Real-Life Evidence of Mepolizumab Treatment in Chronic Rhinosinusitis with Nasal Polyps: A Multicentric Study.

Background: The introduction of biological drugs in the management of chronic rhinosinusitis with nasal polyps (CRSwNP) is allowing new and increasingly promising therapeutic options. This manuscript aims to provide a multicenter trial in a real-life setting on Mepolizumab treatment for severe uncontrolled CRSwNP with or without comorbid asthma. Methods: A retrospective data analysis was jointly conducted at the Otolaryngology-Head and Neck Surgery departments of La Sapienza University and San Camillo Forlanini Hospital in Rome. Both institutions participated by sharing clinical information on patients with CRSwNP treated with Mepolizumab. Patients were evaluated before starting Mepolizumab, at six months and at twelve months from the first drug administration. During follow-up visits, patients underwent endoscopic evaluation, quality of life assessment, nasal symptoms assessment, and blood tests to monitor mainly neutrophils, basophils, eosinophils, and IgG, IgA, and IgE assay. Results: Twenty patients affected by CRSwNP and treated with Mepolizumab were enrolled (12 females and 8 males with a mean age of 63.7 years). Sixteen patients (80%) had concomitant asthma. During follow-up, a gradual improvement in nasal polyp score, quality of life and nasal symptoms, assessed by SNOT-22 and VAS and loss of smell measured by olfactory VAS, was found. Regarding blood tests, eosinophils decreased gradually, while other blood parameters showed no statistically significant changes. Conclusions: Mepolizumab has been shown to be effective in the therapeutic management of patients with CRSwNP. Further studies are needed to support our findings and better understand the underlying immune pathways to predict patients' response to biological treatment in CRSwNP.

Refractory Pseudomonas Osteomyelitis of the Skull Base With Gradenigo's Syndrome: Early Dysphagia and Late Abducens Nerve Palsy.

Gradenigo's syndrome (GS) is a rare entity characterized by otitis media, pain in the trigeminal nerve distribution and abducens nerve palsy. The classic triad is uncommon, making the diagnostic workup challenging. Specifically, the diagnostic approach includes medical history, a complete otorhinolaryngological examination, a pure-tone audiogram and radiological investigation such as contrast-enhanced computed tomography scan and magnetic resonance imaging of head and neck. Broad-spectrum antibiotics are the first-line treatment, such as intravenous (IV) ceftriaxone and IV metronidazole. Here, we present the case of a 71-year-old man with a previous history of otitis media and poorly controlled type 2 diabetes mellitus. He presented to our attention with facial pain, left hemilarynx paralysis, dysphagia and otorrhea. The patient was treated with broad-spectrum antibiotics without any clinical improvement. Imaging evaluations demonstrated the presence of wide and poorly defined pathological material with epicenter in the masticatory space, involving all nearby structures. The patient underwent multiple biopsies without obtaining a definitive tissue diagnosis of neoplasia. After 2 months, the patient developed delayed VI cranial nerve palsy, providing evidence of GS. Although incomplete, GS has been described in the literature; however, none of the cases exhibited a latent abducent deficit. To the best of our knowledge, this is the only case with a delayed onset of abducens nerve palsy.

Safety and efficacy of remifentanil target-controlled infusion for conscious sedation in a pregnant woman: a case report.

BACKGROUND: Every year 2% of pregnant women undergo nonobstetric surgical interventions worldwide. According to the American College of Obstetricians and Gynecologists Committee on Obstetric Practice, pregnant women should never be denied the most appropriate surgical treatment, regardless of the trimester of pregnancy. However, additional attention should be paid during the first trimester since it has the highest risk of inducing teratogenic mutations; additionally, during the third trimester, due to the possibility of preterm birth and low birth weight of the newborn, great care should be paid. CASE PRESENTATION: We present the case of a Caucasian 36-year-old woman during her 21st week of pregnancy, with a normal-sized fetus, according to the gestational age on ultrasound exam, and with no additional risk factors. The patient referred to an increasing nasal obstruction associated with rhinorrhea of the left nasal cavity. She also reported episodes of sleep apnea and hyposmia. The patient received a detailed otolaryngological examination, which allowed for identification of a mass within the left nasal cavity. The subsequent nasal endoscopy confirmed a grayish polypoid mass lesion with a multinodular surface occupying the entire left nasal fossa. The lesion totally obliterated the left maxillary sinus, resulting in obstruction of the anterior osteomeatal unit and ethmoidal sinusitis. She was referred for a functional endoscopic sinus surgery using analgosedation with remifentanil target-controlled infusion. DISCUSSION AND CONCLUSION: To the very best of our knowledge, this is the first case described in English literature about the use of analgosedation with remifentanil target-controlled infusion for otolaryngology surgery, specifically in functional endoscopic sinus surgery. It could be an interesting option to avoid the use of inhaled anesthetics that could induce fetal damage, especially during the first months of pregnancy. Furthermore, patient intubation is not necessary, which avoids cases of difficult intubation or any trauma to the airways. An adequate informed consent and appropriate compliance are elements of paramount importance in tailoring the anesthetic strategy for pregnant women who need nonobstetric surgical management.

Multidisciplinary Decision-Making-ITAlian Consensus After Two Years of Real Practice on the Management of Severe Uncontrolled CRSwNP by Biologics (ITACA Study).

PURPOSE OF REVIEW: We aimed to reach an Italian multidisciplinary consensus on some crucial aspects of treatment decision making in CRSwNP, following 2 years of clinical experience in order to support specialists in the management of CRSwNP in clinical practice. We addressed issues relating to therapeutic decision-making and shared criteria for the treatment choice, as well as appropriate timing and criteria for evaluating treatment response, and highlighted the need for repeated multidisciplinary assessments. RECENT FINDINGS: A national survey has been conducted recently to understand how rhinology practice has changed in Italy with the advent of biologics and how this affects patients with uncontrolled, severe CRSwNP. Despite the many published consensus documents, practical recommendations, and protocols on the use of biologics in CRSwNP, heterogenous behaviors in practice are still observed mainly conditioned by the novelty of the topic. The consensus procedure followed a modified Delphi approach. The scientific board included 18 otorhinolaryngologists and 8 allergists, who selected the 4 main topics to be addressed and developed overall 20 statements. Consensus on these statements was sought by a larger group of 48 additional experts, through two rounds of voting, the first web-based, the second in presence with discussion and possible refinement of the statements. The statements reaching an average score ≥ 7 at the second voting round were approved. Five statements were proposed for each of the following topics: baseline evaluation of patients eligible for biologic therapy; choice between different therapeutic options; assessment of the response to biologic treatment; multidisciplinary management. At the first voting round, 19 out of the 20 statements reached a mean score ≥ 7. Following the discussion and a few consequent amendments, at the second round of voting all the 20 statements were approved.

Current role of artificial intelligence in head and neck cancer surgery: a systematic review of literature.

Aim: Artificial intelligence (AI) is a new field of science in which computers will provide decisions-supporting tools to help doctors make difficult clinical choices. Recent AI applications in otolaryngology include head and neck oncology, rhinology, neurotology, and laryngology. The aim of this systematic review is to describe the potential uses of AI in head and neck oncology with a special focus on the surgical field. Methods: The authors performed a systematic review, in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines, in the main medical databases, including PubMed, Scopus, and Cochrane Library, considering all original studies published until February 2023 about the role of AI in head and neck cancer surgery. The search strategy included a combination of the following terms: "artificial intelligence" or "machine learning" and "head and neck cancer". Results: Overall, 303 papers were identified and after duplicate removal (12 papers) and excluding papers not written in English (1 paper) and off-topic (4 papers), papers were assessed for eligibility; finally, only 12 papers were included. Three main fields of clinical interest were identified: the most widely investigated included the role of AI in surgical margins assessment (7 papers); the second most frequently evaluated topic was complications assessment (4 papers); finally, only one paper dealt with the indication of salvage laryngectomy after primary radiotherapy. Conclusions: The authors report the first systematic review in the literature concerning the role of AI in head and neck cancer surgery. An increasing influx of AI applications to clinical problems in otolaryngology is expected, so specialists should be increasingly prepared to manage the constant changes. It will always remain critical for clinicians to use their skills and knowledge to critically evaluate the additional information provided by AI and make the final decisions on each patient.

Biologics in severe uncontrolled chronic rhinosinusitis with nasal polyps: A bicentric experience.

BACKGROUND AND AIM: The introduction of biologics in the management of chronic rhinosinusitis with nasal polyposis (CRSwNP) has allowed new therapeutic options and Dupilumab represents the first approved biological agent. Aim of this paper is to provide a multicentric study in a real-life setting of treatment with Dupilumab for severe uncontrolled CRSwNP in Italy. METHODS: A retrospective data collection was performed from the departments of Otolaryngology of two major health institutions in Rome: San Camillo Forlanini Hospital and Tor Vergata University. Both centres contributed to the study providing information about patients affected by severe uncontrolled CRSwNP and treated with Dupilumab. RESULTS: A total of 83 patients were included in the study (43 males; 40 females; mean age: 55.8 years). Monitoring our patients, we observed improvement in reduction of nasal polyposis and nasal obstruction, respectively measured through NPS and PNIF. Concerning the CRSwNP symptoms and their impact on quality of life, we found an improvement in the olfaction, as measured respectively by SSIT-16 and SNOT-22. CONCLUSIONS: Dupilumab has demonstrated broad efficacy in CRSwNP management. Further studies are needed to confirm our results and to establish biomarkers to identify endotypes and predict response to biologics treatment in CRSwNP.

Dupilumab's Impact on Blood Parameters in Nasal Polyposis: 18-Month Follow-Up in Real Life.

Background: Dupilumab represents the first approved biological for severe uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP). Objective: Aim of this paper is to provide a multicentric real-life study about treatment with dupilumab for CRSwNP with a special focus on blood parameters and IgE, IgG, and IgA. Method: A retrospective data collection was jointly conducted at the Otolaryngology departments of San Camillo Forlanini Hospital and University of Rome "La Sapienza" from December 2020 to January 2023. Results: A total of 130 patients were included in the study. Monitoring our patients for 18 months, we observed a reduction in nasal polyposis and an improvement in symptoms and their impact on quality of life. Regarding blood tests, a transient increase in blood eosinophils was found in most cases. Total IgE showed a gradual decrease in values. IgG and IgA also showed a slight reduction of values, while remaining within normal ranges. Conclusion: To the best of our knowledge, this is the first study to evaluate the impact of dupilumab on several blood parameters in patients receiving treatment for CRswNP. Further studies are needed to confirm our results and to understand the underlying immunological mechanisms.

Diagnostic and Therapeutic Strategy for Vagal Schwannoma: Case Series and Literature Review.

Background and Objectives: Clinical management of vagal schwannoma is a real diagnostic and therapeutic challenge because the medical history and clinical examination are often non-specific and vagal nerve injury following surgical resection still represents an unsolved problem. The aim of this paper is to provide a case series along with a diagnostic and therapeutic algorithm for vagal schwannoma of the head and neck, combining our experience with clinical evidence available in the literature. Materials and Methods: We retrospectively analyzed a series of patients affected by vagal schwannoma who were treated between 2000 and 2020. In addition, a review of the literature on vagal schwannoma management was conducted. Based on the cases described and the literature review, we made a diagnostic and therapeutic algorithm for the management of vagal schwannoma. Results: We were able to identify 10 patients affected by vagal schwannoma and treated between 2000 and 2020. All patients presented with a painless, mobile, slow-growing lateral neck mass with onset varying from a few months to years. The preoperative diagnostic workup included ultrasound (US) in nine cases, computed tomography (CT) with contrast in six patients and magnetic resonance imaging (MRI) of the neck in seven cases. All patients included in this study were surgically treated. Conclusions: Vagal schwannoma management represents a true challenge for clinicians and surgery is currently the most effective therapeutic strategy. A multidisciplinary approach through the collaboration of otolaryngologist with other specialists is desirable to develop a tailored treatment plan for the patient.

Practical recommendations for managing severe chronic rhinosinusitis with nasal polyps in the era of biologics.

Objective: We conducted a national survey to understand how rhinology practice has changed with the advent of biologics and how this affected patients with uncontrolled, severe chronic rhinosinusitis with nasal polyps (CRSwNP). We aimed to analyse the results of the survey and infer practical recommendations for clinical practice. Methods: A group of ear, nose, and throat specialists (ENTs) experienced in the management of CRSwNP developed a 74-question survey. ENTs from rhinology centres authorised to prescribe biologics in the context of the national health system were invited to answer it between 01/05/2022 and 31/07/2022. The responses underwent descriptive analyses, and the authors discussed the results and derived practical recommendations for clinical practice. Results: ENTs working in rhinology centres changed their practices coinciding with the advent of biologics. CRSwNP evaluations have become more complex because they involve diagnostic confirmation, determining the patients' immunologic profile, and other factors. We observed heterogenous behaviours in practice that may be conditioned by the novelty of the topic. The results of the survey were used to develop practical recommendations for ENTs and are summarised herein. Conclusions: Clinical practice in rhinology outpatient clinics has changed profoundly in the era of biologics. Our practical recommendations for clinicians working in rhinology centres are expected to help standardise practice and improve care.

External Auditory Canal Cholesteatoma after Radiation Therapy for Nasopharyngeal Cancer: Case Series and Systematic Review.

The authors performed a systematic review, in accordance with the PRISMA guidelines, across multiple databases, including all original studies published until November 2022, focusing on External auditory canal cholesteatoma (EACC) after radiation therapy (RT) for nasopharyngeal cancer (NC). Inclusion criteria were original articles reporting on secondary EACC after RT for NC. Articles were critically appraised to assess level of evidence using the Oxford Center for Evidence-Based Medicine criteria. Overall, 138 papers were identified and after duplicate removal (34 papers) and excluding papers not in English, 93 papers were assessed for eligibility; finally, only five papers were included and summarized with the three cases coming from our institution. These mainly involved the anterior and the inferior part of the EAC. The mean time of diagnosis after RT was the largest series of 6.5 years (with a range from 0.5 to 15.4 years). Patients undergoing RT for NC have 18 times a higher risk of developing EACC compared to the normal population. EACC is probably one of the most underreported side effects, because patients may present variable clinical findings, which could lead to misdiagnosis. Early diagnosis of RT related EACC is advised to enable conservative treatment.

A Practical Clinical Protocol for Monitoring Patients with Severe Uncontrolled Chronic Rhinosinusitis with Nasal Polyposis Treated with Biologics.

OBJECTIVES: Chronic rhinosinusitis with nasal polyposis (CRSwNP) is a pathological condition which leads to high healthcare-related costs and low quality of life for patients. The introduction of new biological therapies (monoclonal antibodies, MAbs) in CRSwNP patients has allowed new therapeutic options for non-responders to conventional therapies and Dupilumab represents the first approved biological agent. The aim of this paper is to provide a practical clinical multidisciplinary protocol which might help clinicians involved in this field to monitor the clinical outcomes. METHODS: Our centre of Rhinology and Rhino-Allergology has developed a dedicated collection form to observe the outcomes of patients treated with Dupilumab. Our research started from the indications given in EPOS 2020 as main reference. We then implemented these references in an electronic database trying to apply Evidence Based Medicine (EBM) in current clinical practice. RESULTS: The result consists of three parts: an anamnestic collection data, a clinician reported outcome and two patient reported outcomes (PROMs) questionnaire, the visual analogue scale (VAS) and the Sino-Nasal Outcome Test-22 (SNOT-22). The tables we propose should provide an adequate correlation with the patients' adherence to therapy and their treatment outcomes. Such periodical evaluation (after a month, after 3 months, after 6 months and at one year) should quickly allow to monitor if the patient is correctly assuming the therapy and the eventual objective improvements. CONCLUSIONS: We propose a practical monitoring protocol formulated to analyse both objective and subjective aspects of patients with severe uncontrolled CRSwNP treated with MAbs, thus helping to define in future a better comparison between the clinical results of different institutes.

Foreign bodies in the pediatric age: the experience of an Italian tertiary care hospital.

Foreign bodies in pediatric age represent an extremely frequent pathological condition and can undergo fearsome complications. Within the ENT area, foreign bodies in the pediatric age can be found in various districts such as external auditory canal, nasal passages, oral cavity, pharynx, larynx and trachea. They can be various and shape; generally, the main ones are buttons, beads, small parts of toys, caps of pens, pebbles, fragments of food bolus and others. As described in the literature, the main localizations are the external auditory canal and nasal cavities. Laryngeal and tracheal localization is infrequent but can be fatal. The aspiration of foreign bodies, mainly small parts of toys, occurs more frequently under three years age and mainly-especially in males. The experience of the ENT Department of the San Camillo-Forlanini Hospital in Rome, in the period between January 2007 and December 2018, consists a total of 1443 patients, aged between 0 and 14, who arrived in the emergency room with a foreign body diagnosis; of these, 613 (42.5%) were found with foreign body in the external auditory canal, 458 (31.7%) in nasal fossa, 298 (20.5%) in pharynx, 64 (4.4%) in oropharynx, and 10 (0.7%) in larynx and trachea. Treatment was in 1255 (87%) removal in the emergency room and home discharge, 79 (5.4%) with outpatient discharge, 40 (2.7%) need for hospitalization and surgery, 64 (4.4 %) refusal of hospitalization and 1 case (0.07%) died in the emergency room.

Middle Ear and Mastoid Diseases: Literature Review and New Classification Proposal.

There are many classifications for cholesteatomatous otitis media but none correspond exactly to the formulation of a surgical protocol for the middle ear and mastoid nor are any specific for the extension of the otitis media, making it difficult to interpret the published results.  All the available classifications are limited to the cholesteatoma and, moreover, the variety of the reported studies in literature does not allow a standardization to define middle ear pathology and surgical procedures.  The aim of this paper is to propose a novel staging system for middle ear diseases paying attention to the involvement of tympanic Cavity (C), Attic (A), and Mastoid (M): the CAM classification. In particular, CAM classification is composed of three symbols (0 / + / ρ) and two letters (t and m, tiny and ivory mastoid cases) related to the alphabetic initial of the macroscopic region, being able to allow a clear and specific description of the local situation. Moreover, the possibility to describe the temporal bone and the potential use of sub-groups to specifically define the involvement of the tympanic cavity and the attic could allow the creation of a common otologic language among all the different centres.

A rare case report of a typical variant ossifying fibromyxoid tumor (OFMT), located in the retroauricular perimastoid region.

INTRODUCTION: Ossifying fibromixoid tumor of soft parts (OFMT) is a rare soft tissue and bone tumor. In its classic form, is considered benign, nevertheless aggressive clinical behaviour tumors with a different cytoarchitectural features of a malignant variant, have been described.The classification contains "typical", "atypical" and "malignant" variants. METHODS: A CT ear scan without contrast enhancement was carried out (October 2015), with coronal, sagittal and 3D reconstructions. It was decided the removal of the neoformation with a simple dissection. RESULTS: In this report, we present a case of a typical variant OFMT localized in the retroauricular perimastoid region, with mastoid bone cortex not involved. CONCLUSIONS: Considering the extreme rarity of this "enigmatic" tumor which displays an uncertain line of differentiation, renders the differential diagnosis a true challenge.

Is Electrocochleography Still Helpful in Early Diagnosis of Meniere Disease?

BACKGROUND AND OBJECTIVES: Despite the extensive research for the Meniere's disease (MD), it's pathophysiology still remains uncertain and questionable among scientists. Clinical symptoms and audiometric tests form the basis for the diagnosis. Nevertheless the differential diagnosis can be extremely challenging, due to subjective and not specific results. Incorrect diagnosis is most likely and for this reason there is a great demand for objective and reliable tests. SUBJECTS AND METHODS: The presence of endolymphatic hydrops is necessary condition but non enough for the diagnosis. In this study we analyze retrospectively the summating potentials (SP)/action protentials (AP) ratio from peritympanic electrocochleography in 34 patients,divided in two groups (13 patients classified as defined MD and 21 patients classified as probable MD). The purpose was to identify the utility of the exam so to be able to achieve an early defined diagnosis. Furthermore our intention was to obtain an objective test, besides the clinical criteria currently in use for the diagnosis and the classification of the MD. RESULTS: The analysis of the SP/AP results shows high predictability for the MD (positive in six out of seven cases with a sensitivity greater than 80%). CONCLUSIONS: Our study demonstrates a satisfactory sensibility percentage in recurrent defined MD presentation (>80%). Early identification of MD can lead to an early treatment and control of the progression of the disease. Furthermore it could be a valuable instrument for the follow up and evaluation of the patients classified as probable MD in accordance with the criteria of the American Academy of Otolaryngology-Head and Neck Surgery (1995).

Lipoma of Piriform Sinus: A Case Report and Review of the Literature.

The lipomas of oropharynx, hypopharynx, and larynx are so rare that up to now approximately there have been 100 cases reported. The lipomas are slow-growing lesions that are capable of reaching considerable dimensions and are often detected at a late stage. The symptoms can vary both in dimension and in location, semiobstructing the aerodigestive tract or exerting compression on adjacent structure. In this case, the lesion, which originated from the piriform sinus, was removed endoscopically urgently due to obvious signs of tissue suffering caused by stretching of the pedicle as a result of displacement of the mass. The two aims of this case report are to expose an interesting and rare case study mainly for an Emergency Room Specialist and an ENT (Ear, Nose, and Throat) Specialist involved in solving the problem and to demonstrate that the choice of an endoscopic approach is useful in order to have an optimal visualization of the lesion and to perform a total eradication. The use of endoscopic devices also allows a rapid postoperative recovery, compared to external access and optimum locoregional control in the follow-up procedures to prevent possible relapses.

Helical tomotherapy: an innovative radiotherapy technique for the treatment of locally advanced oropharynx and inoperable oral cavity carcinoma.

BACKGROUND: To report our initial clinical experience of helical tomotherapy (HT) in the treatment of locally advanced oropharynx and inoperable oral cavity cancer. METHODS: Between February 2008 and January 2011, 24 consecutive patients, 15 with oropharyngeal cancer and 9 with oral cavity cancer were treated with exclusive radiotherapy or concomitant chemoradiotherapy. Simultaneous integrated boost (SIB) in 30 fractions scheme was prescribed to all patients, using Helical Tomotherapy. Doses administered to primary tumor, oropharynx/oral cavity and positive lymph-nodes and negative lymph-nodes were 66-67.5 Gy, 60-63 Gy and 54 Gy, respectively. RESULTS: Complete response rate for the oropharynx and the oral cavity group was 86.7% and 77.8%, respectively. The 1 and 2-year Overall Survival (OS) and Disease Free Survival (DFS) rate for the oropharynx group was 92.9%, 85.1%, 92.9% and 77.4% respectively. For the oral cavity group, 1 and 2-year OS and DFS rates were 55.6%, 55.6%, 75% and 75%, respectively. No patient developed grade ≥3 mucositis, dysphagia or dermatitis. The maximum late-toxicity grade observed was 2, for all the variables examined. CONCLUSIONS: HT appears to achieve encouraging clinical outcomes in terms of response, survival and toxicity rates.