The German cochlear implant registry: one year experience and first results on demographic data.

PURPOSE: Clinical registries have great potential for quality control of medical procedures regarding the indications, therapeutic processes and results, including their possible complications. This is particularly true when providing patients with severe hearing loss or deafness with a cochlear implant (CI). This treatment represents a lifelong care process that requires continuous quality control over time. On the initiative of the Executive Committee of the German Society of Otorhinolaryngology (Deutsche Gesellschaft für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie e.V., DGHNO-KHC), a national German CI registry (Deutsches Cochlear Implant Register, DCIR) was established in January 2022. This article focuses on the first demographic and baseline data of the DCIR. METHODS: The DCIR covers the complete therapeutic process from indication, surgery, fitting and lifelong aftercare in CI therapy. By the end of 2022, 75 hospitals in Germany had agreed to contribute to the DCIR. RESULTS: During the year 2022, 63 hospitals actively contributed data to the DCIR. Pseudonymized data from 2,292 CI implantations (2,176 primary implantations, 99 explantations with immediate re-implantations and 17 re-implantations following an earlier explantation) in 2,108 patients were documented. Cochlear implantation was accomplished in 1,807 adults (≥ 18 years) and 301 children (< 18 years). Fourty patients (1,9%) were children < 1 year of age and 55 (2,6%) were patients > 85 years. From the total of 2,292 implantations, 226 (9.9%) were performed as simultaneous bilateral implantations (CI implantation in both ears of 113 patients on the same day of surgery) and 412 implantations (19.1% of 2,162 implantations with data provided on the contralateral ear's hearing status) were in patients with single sided deafness (normal hearing in the contralateral ear). In addition, the reported complications in 2022 were also evaluated. Seven reports (0.4%) of mild to moderate severe facial nerve dysfunctions were documented. No reports of severe or total facial nerve dysfunction (House-Brackmann grade V/VI), meningitis or death related to CI therapy were documented. CONCLUSION: Although still in the start-up phase, these initial DCIR data already provide an interesting first insight into the demographic structure and baseline data of CI therapy in Germany. The successful implementation of the DCIR represents an important step towards continuous quality control of CI care.

[Interdisciplinary Management of Orbital Diseases]. / Interdisziplinäre Therapie der Erkrankungen der Orbita.

Diagnosis and therapy of orbital diseases is an interdisciplinary challenge, in which i.e. otorhinolaryngologists, ophthalmologists, radiologists, radiation therapists, maxillo-facial surgeons, endocrinologists, and pediatricians are involved. This review article describes frequent diseases which both, otolaryngologists and ophthalmologists are concerned with in interdisciplinary settings. In particular the inflammatory diseases of the orbit including orbital complications, autoimmunological diseases of the orbit including Grave´s orbitopathy, and primary and secondary tumors of the orbit are discussed. Beside describing the clinical characteristics and diagnostic steps the article focusses on the interdisciplinary therapy. The review is completed by the presentation of most important surgical approaches to the orbit, their indications and possible complications. The authors tried to highlight the relevant facts despite the shortness of the text.

[Statement on the lower age limit for outpatient adenotomies and tonsillotomies]. / Stellungnahme zur Altersuntergrenze bei der ambulanten Durchführung von Adenotomien und Tonsillotomien.

At the beginning of 2023, there have been significant changes to the regulations for outpatient surgery in Germany, which were set out in a trilateral self-administration agreement between the umbrella association of statutory health insurance companies, the German Hospital Association and the Federal Association of Statutory Health Insurance Physicians. Among other things, a catalog stated circumstances under which an operation should not be carried out on an outpatient basis or should only be carried out with doubt. This catalog explains the patient's age: up to the first year of life, inpatient performance of a service can be justified. This formulation in itself means that children from one year of age on should regularly undergo outpatient surgery.In the german scientific societies for otolaryngology, head and neck surgery as well as for anesthesiology and intensive care medicine, doubts arose as to whether this age limit could also be scientifically justified for operations in the throat such as adenotomy or tonsillotomy.A search was carried out in international guidelines and in the international literature and the statements were evaluated. The results of this literature search were discussed with representatives of the Pediatric Otorhinolaryngology Working Group (AG PädHNO) of the German Society for Otorhinolaryngology, Head and Neck Surgery (DGHNO-KHC) and the scientific working group for pediatric anesthesia (WAKKA) of the German Society for Anesthesiology and Intensive Care Medicine (DGAI) in conferences.The consensus revealed that a strict age limit of the first year of life is not appropriate for the outpatient performance of adenotomies and tonsillotomies. First of all, specifying a strict age limit is questionable because, regardless of age, a number of other medical and social factors influence the responsible performance of outpatient operations. Furthermore, the age limit of one year is not considered appropriate in view of literature, guidelines and practical experience in the international area. The assessment of the literature and the consideration of the implementation in the international area make an age limit in the range of 2-3 years seem more appropriate.This review provides the responsible doctors with a variety of insights, aspects and arguments so that they can make their decision to carry out these operations on an outpatient or inpatient basis appropriately and responsibly.

Structure and establishment of the German Cochlear Implant Registry (DCIR).

Hearing rehabilitation of patients with severe hearing loss or deafness using cochlear implants (CI) is a very successful but also complex and lifelong process that requires high quality standards for structure, process, and results. Medical registries represent an ideal tool for conducting quality control relevant to care while at the same time collecting scientific data. Therefore, at the initiative of the Executive Committee of the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery (DGHNO-KHC), a Germany-wide CI registry (the German Cochlear Implant Register, DCIR) was to be established. The following goals were to be achieved: 1) legal and contractual basis for the register; 2) definition of the register contents; 3) development of evaluation standards (hospital-specific and national annual reports); 4) development of a logo; 5) practical operation of the registry. After defining a catalog of services that defines the content, structure, and operation of the DCIR, a registry operator with audiological expertise was sought. After considering various offers, the registry was technically implemented in cooperation with the provider INNOFORCE (Ruggell, Liechtenstein) as registry operator. This also included the realization of an interface for data transfer from previously existing databases and development of a data protection concept for productive operation of the DCIR under the scientific leadership of the DGHNO-KHC Executive Committee. Since January 2022, it has been possible for participating hospitals to enter pseudonymized data into the DCIR. To date, 75 hospitals in Germany have contractually agreed to participate in the registry. During the first 15 months, data from over 2500 implants in over 2000 patients were registered in the DCIR. The work presented here describes the structuring, development, and successful establishment of the DCIR. Introduction of the DCIR represents an important milestone of future scientifically based quality control in CI care. The registry presented here can therefore be considered as an example for other areas of medical care and thus also sets an international standard.

Conception and implementation of a certification system for quality control of cochlear implant treatment in Germany.

A standardized and structured process is indispensable for optimal hearing rehabilitation with cochlear implants (CI). The Executive Committee of the German Society of Otorhinolaryngology, Head and Neck Surgery (DGHNO-KHC), initiated the conception of a certification program and a Whitepaper based on the Association of the Scientific Medical Societies in Germany (AWMF) clinical practice guideline (CPG) describing the current medical standards of CI care in Germany. The goal was to independently confirm implementation of this CPG and make this information publicly available. With the support of an independent certification organization, successful implementation of the CI-CPG by a hospital would then be verified and confirmed by awarding the "Cochlear implant-provision institution" (Cochlea-Implantat-versorgende Einrichtung, CIVE) quality certificate. A structure for implementation of a certification system was developed based on the CI-CPG. The following steps were required: 1) conception of a quality control system for certification of hospitals working in accordance with the CI-CPG; 2) development of required structures for an independent review of quality-relevant structure, process, and result parameters; 3) development of a standard procedure for independent certification of hospitals; 4) development of a certificate and a logo to demonstrate successful certification; 5) practical implementation of the certification. Following design of the certification program and the required organizational structure, the certification system was successfully launched in 2021. Applications for the quality certificate could be formally submitted from September 2021. A total of 51 off-site evaluations were performed by December 2022. In the first 16 months from introduction, 47 hospitals were successfully certified as CIVE. In this period, 20 experts were trained as auditors, who have since then carried out 18 on-site audits in hospitals. In summary, the conceptual design, structure, and practical implementation of a certification program for quality control in CI care was successfully implemented in Germany.

[Structure and establishment of the German Cochlear Implant Registry]. / Struktur und Einrichtung des Deutschen Cochlea-Implantat-Registers (DCIR).

Hearing rehabilitation of patients with severe hearing loss or deafness using cochlear implants (CI) is a very successful but also complex and lifelong process that requires high quality standards for structure, process, and results. Medical registries represent an ideal tool for conducting quality control relevant to care while at the same time collecting scientific data. Therefore, at the initiative of the Executive Committee of the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery (DGHNO-KHC), a Germany-wide CI registry (the German Cochlear Implant Register, DCIR) was to be established. The following goals were to be achieved: 1) legal and contractual basis for the register; 2) definition of the register contents; 3) development of evaluation standards (hospital-specific and national annual reports); 4) development of a logo; 5) practical operation of the registry. After defining a catalog of services that defines the content, structure, and operation of the DCIR, a registry operator with audiological expertise was sought. After considering various offers, the registry was technically implemented in cooperation with the provider INNOFORCE (Ruggell, Liechtenstein) as registry operator. This also included the realization of an interface for data transfer from previously existing databases and development of a data protection concept for productive operation of the DCIR under the scientific leadership of the DGHNO-KHC Executive Committee. Since January 2022, it has been possible for participating hospitals to enter pseudonymized data into the DCIR. To date, 75 hospitals in Germany have contractually agreed to participate in the registry. During the first 15 months, data from over 2500 implants in over 2000 patients were registered in the DCIR. The work presented here describes the structuring, development, and successful establishment of the DCIR. Introduction of the DCIR represents an important milestone of future scientifically based quality control in CI care. The registry presented here can therefore be considered as an example for other areas of medical care and thus also sets an international standard.

[Conception and implementation of a certification system for quality control of cochlear implant treatment in Germany. German version]. / Konzeption und Implementierung eines Zertifizierungssystems zur Qualitätssicherung der Cochlea-Implantat-Versorgung in Deutschland.

A standardized and structured process is indispensable for optimal hearing rehabilitation with cochlear implants (CI). The Executive Committee of the German Society of Otorhinolaryngology, Head and Neck Surgery (DGHNO-KHC), initiated the conception of a certification system and a Whitepaper based on the Association of the Scientific Medical Societies in Germany (AWMF) clinical practice guideline (CPG) describing the current medical standards of CI care in Germany. The goal was to independently confirm implementation of this CPG and make this information publicly available. With the support of an independent certification organization, successful implementation of the CI-CPG by a hospital would then be verified and confirmed by awarding the "Cochlear implant-provision institution" (Cochlea-Implantat-versorgende Einrichtung, CIVE) quality certificate. A structure for implementation of a certification system was developed based on the CI-CPG. The following steps were required: 1) conception of a quality control system for certification of hospitals working in accordance with the CI-CPG; 2) development of required structures for an independent review of quality-relevant structure, process, and result parameters; 3) development of a standard procedure for independent certification of hospitals; 4) development of a certificate and a logo to demonstrate successful certification; 5) practical implementation of the certification. Following design of the certification system and the required organizational structure, the certification system was successfully launched in 2021. Applications for the quality certificate could be formally submitted from September 2021. A total of 51 off-site evaluations were performed by December 2022. In the first 16 months from introduction, 47 hospitals were successfully certified as CIVE. In this period, 20 experts were trained as auditors, who have since then carried out 18 on-site audits in hospitals. In summary, the conceptual design, structure, and practical implementation of a certification system for quality control in CI care was successfully implemented in Germany.

[On the state of intersectoral treatment in otolaryngology in Germany - Results of a survey]. / Zum Stand der intersektoralen Behandlung in der HNO-Heilkunde in Deutschland ­ Ergebnisse einer Umfrage.

BACKGROUND: The German Healthcare System is currently subject of significant structural changes. Due to politic influences it is obvious that more and more even complex diagnostic and therapeutic procedures will be performed in an office setting or as day treatments. This is due to the high rate of hospital treatments in Germany compared to other OECD countries. A revision of the healthcare system will include both, ambulatory and hospital treatments, which will only be possible with some new structures for this "intersectoral" treatment. Currently there are no data available on the status, possibilities and structure of the "intersectoral" treatment in ENT in Germany. METHODS: To get an overview on the possibilities for an "intersectoral" treatment in ENT in Germany a survey was conducted. Each chariman of an ENT clinic/Department and all ENT specialists in private practice were contacted and got a questionnaire. The evaluation was performed differently for chairmen of an ENT department, ENT specialists in private practice without and with a ward for inpatients in hospitals. RESULTS: 4,548 questionnaires were mailed. Out of them 493 were filled and came back (10.8%). The return rate in the group of ENT Department chairmen was with 52.9% even higher. "Intersectoral" for physicians in hospitals means that they are usually working with a personal authorization by the local Association of Statutory Health Insurance Physicians, ENT specialists in private practice usually with a ward for inpatient authorization in a hospital. Appropriate structures for an intersectoral organization of patients´s treatment are currently missing. Both, ENT Department chairmen and ENT specialists in private practice declared the current remuneration system for ambulatory and day surgery as completely inaedequate and is urgently to be revised. Beside this, ENT Department chairmen declared problems with the emergency care of patients with complications operated on outside the hospital, problems with the continuing education of residents and with information transfer. They request that hospital specialists should be allowed to work in the contractual medical care of outpatients without a restriction. ENT specialists in private practice mentioned positively the good cooperation possibilities with hospital physicians, knowledge sharing, and wide ranges of indications in the ENT Departments. Negative points could be possible worse information sharing when there is no distinct contact person in the ENT Departments, a possible competitive situation between ENT Departments and specialists in private practice, and sometimes long waiting times for the patients. DISCUSSION: The German health care system is currently facing a radical reform with the overcoming of traditional rigid and inflexible sectors in outpatient care and inpatient hospital care. To achieve this, the intersectoral patient treatment should play the key role. "Intersectoral" means that the whole process of patient care from diagnosis to therapy is closely interlinked and can also be managed by the same physicians, no matter whether they are working as spcialists in an ENT-Department in a hospital or in private practice. However, currently there are no appropriate structures available to achieve this goal. Beside creating structural conditions for intersectoral treatment the current remuneration system for outpatient procedures and dayclinic treatments must be renewed in a way to cover all the costs. Further conditions are the development of good cooperation models between ENT Departments and specialists in private practice, and the possibility for hospital ENT physicians to work in the contractual medical care of outpatients without a restriction. Intersectoral patient care must take the quality management, the continuing education of residents and the patient safety under consideration.

Empfehlungen zur Überprüfung der Wirksamkeit und Verlaufsdokumentation von Mepolizumab bei chronischer Rhinosinusitis mit Nasenpolypen (CRSwNP) im deutschen Gesundheitssystem ­ Empfehlungen des Ärzteverbandes Deutscher Allergologen (AeDA) und der AGs Klinische Immunologie, Allergologie und Umweltmedizin und Rhinologie und Rhinochirurgie der Deutschen Gesellschaft für HNO-Heilkunde, Kopf- und Halschirurgie (DGHNOKHC).

BACKGROUND: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a multifactorial inflammatory disease of the mucous membranes of the nose and sinuses. Eosinophilic inflammation is described as a common endotype. The anti-IL5 antibody mepolizumab was approved in November 2021 as an add-on therapy to intranasal glucocorticosteroids for the treatment of adults with severe chronic rhinosinusitis with nasal polyps when systemic glucocorticosteroids or surgery do not provide adequate disease control. While national and international recommendations exist for the use of mepolizumab in CRSwNP, it has not yet been adequately specified how this therapy is to be monitored, what follow-up documentation is necessary, and when it should be terminated if necessary. METHODS: A literature search was performed to analyze previous data on the treatment of CRSwNP with mepolizumab and to determine the available evidence by searching Medline, Pubmed, the national and international trial and guideline registries and the Cochrane Library. Human studies published in the period up to and including 10/2022 were considered. RESULTS: Based on the international literature and previous experience by an expert panel, recommendations for follow-up, adherence to therapy intervals and possible therapy breaks, as well as termination of therapy when using mepolizumab for the indication CRSwNP in the German health care system are given on the basis of a documentation sheet. CONCLUSIONS: Understanding the immunological basis of CRSwNP opens up new non-surgical therapeutic approaches with biologics for patients with severe, uncontrolled courses. Here, we provide recommendations for follow-up, adherence to therapy intervals, possible therapy pauses, or discontinuation of therapy when mepolizumab is used as add-on therapy with intranasal glucocorticosteroids to treat adult patients with severe CRSwNP that cannot be adequately controlled with systemic glucocorticosteroids and/or surgical intervention.

Vagus nerve stimulation for conservative therapy-refractive epilepsy and depression. / Die Vagusnervstimulation bei konservativ therapierefraktärer Epilepsie und Depression.

Numerous studies confirm that the vagus nerve stimulation (VNS) is an efficient, indirect neuromodulatory therapy with electrically induced current for epilepsy that cannot be treated by epilepsy surgery and is therapy-refractory and for drug therapy-refractory depression. VNS is an established, evidence-based and in the long-term cost-effective therapy in an interdisciplinary overall concept.Long-term data on the safety and tolerance of the method are available despite the heterogeneity of the patient populations. Stimulation-related side effects like hoarseness, paresthesia, cough or dyspnea depend on the stimulation strength and often decrease with continuing therapy duration in the following years. Stimulation-related side effects of VNS can be well influenced by modifying the stimulation parameters. Overall, the invasive vagus nerve stimulation may be considered as a safe and well-tolerated therapy option.For invasive and transcutaneous vagus nerve stimulation, antiepileptic and antidepressant as well as positive cognitive effects could be proven. In contrast to drugs, VNS has no negative effect on cognition. In many cases, an improvement of the quality of life is possible.iVNS therapy has a low probability of complete seizure-freedom in cases of focal and genetically generalized epilepsy. It must be considered as palliative therapy, which means that it does not lead to healing and requires the continuation of specific medication. The functional principle is a general reduction of the neuronal excitability. This effect is achieved by a slow increase of the effectiveness sometimes over several years. Responders are those patients who experience a 50% reduction of the seizure incidence. Some studies even reveal seizure-freedom in 20% of the cases. Currently, it is not possible to differentiate between potential responders and non-responders before therapy/implantation.The current technical developments of the iVNS generators of the new generation like closed-loop system (cardiac-based seizure detection, CBSD) reduce also the risk for SUDEP (sudden unexpected death in epilepsy patients), a very rare, lethal complication of epilepsies, beside the seizure severity.iVNS may deteriorate an existing sleep apnea syndrome and therefore requires possible therapy interruption during nighttime (day-night programming or magnet use) beside the close cooperation with sleep physicians.The evaluation of the numerous iVNS trials of the past two decades showed multiple positive effects on other immunological, cardiological, and gastroenterological diseases so that additional therapy indications may be expected depending on future study results. Currently, the vagus nerve stimulation is in the focus of research in the disciplines of psychology, immunology, cardiology as well as pain and plasticity research with the desired potential of future medical application.Beside invasive vagus nerve stimulation with implantation of an IPG and an electrode, also devices for transdermal and thus non-invasive vagus nerve stimulation have been developed during the last years. According to the data that are currently available, they are less effective with regard to the reduction of the seizure severity and duration in cases of therapy-refractory epilepsy and slightly less effective regarding the improvement of depression symptoms. In this context, studies are missing that confirm high evidence of effectiveness. The same is true for the other indications that have been mentioned like tinnitus, cephalgia, gastrointestinal complaints etc. Another disadvantage of transcutaneous vagus nerve stimulation is that the stimulators have to be applied actively by the patients and are not permanently active, in contrast to implanted iVNS therapy systems. So they are only intermittently active; furthermore, the therapy adherence is uncertain.

Positionspapier: Empfehlungen zur Anwendung von Mepolizumab bei chronischer Rhinosinusitis mit Polyposis nasi (CRSwNP) im deutschen Gesundheitssystem ­ Empfehlungen des Ärzteverbandes Deutscher Allergologen (AeDA) und der AGs Klinische Immunologie, Allergologie und Umweltmedizin und Rhinologie und Rhinochirurgie der Deutschen Gesellschaft für HNO-Heilkunde, Kopf- und Hals-Chirurgie (DGHNO-KHC).

BACKGROUND: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a multifactorial inflammatory disease of the paranasal sinus mucosa with eosinophilic inflammation as the most common endotype. The anti-IL5 antibody mepolizumab was approved for the treatment of severe CRSwNP in the EU in November 2021. METHODS: A literature search was performed to analyze the immunology of CRSwNP and determine the available evidence by searching Medline, Pubmed, and the German national and international trial and guideline registries and the Cochrane Library. Human studies published in the period up to and including 12/2021 that investigated the effect of mepolizumab in CRSwNP were considered. RESULTS: Based on the international literature and previous experience, recommendations for the use of mepolizumab in CRSwNP in the German health care system are given by an expert panel on the basis of a documentation form. CONCLUSIONS: Understanding about the immunological basis of CRSwNP opens new non-surgical therapeutic approaches with biologics for patients with severe courses. Mepolizumab is approved since November 2021 for add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP who cannot be adequately controlled with systemic corticosteroids and/or surgical intervention.

Empfehlungen zur Überprüfung der Wirksamkeit und Verlaufsdokumentation von Dupilumab bei chronischer Rhinosinusitis mit Nasenpolypen (CRSwNP) im deutschen Gesundheitssystem.

BACKGROUND: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a multifactorial inflammatory disease of the nasal and paranasal mucosa. A Type-2 inflammation is described as the most common endotype. Since October 2019 the anti-IL-4/-IL-13 antibody dupilumab has been approved in Germany as an add-on therapy to intranasal corticosteroids for the treatment of adults with severe chronic rhinosinusitis with nasal polyps, when systemic corticosteroids alone or surgery do not provide adequate disease control. While recommendations for the use of dupilumab in CRSwNP exist at both national and international levels, until now it has not been adequately established, how therapy should be monitored and when it should be discontinued in the German Health Care System. METHODS: A literature search was performed analyzing previous data on the treatment of CRSwNP with dupilumab and to determine the available evidence by searching Medline, Pubmed, the national and international trial and guideline registries and the Cochrane Library. Human studies published in the period up to 05/2022 were included. RESULTS: Based on international literature and previous experience, recommendations are given by an expert panel for follow-up and possible therapy breaks, therapy intervals or termination of therapy when using dupilumab for the indication CRSwNP in the German health care system based on a documentation form. CONCLUSIONS: Understanding the immunological basis of CRSwNP opens new non-surgical therapy approaches with biologics for patients with severe courses. The authors give recommendations for follow-up, possible therapy breaks, therapy intervals and a termination for dupilumab treatment as add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP that cannot be adequately controlled with systemic corticosteroids and/or surgical intervention.

[Outpatient Surgery in German ENT]. / Ambulantes Operieren in der HNO-Heilkunde in Deutschland.

Currently there is an intense discussion ongoing to enhance and expand outpatient surgery in the ENT in Germany, which is the intention by several politicians. The goal is to achieve a frequency of outpatient surgery comparable to an international level.To achieve this goal, acceptance of outpatient interventions by both, surgeons and patients is required, particularly in regard of equal quality standards and patient safety requirements.In the following review the organization, outcome, quality management and strategies for different ENT outpatient surgery worldwide is analyzed. Basically, outpatient surgery is organized in different ways: office-based-procedures in local anesthesia, procedures in ambulatory surgery center settings as standalone facilities or in connection with and adjacent to a hospital with possible inpatient treatment. Contact and resident times of the patients in the outpatient surgery centers differ between some hours through 23 hours. A deliberated and careful selection of patients which are suitable for outpatient procedures is required and should address comorbidities, medications, social circumstances, health literacy of the patient and its relatives, and distance from home to the hospital. A careful and strict quality management is mandatory which comprises the entire process from patient selection through patient entry, surgery, discharge and postoperative care in a multidisciplinary setting.Zur besseren Lesbarkeit des Textes wird bei geschlechterbezogenen Bezeichnungen die männliche Form benutzt. Es sind jedoch in gleicher Rangfolge auch das jeweilige weibliche Geschlecht oder andere Geschlechtsausprägungen gemeint.

[First time online 92nd annual meeting of the DGHNO-KHC 2021 - a critical assessment based on the participant's evaluation]. / 92. Jahresversammlung der DGHNO-KHC 2021 erstmals im Online-Format ­ eine kritische Bewertung auf Basis der Teilnehmerevaluation.

First time ever, the 92nd annual meeting of the DGHNO-KHC was carried out completely in an online format in May 2021 due to the new framework conditions caused by the corona pandemic. The participants from the ranks of members, guests and industrial partners were asked to complete an evaluation questionnaire from the responsible State Medical Association of North Rhine, which was supplemented with questions about the new virtual format. The publication summarizes the evaluation of the 187 (10 % of the total number of participants) medical/scientific and 25 industrial exhibitors (60 % of the participating industrial partners) responses and provides an initial conclusion. Roughly speaking, the congress was rated positively by the medical/scientific participants despite the total lack of social interaction and scientific open debates. On the industrial side, the picture was different. The medical participants were asked about the future format of the next annual ENT congresses. 16 % were in favor of a purely online congress, 67 % in favor of a face-to-face congress with online elements, and only 17 % in favor of a purely face-to-face congress. The question, which type of exhibition would be preferred in the future for industrial partners, 68 % were in favor of a purely face-to-face exhibition as part of a face-to-face congress. 32 % accepted a combination of presence with online elements. A future complete online industrial exhibition was voted out with 0 % approval.

Prognostic factors and risk factors for development and recurrence of sinonasal papillomas: potential role of different HPV subtypes.

PURPOSE AND METHODS: A retrospective study was conducted to identify and assess potential clinical and molecularbiological risk factors for development and recurrence of sinonasal papillomas (i.e. inverted (IP), fungiform (FP), and oncocytic papillomas (OCP)). Investigated risk factors included age, gender, tumor size and localization, tobacco smoking, regular alcohol consumption, essential hypertension, anticoagulant medication, allergies, surgical approach, and HPV infection. Risk factors were evaluated by regression analysis. RESULTS: Apart from age and incomplete tumor resection, the recurrence of Schneiderian papillomas is independent of conventional risk factors. Patients in this study displayed higher HPV infections rates in IP (38.8%) and in FP (100%) than in healthy mucosa, which is reported 0-5.8% in Germany and central Europe. The proportion of HPV-positive IP decreased with advanced tumor stages: 100% HPV positivity of T1 IP (2/2), 40.9% of T2 IP (9/22), and 35.7% of T3 IP (20/56). Most commonly detected HPV types were HPV 6, 11, and 16; however, patients in this study also displayed HPV types that have rarely or not at all been described in sinonasal papillomas before, such as HPV 58, 42, 83, and 91. Recurrent sinonasal papillomas displayed higher rates of HPV infections than non-recurrent tumors. CONCLUSIONS: Young age at initial diagnosis and incomplete tumor resection are risk factors for recurrence of sinonasal papillomas. Our data suggest that HPV infection supports development and/or perpetuation of sinonasal papillomas. Additionally, sinonasal papillomas seem to display a unique subset of HPV genotypes, including genotypes that have not often been described before.

[Regional distribution of the cochlear implant (CI) centers in Germany]. / Regionale Verteilung der Cochlea-Implantat (CI)-versorgenden Einrichtungen in Deutschland.

The treatment of patients with severe hearing loss or deafness with a cochlear implant (CI) represents a standard in Germany today. However, there is hardly any data on the current number of clinical CI centers (CI clinics) and their geographical distribution. The patient self-help organization, German Cochlear Implant Society (DCIG), and the German Society for Otorhinolaryngology, Head and Neck Surgery (DGHNO-KHC) have therefore initiated a survey to determine the regional distribution, the range of services, the consideration of existing quality standards and cooperation with patient self-help organizations of the individual clinical CI centers.For this purpose, a total number of 170 ENT departments or their directors (37 professors and 133 chief physicians), respectively, were contacted by e-mail and provided with a questionnaire. The survey took place from October 2019 to February 2020.Of the 170 departments contacted, 71 (41.8 %) took part in the survey. Of these, 70 departments (98.6 %) confirmed to perform CI surgeries. Thus, 41.8 % of all clinics contacted reported to perform CI surgeries (70 of 170 clinics), while this information was not available from 99 clinics. All 70 clinical CI centers (100 %) reported to conduct CI surgeries on adults, 60 centers (85.7 %) also on children (< 18 years). 36 departments (51.4 %) reported that the total number of CI surgeries at their facility in 2018 was more than 50. In 64 departments (91.4 %), the recommendations of the DGHNO-KHC on CI care (according to the White Paper CI care 2018) were followed. A collaboration between the department and patient self-help organization was confirmed by 67 institutions (95.7 %). The geographical distribution of the clinical CI centers showed a heterogeneous distribution pattern between the individual federal states and also within the respective federal state.The work presented here is a first assessment of the situation with regard to the regional distribution of clinical CI centers in Germany. A clustering of CI centers was noticeable in metropolitan areas, sometimes with several facilities in one city. The predominant attention to quality-related aspects, such as the consideration of the DGHNO-KHC white paper and the cooperation with patient self-help, is gratifying. The limitations of the study result from limited participation in the survey (41.8 % of the contacted clinics).

Induction chemotherapy (IC) followed by radiotherapy (RT) versus cetuximab plus IC and RT in advanced laryngeal/hypopharyngeal cancer resectable only by total laryngectomy-final results of the larynx organ preservation trial DeLOS-II.

Background: The German multicenter randomized phase II larynx organ preservation (LOP) trial DeLOS-II was carried out to prove the hypothesis that cetuximab (E) added to induction chemotherapy (IC) and radiotherapy improves laryngectomy-free survival (LFS; survival with preserved larynx) in locally advanced laryngeal/hypopharyngeal cancer (LHSCC). Patients and methods: Treatment-naïve patients with stage III/IV LHSCC amenable to total laryngectomy (TL) were randomized to three cycles IC with TPF [docetaxel (T) and cisplatin (P) 75 mg/m2/day 1, 5-FU (F) 750 mg/m2/day days 1-5] followed by radiotherapy (69.6 Gy) without (A) or with (B) standard dose cetuximab for 16 weeks throughout IC and radiotherapy (TPFE). Response to first IC-cycle (IC-1) with ≥30% endoscopically estimated tumor surface shrinkage (ETSS) was used to define early responders; early salvage TL was recommended to non-responders. The primary objective was 24 months LFS above 35% in arm B. Results: Of 180 patients randomized (July 2007 to September 2012), 173 fulfilled eligibility criteria (A/B: larynx 44/42, hypopharynx 41/46). Because of 4 therapy-related deaths among the first 64 randomized patients, 5-FU was omitted from IC in the subsequent 112 patients reducing further fatal toxicities. Thus, IC was TPF in 61 patients and TP in 112 patients, respectively. The primary objective (24 months LFS above 35%) was equally met by arms A (40/85, 47.1%) as well as B (41/88, 46.6%). One hundred and twenty-three early responders completed IC+RT; their overall response rates (TPF/TP) were 94.7%/87.2% in A versus 80%/86.0% in B. The 24 months overall survival (OS) rates were 68.2% and 69.3%. Conclusions: Despite being accompanied by an elevated frequency in adverse events, the IC with TPF/TP plus cetuximab was feasible but showed no superiority to IC with TPF/TP regarding LFS and OS at 24 months. Both early response and 24 months LFS compare very well to previous LOP trials and recommend effective treatment selection and stratification by ETSS. Clinical trial information: NCT00508664.

[Possible surgical approaches to the orbit]. / Möglichkeiten des chirurgischen Zugangs zur Orbita.

For removal of tumors and foreign bodies from the orbit, for treatment of severe inflammatory diseases, and for repositioning of bone fragments following fractures or during reconstruction of the bony orbit, several different surgical approaches are available. During the past decade, improved understanding of the pathology and pathophysiology of particular orbital diseases, advancements in clinical endoscopy and microscopy, the introduction of modern imaging techniques for preoperative visualization of pathologic findings, modern approaches to orbital reconstruction, as well as developments in adjuvant therapy have led to a reduction in invasiveness and development of the modern minimally invasive surgical approaches to the orbit usually used today. This review article aims to describe several surgical approaches to the orbit that are nowadays commonly applied-frequently in the context of interdisciplinary therapy-as well as their indications and potential complications. Particular attention is paid to minimally invasive approaches. These different surgical approaches allow a 360-degree exposure of the internal orbital structures with the optic nerve at the center ("round the clock access to the orbit"). The review is complemented by hints and tricks for particular approaches, as well as by a review of the latest literature in the field.

[Orbital traumatology]. / Traumatologie der Orbita.

BACKGROUND: In the case of trauma to the midface, an accompanying fracture of the orbit is common because to the anatomical conditions (bony buttresses of the midface). Etiology varies according to locoregional conditions. MATERIALS AND METHODS: An overview of orbital traumatology including diagnostic procedures, symptoms and therapy is provided. In addition, our own patient collective over one year including a 5-year follow-up was prospectively analyzed. RESULTS: The possible fractures of the midface with involvement of the orbit including their classifications are listed. The key clinical symptoms and the diagnostic procedure are described. As part of the therapeutic management, in addition to the-mostly required-surgical approach, the conservative therapeutic options and prerequisites for conservative therapy are discussed. In our own patients, clear differences in the accident mechanisms were evident. Violence was the most frequent mechanism for younger, male patients, while in female, elderly patients a fall was the reason for the fracture. Overall, 17% of cases received conservative therapy and 83% underwent surgical treatment. CONCLUSION: Traumatology of the orbit requires that therapeutic decisions be made on an individual patient basis. Even a conservative regime can lead to good results. The treatment of fractures of the orbit and the midface should be in the hands of experienced midface surgeons due to the technical competence with regard to the anatomy of the neighboring structures.