Comparison of mucus and serum biomarker sampling in chronic rhinosinusitis with nasal polyps.

OBJECTIVE: The objective of this study was to analyze advantages and disadvantages of mucus and serum for biomarker analysis. METHODS: This study includes prospective study of 61 CRS with nasal polyps patients who were followed over 24 months and over nine time points after functional endoscopic sinus surgery. At each time points, the nasal polyp score (NPS) was assessed and mucus as well as serum was collected. Selected were measured in mucus and serum. Mean, standard deviation and variance, undetectable values, and the correlation of the biomarkers to the NPS over time and to early recurrences were calculated, and the effect of surgery on the biomarkers was assessed. Additionally, the diurnal rhythm of all biomarkers was measures in order to assure stable biomarker values during sampling times. RESULTS: All biomarkers showed stable values during sampling times. Serum biomarker levels displayed higher percentages of undetectable values compared to mucus biomarkers. Mucus periostin (p < 0.001, r = 0.89), mucus IgE (p < 0.001, r = 0.51), serum periostin (p < 0.001, r = 0.53), mucus CST1 (p < 0.001, r = 0.27), and serum IgE (p < 0.01, r = -0.18) were the best marker and medium combinations to track the NPS over time and to predict recurrences. Mucus serpinF2 was negatively correlated and predicted early recurrences (p = 0.026, R2  = 0.015). CONCLUSIONS: Serum and mucus both represent viable mediums for "liquid biopsies." The most promising biomarker/medium combinations over time to track disease severity were mucus periostin, mucus IgE, serum periostin, mucus CST1, and serum IgE. Mucus serpinF2 was the best biomarker to predict early recurrences.

Extracting continuous sleep depth from EEG data without machine learning.

The human sleep-cycle has been divided into discrete sleep stages that can be recognized in electroencephalographic (EEG) and other bio-signals by trained specialists or machine learning systems. It is however unclear whether these human-defined stages can be re-discovered with unsupervised methods of data analysis, using only a minimal amount of generic pre-processing. Based on EEG data, recorded overnight from sleeping human subjects, we investigate the degree of clustering of the sleep stages using the General Discrimination Value as a quantitative measure of class separability. Virtually no clustering is found in the raw data, even after transforming the EEG signals of each 30-s epoch from the time domain into the more informative frequency domain. However, a Principal Component Analysis (PCA) of these epoch-wise frequency spectra reveals that the sleep stages separate significantly better in the low-dimensional sub-space of certain PCA components. In particular the component C1(t) can serve as a robust, continuous 'master variable' that encodes the depth of sleep and therefore correlates strongly with the 'hypnogram', a common plot of the discrete sleep stages over time. Moreover, C1(t) shows persistent trends during extended time periods where the sleep stage is constant, suggesting that sleep may be better understood as a continuum. These intriguing properties of C1(t) are not only relevant for understanding brain dynamics during sleep, but might also be exploited in low-cost single-channel sleep tracking devices for private and clinical use.

Effect of postoperative systemic prednisolone on short-term and long-term outcomes in chronic rhinosinusitis with nasal polyps: A multi-centered randomized clinical trial.

Introduction: The objective of this study was to determine whether postoperative additive systemic steroid administration in chronic rhinosinusitis with nasal polyps (CRSwNP) impacted selected endoscopic, subjective and objective outcome measures. Methods: This was a prospective, randomized, double-blind, placebo-controlled, noninferiority multicenter trial of n=106 patients with CRSwNP. All patients underwent primary functional endoscopic sinus surgery (FESS) followed by topical nasal steroids. Patients were randomized to a systemic steroid or placebo for 1 month. Patients were followed up for 2 years over 9 time points. The primary outcome measures were the differences between groups with respect to the nasal polyp score (NPS) and sinonasal quality of life (SNQoL). Secondary outcome measures included interactions with respect to the Lund-Kennedy score (LKS), sinonasal symptoms, general quality of life (GQoL), 16-item odor identification test scores, recurrence rates, need for revision surgery and mucus biomarker levels. Results: 106 patients were randomized to either the placebo or the systemic steroid group (n=53 per group). Postoperative systemic steroids were not superior to placebo with respect to all primary (p= 0.077) and secondary outcome measures (p>0.05 for all). Reported adverse events were similar between the two groups. Conclusion: In conclusion, the addition of postoperative systemic steroids after primary FESS did not confer a benefit over topical steroid nasal spray alone with respect to NPS, SNQOL, LKS, GQOL, sinonasal symptoms, smell scores, recurrence rates, the need for revision surgery or biomarkers over a short-term follow-up of up to 9 months and a long-term follow-up of up to 24 months in CRSwNP patients. Functional endoscopic surgery did, however, show a strong effect on all outcome measures, which remained relatively stable up to the endpoint at 2 years.

Classification at the accuracy limit: facing the problem of data ambiguity.

Data classification, the process of analyzing data and organizing it into categories or clusters, is a fundamental computing task of natural and artificial information processing systems. Both supervised classification and unsupervised clustering work best when the input vectors are distributed over the data space in a highly non-uniform way. These tasks become however challenging in weakly structured data sets, where a significant fraction of data points is located in between the regions of high point density. We derive the theoretical limit for classification accuracy that arises from this overlap of data categories. By using a surrogate data generation model with adjustable statistical properties, we show that sufficiently powerful classifiers based on completely different principles, such as perceptrons and Bayesian models, all perform at this universal accuracy limit under ideal training conditions. Remarkably, the accuracy limit is not affected by certain non-linear transformations of the data, even if these transformations are non-reversible and drastically reduce the information content of the input data. We further compare the data embeddings that emerge by supervised and unsupervised training, using the MNIST data set and human EEG recordings during sleep. We find for MNIST that categories are significantly separated not only after supervised training with back-propagation, but also after unsupervised dimensionality reduction. A qualitatively similar cluster enhancement by unsupervised compression is observed for the EEG sleep data, but with a very small overall degree of cluster separation. We conclude that the handwritten letters in MNIST can be considered as 'natural kinds', whereas EEG sleep recordings are a relatively weakly structured data set, so that unsupervised clustering will not necessarily re-cover the human-defined sleep stages.

Radio(chemo)therapy in anaplastic thyroid cancer-high locoregional but low distant control rates-a monocentric analysis of a tertiary referral center.

BACKGROUND: Anaplastic thyroid cancer (ATC) is a lethal disease with highly aggressive disease progression. This study analyses the influence of radio(chemo)therapy, R(C)T, on disease control, survival rates and predictors for survival. PATIENTS AND METHODS: A total of 33 patients with ATC, treated at a tertiary referral center between May 2001 and April 2020 were included. Univariate and multivariate analysis were used to investigate correlates of R(C)T and predictors on disease control and survival rates. RESULTS: Median follow-up was 4 months. In UICC stage IVA and IVB median overall survival (OS) was 8 months, median progression-free survival (PFS) was 6 months. Patients with UICC stage IVA and IVB and patients being irradiated with a radiation dose of more than 60 Gy showed increased OS. Of these patients, 3 were alive and free from disease. All of them receiving cisplatin-based radiochemotherapy and a minimum radiation dose of 66 Gy. UICC stage IVC showed a median OS of 2.5 months and a median PFS of 1 month. Only 2 of 16 patients had local failure. CONCLUSION: Depending on UICC stage, RT with high radiation dose can lead to improved OS or at least higher locoregional control. A limiting factor is the high incidence of distant metastases; therefore modern systemic treatment options should be integrated into multimodal therapy concepts.

Depression and female gender associated with higher postoperative pain scores after sinonasal surgery.

BACKGROUND: Although it is extremely necessary to reduce the number of opioids taken postoperatively after sinonasal surgery, this is the subject of controversial discussion. OBJECTIVES: The objective of this study was to identify factors that predict higher postoperative pain scores (PPS) and the need for opioid analgesics after sinonasal surgery. MATERIAL AND METHODS: This was a retrospective study of n = 492 patients who underwent functional endoscopic sinus surgery (FESS), septoplasty or a combination of both in the Otolaryngology Department in Erlangen between January and December 2018. Postoperative pain using the numeric rating scale and the postoperative need for non-opioid and opioid analgesics in relation to demographic and surgical parameters were evaluated. RESULTS: Significant predictors for a higher pain score were depression (p = .009) and female gender (p < .001). A significant predictor of the need for postoperative opioids was the female gender (p < .001), whereas FESS alone showed a significantly lower need for opioids (p = .035) and a significantly lower PPS compared to septoplasty (p < .001). CONCLUSIONS AND SIGNIFICANCE: The study identified risk factors for a higher PPS and the need for opioids. The results indicated that reducing postoperative opioids might be possible in patients without these risk factors and might help guide individualized postoperative therapy.

[Salvage laryngectomy after primary radio- and radiochemotherapy : A retrospective study. German version]. / Salvage-Laryngektomie nach primärer Radio- und Radiochemotherapie : Eine retrospektive Fallzusammenfassung.

BACKGROUND: Recurrent and residual laryngeal cancer after organ-preserving radio- or radiochemotherapy is associated with a poor prognosis. Salvage surgery is the most important therapeutic option in these cases. OBJECTIVE: The study assessed rates of recurrence and residual tumor as well as survival and complication rates after salvage laryngectomy at the authors' academic cancer center. MATERIALS AND METHODS: A retrospective examination of all patients receiving laryngectomy between 2001 and 2019 due to tumor residuals or recurrence after primary radio- and radiochemotherapy was conducted. RESULTS: A total of 33 salvage procedures were performed. Defect reconstruction was performed by free flap surgery in 30.3% (n = 10) and regional flap surgery in 15.2% (n = 5) . One patient received regional flap surgery and free flap surgery simultaneously. Overall survival after 1, 2, and 5 years was 68.7, 47.9, and 24.2%, and disease-free survival was 81.6, 47.8, and 24.2%, respectively, with 48.5% (n = 16) postoperative tumor recurrences overall. Disease-free survival was significantly shorter for tumor extension into or onto the hypopharynx (p = 0.041). Postoperatively, 72.7% of patients developed a pharyngocutaneous fistula, of which 24.2% required surgical treatment. The hospital stay was 28.0 ± 16.1 days. CONCLUSION: Salvage laryngectomy is associated with a high rate of treatable complications and high morbidity. Nevertheless, considering the advanced tumor stages treated, it allows for respectable oncological results.

Sleep as a random walk: a super-statistical analysis of EEG data across sleep stages.

In clinical practice, human sleep is classified into stages, each associated with different levels of muscular activity and marked by characteristic patterns in the EEG signals. It is however unclear whether this subdivision into discrete stages with sharply defined boundaries is truly reflecting the dynamics of human sleep. To address this question, we consider one-channel EEG signals as heterogeneous random walks: stochastic processes controlled by hyper-parameters that are themselves time-dependent. We first demonstrate the heterogeneity of the random process by showing that each sleep stage has a characteristic distribution and temporal correlation function of the raw EEG signals. Next, we perform a super-statistical analysis by computing hyper-parameters, such as the standard deviation, kurtosis, and skewness of the raw signal distributions, within subsequent 30-second epochs. It turns out that also the hyper-parameters have characteristic, sleep-stage-dependent distributions, which can be exploited for a simple Bayesian sleep stage detection. Moreover, we find that the hyper-parameters are not piece-wise constant, as the traditional hypnograms would suggest, but show rising or falling trends within and across sleep stages, pointing to an underlying continuous rather than sub-divided process that controls human sleep. Based on the hyper-parameters, we finally perform a pairwise similarity analysis between the different sleep stages, using a quantitative measure for the separability of data clusters in multi-dimensional spaces.

Relevance of the time interval between surgery and adjuvant radio (chemo) therapy in HPV-negative and advanced head and neck carcinoma of unknown primary (CUP).

INTRODUCTION: In contrast to head and neck squamous cell carcinoma (HNSCC), the effect of treatment duration in HNSCC-CUP has not been thoroughly investigated. Thus, this study aimed to assess the impact of the time interval between surgery and adjuvant therapy on the oncologic outcome, in particular the 5-year overall survival rate (OS), in advanced stage, HPV-negative CUPs at a tertiary referral hospital. 5-year disease specific survival rate (DSS) and progression free survival rate (PFS) are defined as secondary objectives. MATERIAL AND METHODS: Between January 1st, 2007, and March 31st, 2020 a total of 131 patients with CUP were treated. Out of these, 59 patients with a confirmed negative p16 analysis were referred to a so-called CUP-panendoscopy with simultaneous unilateral neck dissection followed by adjuvant therapy. The cut-off between tumor removal and delivery of adjuvant therapy was set at the median, i.e. patients receiving adjuvant therapy below or above the median time interval. RESULTS: Depending on the median time interval of 55 days (d) (95% CI 51.42-84.52), 30 patients received adjuvant therapy within 55 d (mean 41.69 d, SD = 9.03) after surgery in contrast to 29 patients at least after 55 d (mean 73.21 d, SD = 19.16). All patients involved in the study were diagnosed in advanced tumor stages UICC III (n = 4; 6.8%), IVA (n = 27; 45.8%) and IVB (n = 28; 47.5%). Every patient was treated with curative neck dissection. Adjuvant chemo (immune) radiation was performed in 55 patients (93.2%), 4 patients (6.8%) underwent adjuvant radiation only. The mean follow-up time was 43.6 months (SD = 36.7 months). The 5-year OS rate for all patients involved was 71% (95% CI 0.55-0.86). For those patients receiving adjuvant therapy within 55 d (77, 95% CI 0.48-1.06) the OS rate was higher, yet not significantly different from those with delayed treatment (64, 95% CI 0.42-0.80; X2(1) = 1.16, p = 0.281). Regarding all patients, the 5-year DSS rate was 86% (95% CI 0.75-0.96). Patients submitted to adjuvant treatment in less than 55 d the DSS rate was 95% (95% CI 0.89-1.01) compared to patients submitted to adjuvant treatment equal or later than 55 d (76% (95% CI 0.57-0.95; X2(1) = 2.32, p = 0.128). The 5-year PFS rate of the entire cohort was 72% (95% CI 0.59-0.85). In the group < 55 d the PFS rate was 78% (95% CI 0.63-0.94) and thus not significantly different from 65% (95% CI 0.45-0.85) of the group ≥55 d; (X2(1) = 0.29, p = 0.589). CONCLUSIONS: The results presented suggest that the oncologic outcome of patients with advanced, HPV-negative CUP of the head and neck was not significantly affected by a prolonged period between surgery and adjuvant therapy. Nevertheless, oncologic outcome tends to be superior for early adjuvant therapy.

Reduction of Elective Radiotherapy Treatment Volume in Definitive Treatment of Locally Advanced Head and Neck Cancer-Comparison of a Prospective Trial with a Revised Simulated Contouring Approach.

Definitive radiochemotherapy of locally advanced head and neck squamous cell cancer (HNSCC) achieves high locoregional tumor control rates; but is frequently associated with long-term toxicity. A future direction could be a de-escalation strategy focusing on treated volume rather than radiotherapy dose. This analysis evaluates radiotherapy dose and volume parameters of patients treated with a standard contouring approach in a clinical trial context compared with a revised volume-reduced contouring approach. In this case, 30 consecutive patients from the CheckRad-CD8 trial treated at a single study center were included in this analysis. Treatment toxicity and quality of life were assessed at the end of radiotherapy. Standard treatment plans (ST) following state of the art contouring guidelines that were used for patient treatment and volume reduced treatment plans (VRT) according to a revised simulated approach were calculated for each patient. Planning target volumes (PTV) and mean doses to 38 organs-at-risk structures were compared. At the end of radiotherapy patients reported high rates of mucositis; dysphagia and xerostomia. In addition; patient reported quality of life as assessed by the EORTC QLQ-HN35 questionnaire deteriorated. Comparing the two contouring approaches; the elective PTV_56 Gy and the high risk PTV_63 Gy (shrinking field) were significantly smaller in the VRT group. Significant reduction of mean dose to structures of the oral cavity; the larynx as well as part of the swallowing muscles and the submandibular glands was achieved in the simulated VRT-plan. Treatment de-intensification by reduction of the irradiated volume could potentially reduce treatment volume and mean doses to organs at risk. The proposed contouring approach should be studied further in the context of a clinical trial.

Salvage laryngectomy after primary radio- and radiochemotherapy : A retrospective study.

BACKGROUND: Recurrent and residual laryngeal cancer after organ-preserving radio- or radiochemotherapy is associated with a poor prognosis. Salvage surgery is the most important therapeutic option in these cases. OBJECTIVE: The study assessed rates of recurrence and residual tumor as well as survival and complication rates after salvage laryngectomy at the authors' academic cancer center. MATERIALS AND METHODS: A retrospective examination of all patients receiving laryngectomy between 2001 and 2019 due to tumor residuals or recurrence after primary radio- and radiochemotherapy was conducted. RESULTS: A total of 33 salvage procedures were performed. Defect reconstruction was performed by free flap surgery in 30.3% (n = 10) and regional flap surgery in 15.2% (n = 5) . One patient received regional flap surgery and free flap surgery simultaneously. Overall survival after 1, 2, and 5 years was 68.7, 47.9, and 24.2%, and disease-free survival was 81.6, 47.8, and 24.2%, respectively, with 48.5% (n = 16) postoperative tumor recurrences overall. Disease-free survival was significantly shorter for tumor extension into or onto the hypopharynx (p = 0.041). Postoperatively, 72.7% of patients developed a pharyngocutaneous fistula, of which 24.2% required surgical treatment. The hospital stay was 28.0 ± 16.1 days. CONCLUSION: Salvage laryngectomy is associated with a high rate of treatable complications and high morbidity. Nevertheless, considering the advanced tumor stages treated, it allows for respectable oncological results.

A complex fracture of the hyoid bone and the larynx after a bicycle accident - Case report and review of literature.

INTRODUCTION AND IMPORTANCE: Reports about laryngeal trauma and fractures of the hyoid bone are rare in the literature. Most cases are forensic cases and the results of postmortem analysis. Traumatic larynx and hyoid bone fractures represent a rare but important differential diagnosis of the common symptom hoarseness. CASE PRESENTATION: A 60-year-old female patient presented with unclear dysphonia and globus sensation following intubation for a surgical treatment for a lower leg fracture after a bicycle accident two months ago. Endoscopy and the computed tomography (CT) of the neck revealed a fixed and immobile fractured piece of the larynx, a hyoid bone fracture and a pseudarthrosis between the greater horn of the hyoid bone and the upper edge of the thyroid cartilage. The hyoid bone fracture led to a distortion of the supraglottis. After surgical removal of the fractured part of the hyoid bone and the pseudarthrosis separation, the supraglottis appeared symmetrical again. Four weeks after surgery the patient was symptom-free. CLINICAL DISCUSSION: Though combined hyoid bone and larynx fractures after traumatic injuries are rare, they represent an important differential diagnosis in trauma patients with dysphagia or dysphonia. The clinical symptoms can vary and occur immediately or within a latent period taking weeks or months until the proper diagnosis. Depending on the symptoms, surgical management can be effective. CONCLUSION: An isolated partial resection of the hyoid bone with separation of the pseudarthrosis is a reasonable therapeutic option and can lead to completely resolving symptom. Preoperatively, a CT provides further valuable information.

The value of transcutaneous ultrasound in the diagnosis of tonsillar abscess: A retrospective analysis.

OBJECTIVE: To identify the appropriate treatment in the tonsillar region's infections, a distinction between tonsillitis with or without abscess formation is essential. Ultrasound proved to be a valuable method in identifying abscess formation in the head and neck region. However, no report described the assessment of the tonsil region. This study aims to determine the feasibility of transcervical ultrasound for abscess visualization in the palatal tonsillar region. METHODS: Retrospective analysis of 354 patients presenting with clinical suspicion of tonsillar abscess to a tertiary referral center and university hospital. All patients received a transcervical ultrasound to establish a primary diagnosis. The existence of an abscess was confirmed by puncture and incision, or final tonsillectomy. If no abscess could be delineated, non-abscessing tonsillitis was supposed, and conservative primary therapy and closed follow-up examinations were performed. RESULTS: After the first diagnostic ultrasound examination, in 257 cases (72.59%), the diagnosis of an abscess could be established, but in 97 cases (27.40%), due to missing abscess formation criteria, non-abscessing tonsillitis was documented. Overall, ultrasonography demonstrated an overall accuracy of 78.8% in this selected cohort. The sensitivity, specificity, PPV, and NPV after the first ultrasound examination were calculated with 75.1%, 88.6%, 94.6%, and 57.3%, respectively. CONCLUSION: The presented data confirm that an abscess formation due to tonsillitis can be detected by transcervical ultrasound, enabling prompt, adequate management. As transcervical ultrasound can be conducted fast and is not associated with radiation, it can be regarded as a first-line diagnostic tool in this condition.

Implementation of Double Immune Checkpoint Blockade Increases Response Rate to Induction Chemotherapy in Head and Neck Cancer.

To determine whether a single dose of double immune checkpoint blockade (induction chemoimmunotherapy (ICIT)) adds benefit to induction single-cycle platinum doublet (induction chemotherapy (IC)) in locally advanced head and neck squamous cell carcinoma (HNSCC), patients treated with cisplatin 30 mg/m2 d1-3 and docetaxel 75 mg/m2 d1 combined with durvalumab 1500 mg fixed dose d5 and tremelimumab 75 mg fixed dose d5 (ICIT) within the CheckRad-CD8 trial were compared with a retrospective cohort receiving the same chemotherapy (IC) without immunotherapy. The endpoint of this analysis was the complete response rate (CR). A total of 53 patients were treated with ICIT and 104 patients with IC only. CR rates were 60.3% for ICIT and 40.3% for IC (p = 0.018). In the total population (n = 157), the most important predictor to achieve a CR was treatment type (OR: 2.21 for ICIT vs. IC; p = 0.038, multivariate analysis). The most diverse effects in CR rates between ICIT and IC were observed in younger (age ≤ 60) patients with HPV-positive OPSCCs (82% vs. 33%, p = 0.176), while there was no difference in older patients without HPV-positive OPSCCs (53% vs. 48%). The analysis provides initial evidence that ICIT could result in higher CR rates than IC. Young patients with HPV-positive OPSCCs may have the greatest benefit from additional immune checkpoint inhibitors.

Analysis and visualization of sleep stages based on deep neural networks.

Automatic sleep stage scoring based on deep neural networks has come into focus of sleep researchers and physicians, as a reliable method able to objectively classify sleep stages would save human resources and simplify clinical routines. Due to novel open-source software libraries for machine learning, in combination with enormous recent progress in hardware development, a paradigm shift in the field of sleep research towards automatic diagnostics might be imminent. We argue that modern machine learning techniques are not just a tool to perform automatic sleep stage classification, but are also a creative approach to find hidden properties of sleep physiology. We have already developed and established algorithms to visualize and cluster EEG data, facilitating first assessments on sleep health in terms of sleep-apnea and consequently reduced daytime vigilance. In the following study, we further analyze cortical activity during sleep by determining the probabilities of momentary sleep stages, represented as hypnodensity graphs and then computing vectorial cross-correlations of different EEG channels. We can show that this measure serves to estimate the period length of sleep cycles and thus can help to find disturbances due to pathological conditions.

Questionnaire-based detection of immune-related adverse events in cancer patients treated with PD-1/PD-L1 immune checkpoint inhibitors.

BACKGROUND: Immune checkpoint inhibitors (ICI) have become standard treatment in different tumor entities. However, safe treatment with ICI targeting the PD-1/PD-L1 axis requires early detection of immune-related adverse events (irAE). There exist different questionnaires of drug manufacturers for the detection of irAE that have not been validated so far. METHODS: The prospective non-interventional ST-ICI trial studied treatment with PD-1/PD-L1 ICI alone or combined with radiotherapy. In the current analysis, the detection rate of self-reported irAE with a patient questionnaire containing 41 different questions was compared to clinician-reported irAE. RESULTS: Between April 2017 and August 2019, a total of 104 patients were prospectively enrolled. NSCLC (44%) and HNSCC (42%) were the most frequent tumor entities. A total of 784 questionnaires were collected. A total of 29 irAE were reported by clinicians. The most frequent irAE was hypothyroidism (9%), followed by skin reactions (5%), hepatitis (4%), diarrhea (3%), and pneumonitis (3%). Questions that became significantly more often positive at time points of clinician-reported irAE were "weight change", "difficulty to grip things", "bloody or mucous stool" and "insomnia". Self-reported organ-specific questions detected at least 50% of clinician-reported irAE of gastrointestinal, lung, endocrine, and skin irAE. It was not possible to detect hepatic irAE with the questionnaire. CONCLUSION: Questionnaires can help to detect gastrointestinal, lung, endocrine, or skin irAE, but not hepatic irAE. Questions on "weight change" and "insomnia" may help to increase the detection rate of irAE, besides organ-specific questions. These results are a valuable contribution to the future development of a specific and practicable questionnaire for early self-reported detection of irAE during ICI therapy in cancer patients. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03453892 . Registered on 05 March 2018.

Ultrasound-Controlled Manual Magnet Repositioning in Magnet Dislocation of Cochlear Implants.

OBJECTIVE: To investigate whether ultrasound is a helpful and reliable diagnostic tool to survey the status of the magnet previous and after manual repositioning in patients with partially dislocated cochlear implant (CI) magnets and to assess the success rate of a manual repositioning maneuver. DESIGN: A prospective cohort study. SETTING: A tertiary referral medical center. PATIENTS: Patients with a cochlear implant who presented with magnet dislocation after magnetic resonance imaging (MRI) between June 1, 2019 and July 15, 2020. INTERVENTIONS: Manual repositioning of the partially dislocated CI magnet surveyed by pre- and post-interventional ultrasound. MAIN OUTCOME MEASURES: Rate of successfully diagnosed and manually repositioned magnets; complication rate and recurrence rate after initial manual repositioning maneuver. RESULTS: Nine patients presented with a partial magnet dislocation diagnosed by pre-interventional ultrasound following MRI (n = 9 magnets; three ♀; eight right-sided implants; 65.4 ±â€Š21.7 yr). All magnets were repositioned manually. The magnets were successfully repositioned at the first attempt in six out of eight patients. Two patients required a second and one patient a third attempt of manual repositioning. Post-interventional ultrasound confirmed the entirely restored magnet position in all cases. During the mean follow-up period of 7.3 months (±5.4 mo) no patient experienced any complication or recurrent dislocation of the respective magnet. CONCLUSION: Manual magnet repositioning is a feasible and reliable method with a high success rate for partially dislocated CI magnets. The pre-interventional diagnosis as well as the post-interventional confirmation of the magnet status can be effectively determined by ultrasound. Thus, manual magnet repositioning and ultrasound investigation can be advocated as first-line therapeutic and diagnostic instruments when dealing with partial magnet dislocation.

Influence of p16 status on indication and outcome of salvage neck dissection in oropharyngeal cancer.

BACKGROUND: Human papillomavirus (HPV)+ and HPV- oropharyngeal squamous cell carcinomas (OPSCC) are separate tumor entities. AIMS/OBJECTIVES: The aim of this study was to examine if the p16 status influences the need and outcome of a salvage neck dissection (SND) after primary radiochemotherapy (pRCT). MATERIAL AND METHODS: Retrospective study of 164 patients (n = 108 p16-, n = 56 p16+) who underwent pRCT for OPSCC between 2009 and 2016. HPV status was defined via p16 immunohistochemical staining. Clinical nodal status was assessed using ultrasound and computed tomography of the neck with contrast. RESULTS: Of the 56 p16+ patients, 17 (30.4%) patients were given an indication for a SND after pRCT with 4 (23.5%) patients showing persistent malignant nodes. Of the 108 p16- patients, 24 (22.2%) patients underwent a SND with 8 (33.3%) patients showing persistent malignant nodes. There was no significant association of the p16 status and neither the indication for SND (p(Chi2(two-sided)-Test) = 0.25, ϕ = 0.34) nor the occurrence of positive nodes (p(Chi2(two-sided)-Test) = 0.74, ϕ = 0.50). The probability for persistence of the ypN + nodal status independent of HPV-status was 29.2%(12/41). CONCLUSIONS AND SIGNIFICANCE: There was neither a significant association between the p16 status and the indication for a SND nor for persistent malignant nodal disease after pRCT.

Considerations for Continuing Semielective and Emergency Otolaryngological Procedures During the COVID-19 Pandemic.

INTRODUCTION: During the COVID-19 pandemic, worldwide over 600,000 human beings died due to the cause of the disease. In order to deescalate the transmission rate and to avoid crush loading the countries medical health systems social distancing, face masks, and lockdowns have been considered essential by the majority of governments. Whereas some countries have highly reduced or completely stopped otorhinolaryngological procedures, other countries have continued selected surgeries. The objective of this study was to analyze procedures and outcomes of continuing semielective and emergency surgeries during the COVID-19 pandemic. METHODS: Retrospective analysis of n = 750 patients who received semi-elective or emergency surgery between March 26 and June 16, 2020, in the Otolaryngology Department of the Friedrich-Alexander-University of Erlangen-Nürnberg. All patients were screened for COVID symptoms and swabbed for SARS-CoV-2 prior to surgery. RESULTS: Of the n = 750 patients, n = 699 patients received semielective surgery and n = 51 emergency surgery. For 27 patients, the swab result could not be awaited due to a life-threatening condition. In these cases, surgery was performed in full protective equipment. No patient was tested positive during or after the surgery (follow-up 45 to 127 days). No member of the medical personnel showed symptoms or was tested positive after contact with patients. Due to the continuation of surgeries, patients' lives were saved and improvement of long-term quality-of-life and outcomes is anticipated. CONCLUSIONS: Continuing selected otorhinolaryngological surgeries is crucial for patients' health, survival, and long-time quality of life, yet, the protection of the medical personnel has to be granted.