Detection accuracy of soft tissue complications during remote cochlear implant follow-up.

PURPOSE: After cochlear implantation (CI), long-term follow-up is obligatory. Remote-care options which provide a standard of care comparable to in-person consultations, could be an attractive addition to a cochlear implant centre's portfolio. The aim of this study was to evaluate the accuracy of photographs of the skin covering the implant to reliably detect skin irritations or soft tissue complications. METHODS: During routine follow-up consultations, 109 CI patients were examined in person and asked to take a photograph of the skin covering the implant using their smartphones. Photographs were digitally and remotely evaluated by two CI physicians who were blinded to the findings during the in-person examination. RESULTS: In nine cases, skin abnormalities were detected by the CI physician upon in-person examination, seven of which required immediate treatment. Both digital evaluators reliably detected all treatment-requiring conditions. Overall, more skin irritations were suspected digitally compared to in-person examination. Without additional information from the patients' medical record, sensitivity was 100% and specificity was 63%; with additional information provided, sensitivity was 100%, and specificity increased to 65.3%. CONCLUSION: Digital photographic assessment of the skin covering the implant is a highly sensitive method to detect skin irritations and could reduce the number of necessary in-person consultations.

Magnet dislocation following magnetic resonance imaging in cochlear implant users: Diagnostic pathways and managment.

OBJECTIVES: Although modern cochlear implants (CIs) are approved for magnetic resonance imaging (MRIs) adverse events still occur with unacceptable frequency. Methods: In this retrospective study, magnet displacement due to MRIs was analysed. Relevant factors e.g. symptoms during MRI, diagnostics, surgical intervention following the diagnosis and possible subsequent damage were assessed. RESULTS: 16 patients were enclosed. All patients complained about pain while the scan was conducted. Computed tomography (CT) scans of the temporal bone or X-rays of the skull were performed to confirm diagnosis. Artefacts on CT scans delayed immediate diagnosis in some cases. DISCUSSION: Despite various studies demonstrating the range of adverse events related to CIs following MRI, little information is available on diagnosis and radiologic recognition of magnet dislocation. In patients complaining about pain following an MRI scan an X-ray of the head should be performed immediately. Most adverse events occur in radiological centres without expertise in cochlear implants. CONCLUSION: Comprehensive training of patients, surgeons and radiologists is the most efficient tool to prevent damage to the CI and the patient. X-ray of the skull is suggested to be used as the method of choice in imaging.

[Results of surgical and radiotherapeutic treatment of adenoid cystic carcinoma of the salivary glands]. / Resultate der operativen und strahlentherapeutischen Behandlung von adenoidzystischen Karzinomen der Speicheldrüsen.

Surgical treatment in patients with rare adenoid cystic carcinoma (ACC) of the salivary glands is considered to be the state of the art. With respect to an additional radiotherapy there are different approaches regarding the type of radiotherapy and timing. In this study the overall survival and recurrence-free survival in 52 individuals with salivary gland ACC who were treated at the University Hospital in Essen and received irradiation with fast neutrons and photons (mixed beam technique) either A) immediately following surgical treatment or B) only after the appearance of local recurrence were compared. Group A (n = 28, first diagnosis, FD September 1991-September 2009) received adjuvant radiotherapy immediately postoperative, group B (n = 24, FD June 1979-November 2001) underwent primarily surgical tumor resection according to the treatment regimen at that time and were irradiated only on the appearance of a local recurrence. In comparison to group B, patients in group A showed a lower recurrence rate and a significantly longer local relapse-free survival. Group B, however, showed a significantly higher overall survival. The frequency of distant metastasis occurred equally in both groups but the onset of distant metastasis was significantly earlier in group A. In general, overall survival was negatively influenced by distant metastasis. The local recurrence rate was very high after primary surgical treatment only. The immediate adjuvant high-linear energy transfer (LET) radiotherapy reduced the local recurrence rates. Irradiation after the appearance of a recurrence had a positive influence on overall survival. Overall, definitive high-LET radiotherapy in the mixed beam technique enabled high local control rates both primarily postoperative and also locoregional recurrences.

Electrophysiological detection of electrode fold-over in perimodiolar cochlear implant electrode arrays: a multi-center study case series.

PURPOSE: It is important for the surgeon to determine the position of the CI electrode array during and after its placement within the cochlea. Most preferably, this should be within the scala tympani to obtain the best audiological outcome. Thus, misplacement into the scala vestibuli or tip fold-over should be prevented. Since there are different ways to ensure proper positioning of the electrode array within the scala tympani (e.g., intraoperative radiography, electrophysiological recordings), our study was aimed at detecting intraoperative electrophysiologic characteristics to better understand the mechanisms of those electrode tip fold-overs. MATERIAL AND METHODS: In a multi-centric, retrospective case-control series, patients with a postoperatively by radiography detected tip fold-over in perimodiolar electrodes were included. The point of fold-over (i.e., the electrode position) was determined and the intraoperative Auto-NRT recordings were analysed and evaluated. RESULTS: Four patients were found to have an electrode tip fold-over (out of 85 implantees). Significant changes of the Auto-NRT recordings were not detected. All tip fold-overs occurred in the most apical part of the electrodes. DISCUSSION: Cochlear implantation for hearing impaired patients plays a decisive role in modern auditory rehabilitation. Perimodiolar electrode arrays may fold over during the insertion and, hence, could have a negative impact on audiological outcome. Characteristic electrophysiologic changes to possibly predict this were not found in our series.

Electric compound action potentials (ECAPs) and impedances in an open and closed operative site during cochlear implantation.

INTRODUCTION: In patients undergoing cochlear implantation, intraoperative measures of impedance and electrically evoked compound action potentials (ECAPs) are used to confirm device integrity and electrode array position. However, these electrophysiological parameters have been shown to decrease over time, with a small decrement observable as early as 24 h post implantation and becoming more apparent after 6 months. Whether the intraoperatively measured impedances and ECAPs recorded immediately after electrode insertion versus later in the operation or in an open versus closed operative site vary has not been documented. Such variation in measurement procedure may affect the ultimate operative outcome. PATIENTS AND METHODS: Between February and October 2016, 38 patients received a cochlear implant (Cochlear®), with half receiving a CI 522 device and the other half receiving a CI 512 device. These patients were distributed into three groups. In the first (group A; n = 21), the impedance and threshold neural response telemetry (tNRT) measures were taken before (M1) and after cutaneous suture (M2), whereas in the second group (group B; n = 11) they were taken twice in the open operative site, once at the time of electrode insertion (M1) and then again 10 min later (M2). The last group (group C; n = 6) was measured only once after a 10 min waiting time before closing the operative site. RESULTS: tNRTs of both group A and B were significantly higher at M1 than measured at M2. The magnitude of change in tNRT did vary significantly by group (P = .027) with group A having a bigger decrease than group B. For impedances there was evidence for a significant difference in M2 between the three groups (P = .012), with group C having significantly higher values compared to group A and B. CONCLUSION: Intraoperative tNRT measures change significantly over time, including within the first 10 min of implantation. One underlying etiology of this phenomenon for tNRTs seems to be the condition of the surgical site whereas changes of impedances can be best explained by the 'electrochemical cleaning' theory associated with the first stimulation of the electrode. However, for both impedances and tNRTs there also is an important impact of time as well as of acute perioperative changes in electrical conductivity.

Comparison of radiation doses imparted during 128-, 256-, 384-multislice CT-scanners and cone beam computed tomography for intra- and perioperative cochlear implant assessment.

PURPOSE: To examine radiation-doses imparted during multislice (MSCT) and cone-beam computed-tomography (CBCT) for perioperative examination of cochlear-implant insertion. METHODS: Radiation-doses were assessed during standardized petrous-bone CT-protocols at different MSCT ((I) single-source CT-scanner Somatom-Definition-AS+, (II) 2nd generation of dual-source CT-scanner Somatom-Definition-Flash, (III) 3rd generation of dual-source CT-scanner Somatom-Force and at the CBCT Ziehm-Vision-RFD3D ((IV) (a) RFD-3D (Standard-modifier), (b) RFD-3D (Low-dose-modifier)). Image quality was examined by two radiologists appraising electrode-array placement, quality-control of cochlear-implant surgery and complications based on real patients' examinations (n=78). RESULTS: In MSCT-setting following radiation-doses were assessed (CTDIw; DLP): (I) 21.5mGy; 216mGycm; (II) 19.7mGy; 195mGycm; (III) 12.7mGy; 127mGycm; in the CBCT setting radiation doses were distributed as follows: (IV) (a) 1.9mGy; 19.4mGycm; (b) 1.2mGy; 12.9mGycm. Overall, image quality was evaluated as good for both, MSCT- and CBCT-examinations, with a good interrater reliability (r=0.81). CONCLUSION: CBCT bears considerable dose-saving potential for the perioperative examination of cochlear-implant insertion while maintaining adequate image quality.

Electrophysiological detection of scalar changing perimodiolar cochlear electrode arrays: a long term follow-up study.

The position of the cochlear electrode array within the scala tympani is essential for an optimal hearing benefit. An intraoperative NRT-ratio was established, which can provide information about the intraoperative intracochlear electrode array position for perimodiolar electrodes. The aims of this study were to verify the longterm reliability for the NRT-ratio in perimodiolar electrodes. In a retrospective controlled study in a Tertiary Referral Center the electrophysiological data sets of 123 patients with implanted Nucleus Contour Advance electrodes were enclosed. Intraoperative and up to 1 year follow-up Auto-NRTs were evaluated. A NRT-ratio was calculated by dividing the average Auto-NRT data from electrode 16 to 18 with the average from electrode 5 to 7. Using a flat panel tomography system, the position of the electrode array was certified radiological. 31 patients with perimodiolar electrodes with 1 year follow-up data were included in the study. Eleven patients showed regular follow-up NRT-ratio with a correlated and radiologically confirmed electrode position. 20 patients showed mismatches between the NRT-ratio and the radiological position. These patients were highly variable in terms of duration of deafness and neural spectrum disorders. The NRT-ratio can be used to determine the intracochlear position of the electrode array for perimodiolar electrodes. Intraoperatively the NRT-ratio predicts the array position within the cochlea highly reliable for perimodiolar electrodes. We showed that after 6 months and a year, the NRT-ratio remains unchanged in most of the cases and shows a good correlation to the radiological determined position of the array. Nevertheless, the condition of the neural structures is highly important for reproducible responses. Limited validity is given in patients with degenerative and structural neural disorders.

ECAP analysis in cochlear implant patients as a function of patient's age and electrode-design.

INTRODUCTION: Electric compound action potentials (ECAPs) provide information about the nerve's and device's function in and after cochlear implantation. In general, lower ECAP values are expected to generate better results. Aim was an analysis of ECAPs in the course of time as a function of the patient's age and electrode design. PATIENTS AND METHODS: Between 2008 and 2013, 168 patients of eight defined age groups were included into the investigation. NRTs were measured intraoperatively, after 6 and after 12months. RESULTS: The intraoperative mean value of ECAP was 174.14CL (current level) and decreased after 6months to 156.38CL. Highest ECAPs were achieved intraoperatively in the clusters "younger than 18months" (181.04CL) and "older than 80 years" (190.45CL). CI 422 showed apparently higher ECAP thresholds (182.69) during surgery than CI 24 RE (171.47) and CI 512 (170.64). CONCLUSION: ECAPs are a well-established method to get information about the CI's and nerve's function during and after surgery. After initial higher values NRTs decrease after 6months and remain stable in the following controls. Very young and older patients tend to have higher thresholds than middle-aged groups. Perimodiolar electrodes are significantly attached to lower values because there is a closer nerve-electrode interaction.

[Surgical Risk Profile and Audiological Outcome in the Elderly after Cochlea-implantation]. / Operatives Risikoprofil und Hör-Spracherfolg bei älteren Cochlea-Implantat-Patienten.

BACKGROUND: The number of elderly patients with indication for cochlear implantation is increasing. Our aim was to investigate whether seniors with cochlea implants differ from younger patients with regard to hearing improvement, surgical complications and rehabilitation. PATIENTS AND METHODS: Patients older than 60 years (ys) having received a cochlea implant in 2007-2012 were included (Group I 60-70 ys; Group II <70 ys). Preoperative risk factors according to ASA-Criteria and postoperative complications were analyzed. Improvements in quality of live were evaluated by questionnaire. Audiological outcome was tested by Freiburger speech test and OLSA sentence test with background noise. Patients with comparable conditions for cochlea implantation between 40 and 59 years of age served as control group (Group K). RESULTS: Patient cohort consisted of 94 patients, 29 of which being older than 70 years. Severe complications were inexistent postoperatively. Gr. II achieved a speech perception for numbers of 95% (65 dB) and 50% (65 dB) for monosyllables. The speech perception in Gr. II was not significantly different from Gr. I or K. According to the quality of life test all groups experienced an improvement in their social life. CONCLUSION: Old age itself is no contraindication to cochlea implantation. It has little influence on the postoperative speech perception even though the learning curve of the elderly rises slower. However, careful assessment with regard to surgical risk factors and expected outcome is necessary.

[The treatment of chronic wounds in the head and neck area after radiotherapy with medical honey]. / Die Behandlung chronischer Wunden im Kopf-Hals-Bereich nach Radiatio mit medizinischem Honig.

BACKGROUND: Wound healing problems and chronic wounds can be a therapeutic challenge are a frequent problem after radiotherapy. They can appear spontaneously or after further surgery. The permanently altered tissue is associated with recurrent bacterial infections with weeping wounds, which cannot be treated sufficiently by conventional conservative wound care. The topical application of medical honey seems to have a positive effect in such cases. The aim of this prospectively study is to check this effectiveness in the treatment of wound healing problems and chronic wounds in the head and neck area of irradiated patients. PATIENTS AND METHODS: In the period of July 2012 until August 2013 nine patients were treated with medical honey. All pa-tients had previously radiotherapy in the head and neck area. 5 patients had protracted wound healing problems after salvage surgery. The remaining 4 cases had spontaneously dehiscenced wounds at the beginning of the study. The wound healing was confirmed by measurement of the wound edges and depth and by adequate photo documentation. RESULTS: In all cases, the conventional wound care was unsuccessfully. In 8 of 9 cases, the wounds could be brought to cure by the application of medical honey over 3-8 weeks. Side effects or allergic reactions to the medical honey were not seen in any -cases. CONCLUSION: Based on our clinical experience we believe that the topical application of medical honey in non-healing or recurrent wounds in the head and neck area after radiotherapy is a reason-able and successful alternative therapy.

[Coagulation factors as potential tumour markers in patients with head and neck carcinomas?]. / Gerinnungsfaktoren als Potenzielle Tumormarker bei Patienten mit Kopf-Hals-Karzinomen?

OBJECTIVE: Carcinomas can have influence on the coagulation system by different factors. Locally pathological changes of metabolism, neo-vascularisation, oxygenation and tissue pressure as well as locally and systemically activities of the tumor cells, are part of it. The coagulation situation in patients with head and neck carcinomata is characterized only insufficiently till now. MATERIAL AND METHODS: In a prospective pilot study 20 male patients with squamous-cell carcinomas of the head and neck area were subjected to a detailed coagulation diagnostics pre and post therapeutically and, age and sex corrected, compared with a control group (n=37). RESULTS: For the routine parameters PTT, Quick, TZ and INR no differences between the groups could be recognized. For the tumour patients a statistically significant increase arose for the acute phase proteins like factor I (fibrinogen), factor VIII, factor IX, von- Willebrand antigen and activity before therapy. Increased values were found also for plasmin, factor II, factor V and the thrombin-antithrombin-III-complex (TAT) whereas the values for antithrombin-III were degraded significantly. In the tumour patients the pre-therapeutical increased values for the activation marker TAT brought themselves back to normal after the tumour ablative therapy. CONCLUSIONS: TAT could be suitable as a potential tumour marker but also for relapse tumours. To evidence this, a study of longer duration and with a larger number of patients is necessary.

[Optimizing interdisciplinary flow of information : development of a communication system for a cochlear implant center with out-patient rehabilitation]. / Optimierung des interdisziplinären Informationsflusses : Entwicklung eines Kommunikationssystems für ein Cochlear-implant-Zentrum mit ambulanter Rehabilitation.

BACKGROUND: Due to the growing number of cochlear implant (CI) patients, a well organized system of patient data allowing swift access is required. Therefore, a databank has been designed to achieve an effective interdisciplinary flow of information between diagnostics, therapy and rehabilitation. METHODS: The departments of audiology, CI fitting, speech and hearing rehabilitation, logopaedics and medical staff were requested to design forms containing relevant data for the evaluation of diagnostic, therapeutic and rehabilitation outcome. Forms were optimized and finally adjusted to an Access database. Time management and satisfaction of employees were evaluated by questionnaire. The local ethics committee authorized the project. RESULTS: To achieve optimal administration of CI patient data a working platform founded on an Access data base was designed. Patient data were available almost immediately after diagnosis and therapy to all other partners within the CI centre, leading to better time management in the planning of CI therapy and consequently improved rehabilitation. In addition, internal communication between the different disciplines improved significantly. A number of data sheets are used to illustrate how the database functions. CONCLUSION: Using this database we were able to improve the flow of information in our CI centre, as well as significantly reduce the time required for administrative tasks such as letters to doctors, health insurances, schools. Finally, data are available for scientific and economic purposes, including their possible long-term integration in an electronic patient file.

A prospective evaluation of the Essen titanium stapes prosthesis.

OBJECTIVES: This is the first clinical trial to evaluate the suitability of a new titanium stapes prosthesis, which we developed jointly with the Kurz Company (Dusslingen). DESIGN: In a prospective clinical study, patients with otosclerosis underwent stapes surgery using our new titanium stapes prosthesis during a period of 14 months. One year after surgery pre- and postoperative audiograms were performed and all patients participated in a structured interview. SETTING: Tertiary otorhinolaryngological university department PARTICIPANTS: Of 49 patients with otosclerosis, entering the study, two patients were excluded, because they were not located any more. MAIN OUTCOME MEASURES AND RESULTS: All patients experienced a hearing improvement of 21 dB on average except one patient. Sixty percentage of patients achieved a reduction of the air-bone gap to less than 10 dB and 31% of patients having their air-bone gap closed to within 20 dB--averaged across 0.5, 1.0, 2.0 and 4 kHz. The hearing level improved significantly in the air and in the bone conduction thresholds. CONCLUSIONS: This paper presents our first '1 year postimplantation' results of our titanium stapes prosthesis. We consider the development of this implant to be beneficial. The results confirm significant improvement in hearing status and tinnitus levels.

Does metal coating improve the durability of silicone voice prostheses?

Voice prostheses, which are used for voice rehabilitation in cancer patients after laryngectomy, usually become colonized with a mixed biofilm of bacteria and Candida after 2-4 months and lose their efficiency. It is essential to ensure the stability and biocompatibility of these implants. With the aid of surface frame analysis we have shown that local antifungal treatment is inadequate for eliminating the deep infiltration and encapsulation of Candida colonies in silicone. A surface that prevents the adhesion of microorganisms is required. Because of its special properties there are few methods available for coating silicone. We employed, for the first time, a new method of surface modification using anodic vacuum arc coating. Using this method it was possible to obtain a solid film of gold or titanium metal with a layer thickness < 100 nm. Resistance against Candida colonization and destruction of coated prostheses were tested both in vitro and in vivo. A titanium coating seemed to provide the optimal solution to the problem, because surface adhesion and the smoothness of the material appeared to be superior to those of a gold coating.