Long-term follow-up of the German post-market study for upper airway stimulation for obstructive sleep apnea.

PURPOSE: Upper airway stimulation (UAS) is an effective treatment for obstructive sleep apnea (OSA) in positive airway pressure (PAP) failure. Most reports have presented short-term data, so long-term safety and efficacy reports are rare. The German post-market study (G-PMS) has followed approximately 60 patients from three implanting centers for several years. METHODS: Patients with OSA and PAP failure qualified for the G-PMS by the absence of obesity class 2 an AHI between 15 and 65 events/h and absence of complete concentric collapse at the velum during drug-induced sleep endoscopy. Optional 2- and 3-year follow-ups after implantation were collected during routine clinical practice. We measured respiratory parameters such as apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) and daytime sleepiness using the Epworth sleepiness scale (ESS) in a per protocol analysis. Usage was calculated from device-downloaded reports. Device-related complications were documented. RESULTS: Of the 60 original patients, 41 returned for 2-year follow-up, and 38 for 3 years. About 76% at 2 years and 68% at 3 years met the criterion of therapy success defined as an AHI below 15/h. The median AHI was reduced from 28.6/h (baseline) to 9.0/h (2 years) and 10.0/h (3 years); whereas median ODI decreased from 27.0 to 6.3/h (2 years), and 8.3/h (3 years). Median ESS improved from baseline 13 points to 4 (2 years) and 6 (3 years). Usage was stable at approximately 45 h per week at 2 and 3 years. Serious device-related adverse events were rare, with two-device explantation between 12 to 36 months postoperatively. CONCLUSIONS: The German multi-center long-term outcomes compare favorably with previously published studies. Respiratory and sleepiness efficacy outcomes were sustained over 2 and 3 years, with a favorable safety profile, supporting the safety and efficacy of a chronic implantable therapy.

[Survey on current situation in otolaryngology residency]. / Umfrage der "Jungen HNO" zur aktuellen Situation der Weiterbildung von HNO-Ärzten.

BACKGROUND: Residents of ENT were asked about their situation in residency. A good and well structured training is the key for an attractive residency. METHODS: Between April 25-August 1, 2019, 691 residents registered with the German Society of Otorhinolaryngology, Head- and Neck Surgery ENT society were invited to anonymously participate in an online survey using SurveyMonkey® on the situation of the education in ENT and their working conditions. 25 of 80 questions were asked on the topics of structure and quality of the education in residency. RESULTS: The response rate was 36 % (n = 249). The participants attested their further training an average result. Mainly they see deficits in the further education and training structure and culture with a desire for improved feedback and improved surgical training. Participants were more dissatisfied with advanced further training time, regardless of ownership of the institution and level of care. CONCLUSIONS: The survey proposes concrete advice for improvement of ENT medical training in Germany. Suggestions for improvement are further development of the associated training and continuing education programs in cooperation with professional associations, structured feedback and supervision as well as transparent rotation plans and reliable working conditions.

[Effort-Reward Imbalance among otolaryngology residents in Germany]. / Psychosoziale Arbeitsbelastung von Ärzten in der HNO-Facharztweiterbildung.

INTRODUCTION: An increased psychosocial workload can have an negative impact on health. An effective way to record this is the effort reward imbalance model postulated by Siegrist. Values on this topic from ENT residents are missing, which is why the concept and corresponding questions were included in the survey on the current situation in further education. MATERIAL AND METHODS: An online survey on the current situation of the ENT residency including the recording of psychosocial workload was developed by ENT physicians on the basis of a well-known questionnaire of colleagues of the Alliance of Young Physicians. The short version of the validated questionnaire on the effort reward imbalance model according to Siegrist with 16 items was used. An online survey was carried out addressing all ENT residents in Germany known to the German society of Oto-Rhino-Laryngology, Head and Neck surgery. The survey was sent by e-mail and was available from April 1st to July 31st in 2019. RESULTS: 92,3 % of the participants had an effort-reward imbalance. The mean value of effort reward imbalance was 1.57 ± 0.43, adjusted 2.16 ±â€Š1.36. The effort scale was 10.71 ±â€Š1.40 (3-12), adjusted 85.72 ±â€Š15.52, reward scale 16.58 ±â€Š2.86 (7-28), adjusted 45.61 ±â€Š13.63, over commitment 17 ±â€Š3.37, adjusted 61.14 ±â€Š18.73. A high effort reward imbalance had positive significant correlations with regard to the duration of residency, the number of working hours per week and the number of duty hours per month. CONCLUSION: The effort and reward imbalance is comparable to other specialty physicians in residency. It is related to working hours, services and the progress of training. It can be improved through personal initiative and could be supplemented with the support of the hospital's internal stakeholders.

[Survey on the need for an e-learning-platform for ENT residents]. / Umfrage zum Bedarf einer e-Learning-Plattform für Ärzte in der HNO-Facharzt-Weiterbildung.

OBJECTIVE: Interactive e-learning-platforms may replace the classical textbook in the future. Such media have the possible advantage of including video and audio files in a more comprehensive way, but ENT-specific platforms do not currently exist. So far, the actual needs and wishes of ENT residents are unclear and may be affected by the so called digital revolution. MATERIAL AND METHODS: An online survey was carried out addressing all ENT residents in Germany known to the German society of oto-rhino-laryngology, head and neck surgery. A 17-items survey was developed by ENT doctors receiving and providing training and distributed by e-mail. The survey was available to answer in April and May 2019. RESULTS: A total of 150 out of 671 ENT specialists and residents took part in the study. Of these, 80 % were residents and 20 % were ENT specialists. 63-80 % of the respondents already use online media in general at work, in preparation for the ENT specialist examination, for training purposes and for support as a clinician. 92-95 % of the participants indicated the willingness to use an interactive platform for their ENT specialist examination preparation and further training. On average, e-learning media are used by the responders to prepare for the ENT specialist examination or in clinical everyday life and for further training 108 or 130 min/week. The desire for surgical instruction videos is also very high. CONCLUSION: There is a high demand for a structured e-learning-platform especially for ENT. An interactive e-learning-platform would ensure, supplement and support qualified education and training.

Home Sleep Testing to Direct Upper Airway Stimulation Therapy Optimization for Sleep Apnea.

OBJECTIVES/HYPOTHESIS: Selective upper airway stimulation (sUAS) is a well-established treatment option for obstructive sleep apnea (OSA). This study aimed to determine if there are benefits in performing a home sleep test (HST) to evaluate postoperative sUAS effectiveness after patient acclimatization compared to the generally used polysomnography (PSG) titration, as measured by long-term follow-up outcomes. STUDY DESIGN: Retrospective comparative cohort analysis. METHODS: We conducted an analysis of consecutive patients at our center who had completed a 6-month follow-up (month 6 [M6]) and recorded data from M6, month 12 (M12), and month 24 (M24). After device activation, we performed an HST with the patient's stimulation settings, and measured the apnea-hypopnea index (AHI), Epworth Sleepiness Scale (ESS), and device usage. These values were compared to patients who had undergone PSG-based device titration. RESULTS: Baseline values of the initial 131 patients show high ESS and moderate OSA. At the 2-month time point of the HST, nearly half of the patients (46.2%) reached an AHI ≤15/hr, and approximately a fifth (19.2%) reached <5/hr. The PSG and HST groups differed in median ESS at M24, but no other differences were observed for ESS at M6 and M12. Both groups showed similar AHI, oxygen desaturation, and usage hours per week. CONCLUSIONS: Adjusting therapy by using the HST technique after device activation and acclimatization has clinical and economic advantages. These advantages are contingent on several conditions being met when deviating from the standard device protocol, including precise communication with the referring sleep medicine physicians, especially their role in helping with long-term follow-up. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:E1375-E1379, 2021.

Upper-Airway Stimulation Before, After, or Without Uvulopalatopharyngoplasty: A Two-Year Perspective.

OBJECTIVE: Upper airway stimulation (UAS) is an effective second-line treatment for obstructive sleep apnea (OSA). In certain patients, there is a considerable need for advanced programming, notably with inadequate palatal response to therapy. The aim of the study was to investigate the impact of uvulopalatopharyngoplasty and tonsillectomy (UPPP-TE) on UAS therapy outcomes from a 2-year perspective after implantation. METHODS: This study included all consecutive patients implanted with UAS in which a full set of 1- and 2-year follow-up assessments (M12 and M24) were obtained. Cases were analyzed in three groups: patients with UPPP-TE after (group 1) and before (group 2) UAS, and those without UPPP-TE (group 3). RESULTS: Therapy success could be achieved in about 80% of the entire cohort. Groups 2 and 3 did not differ significantly with regard to obesity, Apnea-Hypopnea Index, or Oxygen Desaturation Index. With regard to initial sleep endoscopy, there were fewer patients without any obstruction at the palatal and oropharyngeal levels and higher prevalence of lateral obstruction patterns at oropharynx in group 1 in contrast to groups 2 and 3. Groups 2 and 3 showed similar results, although group 2 patients underwent UPPP-TE before UAS implantation. CONCLUSION: UPPP-TE should be considered in patients with persistent OSA after UAS implantation if the obstruction is identified at the level of velum and oropharynx. Although this approach has higher response rates and better outcomes can be achieved in patients with UAS, there is no indication for patients to routinely undergo UPPP-TE prior to UAS implantation. LEVEL OF EVIDENCE: 4 Laryngoscope, 129:514-518, 2019.