A systematic review on the efficacy of tranexamic acid in head and neck surgery.

BACKGROUND: Intraoperative and postoperative blood loss is a major risk in head and neck (H&N) surgery. Recently the use of tranexamic acid (TXA) has been investigated by multiple studies for reducing intraoperative and postoperative bleeding, however reported results are variable. OBJECTIVES: To determine the safety and efficacy of TXA use in H&N surgery. METHODS: Systematic review of MEDLINE, EMBASE, CINAHL, Cochrane Library, PubMed, ClinicalKey, and Clinicaltrials.gov according to the PRISMA guidelines. Studies were included if they reported on intraoperative bleeding, volume or duration of postoperative drain or return to theatre rate for postoperative haemorrhage in adult populations following use of TXA. Risk of bias assessment with Cochrane Risk of Bias (RoB2) tool for randomised controlled trials and Newcastle-Ottawa Scale tool for non-randomised studies. RESULTS: Sixteen studies were identified (114 407 patients). Eight studies evaluated TXA in major H&N surgery and eight studies in tonsillectomy. Primary outcomes were reduction in intraoperative or postoperative bleeding. Secondary outcomes included the duration of postoperative drain placement and return to theatre rate. No adverse events were reported in any patients. TXA is effective in reducing intraoperative blood loss in tonsillectomy. However, the effect on posttonsillectomy haemorrhage was unclear. Insufficient evidence exists of benefit of TXA on intraoperative bleeding in major H&N procedures. Postoperative drainage volumes were significantly reduced in most major H&N studies. The duration of drain placement and risk of blood transfusion was unchanged in most cases. CONCLUSION: TXA use is safe in H&N patients. Whilst sufficient evidence exists to support the use of TXA in tonsillectomy, insufficient evidence exists to recommend use in major H&N surgery.

A retrospective cohort study of telephone versus face-to-face clinics for the management of new otology referrals.

PURPOSE: To compare outcomes of telephone and face-to-face consultations for new otology referrals and discuss the wider use of telemedicine in otology. METHODS: Retrospective cohort study including new adult otology referrals to our unit, sampled consecutively between March 2021 and May 2021, seen in either a face-to-face or telephone clinic. Primary outcome measure was the proportion of patients with a definitive management outcome (discharged or added to waiting list for treatment) versus the proportion of patients requiring follow-up for further assessment or review. RESULTS: 150 new patients referred for a routine otology consultation (75 telephone, 75 face-to-face) were included. 53/75 patients (71%) undergoing a face-to-face consultation received a definitive outcome following initial review, versus 22/75 (29%) telephone patients (χ2 < 0.001, OR 5.8). 52/75 (69%) telephone patients were followed up face-to-face for examination. The mean (SD) number of appointments required to reach a definitive outcome was 1.22 (0.58) and 1.75 (0.73) in the face-to-face and telephone cohorts, respectively (p < 0.001). CONCLUSIONS: Telephone clinics in otology have played an important role as part of the COVID19 response. However, they are currently limited by a lack of clinical examination and audiometry. Remote assessment pathways in otology that incorporate asynchronous review of recorded examinations alongside audiometry, either conventional or boothless, may mitigate this problem; however, further research is required.

Electrical impedance guides electrode array in cochlear implantation using machine learning and robotic feeder.

Cochlear Implant provides an electronic substitute for hearing to severely or profoundly deaf patients. However, postoperative hearing outcomes significantly depend on the proper placement of electrode array (EA) into scala tympani (ST) during cochlear implant surgery. Due to limited intra-operative methods to access array placement, the objective of the current study was to evaluate the relationship between EA complex impedance and different insertion trajectories in a plastic ST model. A prototype system was designed to measure bipolar complex impedance (magnitude and phase) and its resistive and reactive components of electrodes. A 3-DoF actuation system was used as an insertion feeder. 137 insertions were performed from 3 different directions at a speed of 0.08 mm/s. Complex impedance data of 8 electrode pairs were sequentially recorded in each experiment. Machine learning algorithms were employed to classify both the full and partial insertion lengths. Support Vector Machine (SVM) gave the highest 97.1% accuracy for full insertion. When a real-time prediction was tested, Shallow Neural Network (SNN) model performed better than other algorithms using partial insertion data. The highest accuracy was found at 86.1% when 4 time samples and 2 apical electrode pairs were used. Direction prediction using partial data has the potential of online control of the insertion feeder for better EA placement. Accessing the position of the electrode array during the insertion has the potential to optimize its intraoperative placement that will result in improved hearing outcomes.

A Capacitive Cochlear Implant Electrode Array Sensing System to Discriminate Fold-Over Pattern.

Purpose During insertion of the cochlear implant electrode array, the tip of the array may fold back on itself and can cause serious complications to patients. This article presents a sensing system for cochlear implantation in a cochlear model. The electrode array fold-over behaviors can be detected by analyzing capacitive information from the array tip. Method Depending on the angle of the array tip against the cochlear inner wall when it enters the cochlear model, different insertion patterns of the electrode array could occur, including smooth insertion, buckling, and fold-over. The insertion force simulating the haptic feedback for surgeons and bipolar capacitance signals during the insertion progress were collected and compared. The Pearson correlation coefficient (PCC) was applied to the collected capacitive signals to discriminate the fold-over pattern. Results Forty-six electrode array insertions were conducted and the deviation of the measured insertion force varies between a range of 20% and 30%. The capacitance values from electrode pair (1, 2) were recorded for analyzing. A threshold for the PCC is set to be 0.94 that can successfully discriminate the fold over insertions from the other two types of insertions, with a success rate of 97.83%. Conclusions Capacitive measurement is an effective method for the detection of faulty insertions and the maximization of the outcome of cochlear implantation. The proposed capacitive sensing system can be used in other tissue implants in vessels, spinal cord, or heart.

A Novel Capacitive Cochlear Implant Electrode Array Sensing System to Discriminate Failure Patterns.

OBJECTIVES: The research is to propose a sensing system to ensure the electrode array being correctly placed inside the cochlea. Instead of applying extra sensors to the array, the capacitive information from multiple points of the array is gathered and analyzed to determine the state and behavior of the electrode array. METHODS: The sensing system measures electrode bipolar capacitances between multiple pairs of electrodes during the insertion. The principal component analysis (PCA) method is then applied to analysis the recorded data to discriminate insertion patterns. RESULTS: In total, 384 capacitance profiles from electrode pair (1, 2), and electrode pair (15, 16) were analyzed and compared. In an account of both the electrode pairs, the threshold distance was examined to be d = 1.99 at the average comparison type. The experiment results showed the success rate is over 80% to identify buckling during the insertion on a 2D cochlear model. CONCLUSION: This early-stage investigation shows great potential compared with the current practice, which does not provide any feedback to surgeons. The system demonstrates the feasibility of a sensing method for auto-reoccupation electrodes behavior, and it will help surgeons to avoid misplacement of the electrode array inside the cochlea.

Noise Exposure on Human Cochlea During Cochleostomy Formation Using Conventional and a Hand Guided Robotic Drill.

OBJECTIVE: To investigate the disturbance induced in the cochlea during cochleostomy using conventional drill and a hand guided robotic drill. STUDY DESIGN: The study is based on experimental measurements using the Laser Doppler Vibrometer during the drilling processes converted to Sound Pressure Levels (SPL) for comparison. SETTING: The study is based on experimental results of three sets of cochleostomies on human cadaver heads. MAIN OUTCOME MEASURE(S): Robotic drilling, in comparison to the conventional drilling method, creates a consistently lower level of disturbance in cochlea across the hearing frequency range. RESULTS: Robotic drilling, in comparison to the conventional drilling method, creates a consistently lower level of disturbance in cochlea across the hearing frequency range. CONCLUSIONS: It is reasonable to conclude that robotic drilling has a lower possibility of creating acoustic trauma in cochlea that endangers the residual hearing of patients.

Telescopic otology referrals: Evaluation of feasibility and acceptability.

OBJECTIVE: A remote telemedical otology referral and advice service was introduced to interested general practices. General practitioners (GPs) were given a new device, "endoscope-i" that combines an optimized smartphone high definition video app with an otoendoscope. They were specifically trained to examine and capture images of patients' eardrums, which were sent electronically with a summary of clinical information and an in-app hearing testing (if required), for specialist advice to two ear, nose, and throat (ENT) consultants. We describe the findings from an evaluation of the first 6 months of this service to establish the feasibility and acceptability of an otology telemedical referral and advice service. METHODS: The new service was advertised to GP practices in Northern Staffordshire. All interested GPs were provided with training and equipment to deliver the remote referral service. Data were collected from GPs at baseline, informal feedback in response to referral outcomes and end of service feedback. Referral data were collected routinely during the service delivery. RESULTS: Fifteen GP leads from 15 practices received training and equipment. One quickly lost the equipment. Of the remaining 14 practices, eight sent a total of 53 remote referrals using this technology over 6 months. The most common reason for referral was an uncertainty of what could be seen in or around the eardrum. The primary barrier for implementation was lack of wireless internet connections within practices. GPs reported that they used this technology to share examination findings with patients. CONCLUSIONS: GPs were positive about the technology, from initial engagement with training and after advice were given. Some GPs expanded the role of the technology to a consultation aid. Referral volume was manageable. Commissioners should consider tariffs structures for such services; empirical cost-effectiveness and workload-impact evaluation would inform this.

Can Preoperative High Resolution Computed Tomography Be Rationalized in Adult Cochlear Implant Candidates?

OBJECTIVE: To establish whether criteria can be used to identify patients who do not need high resolution computed tomography (HRCT) scans before cochlear implant operations, by retrospectively applying a preoperative selection pathway, the Cambridge Cochlear Implant Protocol (CCIP). STUDY DESIGN: Retrospective case series. SETTING: Tertiary referral center, Queen Elizabeth Hospital, Birmingham, UK (QEHB). PATIENTS: One hundred adult patients receiving primary cochlear implantation (CI) operations from April 2015 to July 2016 performed at the QEHB who received preoperative HRCTs. MAIN OUTCOME MEASURES: Etiology of hearing loss and anatomical abnormalities were collected by reanalyzing HRCT scans. Patients were retrospectively grouped according to criteria to restrict HRCT use derived from the Cambridge Cochlear Implant Programme (CCIP). The two main outcomes, recorded management change and significant abnormalities, were compared between the two CCIP groups, scanned and not scanned. RESULTS: Twenty-six patients had significant abnormalities detected on imaging, 16 in the scanned group and 10 in the not scanned group (p = 0.152). Five patients had a recorded management change as a result of HRCT scan, four scanned group, one not scanned group (p = 0.107). Significant abnormalities and recorded management change were seen across all etiological subgroups of hearing loss. CONCLUSION: The anatomy within the temporal bone is variable amongst CI recipients. Recorded management change and significant abnormalities occurred in both CCIP groups and across many etiologies of hearing loss patients. No specific group, based on the etiology of their hearing loss could be identified that do not require preoperative HRCT. Therefore, it is recommended that all CI patients should continue to receive preoperative HRCT imaging.

A hand-guided robotic drill for cochleostomy on human cadavers.

BACKGROUND: An arm supported robotic drill has been recently demonstrated for preparing cochleostomies in a pilot research clinical trial. In this paper, a hand-guided robotic drill is presented and tested on human cadaver trials. METHODS: The innovative smart tactile approach can automatically detect drilling mediums and decided when to stop drilling to prevent penetrating the endosteum. The smart sensing scheme has been implemented in a concept of a hand guided robotic drill. RESULTS: Experiments were carried out on two adult cadaveric human bodies for verifying the drilling process and successfully finished cochleostomy on three cochlea. The advantage over a system supported by a mechanical arm includes the flexibility in adjusting the trajectory to initiate cutting without slipping. Using the same concept as a conventional drilling device, the user will also be benefit from the lower setup time and cost, and lower training overhead. CONCLUSION: The hand-guided robotic drill was recently developed for testing on human cadavers. The robotic drill successfully prepared cochleostomies in all three cases.

A Comparison of Cochlear Nerve Size in Normal-Hearing Adults Using Magnetic Resonance Imaging.

OBJECTIVE: Cochlear implantation is a clinical and cost-effective treatment for severe hearing loss. Cochlear nerve size assessment by magnetic resonance imaging (MRI) has been investigated for use as a prognostic indicator following cochlear implantation. This study aimed to further that research by assessing nerve size in normal-hearing adults for symmetry. MATERIALS AND METHODS: Patients with tinnitus presenting to our center retrospectively had their nerve size assessed by MRI. RESULTS: The study found no significant differences between right and left cochlear nerves in normal-hearing adults, supporting our hypothesis of symmetry in these individuals. This was a previously unproven and uninvestigated hypothesis. CONCLUSION: Nerve size assessment should remain an active area of research in otological disease.

Systematic review: Radiological and histological evidence of cochlear implant insertion trauma in adult patients.

INTRODUCTION: Cochlear implantation (CI) has developed from its origins in the 1980s. Initially, CI was for profound bilateral hearing impairment. However, candidacy for CI have become more widespread in recent years with unilateral implantation and an emphasis on hearing preservation. Evidence supports full electrode insertion in an atraumatic fashion into the scala tympani (ST) provides optimal hearing outcomes. The main aim of this systematic review was to elucidate the degree of trauma associated with CI insertion. METHODS: A systematic literature search was undertaken using PubMed Medline. A grading system described by Eshraghi was used to classify cochlear trauma. Both radiological and histological studies were included. RESULTS: Twenty one papers were identified which were relevant to our search. In total, 653 implants were inserted and 115 (17.6%) showed evidence of trauma. The cochleas with trauma had basilar membrane elevation in 5.2%, ruptured in 5.2%, the electrode passed from the ST to the SV in 84.4% and there was grade 4 trauma in 5.2%. The studies used a variety of histological and radiological methods to assess for evidence of trauma in both cadaveric temporal bones and live recipients. CONCLUSIONS: Minimizing cochlear trauma during implant insertion is important to preserve residual hearing and optimize audiological performance. An overall 17.6% trauma rate suggests that CI insertion could be improved with more accurate and consistent electrode insertion such as in the form of robotic guidance. The correlation of cochlea trauma with post-operative hearing has yet to be determined.

Patient safety in otolaryngology: a descriptive review.

Human evaluation and judgement may include errors that can have disastrous results. Within medicine and healthcare there has been slow progress towards major changes in safety. Healthcare lags behind other specialised industries, such as aviation and nuclear power, where there have been significant improvements in overall safety, especially in reducing risk of errors. Following several high profile cases in the USA during the 1990s, a report titled "To Err Is Human: Building a Safer Health System" was published. The report extrapolated that in the USA approximately 50,000 to 100,000 patients may die each year as a result of medical errors. Traditionally otolaryngology has always been regarded as a "safe specialty". A study in the USA in 2004 inferred that there may be 2600 cases of major morbidity and 165 deaths within the specialty. MEDLINE via PubMed interface was searched for English language articles published between 2000 and 2012. Each combined two or three of the keywords noted earlier. Limitations are related to several generic topics within patient safety in otolaryngology. Other areas covered have been current relevant topics due to recent interest or new advances in technology. There has been a heightened awareness within the healthcare community of patient safety; it has become a major priority. Focus has shifted from apportioning blame to prevention of the errors and implementation of patient safety mechanisms in healthcare delivery. Type of Errors can be divided into errors due to action and errors due to knowledge or planning. In healthcare there are several factors that may influence adverse events and patient safety. Although technology may improve patient safety, it also introduces new sources of error. The ability to work with people allows for the increase in safety netting. Team working has been shown to have a beneficial effect on patient safety. Any field of work involving human decision-making will always have a risk of error. Within Otolaryngology, although patient safety has evolved along similar themes as other surgical specialties; there are several specific high-risk areas. Medical error is a common problem and its human cost is of immense importance. Steps to reduce such errors require the identification of high-risk practice within a complex healthcare system. The commitment to patient safety and quality improvement in medicine depend on personal responsibility and professional accountability.

Quality of Information Available Via the Internet for Patients With Otological Conditions.

OBJECTIVE: Evaluate the type, content, and quality of information available via the Internet for patients with common otological conditions. METHODS: The Google search engine was used to generate responses for the following search terms: glue ear, otitis media, otosclerosis, Ménière's disease, cholesteatoma, and ear perforation. The first 10 websites for each search term were selected for analysis. Websites were evaluated with the validated DISCERN instrument (Institute of Health Sciences, University of Oxford, UK), the LIDA tool (Minervation Ltd, Oxford, UK), the Flesch Readability Formula, the Simple Measure Of Gobbledygook (SMOG) readability score, and against the Journal of the American Medical Association (JAMA) criteria. Comparisons were made with a similar study assessing quality of information in nonotological conditions. RESULTS: Mean SMOG score was 12.19 years of education (range, 6.2-22.8). The health on the net (HON) symbol appeared on 15 of 49 websites (30.61%). Pearson's r was used to identify interactions between variables and demonstrated a significant correlation between LIDA score and Google ranking (R = -0.1195, p = 0.002); between university/hospital affiliation and JAMA score (R = -1.7889, p = 0.0182) and commercial affiliation and JAMA score (R = 1.0561; p = 0.01). Multivariate linear regression analysis showed LIDA to be the strongest predictor of Google ranking (Page rank decreasing by 0.10572 per LIDA score; p = 0.01). CONCLUSION: As websites with better Google ranking were only weakly associated with higher quality rankings patients would benefit from being directed to reliable websites by clinicians. There is currently a gap in the available resources for a high quality repository of otological information aimed at patients.

Tympanoplasty for Chronic Tympanic Membrane Perforation in Children: Systematic Review and Meta-analysis.

OBJECTIVE: To study the effectiveness of Type 1 tympanoplasty for chronic tympanic membrane perforations in the pediatric age group and to investigate factors influencing its success. DATA SOURCES: Searches were conducted of the MEDLINE database and the Cochrane Database of Systematic Reviews using terms focused around tympanoplasty and children. Searches were performed on June 23, 2014 and limited to English language entries since January 1, 1997. STUDY SELECTION: Studies reporting tympanoplasty closure rates in children 18 years and younger, with a minimum follow-up of 6 months, were included. Studies focusing on more advanced forms of tympanoplasty and revision surgery were excluded. DATA EXTRACTION: Five hundred sixty-four articles were screened identifying 2,609 cases from 45 eligible studies. Data were collected by consensus of the first two authors with the third author arbitrating disparities of opinion. Success was taken as the closure rate at 12 months where possible. DATA SYNTHESIS: Forest plots with Mantel-Haenszel analyses were used to compare closure rates with respect to perforation size, adenoidectomy, status of contralateral ear, Eustachian tube function, active infection, and graft position. Linear regression and Fisher's exact were used to analyze closure rate with respect to age. CONCLUSION: The mean weighted closure rate for pediatric tympanoplasty was 83.4%. Subgroup analysis found age not to be a significant factor affecting the closure rate. Tympanoplasties performed on larger perforations or in children with abnormal contralateral ear findings were more likely to fail. Surgery may be best delayed until contralateral otitis media with effusion has settled.

Characterizing human vestibular sensory epithelia for experimental studies: new hair bundles on old tissue and implications for therapeutic interventions in ageing.

Balance disequilibrium is a significant contributor to falls in the elderly. The most common cause of balance dysfunction is loss of sensory cells from the vestibular sensory epithelia of the inner ear. However, inaccessibility of inner ear tissue in humans severely restricts possibilities for experimental manipulation to develop therapies to ameliorate this loss. We provide a structural and functional analysis of human vestibular sensory epithelia harvested at trans-labyrinthine surgery. We demonstrate the viability of the tissue and labeling with specific markers of hair cell function and of ion homeostasis in the epithelium. Samples obtained from the oldest patients revealed a significant loss of hair cells across the tissue surface, but we found immature hair bundles present in epithelia harvested from patients >60 years of age. These results suggest that the environment of the human vestibular sensory epithelium could be responsive to stimulation of developmental pathways to enhance hair cell regeneration, as has been demonstrated successfully in the vestibular organs of adult mice.

Cholesteatoma: a disease of the poor (socially deprived)?

Cholesteatoma is a condition describing the accumulation of squamous epithelium and keratinocytes within the middle ear space. There is conflicting evidence regarding the influence of socioeconomical status on the prevalence of cholesteatoma. Hospital episode statistics (HES) data detailing the numbers of cholesteatoma surgeries performed per area were compared with the Index of Multiple Deprivation 2010 (IMD 2010) data that give a statistical measure of deprivation per local health authority in the UK. Statistical analysis of this data was performed to identify correlations between prevalence of cholesteatoma and deprivation. A trend was identified showing that health authorities associated with an overall low IMD 2010 value indicating more deprived, had higher numbers of mastoid operations. Our results have found that increasing levels of deprivation are associated with greater numbers of mastoid operations and thus greater numbers of cholesteatomas. Our work suggests that there is a need for additional input in deprived areas to accommodate the increased numbers of mastoid operations and chronic middle ear disease.

Mechatronic feasibility of minimally invasive, atraumatic cochleostomy.

Robotic assistance in the context of lateral skull base surgery, particularly during cochlear implantation procedures, has been the subject of considerable research over the last decade. The use of robotics during these procedures has the potential to provide significant benefits to the patient by reducing invasiveness when gaining access to the cochlea, as well as reducing intracochlear trauma when performing a cochleostomy. Presented herein is preliminary work on the combination of two robotic systems for reducing invasiveness and trauma in cochlear implantation procedures. A robotic system for minimally invasive inner ear access was combined with a smart drilling tool for robust and safe cochleostomy; evaluation was completed on a single human cadaver specimen. Access to the middle ear was successfully achieved through the facial recess without damage to surrounding anatomical structures; cochleostomy was completed at the planned position with the endosteum remaining intact after drilling as confirmed by microscope evaluation.

Feasibility study of a hand guided robotic drill for cochleostomy.

The concept of a hand guided robotic drill has been inspired by an automated, arm supported robotic drill recently applied in clinical practice to produce cochleostomies without penetrating the endosteum ready for inserting cochlear electrodes. The smart tactile sensing scheme within the drill enables precise control of the state of interaction between tissues and tools in real-time. This paper reports development studies of the hand guided robotic drill where the same consistent outcomes, augmentation of surgeon control and skill, and similar reduction of induced disturbances on the hearing organ are achieved. The device operates with differing presentation of tissues resulting from variation in anatomy and demonstrates the ability to control or avoid penetration of tissue layers as required and to respond to intended rather than involuntary motion of the surgeon operator. The advantage of hand guided over an arm supported system is that it offers flexibility in adjusting the drilling trajectory. This can be important to initiate cutting on a hard convex tissue surface without slipping and then to proceed on the desired trajectory after cutting has commenced. The results for trials on phantoms show that drill unit compliance is an important factor in the design.