statistically significant differences for any of the parameters studied. After a learning period, compound imaging methods improve image quality of the soft tissues of neck and may be included in the routine settings of ultrasound systems. [ABSTRACT FROM AUTHOR]

Abstract: Several criteria in B-scan and colour-coded Doppler ultrasound have been shown to discriminate malignant transformation of cervical lymph nodes. All these parameters tend to be operator dependent. We describe the first use of computer-assisted analysis of contrast-enhanced ultrasound images evaluating cervical lymphadenopathy in differentiation between benign and malignant lesions. The results from sonography were compared with the histologic findings in 60 patients. Subjective sonomorphologic parameters were evaluated and compared with quantitative criteria obtained from computer analysis after intravenous contrast medium (SonoVue) application to estimate diagnostic impact. Our results confirm that malignant lymph nodes are round in shape (p < 0.001) and show peripheral perfusion (p = 0.0089). Dynamic parameters revealed that malignant nodes were characterized by contrast medium wash-in time (p = 0.0487). However, the contrast-related criteria did not improve the pretherapeutic prediction of malignancy. Although contrast medium kinetics provided statistically significant new criteria for identifying malignant lymph nodes, differentiating between malignant and inflammatory changes in lymph nodes remains a diagnostic challenge. (E-mail: johannes.zenk@hno.imed.uni-erlangen.de) [Copyright &y& Elsevier]

The glycerol test is an easy‐to‐use instrument to elucidate fluctuations of electrical hearing in patients with Meniere's disease and it might be also used as a therapeutic option. [ABSTRACT FROM AUTHOR]

BACKGROUND Many countries have stockpiled vaccines because of concerns about the reemergence of smallpox. Traditional smallpox vaccines are based on replicating vaccinia viruses; these vaccines have considerable side effects. METHODS To evaluate the efficacy of modified vaccinia Ankara (MVA) as a potential smallpox vaccine, we randomly assigned 440 participants to receive two doses of MVA followed by one dose of the established replicating-vaccinia vaccine ACAM2000 (the MVA group) or to receive one dose of ACAM2000 (the ACAM2000-only group). The two primary end points were noninferiority of the MVA vaccine to ACAM2000 with respect to the peak serum neutralizing antibody titers and attenuation of the ACAM2000-associated major cutaneous reaction by previous MVA vaccination, measured according to the maximum lesion area and the derived area attenuation ratio. RESULTS A total of 220 and 213 participants were randomly assigned and vaccinated in the MVA group and ACAM2000-only group, respectively, and 208 participants received two MVA vaccinations. At peak visits, MVA vaccination induced a geometric mean titer of neutralizing antibodies of 153.5 at week 6, as compared with 79.3 at week 4 with ACAM2000 (a ratio of 1.94 [95% confidence interval {CI}, 1.56 to 2.40]). At day 14, the geometric mean titer of neutralizing antibodies induced by a single MVA vaccination (16.2) was equal to that induced by ACAM2000 (16.2), and the percentages of participants with seroconversion were similar (90.8% and 91.8%, respectively). The median lesion areas of the major cutaneous reaction were 0 mm2 in the MVA group and 76.0 mm² in the ACAM2000-only group, resulting in an area attenuation ratio of 97.9% (95% CI, 96.6 to 98.3). There were fewer adverse events or adverse events of grade 3 or higher after both MVA vaccination periods in the MVA group than in the ACAM2000-only group (17 vs. 64 participants with adverse events of grade 3 or higher, P<0.001). CONCLUSIONS No safety concerns associated with the MVA vaccine were identified. Immune responses and attenuation of the major cutaneous reaction suggest that this MVA vaccine protected against variola infection. (Funded by the Office of the Assistant Secretary for Preparedness and Response Biomedical Advanced Research and Development Authority of the Department of Health and Human Services and Bavarian Nordic; ClinicalTrials.gov number, NCT01913353. opens in new tab.) [ABSTRACT FROM AUTHOR]

Objectives: To report on electrode array measurements for the Nucleus® CI532 Slim Modiolar Electrode device including: ECAP thresholds, electrode impedances, and psychophysical comfort levels, as well as speech perception results pre- and post-operatively and standardized evaluations of quality of life.Methods: Forty-four subjects were implanted with the CI532. Electrically evoked compound action potential (ECAP) thresholds and impedances were measured using automatic Neural Response Telemetry intra-operatively, at activation and at six months post implant. Pre- and post-operative measures of words in quiet and sentences in noise were made in multiple languages. Quality of life was assessed using The Speech Spatial Qualities questionnaire (SSQ) and Glasgow Benefit Inventory (GBI).Results: Intra-operative ECAP thresholds were recorded successfully from 90% of electrodes tested. ECAP thresholds varied across the array and a post-hoc Dunn's test showed that median thresholds for electrodes E1-E13 were significantly greater than those for E17-E22 (all P < 0.001). Impedances increased significantly between surgery and activation. Speech recognition scores for words in quiet and sentences in noise showed a significant improvement for the group at six months, when using the cochlear implant, compared with pre-operative performance (P < 0.001). There was a significant increase compared to pre-operative ratings for all sections of the SSQ at six months post activation (P < 0.001). The GBI gave scores significantly above zero for the 'general' subscale and total score.Conclusion: Objective ECAP and impedance measures for this new electrode array were as expected and similar to results reported for other array types. Speech perception and quality of life improved significantly following implantation. (Registered as NCT02392403 on ClinicalTrials.gov PRS). [ABSTRACT FROM AUTHOR]

Aims: The Nucleus CI532 cochlear implant incorporates a new precurved electrode array, i.e., the Slim Modiolar electrode (SME), which is designed to bring electrode contacts close to the medial wall of the cochlea while avoiding trauma due to scalar dislocation or contact with the lateral wall during insertion. The primary aim of this prospective study was to determine the final position of the electrode array in clinical cases as evaluated using flat-panel volume computed tomography.Methods: Forty-five adult candidates for unilateral cochlear implantation were recruited from 8 centers. Eleven surgeons attended a temporal bone workshop and received further training with a transparent plastic cochlear model just prior to the first surgery. Feedback on the surgical approach and use of the SME was collected via a questionnaire for each case. Computed tomography of the temporal bone was performed postoperatively using flat-panel digital volume tomography or cone beam systems. The primary measure was the final scalar position of the SME (completely in scala tympani or not). Secondly, medial-lateral position and insertion depth were evaluated.Results: Forty-four subjects received a CI532. The SME was located completely in scala tympani for all subjects. Pure round window (44% of the cases), extended round window (22%), and inferior and/or anterior cochleostomy (34%) approaches were successful across surgeons and cases. The SME was generally positioned close to the modiolus. Overinsertion of the array past the first marker tended to push the basal contacts towards the lateral wall and served only to increase the insertion depth of the first electrode contact without increasing the insertion depth of the most apical electrode. Complications were limited to tip fold-overs encountered in 2 subjects; both were attributed to surgical error, with both reimplanted successfully.Conclusions: The new Nucleus CI532 cochlear implant with SME achieved the design goal of producing little or no trauma as indicated by consistent scala tympani placement. Surgeons should be carefully trained to use the new deployment method such that tip fold-overs and over insertion may be avoided. [ABSTRACT FROM AUTHOR]

Aims Neuroendocrine middle ear adenoma ( MEA) is a rare epithelial neoplasm of uncertain histogenesis that frequently shows neuroendocrine features. To date, <120 cases have been reported. The aims of the current study were to describe our experience with neuroendocrine MEA, to assess the frequency of specific neuroendocrine differentiation, and to test these lesions for transcription factors known to be expressed in a variety of other neuroendocrine tumours. Methods and results We investigated six cases of neuroendocrine MEA, and stained them, for the first time, for the transcription factors CDX2, TTF1, PAX8, and ISL1 (islet-1). The patients were four men and two women (mean age, 39 years; range, 27-53 years). Two of four patients with extended follow-up (4.5-22 years) experienced recurrence at 92 months, and at 9 and 22 years, respectively. One case extending into the external ear coexisted with cholesteatoma. Histological examination showed trabecular, solid, acinar, glandular, cribriform, organoid, nested, diffuse non-cohesive plasmacytoid and pseudoalveolar patterns in varying combinations. Immunohistochemistry showed consistent expression of vimentin (4/4), pancytokeratin (6/6), synaptophysin (6/6), CD56 (4/4), and ISL1 (6/6). A CK7 antibody stained scattered cells in two of five cases. The myoepithelial markers and transcription factors TTF1, CDX2 or PAX8 were not expressed in any of the cases. Conclusions Middle ear adenoma is an indolent, locally recurring, but generally non-metastasizing neoplasm with uniform expression of synaptophysin and ISL1, indicating true neuroendocrine differentiation. Because of its highly varied cellular and architectural appearance, MEA should be distinguished from tympanic paraganglioma and a variety of rare benign and malignant lesions at this site. [ABSTRACT FROM AUTHOR]

This report describes a rare case of histopathologically confirmed glomus faciale tumor. The role of imaging in the differential diagnosis is discussed and therapeutic options are evaluated, along with a review of the previous literature on glomus faciale tumors. A 39-year-old male patient presented with total peripheral facial nerve paralysis. He underwent radical tumor resection and facial nerve grafting for a histopathologically confirmed paraganglioma of the facial nerve. He is now tumor-free after a 4-year follow-up period, and the functional outcome after primary nerve grafting is satisfactory. Facial nerve paragangliomas are a rare cause of facial nerve paralysis. Early imaging using computed tomography and magnetic resonance imaging is essential to clarify the differential diagnosis and assess the location and extent of the tumor. Precise pathological diagnosis requires additional targeted immunohistochemical examinations. The treatment of choice in patients with preoperative facial nerve paralysis is radical tumor resection with nerve reconstruction. [ABSTRACT FROM AUTHOR]

Conclusion: Cochlear implantation assessment is possible using commercially available standard flat-detector computed tomography (FD-CT) protocols. Image quality is superior to multislice CT (MSCT). The radiation dose of FD-CT is lower in comparison with MSCT standard protocols and may therefore overcome the limitations of MSCT in the evaluation of cochlear implants. Objective: FD-CT offers higher spatial resolution than MSCT. Our objective was to compare the image quality of FD-CT to conventional MSCT in the visualization of a cochlear implant electrode array with respect to radiation exposure. Methods: An isolated temporal bone specimen was scanned using a commercially available FD-CT system and a 4 and 64 row MSCT scanner. Different scanning protocols were used. Image quality was assessed by four independent readers using a scoring system with different criteria describing delineation of the cochlea and the electrode array, image noise and spatial resolution. Radiation dose was measured using the CT dose index (CTDI) and a 16 cm acrylic phantom. Results: Image quality was rated superior for FD-CT for all criteria by all readers. Single electrode contacts were only visible in FD-CT and assessment of implant position was improved by FD-CT. The radiation dose of FD-CT was half that of MSCT standard protocols. [ABSTRACT FROM AUTHOR]

Purpose: Severe cochleovestibulopathy is a complication after stapes plasty and CT may be needed to assess intravestibular intrusion depth of the stapes piston. The accuracy of modern CT systems in this task has not been established.Methods: Stapes plasty was performed on six cadaver ears, and Soft CliP titanium pistons were inserted. Specimens were then examined using three different CT systems: single source 64-row, dual source 64-row and flat-panel computed tomography (FD-CT). Piston length, width and intravestibular intrusion were measured by four independent observers. Temporal bone dissection was then performed and vestibular piston intrusion measured microscopically.Results: Piston dimensions were overestimated by all observers and CT systems. Intravestibular penetration as assessed by CT was consistently greater than the value found on cadaveric anatomical dissection. On average, the CT measurement of width was 0.176 mm (44%) greater, length 0.125 mm (6.25%) greater and intrusion 0.333 mm (39.2%) greater than the anatomical measurements. FD-CT showed better image quality and partly less bias in several measurements, but penetration depth was still variably overestimated.Conclusion: CT measurement consistently overestimated intravestibular piston dimensions and vestibular intrusion. Modern temporal bone imaging systems are not yet able to depict the stapes piston position with a sufficient degree of accuracy. [ABSTRACT FROM AUTHOR]

Abstract: Objective: Aim of this study is to evaluate the incidence, infliction patterns and management of dural injuries with cerebrospinal fluid (CSF) rhinorrhea following endoscopic sinus surgery at a teaching hospital. We present our results of over 14 years of experience from endoscopic repair of CSF rhinorrhea with long-term follow-up. Methods: A retrospective study was performed by screening 14 years of sinus surgeries for iatrogenically inflicted CSF leaks of the anterior skull base. Obtained data were analyzed to determine the infliction pattern and location of CSF leaks, surgical closure techniques and outcomes. All incidences were further evaluated with regards to the surgeons training status. Results: 144 patients out of 6908 sinus surgeries were diagnosed with CSF rhinorrhea and underwent subsequent surgical repair. 52 patients had iatrogenic CSF leaks with 32 of the defects inflicted by the department''s physician personnel. Average follow-up was 62 months, with a range of 10–168 months. The side distribution was 56.3% to the patient''s right side and in 40.6% to the patient''s left side. 68.7% became apparent during the initial surgery whereas 31.3% only after surgery. The most common defect location was the anterior ethmoid at the attachment of the medial concha base with 43.7%, followed by the junction between the ethmoid and sphenoid sinus with 21.9%, the frontal sinus aditus with 18.7% and the medial ethmoid region with 9.4%. With increasing training status, surgeons were more prone to cause defects at the frontal sinus aditus whereas surgeons with lesser training status caused more defects at the anterior ethmoid at the medial concha base. The posterior ethmoid and sphenoid sinus was equally prone to defects over all stages of surgical training. Initial endoscopic repair was successful in 87.5% of patients and 95% after revision surgery. Conclusion: The obtained data confirm the safety of the endonasal sinus surgery according to Wigand''s technique. The incidence of iatrogenic CSF leaks at a teaching hospital is not higher than at specialized rhinology departments. We observed a distinct pattern of inflicted skull base defects with different hot-spot areas, prone to damage in various stages of the surgeon''s status of expertise. [Copyright &y& Elsevier]

The aim of this study is to review the long-term results of endonasal endoscopic dacryocystorhinostomy (DCR) according to our experience as well as to evaluate potential prognostic factors for long-term outcomes. The files of 165 patients who underwent endonasal DCR at a tertiary referral centre between 1991 and 2001 were retrospectively assessed. Furthermore, these cases were clinically evaluated at least 5 years after surgery and completed a subjective result evaluation questionnaire. A cure was reported by a total of 112 (67.9%) subjects and significant improvement without need for further treatment was noted in 23 cases (13.9%). Thirty (18.2%) cases were considered as failures. The overall successful outcome according to the subjective symptom evaluation was 81.8%. Poor correlation between clinical findings and subjective report of symptoms was found. None of the prognostic factors that were assessed affected outcomes significantly. In conclusion, long-term success rates for endonasal DCR seem to be comparable to previously published short-term results. [ABSTRACT FROM AUTHOR]

Purpose: To address the value of neck dissection (ND) in patients with advanced head and neck cancer following primary radiochemotherapy and to specifically analyse its impact on locoregional tumour control, survival and toxicity.Patients and methods: Between 1987 and 1997 (9335), a total of 142 patients (pts) were treated by primary radiochemotherapy (RCT) according to prospective protocols. There were 64 pts with involvement of the hypopharynx, 57 pts with oropharyngeal and 21 with oral cavity carcinoma. UICC (1997) stages included: 16 pts in stage III, 113 pts in stage IV A, 13 pts in stage IV B. All pts received platin-based RCT up to a median total dose of 70 Gy (range, 60–72 Gy). Six weeks after RCT, pts with complete response of the primary tumour (N=97) were offered a uni- or bilateral ND depending on the initially diagnosed nodal disease as part of a strict institutional policy. Fifty-six pts consented to ND and 41 refused. These two groups were analysed in terms of characteristics, local and regional tumour control, survival and long-term side effects. Median follow-up was 37 months (range, 22–124 months).Results: Among the 56 pts receiving ND, a total of 13 (23%) was found to have residual tumour in the neck specimen. The rates of positive histology according to clinical N category after RCT were: yN0 (2/22[9%]), yN1 (2/10[20%]), yN2a-b (2/10[20%), yN2c-3 (7/14[54%]). Five-year overall survival and disease-specific survival rates for pts with ND were 44 and 55%, for pts without ND 42 and 47%, respectively (P=0.9). No difference was seen for long-term local and regional control between the two patient groups. Comparing the group of patients with and without ND, a trend towards higher subjective morbidity of grade 3 and 4 (LENT-SOMA), i.e. pain recording (24% vs. 17%), dysphagia (48% vs. 35%) and hoarseness (20% vs. 9%) was evident in patients with ND.Conclusion: No clear evidence for routine clinical use of ND after RCT in advanced head and neck tumours can be derived from these data. ND may be contemplated in selected cases with multiple residual nodes only. [Copyright &y& Elsevier]