Study protocol: the biologics in severe chronic rhinosinusitis with nasal polyps survey.

INTRODUCTION: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a frequent condition affecting approximately 2% of the population. Medical treatment consists long-term use of intranasal corticosteroids and short-term use of oral corticosteroids, in adjunct with saline solution rinses. Surgical management is proposed in patients who failed after medical treatment. In France, two biologics are reimbursed in case of severe uncontrolled CRSwNP despite medical treatment and endoscopic sinus surgery. Waiting for head-to-head biologics comparison, studies should report the efficacy and safety of biologics in large real-life cohorts. This study protocol describes the aims and methods of a prospective, observational, national, multicentric cohort of patients with CRSwNP treated with biologics. METHODS AND ANALYSIS: The BIOlogics in severe nasal POlyposis SurvEy is a French multicentre prospective observational cohort study. The main aim is to assess the efficacy and tolerance of biologics in patients with CRSwNP, with or without association with other type 2 diseases, and to determine the strategies in case of uncontrolled disease under biologics. Patients over 18 years old requiring biologics for CRSwNP in accordance with its marketing approval in France (ie, severe nasal polyposis, with lack of control under nasal corticosteroid, systemic corticosteroids and surgery) are invited to participate. Collected data include topical history of surgical procedures and biologics, medication and use of systemic corticosteroids, visual analogical scales for specific symptoms, Sino-Nasal Outcome Test-22 questionnaire, nasal polyp score, asthma control test, Lund-Mackay score on CT scan and IgE concentration and eosinophilic count on blood sample. TRIAL REGISTRATION: NCT05228041/DRI_2021/0030.

Unraveling the Complexities of Oxidative Stress and Inflammation Biomarkers in Obstructive Sleep Apnea Syndrome: A Comprehensive Review.

BACKGROUND: Obstructive sleep apnea syndrome (OSAS), affecting approximately 1 billion adults globally, is characterized by recurrent airway obstruction during sleep, leading to oxygen desaturation, elevated carbon dioxide levels, and disrupted sleep architecture. OSAS significantly impacts quality of life and is associated with increased morbidity and mortality, particularly in the cardiovascular and cognitive domains. The cyclic pattern of intermittent hypoxia in OSAS triggers oxidative stress, contributing to cellular damage. This review explores the intricate relationship between OSAS and oxidative stress, shedding light on molecular mechanisms and potential therapeutic interventions. METHODS: A comprehensive review spanning from 2000 to 2023 was conducted using the PubMed, Cochrane, and EMBASE databases. Inclusion criteria encompassed English articles focusing on adults or animals and reporting values for oxidative stress and inflammation biomarkers. RESULTS: The review delineates the imbalance between pro-inflammatory and anti-inflammatory factors in OSAS, leading to heightened oxidative stress. Reactive oxygen species biomarkers, nitric oxide, inflammatory cytokines, endothelial dysfunction, and antioxidant defense mechanisms are explored in the context of OSAS. OSAS-related complications include cardiovascular disorders, neurological impairments, metabolic dysfunction, and a potential link to cancer. This review emphasizes the potential of antioxidant therapy as a complementary treatment strategy. CONCLUSIONS: Understanding the molecular intricacies of oxidative stress in OSAS is crucial for developing targeted therapeutic interventions. The comprehensive analysis of biomarkers provides insights into the complex interplay between OSAS and systemic complications, offering avenues for future research and therapeutic advancements in this multifaceted sleep disorder.

Obstructive sleep apnea syndrome: A frequent and difficult-to-detect complication of radiotherapy for oropharyngeal cancers.

This pilot study reveals a higher prevalence of obstructive sleep apnea syndrome (OSAS) in patients treated for oropharyngeal squamous cell carcinoma with radiotherapy compared to the general population. OSAS indicators such as the Epworth Sleepiness Scale seem insufficient in the diagnostic approach to OSAS in this population and systematic screenings should be considered.

Chat GPT for the management of obstructive sleep apnea: do we have a polar star?

PURPOSE: This study explores the potential of the Chat-Generative Pre-Trained Transformer (Chat-GPT), a Large Language Model (LLM), in assisting healthcare professionals in the diagnosis of obstructive sleep apnea (OSA). It aims to assess the agreement between Chat-GPT's responses and those of expert otolaryngologists, shedding light on the role of AI-generated content in medical decision-making. METHODS: A prospective, cross-sectional study was conducted, involving 350 otolaryngologists from 25 countries who responded to a specialized OSA survey. Chat-GPT was tasked with providing answers to the same survey questions. Responses were assessed by both super-experts and statistically analyzed for agreement. RESULTS: The study revealed that Chat-GPT and expert responses shared a common answer in over 75% of cases for individual questions. However, the overall consensus was achieved in only four questions. Super-expert assessments showed a moderate agreement level, with Chat-GPT scoring slightly lower than experts. Statistically, Chat-GPT's responses differed significantly from experts' opinions (p = 0.0009). Sub-analysis revealed areas of improvement for Chat-GPT, particularly in questions where super-experts rated its responses lower than expert consensus. CONCLUSIONS: Chat-GPT demonstrates potential as a valuable resource for OSA diagnosis, especially where access to specialists is limited. The study emphasizes the importance of AI-human collaboration, with Chat-GPT serving as a complementary tool rather than a replacement for medical professionals. This research contributes to the discourse in otolaryngology and encourages further exploration of AI-driven healthcare applications. While Chat-GPT exhibits a commendable level of consensus with expert responses, ongoing refinements in AI-based healthcare tools hold significant promise for the future of medicine, addressing the underdiagnosis and undertreatment of OSA and improving patient outcomes.

SimLife®: A New Dynamic Model for Head and Neck Surgical Oncology Simulation.

The SimLife® model consists in a human cadaver dynamized by pulsatile vascularization. The objective was to evaluate the face, contents, and constructs validity of the SimLife® model in head and neck surgical oncology simulation. Head and neck surgical oncology simulation sessions on SimLife® models were organized with lateral neck dissection and total laryngectomy. Face and contents validity were addressed by questionnaires. Constructs validity was assessed by objective structured assessment of technical skills (OSATS) score. High realism was demonstrated for consistency of tissues (7.1 ± 1.4), color of arteries and veins (7.3 ± 1.9, 8.5 ± 1.1, respectively), and vein consistency (8.5 ± 1.2). The mean OSATS score was 19.7 ± 5.4 for residents and 32.7 ± 1.9 for senior surgeon (P = .0022). SimLife® is a hyperrealistic model for head and neck surgical oncology simulation and it might become a core component of the surgical resident curriculum.

Cross-cultural adaptation of the CRS-PRO questionnaire into French.

BACKGROUND: Chronic rhinosinusitis (CRS), encompasses many different clinical patterns with variable response to treatment. Precise criteria specifying disease severity and control are lacking in the current literature. Our aim was to perform a cross-cultural adaptation of the CRS-PRO, creating a French version for use as a routine questionnaire in the assessment of patients with CRS. METHODS: The CRS-PRO questionnaire was translated according to the recommendations of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) through a three-step procedure including a backward translation. RESULTS: Seven of 12 items were initially discordant between the three translators before achieving consensus (Step 1). Two of 12 items were discordant between the backward translation and the initial CRS-PRO version regarding the word "mucus"(Step 2). Step 3 allowed the creation of a French proof-read version of the CRS-PRO questionnaire. Thirty patients were included for initial validation, mean age of 49.2 ± 15 years and 63.3% (19/30) male. It took them 67 ± 23 s to complete the questionnaire without any patients requiring more than 2 min. CONCLUSION: This study presents the French version of the CRS-PRO questionnaire-an adapted, validated, and well-accepted instrument to evaluate the CRS symptoms in the French speaking population.

Predictors of Success of Pharyngeal Surgery in the Treatment of Obstructive Sleep Apnea: A Narrative Review.

(1) Background: This narrative review aims to explore the predictors of success for pharyngeal surgery in the treatment of obstructive sleep apnea (OSA). An extensive literature search was conducted, identifying relevant studies published up to June 2023, utilizing various databases and key search terms related to OSA, surgical interventions, and predictors of success. The review encompasses both retrospective and prospective studies, case series, and cohort studies to provide a broad understanding of the topic; (2) Methods: Review of English scientific literature on phenotypes of OSA related to predictors of success of pharyngeal surgery; (3) Results: Of 75 articles, 21 were included, in these the following were determined to be factors for surgical success: body mass index (BMI) (8 articles), apnea/hypopnea index (AHI) (8 articles), cephalometry (8 articles), palatine tonsil size (7 articles), Modified Mallampati score (2 articles), genioglossus electromyography (2 articles), Friedman score or upper airway anatomy (3 articles), nasopharyngolaryngoscopy (2 articles), drug-induced sleep endoscopy (DISE) (1 article), oral cavity anatomy (1 article) and oxygen desaturation index (ODI) (1 article); (4) Conclusions: The lack of standardized protocols for the indication of pharyngeal surgery is a reality, however identifying known predictors of surgical success may facilitate homogenizing indications.

Anatomical variations of interest for posterior nasal nerve cryotherapy in the treatment of chronic rhinitis: A radioanatomic study.

KEY POINTS: An unfavorable insertion of the middle turbinate for cryotherapy was present in 74.2% of cases. Placing cryoprobe 15-30 mm above the nasal floor targets the nerves in 95.8% of cases. Centering the cryoprobe 38 mm behind the inferior turbinate axilla targets the nerves in 94.6% of cases.

French translation and validation of the OSATS tool for the assessment of surgical skill.

AIM OF THE STUDY: The OSATS rating scale is one of the tools most widely used in the scientific literature for assessing technical surgical skill. The aim of this study was to translate this scale into French (OSATS-FR) and validate it. METHODS: OSATS was translated into French by two independent translators. The two translations were pooled and back-translated by a third translator into English to produce a consensus version (OSATS-FR). Three independent assessors then used it to assess surgical skill in tracheostomy videos. The reproducibility of the scoring was measured. RESULTS: The OSATS-FR version was easily understood and used by all three assessors. In all, 18 procedures were assessed, performed by 14 interns and 4 senior surgeons. The mean OSATS-FR score was 18.6±4.08 for the interns and 31.6±1.62 for the seniors (p<0.0001). The Pearson correlation coefficient was 0.937 CI95% [0.867-1.269] between assessors 1 and 2, 0.977 CI95% [0.899-1.149] between assessors 1 and 3, and 0.965 CI95% [0.876-1.196] between assessors 2 and 3. Cronbach's alpha was greater than 0.9 for each assessor. CONCLUSION: OSATS-FR can distinguish between two groups with different surgical expertise and assess surgical skill with an inter-assessor reproducibility and internal consistency comparable to those of the English version.

Porcine model for tracheostomy training: evaluation of the content and construct validity.

PURPOSE: Tracheostomy is a key procedure that residents in Oto-Rhino-Laryngology, Head and Neck surgery must master as a fundamental component of their training. Swine is a potential model for tracheostomy training as it mimics human anatomy and provides realistic haptic feedback. The purpose of this study is to evaluate its content and construct validity in surgical tracheostomy training. METHODS: We carried out training sessions on dead swine with three groups of volunteers: young residents [postgraduate year (PGY)-1 to 3], experienced residents (PGY-4 to 6) and senior surgeons. Content validity was studied using questionnaires sent to senior surgeons. Construct validity was assessed by comparing the OSATS score on video analysis, between the three groups. RESULTS: 19 individuals participated in the training sessions. OSATS score were statistically different between groups (p < 0.05) with a mean score of 19 for young residents, 24.7 for experienced residents and 31.3 for senior surgeon, with a good inter-rater reliability (Pearson coefficient > 0.9). Experienced surgeons agreed that the model was a useful training tool, strongly agreed that it improved performance, and that it would be used to train their students. CONCLUSIONS: The dead pig is a suitable model to train for human tracheotomy, with good content and construction validity.

Transverse Venous Sinus Stenosis in Patients With Nasal Cerebrospinal Fluid Leak and Idiopathic Intracranial Hypertension.

OBJECTIVE: Spontaneous nasal cerebrospinal fluid (CSF) leaks are frequently linked to idiopathic intracranial hypertension (IIH). The objectives of our study were: (1) to determine the rate of transverse venous sinus stenosis (TVSS) in patients with spontaneous nasal CSF leak and in patients with IIH without CSF (controls), and (2) to study the correlation between spontaneous nasal CSF leak and brain imaging features. STUDY DESIGN: A multicenter retrospective case-control study. SETTING: Six French tertiary hospitals. METHODS: Patients with spontaneous nasal CSF leaks and patients with IIH without nasal CSF leaks (controls) were included. The transverse venous sinus patency was analyzed by magnetic resonance imaging to identify possible stenosis or hypoplasia. RESULTS: Thirty-two patients with spontaneous nasal CSF leaks and 32 controls were included. TVSS was significantly more frequent in patients with spontaneous nasal CSF leaks than in controls (p = .029). Univariate analysis indicated that TVSS (odds ratio, OR: 4.2; 95% confidence interval, CI [1.352-14.915]; p = .017) and arachnoid granulations (OR: 3; 95% CI [1.065-8.994]; p = .042) were risk factors for spontaneous nasal CSF leak. In multivariate analysis, TVSS and arachnoid granulations were independent risk factors of nasal CSF leak (OR: 5.577, 95% CI [1.485-25.837], p = .016; and OR: 4.35, 95% CI [1.234-17.756], p = .029, respectively). CONCLUSION: This multicenter case-control study shows that TVSS is an independent risk factor for CSF leak in patients with IIH. Stenosis management by interventional radiology may be proposed postoperatively to increase the success of IIH surgical treatment or preoperatively to reduce the need for surgery.

Definition of severity and treatment response in chronic rhinosinusitis with nasal polyps: a Delphi study among French experts.

INTRODUCTION: The introduction of biotherapies has significantly changed the management of patients with chronic rhinosinusitis with nasal polyps (CRSwNP). These drugs are generally reserved for severe or recurrent CRSwNP. Thus, the concepts of severity of the disease and treatment response must be mastered by otorhinolaryngologists. However, a clear definition of these concepts in CRSwNP is missing. METHODS: This article focuses on definitions of severity and treatment response in CRSwNP by providing an expert consensus among French rhinologists, using a Delphi study. RESULTS: The severity assessment should seek the presence of uncontrolled asthma, olfactory disorders, nasal blockage, impaired quality of life (QOL) and cumulative annual dose of systemic corticosteroids.The treatment response should assess the presence of olfactory disorders, nasal blockage, QOL impairment, response to background therapy, resistance and/or dependence to oral corticosteroids, cumulative annual dose of systemic corticosteroids, response to surgery and to biologics.A failure after polypectomy should not be considered as a failure of surgical management of CRSwNP and must discuss the realization of an extended sinus surgery procedure before the prescription of biologics. CONCLUSION: Definitions of severity, control of CRSwNP, as well as therapeutic strategies to improve patients' QOL achieved high level of consensus.

Multicenter study to assess surgical treatments of 452 sinonasal intestinal-type adenocarcinomas: A REFCOR study.

PURPOSE: The objective was to assess the local oncological outcomes of endoscopic versus external surgical treatment of sinonasal intestinal-type adenocarcinomas (ITAC) and the factors of recurrence. METHODS: a retrospective non-randomized case-control multicenter study was carried out, including 452 untreated sinonasal ITACs recruited from 10 tertiary referral centers. The tumors were re-classified according to the UICC 2017 (pT). Survival curves were obtained using the Kaplan-Meier method. Univariate analysis was done with the log-rank test. Multivariate analysis was performed with a Cox model adjusted for age, T stage, and radiotherapy. A binary logistic regression compared surgical complications and performed two supplementary analyses on positive margins. RESULTS: We compared 195 and 257 patients operated by the external and endoscopic approach, respectively. The mean follow-up was 59.2 ± 48.7 months. Post-operative margins were invaded in 30.6 versus 18.9% of patients, respectively (p = 0.007). The overall recurrence rate was 33.8 versus 24.6%, respectively (p = 0.034). There was a significant difference in favor of the endoscopic approach regarding local recurrence-free survival thanks to better surgical margins in univariate and multivariate analysis (Odd Ratio = 2.01 (1.2-3.36) p = 0.0087). The complication rate (Odds Ratio = 3.4 (1.79-6.32) p < 0.001) was significantly lower in the endoscopic group. The histological positivity of signet-ring cells shows a statistically significant difference in recurrence-free survival (p = 0.0028). CONCLUSION: the oncological control of ITAC is better through the endoscopic approach, with negative margins and the absence of signet-ring-cells, two independent factors of recurrence.

Measurement of airborne particle emission during surgical and percutaneous dilatational tracheostomy COVID-19 adapted procedures in a swine model: Experimental report and review of literature.

INTRODUCTION: Surgical tracheostomy (ST) and Percutaneous dilatational tracheostomy (PDT) are classified as high-risk aerosol-generating procedures and might lead to healthcare workers (HCW) infection. Albeit the COVID-19 strain slightly released since the vaccination era, preventing HCW from infection remains a major economical and medical concern. To date, there is no study monitoring particle emissions during ST and PDT in a clinical setting. The aim of this study was to monitor particle emissions during ST and PDT in a swine model. METHODS: A randomized animal study on swine model with induced acute respiratory distress syndrome (ARDS) was conducted. A dedicated room with controlled airflow was used to standardize the measurements obtained using an airborne optical particle counter. 6 ST and 6 PDT were performed in 12 pigs. Airborne particles (diameter of 0.5 to 3 µm) were continuously measured; video and audio data were recorded. The emission of particles was considered as significant if the number of particles increased beyond the normal variations of baseline particle contamination determinations in the room. These significant emissions were interpreted in the light of video and audio recordings. Duration of procedures, number of expiratory pauses, technical errors and adverse events were also analyzed. RESULTS: 10 procedures (5 ST and 5 PDT) were fully analyzable. There was no systematic aerosolization during procedures. However, in 1/5 ST and 4/5 PDT, minor leaks and some adverse events (cuff perforation in 1 ST and 1 PDT) occurred. Human factors were responsible for 1 aerosolization during 1 PDT procedure. ST duration was significantly shorter than PDT (8.6 ± 1.3 vs 15.6 ± 1.9 minutes) and required less expiratory pauses (1 vs 6.8 ± 1.2). CONCLUSIONS: COVID-19 adaptations allow preventing for major aerosol leaks for both ST and PDT, contributing to preserving healthcare workers during COVID-19 outbreak, but failed to achieve a perfectly airtight procedure. However, with COVID-19 adaptations, PDT required more expiratory pauses and more time than ST. Human factors and adverse events may lead to aerosolization and might be more frequent in PDT.

Interdisciplinary challenges and aims of flap or graft reconstruction surgery of sinonasal cancers: What radiologists and radiation oncologists need to know.

In sinonasal cancer surgery, a fundamental challenge is to understand the postoperative imaging changes after reconstruction. Misinterpretation of post-operative imaging may lead to a misdiagnosis of tumor recurrence. Because radiotherapy planning is based on imaging, there are many gaps in knowledge to be filled in the interpretation of postoperative imaging to properly define radiotherapy tumor volumes in the presence of flaps. On the other hand, radiotherapy may be responsible for tissue fibrosis or atrophy, the anatomy of the reconstructed region and the functional outcomes may change after radiotherapy compared to surgery alone. This narrative review illustrates the interdisciplinary aims and challenges of sinonasal reconstructive surgery using flaps or grafts. It is particularly relevant to radiologists and radiation oncologists, at a time when intensity modulated radiotherapy and proton therapy have the potential to further contribute to reduction of morbidity.

Endoscopic transsphenoidal surgery for non-functioning pituitary adenoma: Learning curve and surgical results in a prospective series during initial experience.

Background: To report the initial experience of surgery for non-functioning pituitary adenoma (NFPA) from a neurosurgeon in a dedicated residency training endoscopic transsphenoidal (ETS) program, and detail the surgical and clinical outcomes during this period. Methods: A prospective series of all patients operated for NFPA, using an ETS approach, during the three first years of experience of a newly board-certified neurosurgeon was analysed. Clinical, radiological and peri-operative data were collected. Extent of resection (EOR) was determined by formal volumetric analysis. Impact of the learning curve and predictive factors of gross total resection (GTR) were determined. Results: Fifty-three patients with NFPA were included in this prospective cohort which was divided in two periods of time ("First period": 30 first cases, and "second period": 23 following cases). Baseline characteristics of the patients in the two periods were similar. Overall occurrence of complication was 22% and was not significantly different in the two periods of time. No patient had severe neurological complication. Gross total resection was achieved in 70% of patients. Mean Extent of resection was 96%. In a multiple linear regression model, a higher EOR was positively correlated with experience (p = 0.018) and negatively correlated with Knosp Score equal to 4 (p < 0.001). Predictive factors for GTR were Higher Knosp grade (p = 0,01), higher pre-operative volume (p = 0.03), and second period of time (p = 0.01). Conclusion: NFPA surgery can be safe and efficient during the learning period. Dedicated intensive learning, careful patient selection and multidisciplinary work are key to shorten the learning curve and achieve satisfactory results.