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Background Public health systems are confronted with constantly rising costs. Furthermore, diagnostic as well as treatment services become more and more specialized. These are the reasons for an interdisciplinary project on the one hand aiming at simplification of planning and scheduling patient appointments, on the other hand at fulfilling all requirements of efficiency and treatment quality. Methods As to understanding procedure and problem solving activities, the responsible project group strictly proceeded with four methodical steps: actual state analysis, analysis of causes, correcting measures, and examination of effectiveness. Various methods of quality management, as for instance opinion polls, data collections, and several procedures of problem identification as well as of solution proposals were applied. All activities were realized according to the requirements of the clinic's ISO 9001:2000 certified quality management system. The development of this project is described step by step from planning phase to inauguration into the daily routine of the clinic and subsequent control of effectiveness. Results Five significant problem fields could be identified. After an analysis of causes the major remedial measures were: installation of a patient telephone hotline, standardization of appointment arrangements for all patients, modification of the appointments book considering the reason for coming in planning defined working periods for certain symptoms and treatments, improvement of telephonic counselling, and transition to flexible time planning by daily updates of the appointments book. After implementation of these changes into the clinic's routine success could be demonstrated by significantly reduced waiting times and resulting increased patient satisfaction. Conclusion Systematic scrutiny of the existing organizational structures of the outpatients' department of our clinic by means of actual state analysis and analysis of causes revealed the necessity of improvement. According to rules of quality management correcting measures and subsequent examination of effectiveness were performed. These changes resulted in higher satisfaction of patients, referring colleagues and clinic staff the like. Additionally the clinic is able to cope with an increasing demand for appointments in outpatients' departments, and the clinic's human resources are employed more effectively.
Im Jahr 2003 begann die HNO-Universitätsklinik Frankfurt / Main mit der Einführung eines Qualitätsmanagement-Systems, die im August 2005 zur erfolgreichen Zertifizierung nach der vom Klinikumsvorstand geforderten DIN EN ISO 9001:2000 führte. Ziele unseres Qualitätsmanagements waren die Optimierung der internen Betriebsabläufe und die Standardisierung von Arbeitsvorgängen unter Einbeziehung von logistischen Schnittstellen mit externen Strukturen unter Berücksichtigung der besonderen Anforderungen einer Universitätsklinik. Neben einer grundsätzlichen Prüfung und Optimierung sämtlicher Organisationsabläufe wurden für die Kernprozesse unserer Klinik Zielvorgaben festgelegt. Diese Ziele betrafen die Qualität der Arbeitsabläufe für alle Bereiche der HNO-ärztlichen ambulanten und stationären Versorgung ebenso, wie Aufgaben in Forschung und Lehre, die durch ein Ausbildungscurriculum für Mitarbeiter und Sudenten abgebildet wurde. Es wurden aber auch Serviceaspekte, wie Terminvergabe und Befundübermittlung, sowie ökonomische und wirtschaftliche Aspekte unserer Arbeit optimiert. Durch Umstrukturierung und Neuorganisation konnte die Effizienz der Arbeitsabläufe deutlich gesteigert werden, wovon vor allem Patienten und Mitarbeiter erheblich profitieren. Die Einführung eines Qualitätsmanagementsystems in der Frankfurter HNO-Universitätsklinik war zunächst mit einem entsprechenden Arbeitsaufwand verbunden und erforderte ein Umdenken in den einzelnen Funktionsbereichen. Insgesamt überwiegt der positive Einfluss auf die Struktur und Arbeitsabläufe, sodass die Umsetzung eines Qualitätsmanagementsystems in der Universitätsklinik empfehlenswert ist.
Objectives: To correlate the radiological assessment of the mastoid facial canal in postoperative cochlear implant (CI) cone-beam CT (CBCT) and other possible contributing clinical or implant-related factors with postoperative facial nerve stimulation (FNS) occurrence. Methods: Two experienced radiologists evaluated retrospectively 215 postoperative post-CI CBCT examinations. The mastoid facial canal diameter, wall thickness, distance between the electrode cable and mastoid facial canal, and facial-chorda tympani angle were assessed. Additionally, the intracochlear position and the insertion angle and depth of electrodes were evaluated. Clinical data were analyzed for postoperative FNS within 1.5-year follow-up, CI type, onset, and causes for hearing loss such as otosclerosis, meningitis, and history of previous ear surgeries. Postoperative FNS was correlated with the measurements and clinical data using logistic regression. Results: Within the study population (mean age: 56 ± 18 years), ten patients presented with FNS. The correlations between FNS and facial canal diameter (p = 0.09), wall thickness (p = 0.27), distance to CI cable (p = 0.44), and angle with chorda tympani (p = 0.75) were statistically non-significant. There were statistical significances for previous history of meningitis/encephalitis (p = 0.001), extracochlear-electrode-contacts (p = 0.002), scala-vestibuli position (p = 0.02), younger patients’ age (p = 0.03), lateral-wall-electrode type (p = 0.04), and early/childhood onset hearing loss (p = 0.04). Histories of meningitis/encephalitis and extracochlear-electrode-contacts were included in the first two steps of the multivariate logistic regression. Conclusion: The mastoid-facial canal radiological assessment and the positional relationship with the CI electrode provide no predictor of postoperative FNS. Histories of meningitis/encephalitis and extracochlear-electrode-contacts are important risk factors.
Objective: Vertigo is a common side effect of cochlear implant (CI) treatment. This prospective study examines the incidence of postoperative vertigo over time and aims to analyze influencing factors such as electrode design and insertion angle (IA).
Study Design and Setting: This is a prospective study which has been conducted at a tertiary referral center (academic hospital).
Patients: A total of 29 adults were enrolled and received a unilateral CI using one of six different electrode carriers, which were categorized into “structure-preserving” (I), “potentially structure-preserving” (II), and “not structure-preserving” (III).
Intervention: Subjective vertigo was assessed by questionnaires at five different time-points before up to 6 months after surgery. The participants were divided into four groups depending on the time of the presence of vertigo before and after surgery. Preoperatively and at 6 months postoperatively, a comprehensive vertigo diagnosis consisting of Romberg test, Unterberger test, subjective visual vertical, optokinetic test, video head impulse test, and caloric irrigation test was performed. In addition, the IA was determined, and the patients were divided in two groups (<430°; ≥430°).
Main Outcome Measures: The incidence of vertigo after CI surgery (group 1) was reported, as well as the correlation of subjective vertigo with electrode array categories (I–III) and IA.
Results: Among the participants, 45.8% experienced new vertigo after implantation. Based on the questionnaire data, a vestibular origin was suspected in 72.7%. The results did not show a significant correlation with subjective vertigo for any of the performed tests. In group 1 with postoperative vertigo, 18% of patients showed conspicuous results in a quantitative analysis of caloric irrigation test despite the fact that the category I or II electrodes were implanted, which are suitable for structure preservation. Average IA was 404° for the overall group and 409° for group 1. There was no statistically significant correlation between IA and perceived vertigo.
Conclusions: Though vertigo after CI surgery seems to be a common complication, the test battery used here could not objectify the symptoms. Further studies should clarify whether this is due to the multifactorial cause of vertigo or to the lack of sensitivity of the tests currently in use. The proof of reduced probability for vertigo when using atraumatic electrode carrier was not successful, nor was the proof of a negative influence of the insertion depth.
Langzeiterfahrungen mit der ipsilateralen Elektroakustischen Stimulation (EAS) : meeting abstract
(2006)
Hochgradig hörgeschädigten Patienten mit einem Tieftonrestgehör (Steilabfall im Audiogramm) können mittels ipsilateraler EAS versorgt werden. Dabei wird der völlig taube Hochfrequenzbereich des Innenohres mit einem Cochleaimplantat stimuliert, und die tieffrequente Restfunktion der Schnecke bleibt erhalten. Voraussetzung für eine derartige Versorgung ist ein Erhalt des tieffrequenten Restgehöres bei der Cochlea-Implant-Elektrodeneinführung. Im Rahmen einer klinischen Studie wurden seit 1999 in Frankfurt 25 Patienten mit EAS versorgt. Des Weiteren wurden 16 Patienten im Rahmen einer europäischen Multicenterstudie für EAS implantiert. Ein zumindest teilweiser Erhalt des Restgehöres war in über 90% der Fälle möglich. Es wird über die Langzeitergebnisse (6 bis 70 Monate) nach EAS-Implantation berichtet. In 70% der Fälle blieb das erhaltene Restgehör stabil. Die Patienten zeigten überdurchschnittlich gute Werte bei der Sprachdiskrimination mit ihren Cochleaimplantaten, die durch zusätzliche akustische Stimulation noch verbessert wurden. Besonders deutlich waren die Hörleistungen unter Störgeräuscheinfluss. Seit Kurzem steht auch ein kombinierter Sprachprozessor für die elektrische und akustische Stimulation zur Verfügung.
Background: The standard electrode array for the MED-EL MAESTRO cochlear implant system is 31 mm in length which allows an insertion angle of approximately 720°. When fully inserted, this long electrode array is capable of stimulating the most apical region of the cochlea. No investigation has explored Electrically Evoked Compound Action Potential (ECAP) recordings in this region with a large number of subjects using a commercially available cochlear implant system. The aim of this study is to determine if certain properties of ECAP recordings vary, depending on the stimulation site in the cochlea. Methods: Recordings of auditory nerve responses were conducted in 67 subjects to demonstrate the feasibility of ECAP recordings using the Auditory Nerve Response Telemetry (ART™) feature of the MED-EL MAESTRO system software. These recordings were then analyzed based on the site of cochlear stimulation defined as basal, middle and apical to determine if the amplitude, threshold and slope of the amplitude growth function and the refractory time differs depending on the region of stimulation. Results: Findings show significant differences in the ECAP recordings depending on the stimulation site. Comparing the apical with the basal region, on average higher amplitudes, lower thresholds and steeper slopes of the amplitude growth function have been observed. The refractory time shows an overall dependence on cochlear region; however post-hoc tests showed no significant effect between individual regions. Conclusions :Obtaining ECAP recordings is also possible in the most apical region of the cochlea. However, differences can be observed depending on the region of the cochlea stimulated. Specifically, significant higher ECAP amplitude, lower thresholds and steeper amplitude growth function slopes have been observed in the apical region. These differences could be explained by the location of the stimulating electrode with respect to the neural tissue in the cochlea, a higher density, or an increased neural survival rate of neural tissue in the apex. Trial registration: The Clinical Investigation has the Competent Authority registration number DE/CA126/AP4/3332/18/05.
Hintergrund: Mit der im Jahr 2020 aktualisierten AWMF-Leitlinie zur Versorgung mit einem Cochleaimplantat (CI) wurde erstmals der gesamte Prozess einer CI-Versorgung definiert. In der vorliegenden Studie wurden die Machbarkeit und die Ergebnisse einer sehr frühen Rehabilitationsmaßnahme (Reha) untersucht.
Methodik: Es wurden 54 Patienten in die Interventionsgruppe (IG) eingeschlossen, bei der die Reha innerhalb von 14 (maximal 28) Tagen nach der Implantation eingeleitet wurde. In eine Kontrollgruppe (KG, n = 21) wurden Patienten mit deutlich längerer Wartezeit eingeschlossen. Neben dem Beginn und der Dauer der Reha wurde das mit CI erreichte Sprachverstehen zu verschiedenen Zeitpunkten innerhalb von 12 Monaten erfasst. Zusätzlich wurde mit Fragebögen der Aufwand der Anpassung des CI-Prozessors und die Zufriedenheit der Patienten mit dem Ergebnis sowie dem Zeitpunkt des Beginns der Reha ermittelt.
Ergebnisse: Die Wartezeit zwischen Implantation und Beginn der Reha lag in der IG bei 14 Tagen und in der KG bei 106 Tagen (Mediane). Es konnten 92,6 % der Patienten der IG die Reha innerhalb von 14 Tagen antreten. Der Effekt der Reha lag in der IG bei 35 und in der KG bei 25 Prozentpunkten (Freiburger Einsilbertest). Nach 6 und 12 Monaten (M) CI-Nutzung zeigten beide Gruppen sowohl in der Testbedingung in Ruhe (IG/KG 6M: 70 %/70 %; 12M: 70 %/60 %, Freiburger Einsilbertest) als auch im Störgeräusch (IG/KG 6M: −1,1 dB SNR/–0,85 dB SNR; 12M: −0,65 dB SNR/+0,3 dB SNR, Oldenburger Satztest) vergleichbare Ergebnisse. Die mittels des Fragebogens Speech, Spatial and Qualities of Hearing Scale (SSQ) erfassten Ergebnisse für die Einschätzung der Hörqualität zeigten nach 6 Monaten eine bessere Bewertung in der IG, die sich nach 12 Monaten an die Ergebnisse der KG anglich. Die IG war mit dem Zeitpunkt des Beginns der Reha deutlich zufriedener als die KG. Alle anderen aus Fragebögen ermittelten Daten zeigten keine Unterschiede zwischen den beiden Gruppen.
Schlussfolgerung: Der sehr frühe Beginn einer stationären Reha nach Cochleaimplantation ist erfolgreich umsetzbar. Die Reha konnte innerhalb von 7 Wochen nach der Implantation abgeschlossen werden. Der Vergleich der Ergebnisse der Tests des Sprachverstehens vor und nach der Reha zeigte eine deutliche Steigerung. Somit ist ein deutlicher Reha-Effekt nachweisbar. Die Aufnahme der CI-Rehabilitation in den Katalog der Anschlussheilbehandlungen ist somit wissenschaftlich begründet und damit dringend zu empfehlen.
Purpose: Monocentric, prospective study to investigate whether concomitant support of cochlear implant (CI) patients by CI-trained otolaryngologists and application of a standardized head bandage can minimize potential complications during magnetic resonance imaging (MRI).
Methods: Thirty-seven patients with 46 CIs underwent MRI with a prophylactic head bandage. All participants and the otolaryngologist at the CI center completed pre- and post-MRI questionnaires documenting body region scanned, duration of MRI and bandage wear, field strength during the scan, and any complications. If pain was experienced, it was assessed using a visual analog scale (1–10).
Results: MRI was performed without adverse events in 37.8% of cases. Magnet dislocation requiring surgical revision occurred in 2% of cases. Pain was reported in 86% of cases, often due to the tightness of the dressing. Patients with rotating, MRI-compatible magnets reported significantly less pain than participants with older-generation implants. In 11% of cases, the MRI was discontinued.
Conclusion: Serious complications during MRI in cochlear implant patients are rare. Pain is the most common adverse event, probably mainly due to the tight bandage required by most implant types. With newer generations of magnets, these patients experience less pain, no dislocation of the magnets, and no need for bandaging. Although magnet dislocation cannot be completely prevented in older generations of implants, it appears to be reduced by good patient management, which recommends examination under the guidance of physicians trained in the use of hearing implants.
Background: The Association of the Scientific Medical Societies in Germany (AWMF) clinical practice guideline on cochlear implant (CI) treatment, which was updated in 2020, defined the entire process of CI care for the first time. In the present study, the feasibility and results of very early rehabilitation were examined.
Materials and methods: The intervention group (IG) comprised 54 patients in whom rehabilitation was initiated within 14 (maximally 28) days after implantation. Patients with a significantly longer waiting time were included in the control group (CG, n = 21). In addition to the start and duration of rehabilitation, the speech intelligibility achieved with CI was recorded at different timepoints within a 12-month period. In addition, questionnaires were used to assess the effort of fitting the CI processor and the patients’ satisfaction with the outcome as well as the timing of the start of rehabilitation.
Results: Median waiting time between implantation and start of rehabilitation was 14 days in the IG and 106 days in the CG; 92.6% of IG patients were able to start rehabilitation within 14 days. The effect of rehabilitation in the IG was 35 and in the CG 25 percentage points (Freiburg monosyllabic test). After 6 and 12 months of CI use, both groups showed comparable results in the test condition in quiet (IG/CG 6 months: 70%/70%; 12 months: 70%/60%, Freiburg monosyllabic test) and in noise (IG/CG 6 months: −1.1 dB SNR/–0.85 dB SNR; 12 months: −0.65 dB SNR/+0.3 dB SNR, Oldenburg sentence test). Hearing quality assessment scores collected by SSQ (Speech, Spatial and Qualities of Hearing Scale) questionnaire showed better scores in the IG at 6 months, which converged to CG scores at 12 months. The IG was significantly more satisfied with the timing of the start of rehab than the CG. All other data obtained from questionnaires showed no differences between the two groups.
Conclusion: A very early start of inpatient rehabilitation after cochlear implantation was successfully implemented. The rehabilitation was completed within 7 weeks of CI surgery. Comparison of speech recognition test results before and after rehabilitation showed a significant improvement. A clear rehabilitation effect can therefore be demonstrated. Inclusion of CI rehabilitation in the German catalog of follow-up treatments is thus scientifically justified and therefore strongly recommended.
Bilateral simultaneous cochlear implantation is a safe method of hearing rehabilitation in adults
(2023)
Purpose: Bilateral cochlear implantation is an effective treatment for patients with bilateral profound hearing loss. In contrast to children, adults mostly choose a sequential surgery. This study addresses whether simultaneous bilateral CI is associated with higher rates of complications compared to sequential implantation.
Methods: 169 bilateral CI surgeries were analyzed retrospectively. 34 of the patients were implanted simultaneously (group 1), whereas 135 patients were implanted sequentially (group 2). The duration of surgery, the incidence of minor and major complications and the duration of hospitalization of both groups were compared.
Results: In group 1, the total operating room time was significantly shorter. The incidences of minor and major surgical complications showed no statistically significant differences. A fatal non-surgical complication in group 1 was particularly extensively reappraised without evidence of a causal relationship to the chosen mode of care. The duration of hospitalization was 0.7 days longer than in unilateral implantation but 2.8 days shorter than the combined two hospital stays in group 2.
Conclusion: In the synopsis of all considered complications and complication-relevant factors, equivalence of simultaneous and sequential cochlear implantation in adults in terms of safety was found. However, potential side effects related to longer surgical time in simultaneous surgery must be considered individually. Careful patient selection with special consideration to existing comorbidities and preoperative anesthesiologic evaluation is essential.
